Advanced Search

Notice Of Board Of Health's Tasks In Connection With Different Application Procedures, Cooperation Procedures On Pharmacovigilance And The Procedures For Arbitration Proceedings

Original Language Title: Bekendtgørelse om Sundhedsstyrelsens opgaver i forbindelse med forskellige ansøgningsprocedurer, samarbejdsprocedurerne om lægemiddelovervågning og procedurerne for voldgiftssager

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
Table of Contents
Appendix 1 PARLIAMENT OF THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2001 /83/EF
Appendix 2 PARLIAMENT OF THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2001 /82/EF

Publication of the tasks of the Board of Health in the context of various application procedures, cooperation procedures for the pharmacovigilance and the procedures for arbitration proceedings 1)

In accordance with section 9 (4), 3, section 17, paragraph. 3, section 34, no. 5 and 6, and section 56 (3). ONE, TWO. pkt., in Law No 1180 of 12. In December 2005 on medicinal products, as amended by law no. 605 by 18. June 2012 shall be determined :

§ 1. The announcement shall implement the procedural aspects of Directive 2001 /83/EC of the European Parliament and of the Council establishing a Community code of medicinal products for human use, as amended by the European Parliament and Council Directive 2010 /84/EU, and Directive 2011 /62/EC of the European Parliament and of the Council, and of Directive 2001 /82/EC of the European Parliament and of the Council, on the establishment of a Community code of veterinary medicinal products, as amended by Regulation (EC) No No later by the European Parliament and of the Council. 596/2009.

Paragraph 2. Depreciation of Directive 2001 /83/EC of the European Parliament and of the Council on the establishment of a Community code on medicinal products for human use, as amended by the European Parliament and Council Directive 2010 /84/EU and the Council of the European Parliament and of the Council Directive 2011 /62/EC shall be included in Annex 1 to this notice.

Paragraph 3. A summary of the Directive 2001 /82/EC of the European Parliament and of the Council on the establishment of a Community code of veterinary medicinal products, as amended by Regulation (EC) No No later by the European Parliament and of the Council. 596/2009 is included in Annex 2 to this notice.

§ 2. Whereas the Board of Health is competent, in accordance with Directive 2001 /83/EC of the European Parliament and of the Council, establishing a Community code of medicinal products for human use, as amended by the European Parliament and Council Directive 2010 /84/EU, and Directive 2011 /62/EC of the European Parliament and of the Council

§ 3. The Board of Health shall be competent, in accordance with Directive 2001 /82/EC of the European Parliament and of the Council, establishing a Community code of veterinary medicinal products, as amended by Regulation (EC) No No later by the European Parliament and of the Council. 596/2009.

Paragraph 2. On the Articles 10, 11, 66, paragraph 1. However, 3 and 37 of the Annex 2 of the notice shall not be competent to the Board of Health.

Paragraph 3. in the case of Article 66 (1), The competent authority for the supply and sale of medicinal products by veterinary surgests shall be divided between the Board of Appeal and of the Food and Food Authority of the Executive Order of Annex 2.

§ 4. The announcement shall enter into force on 3. August 2012.

Paragraph 2. Publication no. 476 of 24. May 2006 on the tasks of the Medicinal Products for the various application procedures shall be repealed.

The Ministry of Health and Prevention, the 1. August 2012

Astrid Krag

-Dorthe Eberhardt Søndergaard


Appendix 1

PARLIAMENT OF THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2001 /83/EF

of 6. November 2001

establishing a Community code of medicinal products for human use,

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION HAVE

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee 1) ,

After the procedure laid down in Article 251 of 2) , and

in the following considerations :

(1) Council Directive 65 /65/EEC of 26. January 1965 on the approximation of legislation on medical specialities 3) , Council Directive 75 /318/EEC of 20. May 1975 on the approximation of the laws and regulations of the Member States relating to analytical, toxicology-pharmacological and clinical studies of medical specialities ; 4) , Council Directive 75 /319/EEC of 20. May 1975 on the approximation of legislation on medical specialities 5) , Council Directive 89 /342/EEC of 3. May 1989 on the extension of the scope of Directive 65 /65/EEC and 75 /319/EEC and laying down additional provisions relating to immunological medicinal products in the form of vaccines, toxins, sera and allergens 6) , Council Directive 89 /343/EEC of 3. May 1989 on the extension of the scope of Directive 65 /65/EEC and 75 /319/EEC and the fixing of suppreed provisions on radioactive medicinal products ; 7) , Council Directive 89 /381/EEC of 14. June 1989 on the extension of the scope of Directive 65 /65/EEC and 75 /319/EEC on the approximation of laws relating to pharmaceutical specialities and laying down special provisions for medicinal products derived from human blood or plasma ; 8) , Council Directive 92 /25/EEC of 31. March 1992 on the wholesbial debate on medicinal products for human use 9) , Council Directive 92 /26/EEC of 31. March 1992 on the classification of the supply of medicinal products for human use. 10) , Council Directive 92 /27/EEC of 31. March 1992 on the labelling and package leaflets for medicinal products for human use 11) , Council Directive 92 /28/EEC of 31. March 1992 on the advertising of medicinal products for human use 12) and Council Directive 92 /73/EEC of 22. September 1992 on the extension of the scope of Directive 65 /65/EEC and 75 /319/EEC on the approximation of legislation on pharmaceutical preparations and laying down additional provisions for homeopathic medicinal products ; 13) have, on several occasions, been subject to extensive changes. The directives should therefore be codified and assembled in a single text so that their provisions can be clearly and rationalised.

(2) All provisions concerning the manufacture, distribution and use of medicinal products must be of primary purpose to protect public health.

(3) This objective must, however, be achieved by means of funds that cannot hinder the development of the pharmaceutical industry and the trade in medicinal products within the Community.

(4) The differences between certain Member States ' provisions, in particular between the provisions on medicinal products, do not include substances and composition of substances which serve as food, animal nutrition or cosmetic products, seem inhibitory to the provisions of the medicinal products concerned ; the trade in medicinal products within the Community and thus has an immediate effect on the functioning of the internal market.

(5) It is therefore important that these obstacles be removed, and for this purpose an approximation of the provisions in question is necessary.

(6) In order to offset the remaining differences, provisions on the control of medicinal products and details should be laid down for the tasks of the competent authorities of the Member States to ensure compliance with the regulations.

(7) The concepts of harmfulness and therapeutic effects can only be assessed in relation to one another and only have a relative significance, taking into account the level of scientific knowledge and the need for which the medicinal product is to be used. The documentation and the information to be attached to the marketing authorisation application shall demonstrate that the benefits associated with the effectiveness outweigh the potential risks.

(8) Standard procedure for carrying out experiments with medicinal products, which is an effective means of monitoring these and, therefore, for the protection of public health, may facilitate the transposition of medicinal products if common rules are established therein ; in the form of the tests, particulars and documents of the documents and the processing of applications.

(9) Experience has shown that it would be fair to specify even more clearly the cases in which it is not necessary to produce results of toxicological, pharmacological or clinical trials for the marketing of a medicinal products which, in the main, are equivalent to a medicinal product, which should, however, be avoided in order to prevent product development from being put into an unfavourable situation.

(10) It is a general requirement that testing on humans or animals should not be repeated unless it is imperative.

(11) The adoption by the Member States of the same standards and regulations will enable the competent authorities to make a statement on the basis of uniform tests and on the basis of common criteria and will thus contribute to the prevention of differences in : the assessment.

(12) With the exception of medicinal products falling within the centralised authorisation procedure by the Community, established by Council Regulation (EEC) No 2 ; 2309/93 of 22. July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary medicinal products and the establishment of a European Medicinal Agency for Medicinal Products ; 14) it should be authorised to place a medicinal product placed on the market of a medicinal product issued by a competent authority of a Member State by the competent authority of the other Member States, except where there is a weighty reason to assume that the approval of the medicinal product concerned should be accepted ; could pose a threat to health. If there is a difference of opinion between Member States on the quality, safety or effic of a medicinal product, a scientific assessment of the issue at Community level should be carried out and the scientific assessment must lead to a single decision ; on the question of the dispute, which must be binding on the Member States concerned. The decision should be adopted by means of a rapid procedure that ensures close cooperation between the Commission and the Member States.

(13) For this purpose, a Committee for Medicinal Products for Medicinal Products should be set up under the European Medicines Evaluation Agency established by the above Regulation (EEC) No 2. 2309/93.

(14) This directive is an important stage in the implementation of the objective of the free movement of medicinal products. However, it may prove necessary, depending on the experience gained and, in particular in the abovementioned committee, for medical specialities, to be able to take new measures in order to abolish yet existing barriers to free movement.

(15) In order to protect public health better and avoid unnecessary duplication of the treatment of applications for marketing authorisations for medicinal products, Member States should systematically prepare evaluation reports for each medicinal product, approves and, on request, exchange these reports. A Member State should also be able to suspend the examination of an application for marketing authorisation, which is for treatment in another Member State, in order to recognise the decision of the latter Member State.

(16) After the establishment of the internal market, specific controls on the quality of medicinal products imported from third countries may be waiving only if the Community has taken appropriate measures to ensure that the necessary checks are carried out ; the exporting country.

(17) It is necessary to adopt specific provisions on immunological, homeopathic, radioactive medicines, as well as for medicinal products derived from human blood or plasma.

(18) When determining the rules on radioactive medicinal products, the Council Directive 84 /466 / Euratom should be taken into account in the case of the 3. September 1984 laying down basic measures for the radiation protection of persons undergoing medical examinations and treatments 15) The Council Directive 80 /836 / Euratom of 15 should also be taken into account. July 1980 amending to the Directives establishing basic standards for the protection of the health of workers and workers against the hazards associated with ionizing radiation 16) for the purpose of preventing the exposure of workers or patients to the overdose of ionizing radiation, and in particular Article 5 (c), prior authorisation for the addition of radioactive substances in the manufacture of medicinal products and the import of such medicinal products.

(19) The Community fully supports the efforts of the Council of Europe to promote voluntary and unpaid donation of blood and plasma for the purpose of the Community ' s self-sufficiency in blood products and to ensure compliance with the ethical principles of trade ; with therapeutic substances of human origin.

(20) Provisions intended to guarantee the quality, safety and efficacy of medicinal products derived from human blood and human plasma shall apply equally to public and private establishments, as well as on blood and plasma ; imported from third countries.

(21) In view of the special characteristics of homeopathic medicinal products, such as their weak concentration of the active components and the difficulty of using the traditional statistical methodology for them, one should be introduced ; a simplified registration scheme for homeopathic medicinal products placed on the market without therapeutic indication and in an pharmaceutical form and a dosage which does not pose a risk to the patient.

(22) Anthroposoc medicinal products, described in an official pharmacopoeia and produced according to a homeopathic manufacturing method, may be treated as equivalent to homeopathic medicinal products.

(23) First of all, the users of homeopathic medicinal products should clearly be informed that these are homeopathic medicinal products, just as they should have sufficient certainty for their quality and harmlessness.

(24) The provisions on the production and supervision and supervision of homeopathic medicinal products should be harmonized in order to permit the placing on the market throughout the Community of safe medicinal products of good quality.

(25) For homeopathic medicinal products placed on the market with information on therapeutic effects or in a form which may present risks related to the expected therapeutic effect, the usual rules for the placing on the market of medicinal products are used In particular, Member States with a tradition of homeopathy should be able to use special rules for evaluating the test results in order to determine the safety and efficacy of these medicinal products, provided that the Commission is informed of : these rules.

(26) In order to facilitate the free movement of medicinal products and avoid the repeated application of checks carried out in one Member State in another Member State, the minimum requirements for the production and entry from third countries and the issuing of it must be laid down in the Member State concerned ; Permission.

(27) It is important that the monitoring and control of the manufacture of medicinal products in the Member States is carried out by a person who satisfies certain minimum qualification requirements.

(28) Before issuing a permit for the placing on the market of an immunological medicinal product or a medicinal product derived from human blood or human plasma, the manufacturer must prove that he is constantly in a position to guarantee uniformity. the parties. In addition, as regards medicinal products derived from human blood or human plasma, he must also, to the extent that the technology level makes it possible, prove that there is no specific viral contamination.

(29) The conditions governing the supply of medicinal products to consumers should be harmonised.

(30) In this respect, travellers within the Community have the right to produce a reasonable amount of medicinal products which they have obtained legally for personal use. It must also be possible for a person residing in a Member State to obtain a reasonable amount of medicinal products for personal use from another Member State.

(31) Furthermore, Regulation (EC) No 2 is required. 2309/93 for some medicinal products a Community marketing authorisation. In this respect, a classification should be laid down for the supply of medicinal products for which such marketing authorization should be available. Consequently, criteria should be laid down which must be taken into account for the decisions to be taken by the Community.

(32) Therefore, as a first step, harmonisation of the principles to be laid down for the classification in relation to the supply of medicinal products in the Community or in the Member State concerned shall be based on the principles which are : have already been laid down in this area of the Council of Europe, as well as in the process of harmonisation carried out by the United Nations in the case of drugs and psychotropic substances.

(33) The provisions relating to the classification in relation to the supply of medicinal products shall not affect the provisions of the Member States ' social security systems for reimbursement or payment for prescription medicinal products.

(34) Many activities in connection with the wholes-use of medicinal products for human use will be able to cover several Member States simultaneously.

(35) The entire distribution chain, from the manufacture or the introduction of medicinal products into the Community for their extradition to the consumer, should be subject to control so as to ensure that the medicinal products are stored, transported and handled in comfort ; relationships. The provisions to be adopted for this purpose will make it considerably easier to withdraw defective products from the market and will open up the possibility of a more effective fight against counterfeiting.

(36) Anyone who operates wholes-use with medicinal products should be in possession of a special permit. However, this requirement should not include pharmacists and persons authorised to supply medicinal products to the consumer, who carry out this task only. However, in the interests of the control of the pharmaceutical distribution chain, it is necessary that pharmacists and persons empowered to supply medicinal products to the consumer keep records of the goods entered into.

(37) The authorisation should apply to certain basic requirements where compliance is borne by the Member State in checking. Each Member State must recognise authorisations issued by the other Member States.

(38) Certain Member States are imposing wholesalers who supply medicinal products to pharmacists and persons authorised to supply medicinal products to consumers, certain obligations to public service. Member States should be able to apply these obligations to wholesalers established in their territory. They should also be able to apply them to wholesalers in the other Member States, provided they do not impose more stringent obligations than those imposed on their own wholesalers and to the extent to which they may be justified in the protection of public health and the state of the public, in relation to the objective of this protection.

(39) The provisions on the manner in which the labelling is to be carried out and the manner in which the package leaflet should be specified should be specified.

(40) The provisions on patient information should ensure a high level of protection for consumers, in order to allow them to use medicinal products correctly on the basis of a complete and comprehensible information.

(41) The placing on the market of medicinal products whose labelling and package leaflet has been drawn up in accordance with this Directive should not be prohibited or prevented only under the reference to their labelling or package leaflet.

(42) The present Directive should not affect the implementation of the measures taken in accordance with Council Directive 84 /450/EEC of 10. September 1984 on the approximation of the laws, regulations and administrative provisions of Member States concerning misleading advertising 17) .

(43) All the Member States have also adopted specific measures for the advertising of medicinal products. These measures differ from one Member State to another. Differences have an impact on the functioning of the internal market, since the advertising that is sent out in one Member State may produce effects in the other Member States.

(44) Council Directive 89 /552/EEC of 3. October 1989 on the coordination of certain laws, regulations and administrative provisions in the Member States concerning the exercise of television broadcasting activities ; 18) prohibit television advertising for medicinal products subject to prescription in the Member State under whose jurisdiction the television broadcaster shall be the responsibility of the broadcaster. This principle should also apply to other media.

(45) Public advertisements for non-prescription medicines will, if they are excessive and not sufficiently thought out, might affect public health. In so far as such advertisements are permitted, they should therefore comply with certain essential criteria to be determined.

(46) For the rest, free distribution of samples for advertising to the public should be prohibited.

(47) Pharmaceuticals, who are designed for persons empowered to prescribe or extradict medicinal products, contribute to providing information to these persons. Such advertising should, however, be subject to strict conditions and an effective control on the basis of another in the work carried out within the framework of the Council of Europe.

(48) Advertising of medicinal products should be subject to adequate and effective control. In this context, it would be appropriate to allow the control mechanisms introduced by Directive 84 /450/EEC to serve as a model.

(49) Medicines consultants play an important role in the promotion of the sale of medicinal products. It is therefore necessary to impose certain obligations on them, including an obligation to give the person who visits, a summary of the product characteristics.

(50) Those who have the authority to prescribe medicinal products must be able to perform this task in full objectively without being influenced by direct or indirect economic incentives.

(51) Free pharmaceutical tests may be extradited under certain restrictive conditions to persons empowered to prescribe or supply medicinal products so that they can be acquainted with the new medicinal products and have a certain experience in the use of : them.

(52) Those who have the authority to prescribe or supply medicinal products must have access to neutral and objective information on the medicinal products available on the market, yet the responsibility of the Member States is to be taken, measures in such a way, depending on their particular situation.

(53) Each undertaking, which produces or imports medicinal products, should establish a system to ensure that all information provided on a medicinal product is in accordance with the conditions approved for its use.

(54) In order to guarantee that it is safe to continue to use medicinal products, it is necessary to ensure that the pharmacovigilance systems in the Community are continually adapted to take account of scientific and technical progress.

(55) It is necessary to take account of changes that are the result of international harmonisation of definitions, terminology and technological development in the field of pharmacovigilance.

(56) The increasing use of electronic networks for the transmission of information on adverse reactions to medicinal products placed on the market in the Community is intended to provide the competent authorities with the possibility of having the data at the same time.

(57) It is in the Community's interest to ensure that there is consistency between the monitoring systems of centrally approved medicinal products and the monitoring systems for medicinal products approved by other procedures.

(58) Economic marketing authorisations should be actively responsible for the ongoing pharmacovigilance of the medicinal products they are placing on the market.

(59) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999 /468/EC of 28. in June 1999 laying down the procedures for the exercise of implementing rules conferred on the Commission (19) .

(60) The Commission should be empowered to adopt the necessary amendments in Annex I, in order to adapt it to scientific and technical progress.

(61) This Directive should not affect the obligations of the Member States in respect of the deadlines for transposition of the Directives listed in Annex II, Part B ;

ISSUED THE FOLLOWING DIRECTIVE :

SECTIONS IN

DEFINITIONS

ARTICLE 1

For the purposes of this Directive :

1) (The case).

2) Medicinal Medium :

-WHAT? Any substance or combination of substances presented as a suitable means of treatment or the prevention of disease in humans ;

or

-WHAT? Any substance or combination of substances which may be used in or given to people for the purpose of either re-establishing, altering or influencing physiological functions by exercising a pharmacological, immunological or metabolic effect, or to make a medical diagnosis.

3) Stof :

any substance, irrespective of its origin, as this may be :

-WHAT? human, such as :

human blood and human blood preparations.

-WHAT? animal, such as :

micro-organisms, whole animals, parts of bodies, animal sects, toxins, extracts extracted by extraction, blood preparations ;

-WHAT? vegetable, for example :

micro-organisms, plants, parts of plants, plant varieties, extracts extracted from the extraction ;

-WHAT? chemical, as for example :

basic substances, natural chemical substances, and chemical preparations, obtained by conversion or synthesis.

3a) Active substance :

any substance or combination of substances intended to be used in the manufacture of a medicinal product and which, by entering its production, becomes an active ingredient of the medicinal product concerned to carry out a pharmacological, immunological or the metabolical effect of re-establishing, altering or influencing physiological functions, or to provide a medical diagnosis.

3b Utias :

any ingredient of a medicinal product other than the active substance and the packaging materials.

4) Immunological medicinal product :

any medicinal product in the form of vaccines, toxins, sera or allergens :

-WHAT? vaccines, toxins or sera shall comprise in particular :

In. means which are used to evoke active immunity, such as cholera vaccine, BCG, vaccine against poliomyelitis and smallpox vaccine ;

(ii) means used for the diagnosis of immunities, such as tuberculin, and PPD tuberculin, toxins used for Schick and Dick samples and brucellin ;

iii. means which are used to evoke a passive immunity, such as diphtherian antitoxin, anti-smallpox, and antilyfocytic globulin.

b. ' allergenic preparation ` means a medicinal product intended to demonstrate or convene a specific acquired change in the immunological reaction to a allergenic substance.

4a) Advanced therapy medicinal product :

a product as defined in Article 2 of the Regulation (EC) No 2 of the European Parliament and of the Council. 1394/2007 of 13. November 2007 on medicinal products for advanced therapy 20) .

5) Homeopathic medicinal product :

A medicinal product obtained from substances called homeopathic tribes, following a homeopathic manufacturing method described in the European Pharmacopoeia, or in the absence thereof, in the pharmacopoeias currently in the official status of the Member States. A homeopathic medicinal product may contain several active substances.

6) Radioactive medicinal product :

any medicinal product which in use contains one or more radionuclides (radioactive isotopes) which are intended for medical purposes.

7) Radionucleid generator :

any system comprehensive a attached mother radionucliid from which a subsidiary radionucleid is produced, which shall be released by eluent or other method and used in a radiomedicinal product.

8) Kit :

any preparation to be reconstituted or combined with radionuclides in the finished radioactive medicinal product, usually prior to its intake.

9) Radionucleid-precursor :

any other radionuclides for radiological labelling of a different substance prior to its intake.

10) Medicinal products derived from blood or plasma from human beings :

medicinal products which are manufactured by public or private companies on the basis of blood components ; these medicinal products in particular concern albumin, coagulating factors and immunoglobulins of human origin.

11) Side effect :

a malicious and unintended response to a medicinal product.

12) Serious adverse reaction : :

a side effect which is lethal, life-threatening requires hospitalisation or prolongation of invalidity or invalidity or invalidity, resulting in permanent or invalidity or incapacity, or which is a congenital anomaly ; or Lamaze.

13) Unexpected side effect :

a side effect whose nature, severity or outcome is not mentioned in the summary of the product characteristics.

14) (Exgo).

15) Post-authorisation security study :

any examination of an approved medicinal product which is carried out in order to identify, characterize or quantify a security risk, confirm the safety profile of the medicinal product or measure the effectiveness of risk management measures.

16) Abuse of medicinal products :

Persidic or sporadic, intentionally excessive use of medicinal products, accompanied by harmful physical or psychological effects.

17) Wholessnegotiation of medicinal products :

any undertaking which consists of taking, storing, supplying or carrying out medicinal products with the exception of the supply of medicinal products to consumers ; this activity is carried out with manufacturers or their depositaries, importers, other wholesalers, or with pharmacists and persons authorised or authorised to supply medicinal products to consumers in the Member State concerned.

17a) Dissemination of medicinal products :

any undertaking relating to the sale or purchase of medicinal products, except for wholesale proceedings, which do not include physical handling and which are to negotiate independently and on behalf of a different legal or physical person.

18) Obligation to public service :

the obligation imposed on the wholesalers concerned, to ensure the continuous guarantee of a selection of medicinal products which meet the needs of a particular geographical area and to ensure the delivery of the products requested by a very short ; the period within which the whole area is concerned.

18a) Representatives of the marketing authorization holder :

The person commonly referred to as the local representative designated by the marketing authorization holder to represent this person in the Member State concerned.

(19) Prescript

a prescription for medicinal products issued by a health expert which is empowered to do so.

20) Name of the medicinal product :

A name that may be either a distinguished name that must not be confused with the common name or a common name or a scientific designation in the context of a trademark or the name of the marketing authorization holder.

21) Common name :

the international community name recommended by the World Health Organisation, or, where such a non-existence is not the common name.

(22) The strength of the medicinal product :

the content of the active substances expressed in quantities per year ; Dosiunit, space-catches or weight unit shall all be presented in presentation.

23) Inner packaging :

the vessel or any other form of packaging which is in direct contact with the medicinal product.

24) Outer packaging :

the packaging of the wrapping of the internal packaging.

25) Labelling :

the information provided on the internal or outer packaging.

26) (Does not concern the Danish version).

the package leaflet that contains information to the user and who is following the medicinal product.

27) Agency :

The European Medicines Agency established by Regulation (EC) No, 726/2004 21) .

28) Risk of the use of the medicinal product :

-WHAT? any risk linked to the quality, safety and effects of the medicinal product on the health or public health of the patient ;

-WHAT? any risk of undesirable effects on the environment.

28a) Relationship between benefits and risks :

An assessment of the positive therapeutic effects of the medicinal product relative to the risks described in paragraph 1. 28), first indent.

28B) Risk Management System :

a number of pharmaceutical monitoring activities and interventions intended to identify, characterize, prevent or minimise the risks of a medicinal product, including evaluation of the effectiveness of the activities and the ingreed agents.

28c) Risk management plan :

a detailed description of the risk management system.

28d) Mediation monitoring system :

a system authorized by the holder of a marketing authorisation and the Member States to carry out the tasks and responsibilities referred to in Section IX, which aim to monitor the safety of approved medicinal products and to demonstrate changes in the relationship between benefits and risks.

28e) Master file for the pharmacovigilance system :

a detailed description of the pharmacovigilance system used by the holder of the marketing authorization for one or more authorized medicinal products.

29) Traditional herbal medicinal product :

Any herbal medicinal product which satisfies the conditions laid down in Article 16a (1). 1.

(30) Deplanesium :

Any medicinal product which, as active components, contains only one or more drogues or herbal preparations or a composition of one or more of these drogues and one or more of these herbal preparations.

31) Droger :

All of the main, fragmented or toasted plants, parts of plants, algae, mushrooms or mosses, which are in the untreated-normally dried, but also fresh-form. Some ex-suers who have not undergone a special treatment are considered to be drogues. An exact definition of drogues shall include the plant part used and the botanical name provided by the binomial system (lineage, species, varietal and autor).

32) Droid Preparations :

Preparations made by treating drogues by means of extraction, distillation, extortion, cleaning, cleaning, cleaning, or fermentation. These include finded or pulverized drogues, tinctures, extracts, ethereal oils, press juices, and processed ex-suviors.

33) Falsished medicinal product :

Any medicinal product with an unreal description of :

-WHAT? its identity, including its packaging and labelling, its name or its composition, in respect of any ingredient, including formulants, and the strength of these constituents,

-WHAT? its origin, including its manufacturing, its manufacturing country, its country of origin, or the marketing authorization holder ; or

-WHAT? its history, including records and documents relating to the distribution ducts used.

This definition does not include unintended quality defects and does not affect infringements of intellectual property rights.

TITLE II

SCOPE OF APPLICATION

ARTICLE 2

This Directive shall apply to medicinal products for human use which shall be placed on the market in the Member States and either produced as industrial or in the use of an industrial process.

2. In case of doubt as to whether a product from a total assessment of its properties may be subject to the definition of medicinal product and the definition of a product falling under other Community legislation, this Directive shall apply.

Notwithstanding this paragraph, paragraph 1 shall be : Article 3 (1) and (3) Paragraph 4 of this Directive shall apply to the manufacture of medicinal products which are intended for export alone, and on intermediate products, active substances and formulants.

Paragraph 1 shall be without prejudice to Article 52b and 85a.

ARTICLE 3

This Directive shall not apply to :

1) medicinal products prepared in a pharmacy following the medical centre of a particular patient (commonly referred to as the magic of the medicinal products),

2) medicinal products prepared in a pharmacy in accordance with the requirements of a pharmacopoeia and intended for direct extradition to the customers of the pharmacist concerned (commonly referred to as official medicinal products) ;

3) medicinal products intended for research or development, subject, however, subject to the provisions of Directive 2001 /20/EC of the European Parliament and of the Council of 4. April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the application of good clinical practice through the conduct of clinical trials of medicinal products for human use ; (22) .

4) intermediate products intended for subsequent processing of an authorized manufacturing plant ;

5) radionuclides in the form of closed sources

6) the blood cells, plasma and blood cells of human origin, except for the plasma used in the use of an industrial process.

7) Advanced therapy medicinal products as defined in Regulation (EC) No, 1394/2007, which is not prepared on a routine basis according to specific quality standards and applied in the same Member State in a hospital on a doctor's sole responsibility to comply with an individual medical degree of view of a tailor-made medicinal product for a single patient.

Manufacture of such medicinal products must be approved by the competent authority of the Member State. Member States shall ensure that national requirements concerning traceability and pharmacovigilance and the specific quality standards referred to in this number correspond to those laid down at Community level in respect of advanced therapy medicinal products ; which authorisation is required under Regulation (EC) No 2 of the European Parliament and of the Council. 726/2004 by 31. March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary medicinal products and the establishment of a European Medicines Agency 23) .

ARTICLE 4

1. This Directive does not offer any derogations from the Community provisions concerning the radiation protection of persons undergoing medical examinations or treatments, or from the Community rules on the basic standards for the protection of : the health of workers and workers against the hazards associated with ionizing radiation.

2. This Directive shall be without prejudice to Council Decision 86 /346/EEC of 25. June 1986 on acceptance on behalf of the Community on behalf of the European Agreement on the exchange of therapeutic substances of human origin 24) .

The provisions of this Directive shall be without prejudice to the powers of the competent authorities of the Member States in relation to the fixing of the prices of medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of : health, economic and social conditions.

4. This Directive shall apply without prejudice to the application of national legislation prohibiting or restricting sales, the supply or use of medicinal products such as contraceptives or abortion-inducing agents. Member States shall communicate to the Commission the relevant national legislation.

5. This Directive and all the Regulations referred to herein shall be without prejudice to the application of national legislation prohibiting or restricting the use of special types of human or animal cells or the sale, supply or use of medicinal products, containing, consisting of or produced from such cells, for reasons not specified in the above Community legislation. Member States shall inform the Commission of the relevant national legislation. The Commission shall make this information publicly available in a register.

Article 5

1. a Member State may, in accordance with applicable law and in order to meet special needs, dispensers from the provisions of this Directive in respect of medicinal products issued in accordance with an order, delivered in good faith and unsolicited and produced in accordance with the instructions of health professionals, which have been added to their personal and direct responsibility to a particular patient.

2. Member States may temporarily authorize the extradition of an unauthorised medicinal product if or confirmation of the spread of pathogenic agents, toxins, chemical agents or nuclear radiation which may cause damage.

3. Without prejudice to the provisions of paragraph 1, Member States may lay down provisions to ensure that the holders of a marketing authorisation, promoters and health workers are not subject to the civil or administrative liability in respect of all the consequences that may be incurred ; by the use of a medicinal product outside of the approved indications or the use of an unauthorized medicinal product when such use is recommended or required by a competent authority in case of each suspect or confirmation of the spread of the disease ; the pathogenic agents, toxins, chemical agents or nuclear radiation which may cause, damage. These provisions shall apply regardless of whether a national or Community authorization has been issued.

4. Product liability in accordance with Council Directive 85 /374/EEC of 25. July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States relating to product liability 25) are not covered by paragraph 1. 3.

TITLE III

MARKETING

CHAPTER 1

Marketing Permission

ARTICLE 6

1. No medicinal product may be placed on the market in a Member State without the competent authority of this Member State to authorize the placing on the market pursuant to this Directive, or authorised thereto in accordance with Regulation (EC) No (EC) No (EC) No (EC) No (EC) No (EC) No Regulation (EC) No 726/2004, together with Regulation (EC) No, 1394/2007.

When a medicinal product has obtained a first marketing authorisation under the first subparagraph, any additional forces, medicinal products, management and package sizes, as well as all changes and extensions, shall also have a permit in : in accordance with the first subparagraph or subject to the original marketing authorization. All of these marketing authorisations shall be deemed to belong under the same comprehensive marketing authorisation, in particular with regard to the application of Article 10 (1). 1.

One a. The marketing authorization holder shall be responsible for the marketing of the medicinal product. The issuer of a representative shall not exempt the marketing authorization holder on his legal responsibility.

The second paragraph of paragraph 1. Paragraph 1 shall also be required for radio-nucleid-generators, kits and radionucleid-precursors of radio armaka, and industrial manufactured radioactive medicinal products.

Article 7

A marketing authorization is not required for radioactive medicinal products prepared at the time of use by a person or an institute which, in accordance with national law, is authorized to use such medicinal products in an approved authorization ; Medicare power. Equine. and which are using only permitted radionucliid-generators, kits, or radio-nucleic precursors in accordance with the manufacturer ' s instructions.

ARTICLE 8

1. In order to obtain a marketing authorisation which is not subject to a procedure established by Regulation (EEC) No 2, In the case of 2309/93, an application shall be submitted to the competent authority of the Member State concerned.

2. A marketing authorisation may be issued only to an applicant established in the Community.

3. The application shall be accompanied by the following particulars and documents presented in accordance with Annex I :

a) the name or business and place of residence or headquarters of the applicant and, where appropriate, for the manufacturer ;

b) Name of the medicinal product.

c) Qualitative and quantitative information on all constituents of the medicinal product, including the international common name (INN), recommended by the World Health Organisation if such a common name for the medicinal product exists or a reference to the chemical ; name (name).

ca) Evaluation of the risks to which the medicinal product may imply the environment. The impact must be assessed, and specific provisions must be introduced in specific cases to limit it.

d) the description of the manufacturing method,

(e) therapeutic indications, counterindications and adverse reactions ;

(f) dosage, pharmaceutical form, method of use, and assumed durability,

g) Indication of the precautionary and precautionary measures to be taken in the storage of the medicinal product when it is given to patients and on the disposal of waste products, together with an indication of potential environmental hazards at the medicinal product.

(h) Description of the control methods used by the manufacturer.

ha) A written confirmation that the manufacturer of the medicinal product is obtained by completing the audits, cf. Article 46,

Paragraph (f) has checked that the manufacturer of the active substance has complied with the principles and guidelines of good manufacturing practice. The written confirmation shall contain a reference to the date of the auditor and a declaration stating that the result of the audit confirms that the manufacture complies with the principles and guidelines of good manufacturing practice.

i) Results of :

-WHAT? Pharmaceutical (physico-chemical, biological or microbiological) tests

-WHAT? pre-clinical (toxicological and pharmacological) tests,

-WHAT? clinical trials.

(ia) a summary of the applicant ' s pharmacovigilance system, which contains the following elements :

-WHAT? proof of the fact that the applicant has a qualified person responsible for pharmacovigilance,

-WHAT? the name of the Member States in which the expert person is resident and carries out its work ;

-WHAT? the contact information of the expert ;

-WHAT? a statement signed by the applicant that he / she has the means to carry out the tasks and responsibilities referred to in Section IX ;

-WHAT? a reference to the place where the master file for the pharmacovigilance system is stored ;

iaa) the risk management plan which describes the risk-management system which the applicant will introduce to the medicinal product concerned and a summary thereof ;

ib) A statement that clinical trials carried out outside the EU comply with the ethical requirements of Directive 2001 /20/EC.

j) A product sume in accordance with Article 11 and a model of the outer packaging of the information referred to in Article 54 and of the internal packaging of the information referred to in Article 55, together with the package leaflet, in accordance with Article 55, 59.

c) a document stating that the manufacturer is authorized to manufacture medicinal products in his country of origin ;

I) resides of the following :

-WHAT? permit for the marketing of the medicinal product in another Member State or in a third country, a summary of the security data, including the information contained in the periodic, updated security reports, in which such reports are available ; and reports of suspected adverse reactions, together with a list of Member States in which an application for marketing authorisation has been submitted in accordance with this Directive is for treatment ;

-WHAT? the product summary proposed by the applicant in accordance with Article 11 or approved by the competent authority of the Member State in accordance with Article 21 and the package leaflet, as proposed in accordance with Article 59 or approved by the competent Member State ; the authority pursuant to Article 61 ;

-WHAT? details of possible decisions on the refusal to grant marketing authorisation, whether within the Union or in a third country, and the reasons for them.

m) A copy of the medicinal product, if any, as a medicinal product for a rare disease, in accordance with Regulation (EC) No 2 of the European Parliament and of the Council. 141/2000 of 16. December 1999 on orphan medicinal products 26) , accompanied by a copy of the Agency ' s opinion on this.

n) (Exgo).

Documentation and information on the results of the pharmaceutical, pre-clinical and clinical trials referred to in the first subparagraph shall be accompanied by detailed summarmes in accordance with Article 12.

The risk management system referred to in point (iaa) of the first subparagraph shall be proportionate to the identified risks and the potential risks of the medicinal product and the need for safety data after authorisation has been granted for marketing.

The information referred to in the first subparagraph shall be updated if and when necessary.

Article 9

In addition to the requirements of Article 8 and Article 10 (1), 1, an application for authorization to market a radionucliid generator shall also include the following information :

-WHAT? a general description of the system and a detailed description of the components of the system which may affect the composition or the quality of the subsidiary nuclear preparation ;

-WHAT? qualitative and quantitative description of the eluate or sublimate.

Article 10

Article 8 (1) notwithstanding Article 8 (1) (3) (i) and without prejudice to the laws relating to the protection of industrial and commercial property, the applicant shall not be obliged to present any results of clinical and clinical trials if he can demonstrate that the medicinal product is a generic ; the equivalent of a reference medicinal product, or has been approved in accordance with Article 6 for at least eight years in a Member State or in the Community.

A generic medicinal product which has obtained approval pursuant to this provision may not be placed on the market until the ten-year period following the initial marketing authorisation for the reference medicinal product has expired.

Paragraph 1 shall also apply where the reference medicinal product has not been approved in the Member State in which the application for the generic medicinal product has been lodged. In this case, the applicant must indicate in the application form the name of the Member State in which the reference medicinal product is or has been approved. At the request of the competent authority of the Member State in which the application has been lodged, the competent authority of the other Member State shall, within one month, transmit confirmation that the reference medicinal product has been or has been approved, the full composition of the reference product and, where appropriate, the relevant documentation.

The period laid down in the second subparagraph of 10 years shall be extended to a maximum of 11 years if the marketing authorization holder has a permit for one or more therapeutic indications as to the marketing authorization during the eight first years of this period of time, as it is at the time of the period ; scientific evaluation carried out in order to approve them is considered to constitute an important clinical advantage in relation to existing treatment.

2. For the purposes of this Article :

a) ' Reference medicinal product ` means a medicinal product approved in accordance with Article 6 and in accordance with Article 8 ;

b) ' generic medicinal product ` means a medicinal product which has the same qualitative and quantitative composition of active substances and the same medicinal product as the reference medicinal product, and if the equivalence of the reference medicinal product is shown by appropriate ; bioavailability studies. The different salts, esters, ethotes, isomers, mixtures of isomers, complexes, or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in the properties of safety and / or effect. If this is the case, the applicant shall provide further information that proves that the various salts, esters or derivatives of an active substance are safe and / or effective. Various oral medicinal products with immediate release shall be regarded as having the same medicinal product as one. The applicant may be exemplify from carrying out bioavailability studies if he is able to demonstrate that the generic medicinal product meets the relevant criteria as defined in the relevant detailed guidelines.

3. If the medicinal product is not covered by the definition of a generic medicinal product in paragraph 1. 2 (b) or bioequivalence cannot be detected in the case of bioavailability studies, or in the case of changes, in relation to the reference medicinal product, of the active substances, the therapeutic indications, the strength, the medicinal product or the administration route shall be submitted to the results of the relevant pre-clinical or clinical trials.

4. If a biological medicinal product corresponding to a biological reference product does not satisfy the conditions laid down in the definition of a generic medicinal product, in particular because of differences resulting from the raw material or because the manufacturing process of the biological agent is used, the medicinal product and the biological reference product are different, shall be submitted to the results of appropriate clinical or clinical trials in relation to these conditions. The additional data to be submitted shall in respect of nature and quantity meet the relevant criteria set out in Annex I and the corresponding detailed guidelines. The results of other tests and tests from the case of the reference box shall not be submitted.

In addition to the provisions of paragraph 1, 1 shall be granted where the application relates to a new indication of a well-known substance, data protection in a non-cumulative period of one year, provided that significant pre-clinical or clinical studies have been carried out in respect of the new ; Indication.

6. The implementation of the necessary studies and experiments for the application of paragraph 1. 1-4 and the resulting practical requirements are not considered to be in breach of patent rights and supplementary protection certificates for medicinal products.

Article 10a

Notwithstanding Article 8 (2), (3) (i) and without prejudice to the legislation on the protection of industrial and commercial property, the applicant shall not be obliged to present any results of clinical or clinical trial if he can demonstrate that the active substances, which : it has been found in the medicinal product generally recognized in the medical area for at least ten years within the Community and that they are effective and adequately secure in relation to the conditions laid down in Annex I. In such cases, the test results shall be submitted to a relevant bibliographic scientific evidence, in such cases.

Article 10b

For medicinal products containing active substances included in the composition of approved medicinal products, which have not been combined for therapeutic purposes, in accordance with Article 8 (2), the composition of the medicinal product shall be subject to the following : Point 3 (i) shall be submitted to the results of new pre-clinical or clinical trials in relation to the new combination, without the need to provide any evidence relating to each active substance.

Article 10c

After the marketing authorization has been issued, the holder may give his consent to reference to the pharmaceutical, pre-clinical and clinical documentation contained in the medicinal product ' s dossiers, with a view to the examination of a subsequent application ; a medicinal product which has the same qualitative and quantitative composition with regard to active substances and the same pharmaceutical form.

Article 11

Product trisuction shall include the following information in this order :

1) Name of the medicinal product, followed by strength and pharmaceutical form ;

2) The qualitative and quantitative composition of the active substances and ancillary substances which must be familiar with a view to the sound use of the medicinal product, in the common denominations or chemical denominations applicable ;

3) Mean shape

4) Clinical information :

4.1. therapeutic indications,

4.2. the dosage and use of adults and, where appropriate, for children,

4.3. contraindications,

4.4. special warnings and special precautions for the use and, in the case of immunological medicinal products, special precautions to be observed by persons handling the immunological medicinal product and the persons who are subject to the immunological medicinal product and persons who : give it to patients, together with the special precautions to be taken, to which the patient may be observed ;

4.5. medicamentelle or other interactions ;

4.6. use during pregnancy and breast-feeding ;

4.7. effects on the ability to drive vehicles and operate machinery ;

4.8. side effects

4.9. overdosing (symptoms, emergency treatment, antitoxin)

5) Pharmacological properties :

5.1. Pharmaco-dynamic properties

5.2. Pharmaco-kinetic properties

5.3. pre-clinical security data ;

6) Pharmaceutical information :

6.1. list of formulants,

6.2. essential inequities

6.3. the durability, where appropriate, after the reconstitution of the medicinal product or after the opening of the package for the first time ;

6.4. special storage rules,

6.5. the contents and the nature of the packaging,

6.6. special precautions for the disposal of a used medicinal product or waste originating from this medicinal product,

7) The marketing authorization holder

8) Marketing license number / numbers

9) Date of first authorization / renewal of the authorization

10) Text Change Date

11) In the case of radioactive medicinal products, complete additional information on internal radiation dosimetry

12) In the case of radioactive medicinal products, additional detailed instructions on the preparation and control of the product and, where appropriate, the longest retention time during which an intermediate product, such as a eluate or a useful type of use, Radioactive medicinal products meet its specifications.

In the case of approvals provided for in Article 10, it is not necessary to include those parts of the product summary for reference megezers which refer to theurapeutic indications or dosage instructions which are still subject to patent law ; at the time when the generic medicinal product is placed on the market.

For the medicinal products listed in the list referred to in Article 23 of Regulation (EC) No 2. The product summary shall contain the following information : ' This medicinal product shall be subject to additional surveillance ` : ' This medicinal product shall be subject to supplementary supervision `. This information shall be followed in accordance with Article 23 of Regulation (EC) No 2, The black symbol referred to in 726/2004 shall be followed by an appropriate standard explanation.

In the case of all medicinal products, the product summary must also include a standard form for which health workers are expressly asked to report any suspected adverse reactions in accordance with the national system of spontaneous, the reporting as referred to in Article 107a (1). 1. It must be possible to make reports in several different ways, including electronic reporting, in accordance with Article 107a (3). 1, second subparagraph.

Article 12

1. The applicant shall ensure that the provisions of Article 8 (1) are taken. the detailed summarmes as referred to in the third subparagraph shall be drawn up and signed by persons with the necessary technical or professional qualifications, which must be indicated in a short-life description before the material is submitted to the competent authorities ; Government.

2. The persons holding the persons who are in possession of the names referred to in paragraph 1. The technical or professional qualifications referred to above shall be subject to the possible use of the scientific bibliographic documentation referred to in Article 10a, in accordance with the conditions laid down in Annex I.

The detailed results of the summarmes are part of the documentation submitted by the applicant to the competent authorities.

CHAPTER 2

Special provisions for homeopathic medicinal products

ARTICLE 13

1. Member States shall ensure that homeopathic medicinal products manufactured and marketed in the Community are approved or recorded in accordance with Articles 14, 15 and 16, except for medicinal products registered or approved in accordance with the provisions of the Community ; with the national legislation forward to and by 31. December 1993. In the case of records, Articles 28 and 29 (4) shall apply. 1-3, use.

2. Member States shall introduce a special, simplified registration procedure for the homeopathic medicinal products referred to in Article 14.

ARTICLE 14

1. Only homeopathic medicinal products which satisfy all of the following conditions may be permitted by a special, simplified registration procedure :

-WHAT? the use of oral or innivory use ;

-WHAT? there are no special therapeutic indications on the label or in the information on the medicinal product,

-WHAT? the degree of dilution must ensure that the medicinal product is harmless ; in particular, it may not contain more than one per per one per 100 of the basic peak dose, or more than one hundred of the lowest dose, which may be used in traditional medicine for active substances, if : presence in a traditional medicinal product requires prescription.

Upon registration, Member States shall draw up a classification for the supply of the medicinal product.

The Commission may, with reference to new scientific knowledge, adapt the provisions of the first subparagraph of the third indent. This measure, which is intended to amend non-essential provisions of this Directive, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 121 (1). 2a.

2. The criteria and procedural rules referred to in Article 4 (2). 4, Article 17 (4). Article 22 (1) and Articles 22 to 26, 112, 116 and 125 shall apply mutatis muthisis to the special, simplified registration procedure for homeopathic medicinal products, but not on the proof of therapeutic effect.

Article 15

The application for special, simplified registration may include a range of medicinal products obtained from the same homeopathic strain (s). The application shall be accompanied by the following documents, in particular, in order to demonstrate the pharmaceutical quality of these medicinal products and the uniformity of the particulate produced by the parties :

-WHAT? the homeopathic stock (s) of the scientific name or other designation of a pharmacopoeia, stating the various forms of administration, pharmaceutical forms and dilution levels to be recorded ;

-WHAT? the documentation describing the manufacture and control of the strain / tribes, which shall prove the homeopathy of homeopathic use by means of an adequate bibliography ;

-WHAT? the documentation for the production and control of each pharmaceutical form and the description of the methods of dilution and potent preparation,

-WHAT? the authorisation to manufacture the medicinal products concerned,

-WHAT? copies of any registrations or approvals for the same medicinal products in other Member States ;

-WHAT? one or more models of the outer and internal packaging of the medicinal products to be recorded.

-WHAT? information concerning the shelf life of the medicinal product.

Article 16

1. Homeopathic medicinal products other than those referred to in Article 14 (1). 1, shall be approved and labelled in accordance with Articles 8 and 10, 10a, 10b, 10c and 11.

2. A Member State may, in its territory, introduce or retain special provisions relating to the pre-clinical and clinical trials of homeopathic medicinal products not covered by Article 14 (1). Paragraph 1, in accordance with the principles and the special practices applicable to homeopathy in this Member State.

In such cases, the Member State shall inform the Commission of the special rules in force.

The provisions of Title IX shall apply to homeopathic medicinal products, with the exception of those referred to in Article 14 (1). 1.

CHAPTER 2a

Special provisions applicable to traditional herbal medicinal products

Article 16a

1. A simplified registration procedure (hereinafter referred to as ' registration as a traditionally used medicinal product ') shall be hereby introduced for herbal medicinal products which satisfy all of the following criteria :

a) they have indications that are only appropriate for traditional herbal medicinal products which, in their composition and purposes, are designed for and designed for use without medical supervision for diagnosis, prescribing or monitoring ; of the treatment

b) they are exclusively for treatment, in accordance with a specified force and dose ;

c) they are taken into orally, for the use and / or the inhalation of the inhale ;

d) the period of traditional use, cf. Article 16c (1), 1 (c) has expired

(e) data on the traditional use of the medicinal product are adequate, in particular the documentary evidence of the means of non-regulatory use and may be presumed to have the pharmacological effect of the medicinal product on the basis of long-term use and experience. or effect.

Notwithstanding Article 1, no. 30, the presence in a herbal medicinal product of vitamins or minerals, where security is well documented, shall not preclude the medicinal product ' s entitlement to registration in accordance with paragraph 1. 1, provided that the effect of vitamins or minerals supports the effect of the active plant components in respect of the indications specified.

The provisions of this Chapter shall not apply in cases where the competent authorities consider that a traditional herbal medicinal product satisfies the criteria for the marketing authorization in accordance with Article 6 or in the case of registration ; pursuant to Article 14.

Article 16b

1. The applicant and the holder of the registration shall be established in the Community.

2. In order for a medicinal product to be registered as a traditionally used herbal medicinal product, the applicant shall submit an application to the competent authorities of the Member State.

Article 16c

1. The application shall be accompanied by :

a) the information and documents :

In. as referred to in Article 8 (2), Point (a) (h) (j) and (k),

(ii) the results of the pharmaceutical tests referred to in Article 8 (1). 3 (i) second indent

iii. the product summary without the data provided for in Article 11 (1). 4

Oh, my. in the case of compositions as specified in Article 1 (2), -30 or Article 16a (1). 2, the information referred to in Article 16a (1). The information referred to in paragraph 1 (e) relating to the composition of the composition of each active ingredient must also relate to the individual active constituents,

b) a marketing authorisation or recording of the medicinal product obtained by the applicant in another Member State or in a third country for the purposes of the placing on the market, and details of any refusal of such authorization ; or registration, both within the Community and in a third country, and the reasons therefor ;

c) the supporting documentation or expert opinion that proves that the medicinal product concerned or a corresponding instrument has been found for at least 30 years prior to the date of application, including at least 15 years in the Community. The Committee on Plant Fund shall prepare, at the request of the Member State in which the application for registration as a traditionally used medicinal product has been submitted, a statement on whether there is sufficient evidence to the medicinal product or the medicinal product, equivalent means have been used over a long time. The Member State shall provide relevant evidence supporting the submission,

d) a bibliographical examination of safety data and an expert report and, if requested by the competent authority, at further request, the necessary data for the evaluation of the safety of the medicinal product.

Annex I shall apply mutatis mues to information and documents referred to in (a).

2. an equivalent means such as those set out in paragraph 1. Paragraph 1 (c) shall be characterized by having the same active components without regard to the aid substances used, the same or similar purposes, equivalent strength and dosage, and the same or similar administration route as the medicinal product to which the application relates.

3. The requirement to document medicinal use throughout this period of 30 years, as set out in paragraph 1. Paragraph 1 (c) has been fulfilled, even though the marketing of the product has not been based on a separate authorisation. The requirement shall also be fulfilled if the number or quantity of ingredients contained in the medicinal product has been reduced during this period.

4. when the means have been used in the Community for less than 15 years, but in the case of simplified registration, the Member State shall submit to the Member State where the application for registration as traditionally used herbal medicinal products has been submitted, the medicinal product of the Committee for Plant medicinal products. The Member State shall provide relevant supporting evidence to support the submission.

The Committee shall adopt a position on the other criteria for a simplified registration, cf. Article 16a is fully satisfied. If the Committee considers that it is possible, it shall draw up a Community drop-down ography, cf. Article 16h (1), The Member States shall take into account when it takes its final decision.

Article 16d

1. Without prejudice to Article 16h (1), the provisions of Chapter 4 of Title III of Title III shall apply mutatis mulations to records issued in accordance with Article 16a, subject to :

a) a Community system of drogemonography has been drawn up in accordance with Article 16h (1). 3, or

b) that the herbal medicinal product consists of herbal herbal preparations, herbal preparations or composition, including those included in the list referred to in Article 16f.

2. In the case of other herbal medicinal products, cf. in Article 16a, each Member State shall, by evaluating an application for registration as traditionally used, duly applied to the registrations issued in another Member State in accordance with this Chapter.

Article 16e

1. Recording as traditionally used herbal medicinal product shall be refused if the application is not in accordance with Article 16a, 16b or 16c, or if it is shown that at least one of the following conditions is met :

a) the qualitative and / or quantitative composition is not as specified ;

b) the indications are not in accordance with the requirements laid down in Article 16a ;

c) the means may be harmful by means of a regulatory use ;

d) data on traditional use is inconclusive, in particular if it is not possible to estimate the use of long term and experience of the means of pharmacological effect or effect.

(e) Pharmaceutical quality is not sufficiently documented.

The competent authorities of the Member States shall inform the applicant, the Commission and any competent authority asking for the decisions to be taken on the refusal of registration as a traditionally used medicinal product and the reasons for such registration.

Article 16f

1. A list of herbal preparations, herbal preparations and composition shall be drawn up in the case of traditional herbal medicinal products in accordance with the procedure referred to in Article 121 (1). 2. This list shall include, in the case of the individual droge, the indication of the specified strength and dosage, the administration road and other necessary information for the safe use of the carriage as traditionally traditional herbal medicinal products.

2. If an application for registration as a traditionally used medicinal product, a herbal preparation or a composition relates to a herbal droid covered by the list referred to in paragraph 1. 1, it is not necessary to submit the data provided for in Article 16c (1). 1 (b), (c) and (d). Article 16e (1). Paragraph 1 (c) and (d) shall not apply.

If a droge, herbal preparation or a composition thereof shall cease to appear on the list referred to in paragraph 1. 1, the registrations issued in accordance with paragraph 1 shall be withdrawn. 2, concerning herbal medicinal products containing this substance, unless the information and documents referred to in Article 16c (1) are mentioned. 1, shall be presented within three months.

Article 16g

Article 3 (1). Article 4 (1) and Article 4 (2), 4, Article 6 (4). Article 12 (1), Article 17 (2), 1, Articles 19, 20, 23, 24, 25, 40-52, 70-85, 101-108b, Article 111 (1). 1 and 3, Rule 112, 116, 117, 118, 122, 123, 125, Article 126 (1). 2, and Article 127 of this Directive and Commission Directive 2003 /94/EC of 8. October 2003 on the principles and guidelines of good manufacturing practice for human use and medicinal products for human use ; 27) shall apply mutatis mutant to registration as a traditionally used medicinal product in accordance with this chapter.

2. In addition to the requirements set out in Article 54-65, any labelling and package leaflet shall contain a declaration of :

a) the product is a traditional herbal medicinal product for use with particular (s) based solely on use over a long period of time ; and

b) the user should consult a doctor if the symptoms, despite the use of the medicinal product, continue, or if there are side effects that are not mentioned in the package leaflet.

A Member State may require that labelling and package leaflets also contain information about the tradition in question.

3. In addition to the requirements set out in Article 86-99, all advertising of a medicinal product registered under this chapter shall contain the following declaration : ' Traditional herbal medicinal product for use by specific (k) indication (s), are based solely on use over a long period of time `.

Article 16h

1. A Committee on herbal medicinal products is hereby established. The Committee shall belong to the Agency and shall be as follows :

a) In the case of simplified registration :

-WHAT? to carry out the tasks provided for by Article 16c (1). 1 and 4

-WHAT? to carry out the tasks provided for by Article 16d ;

-WHAT? to draw up a draft list of drogues, herbal preparations and compositions, cf. Article 16f (s), 1, and

-WHAT? to prepare Community monographs for traditional herbal medicinal products, cf. this Article is paragraph 1. 3.

b) In the case of marketing authorisations for herbal medicinal products, the preparation of Community-herbal remedies for herbal medicinal products, cf. paragraph 3.

c) In the case of referral to the Agency, in accordance with Chapter 4 of Title III concerning herbal medicinal products, cf. Article 16a, to perform the tasks laid down in Article 32.

d) When other medicinal products containing drogues shall be submitted to the Agency in accordance with Chapter 4 of Title III, where appropriate to speak of the drogen.

Finally, the Committee for herbal medicinal products shall carry out all other tasks which it is subject to in accordance with Community legislation.

In accordance with Article 57 (2), paragraph 2 of Regulation (EEC) No 2, 2309/93 sets out the Executive Director a procedure to ensure appropriate coordination with the Committee for Medicinal Medicinal Products.

2. Each Member State shall designate a three-year period, which may be extended, a member and a suppleant of the Committee for herbal medicinal products.

The Supplementes represent and are voting on behalf of absent members. Members and alternates shall be selected on the basis of their role and experience in the assessment of herbal medicinal products and represents the competent national authorities.

The relevant committee may, by self-supplication, designate up to five additional members selected on the basis of their specific scientific qualifications. These members shall be appointed for a three-year period which may be renewed and they shall have no alternates.

When such members are appointed by self-alteration, the relevant committee shall determine the additional Member (s) of the specific scientifically complementary expertise of the Member States. Members chosen by self-alteration shall be selected among the experts who are nominate by the Member States or the Agency.

The members of the relevant committee may be accompanied by experts in exceptional scientific or technical fields.

3. The Committee on herbal medicinal products shall draw up Community and herbal remedies for herbal medicinal products, taking into account the provisions of Article 10 (1). paragraph 1 (a) (a), (ii), as well as for traditional herbal medicinal products. The relevant committee shall carry out any further tasks assigned to it in accordance with the provisions of this Chapter and other Community legislation.

In the case of Community droptographs referred to in this paragraph, Member States shall take them into consideration when processing an application. Where there is no such Community type of carriage, it may be referred to other relevant monographs, publications or data.

When new Community droptographs are drawn up, the holder of the registration shall decide whether it is necessary to amend the registration accordingly. The holder of the registration shall communicate to the competent authority of the registration to the competent authority in question.

The Drogemonic Theoreographers are published.

4. The general provisions of Regulation (EEC) No 2. 2309/93 relating to the Committee for Medicinal Products for Medicinal Products for Medicinal Products shall apply mutatis mueses to the Committee on herbal medicinal products.

Article 16i

By the 30. In April 2007, the Commission shall submit to the European Parliament and the Council a report on the implementation of the provisions of this Chapter.

The report shall include an assessment of the possible extension of the registration as a traditionally used medicinal product to cover other categories of medicinal products.

CHAPTER 3

Experation of the marketing authorisation issue

Article 17

Member States shall take all appropriate measures to ensure that the issue of a marketing authorisation procedure does not exceed 210 days from the time of the submission of a valid application.

Where a marketing authorisation has been issued for a medicinal product for more than one Member State, applications shall be submitted in accordance with Article 28-39.

2. If a Member State ascertains that an application for the marketing of the same medicinal product is already under consideration in another Member State, it shall refuse to examine the application and shall inform the applicant that Articles 28 to 39 shall apply, use.

Article 18

If a Member State in accordance with Article 8 (2), Article 3 (1) shall be informed that another Member State has approved a medicinal product which is subject to an application for marketing authorisation in the Member State concerned, if it is not submitted in accordance with the provisions of the Member State concerned, Article 28-39.

Article 19

In the case of treatment of an in accordance with Articles 8, 10, 10a, 10b and 10c, the Member State ' s competent authority shall :

1) check the conformity of the material referred to in Articles 8 and 10, 10a, 10b and 10c, and examine whether the conditions for the granting of marketing authorization are met ;

2) have the possibility of allowing the medicinal product, its raw materials and, where appropriate, its intermediate products or other ingredients to verify an official Medicinal Control Laboratory or a laboratory designated by a Member State for that purpose and that : ensure that the methods used and in the written material described in writing described in the written material described in accordance with the procedure described in writing. Article 8 (2) ; paragraph 3 (h) is satisfactory ;

3) in the event that the applicant may be required to supplement the material with additional information on the information referred to in Article 8 (2). Article 10, 10a, 10b and 10c, mentioned points. Where the competent authority makes use of this option, the time limits laid down in Article 17 shall be suspended until such time as the additional information required has been given. The time limits shall also be suspended during the time provided for in the event of the applicant to give an explanation of oral or written explanation.

Article 20

Member States shall take all the necessary measures to ensure that :

a) the competent authorities shall verify that the manufacturing and the products of medicinal products from third countries are in a position to carry out their production in accordance with the provisions of Article 8 (1). the information contained in the material referred to in the material referred to in the material referred to in paragraph 3 (d) shall contain information and / or checks to verify the methods described in the material Article 8 (2) ; 3 (h)

b) Whereas the competent authorities may, in duly substantiated cases, grant the manufacturing and manufacture of medicinal products from third countries to allow certain parts of the manufacture and / or of the checks provided for in (a) to be carried out by third parties ; in such cases, the checks carried out by the competent authorities shall be carried out in the designated establishment

Article 21

1. The authorization of the marketing authorization shall send the competent authority of the Member State concerned to the holder of the summary of the product characteristics approved by this authority.

2. The competent authority shall take all necessary measures to ensure that the information contained in the summary corresponds to the information that was available when issuing the marketing authorization or later.

3. The competent authority shall immediately make the marketing authorisation available to the general public with the package leaflet, the product summary and all the conditions laid down in accordance with Articles 21a, 22 and 22a, together with time limits ; for the fulfilment of the conditions for each medicinal product approved.

4. The competent authority of the national competent authority shall draw up an evaluation report and make comments to the application material as regards the results of the pharmaceutical, pre-clinical and clinical trials, the risk management system and the pharmacovigilance system related to the medicinal product concerned. The Evaluation Report shall be updated when new information is available for the evaluation of the quality, safety or effigeance of the medicinal product.

The national competent authority shall forthwith inform the evaluation report and the reasons for its comments, which shall be made available to the public after omission of information which has a commercial confidential nature. The justification shall be given separately for each indication applied for.

The public evaluation report shall contain a summary written in a common intelligible language. In particular, the summary shall include a section relating to the conditions of use of the medicinal product.

Article 21a

In addition to the provisions of Article 19, permit the placing on the market of a medicinal product shall be made subject to the fulfils of one or more of the following conditions :

a) specific measures must be taken to ensure the safe use of the medicinal product included in the risk-management system ;

b) safety examinations must be carried out on the market,

c) the obligations for the registration or reporting of suspected adverse reactions which are more stringent than those laid down in Section IX must be fulfilled ;

d) other conditions or restrictions to ensure the safe and efficient use of the medicinal product ;

(e) the presence of an adequate pharmacovigilance system,

(f) Whereas an impact assessment shall be carried out on the marketing authorization if it is established that there are still concerns concerning certain aspects of the effects of the medicinal product, which can only be remedied after the medicinal product is placed on the market. The obligation to carry out such investigations shall be based on the delegated acts adopted pursuant to Article 22b, taking into account the scientific guidelines provided for in Article 108a.

The marketing authorization shall, where necessary, set deadlines for compliance with these conditions.

Article 22

In exceptional circumstances and in consultation with the applicant, the marketing authorization may be subject to certain conditions, in particular as regards the safety of the medicinal product, informing the national competent authorities of any event in : relating to the application and the measures to be taken.

The marketing authorization may be issued only by objective and demonstrable reasons if the applicant can demonstrate that he is not in a position to provide complete information on the efficuse and safety of the medicinal product by regulatory purposes and shall be based on : one of the reasons referred to in Annex I ;

Maintenance of the marketing authorization shall depend on a renewed annual assessment of these conditions.

Article 22a

1. After issuing a marketing authorisation, the national competent authority may impose an obligation on a holder of a marketing authorisation to :

a) carry out a safety investigation after authorisation is given to the market if there are concerns regarding the risks of an approved medicinal product. If there are the same concerns as regards the risks of more than one medicinal product, the competent national competent authority shall encourage, after consulting the Committee on Risk Assessment, within the Medicinal Products Monitoring, the holders of the medicinal products concerned ; marketing authorisations to carry out a joint security investigation after authorisation to be placed on the market ;

b) conduct an impact study on the marketing authorization if the understanding of the disease or clinical methodology shows that previous impact assessments may need to be substantially modified. The obligation to carry out impact studies on the marketing authorisation shall be based on the delegated acts adopted pursuant to Article 22b, taking into account the scientific information referred to in Article 108a ; Guidelines.

The presentation of such an obligation shall be informed in writing and shall include the purpose and the time frame for presentation and implementation of the investigation.

2. The competent authority of the national competent authority shall permit the holder of the marketing authorization to submit written comments concerning the obligation to impose the obligation within a time limit to be fixed by the authority of the holder of the holder of the authorization, the marketing authorization shall request that effect within 30 days of receipt of the written notification of the obligation.

On the basis of written comments made by the holder of the marketing authorization holder, the national competent authority shall withdraw the obligation or confirm it. Where the national competent authority confirms the obligation, the marketing authorization shall be replaced by the obligation to conclude the obligation on the marketing authorization and shall be updated in accordance with the risk-management system.

Article 22b

1. In order to determine the situations in which the impact studies on the marketing authorisation may be required in accordance with Articles 21a and 22a of this Directive, the Commission may, by means of delegated acts, in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c shall adopt measures which supplement the provisions of Articles 21a and 22a.

When the Commission adopcts such delegated acts, it acts in accordance with the provisions of this Directive.

Article 22c

1. The holder of the marketing authorization shall incorporate all the conditions referred to in Articles 21a, 22 or 22a, in its risk management system.

Member States shall inform the Agency of the marketing authorisations they have issued under the conditions laid down in Articles 21a, 22 or 22a.

Article 23

1. The marketing authorization holder shall, after the marketing authorization issue, as regards the products referred to in Article 8 (2). The presentation and control methods referred to in paragraph 3 (d) and (h) shall take account of scientific and technical progress and to introduce the changes necessary for the preparation of the medicinal product and to be checked by generally accepted scientific knowledge ; methods.

These amendments shall be subject to approval by the competent authority of the Member State concerned.

2. The holder of the authorisation shall immediately forward new information to the competent national competent authority if they may involve any amendments to the information or documents referred to in Article 8 (1). or Articles 10, 10a, 10b and 11, or Article 32 (3). 5, or Annex I.

The holder of the marketing authorization shall in particular be obliged to notify the competent national competent authority immediately of any prohibition or restriction imposed by the competent authorities of the countries where the medicinal product is placed on the market, and on other new information which could affect the assessment of the benefits and risks of the medicinal product concerned. Such information shall include both positive and negative results of clinical trials or any other studies relating to all indications and populations, whether or not they are included in the marketing authorization or not, and the data on the use of the medicinal product, where such use has been applied outside the conditions of marketing authorization.

3. The marketing authorization holder ensures that the product information is updated with the current scientific knowledge, including conclusions of the assessments and recommendations published on the European web portal for medicinal products created in in accordance with Article 26 of Regulation (EC) No, 726/2004.

4. In order to assess the relationship between benefits and risks, the national competent authority may, at any time, request the marketing authorization holder to provide information which will prove that the relationship between benefits and risks is present ; continues to be favorable. The marketing authorization holder shall respond adequately and immediately to any such request.

The national competent authority may, at any time, request the marketing authorization holder to present a copy of the master file for the pharmacovigilance system. The marketing authorization holder shall submit the copy to the copy not later than seven days after receipt of the request.

Article 23a

Where a marketing authorization has been issued, the marketing authorization holder shall inform the competent authority of the Member State which issued the authorisation, when the marketing of the medicinal product for human use is actually placed on the market in that Member State, taking into account the different authorised parting sizes.

The holder shall also inform the competent authority if the medicinal product is temporarily or permanently no longer placed on the market in the Member State. Such notification shall, unless exceptional circumstances exist, take place at least two months before the interruption of the placing on the market.

At the request of the competent authority, in particular as part of pharmacovigilance, the holder of the marketing authorization shall submit to the competent authority all information on the quantity of sale to the medicinal product and all the information he is in possession of the length of the ordination.

Article 23b

1. The Commission shall adopt appropriate arrangements for the treatment of amendments to the conditions of marketing authorisations issued pursuant to this Directive.

The Commission shall adopt the provisions referred to in paragraph 1. Paragraph 1 shall be provided for in a implementing Regulation. This measure, which aims to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 121 (1). 2a.

For the adoption of the provisions referred to in paragraph 1, The Commission shall endeavour to make a single application for one or more identical amendments to the conditions in several marketing authorisations.

4. A Member State may continue to apply the national provisions relating to amendments which were applied at the time of entry into force of the implementing Regulation, on marketing authorisations, as before 1. In January 1998, a medicinal product has been issued to medicinal products which are exclusively approved by the Member State concerned. Where a medicinal product is subject to a national provision in accordance with this Article, subsequently a marketing authorisation in another Member State, the implementing Regulation shall apply to the medicinal product concerned from : this time.

5. a Member State shall continue to apply the national provisions as specified in paragraph 1. The Commission shall notify the Commission of the 4. If no notice is given by the 20. In January 2011, the implementing Regulation applies.

ARTICLE 24

1. The marketing authorization shall be valid for five years, cf. however, paragraph 1 4 and 5.

2. The marketing authorization may be renewed after five years on the basis of a reassessment of the relationship between the benefits and the risks, by the competent authority of the Member State issuing the authorization.

To this end, the marketing authorization holder shall provide the competent national competent authority with consolidated evidence of quality, safety and effimentation, including the evaluation of data in the reports of suspected adverse reactions ; and the periodic, updated security reports submitted in accordance with Title IX, and any changes introduced after the marketing authorization, at least nine months prior to the validity of this expires in accordance with the provisions of the marketing authorization ; with paragraph 1. 1.

3. A marketing authorization that has been renewed has unlimited validity, unless the competent authority of the national competent authority for justified reasons relating to pharmacovigilance, including exposure to an inadequate number of patients, the medicinal product referred to shall decide to renew it for another five-year period in accordance with paragraph 1. 2.

4. if a permit does not actually lead to the marketing of the approved medicinal product in the issuing Member State, the authorization shall be suspended at the latest three years after the issue has been issued.

5. If an approved medicinal product, having been placed on the market in the Member State that issued the authorisation, shall no longer be placed on the market in this Member State for three consecutive years, the authorization shall be disposed of for the medicinal product concerned.

Under exceptional circumstances and in the interest of public health, the competent authority may derogate from paragraph 1. 4 and 5. Such deviations must be duly justified.

ARTICLE 25

The authorisation shall be without prejudice to the responsibility of the manufacturer and, where appropriate, the holder of the authorization.

Article 26

1. The marketing authorization shall be refused if the particulars and documents referred to in Articles 8 and 10, 10a, 10b and 10c referred to in Articles 8 and 10, 10a, 10a, and 10c shall be disregarded, either :

a) the relationship between benefits and risks cannot be regarded as favourable, or

b) the therapeutic effect is not sufficiently demonstrated by the applicant, or

c) the medicinal product does not have the qualitative and quantitative composition of the product.

2. The authorization shall also be refused if they are not to comply with the requirements of Articles 8, 10, 10a, 10b and 10c in support of the documents or information.

3. The applicant or the holder of a marketing authorization shall be responsible for sending the documents and data to be correct.

ARTICLE 27

1. a coordination group shall be set up for the following purposes :

a) examination of all questions relating to the marketing authorisation for a medicinal product for two or more Member States, in accordance with the procedures laid down in Chapter 4 ;

b) examination of questions relating to the surveillance of medicinal products approved by Member States in accordance with Article 107c, 107e, 107g, 107k and 107q ;

c) examination of questions relating to changes to marketing authorisations issued by Member States in accordance with Article 35 (1) ; 1.

The Agency shall provide the secretariat for the coordination group.

The coordination group shall support the taking of its pharmacovigilance tasks, including the approval of risk-management systems and the supervision of their effectiveness, to the scientific assessment and recommendations of the Committee on Risk Assessment, in the field of medical supervision, cf. Article 56 (1). Paragraph 1 (aa) of Regulation (EC) No (EC) No, 726/2004.

2. The Coordination Group shall consist of a representative of each Member State, which is appointed for a period of three years. Member States may designate a supplement for a period of three years which may be extended. Members may, if they so wish, be able to accompany the experts.

Members of the coordination group and experts shall use the scientific and legislative resources available to the competent authorities by the competent national authorities in the exercise of their duties. Each national competent authority shall supervise the professional level of the examinations carried out and shall facilitate the activities of the appointed members and the experts.

Article 63 of Regulation (EC) No, The coordination group will apply to the coordination group as regards transparency and its independence for the coordination of its members.

3. The Coordination Group shall draw up its own rules of procedure, which shall enter into force after the Commission has acceted to it. The rules shall be published.

4. The Executive Director or his representative, as well as the representatives of the Commission, shall have the right to view all meetings of the coordination group.

5. The members of the Coordination Group shall ensure that there is appropriate coordination between the tasks of the group and the work carried out by competent national authorities, including by advisory bodies dealing with marketing authorisations.

Unless otherwise provided for in this Directive, the Member States which are represented in the coordination group shall do their utmost to reach agreement on the measures to be taken. If there is no agreement, then the position adopted by the majority of Member States in the coordination group has been applied.

7. The members of the Coordination Group shall be obliged, even after completion of their duties, to disclose information relating to conditions covered by the confidentiality of professional secrecy.

CHAPTER 4

Procedure for mutual recognition and decentralised approval

Article 28

If a medicinal product is required for the marketing of a medicinal product in several Member States, application, based on identical case files, shall be submitted in the Member States concerned. The dossiers shall include the documentation and information provided for in Articles 8, 10, 10a, 10b, 10c and 11. The attached material shall contain a list of the Member States affected by the application.

The applicant shall ask one of the Member States to act as a ' Member State of reference ' and to draw up an evaluation report on the medicinal product in accordance with paragraph 1. Two and three.

2. If, at the time of submission of the application, a marketing authorisation has already been issued for the medicinal product, the Member States concerned shall recognise the authorisation granted by the reference Member State. To this end, the holder of the reference Member State shall request the reference Member State to draw up an evaluation report on the medicinal product or, where appropriate, to update an existing evaluation report. The reference Member State shall draw up or update the evaluation report within 90 days of receipt of a valid request to this effect. The approved evaluation report, the approved product suction approved, the approved labelling and package leaflet shall be forwarded to the Member States concerned and to the applicant.

3. If, at the time of submission of the application, no marketing authorisation is available for the medicinal product, the applicant Member State shall request the reference Member State to draw up a draft evaluation report, a draft of the product sume and a draft of the product ; labelling and package leaflet. The reference Member State shall draw up these drafts within 120 days of receipt of a valid request and shall forward them to the Member States concerned and to the applicant.

4. Within 90 days of receipt of the documents referred to in paragraph 1. The Member States concerned shall approve the evaluation report, the product summary and the labelling and package leaflet and the reference Member State shall be approved by the Member States concerned. The latter shall register a consensus, terminate the procedure and shall inform the applicant accordingly.

5. Each of the Member States in which an application has been submitted in accordance with paragraph 1. 1, at the latest 30 days after a decision has been determined, a decision that corresponds to the approved evaluation report, product summary, labelling, and package leaflet.

ARTICLE 29

1. If a Member State is unable to approve the evaluation report, the product summary and the labelling and package leaflet within the time limit laid down in Article 28 (1), if any Member State is not able to accept the evaluation report. The latter shall forward a detailed reason for this purpose, respectively, to the reference Member State, the other Member States concerned and the applicant. The disputed points shall immediately be submitted to the Group of Coordination.

The Commission shall adopt guidelines in which it defines the definition of a potential serious risk to public health.

3. In the coordination group, all of the measures referred to in paragraph 1 shall be The Member States shall be as concerned as possible in order to reach agreement on the measures to be taken. They shall give the applicant the opportunity to express his views orally or in writing. If the Member States reach agreement within 60 days from the date of notification of the disputed points, the Member State of reference shall record the agreement, the procedure shall complete and shall inform the applicant accordingly. Article 28 (1). 5, apply.

4. If Member States do not reach agreement within the provisions of paragraph 1, The Agency shall be immediately notified to the Agency for the purposes of applying the procedure laid down in Articles 32, 33 and 34. The Agency shall provide a detailed description of the disputed questions and the reasons for the disunity. A copy shall be sent to the applicant.

As soon as the applicant has been informed that the matter is before the Agency, he shall immediately send this of a copy of the information referred to in Article 28 (5). The information and documents referred to in the first subparagraph are the first subparagraph.

In the first paragraph of paragraph 6. 4 cases where Member States recognise the evaluation report by the Member State of the reference Member State, draft product sumes, labelling and package leaflet, upon request from the applicant, permit the marketing of the medicinal product without waiting to wait ; the result of the procedure laid down in Article 32 In such cases, however, the authorization shall not prejudice the outcome of this procedure.

Article 30

1. is a medicinal product subject to several applications for marketing authorisation submitted in accordance with Articles 8, 10, 10a, 10c, 10c and 11, and have adopted mutual deviant decisions relating to the approval, suspension or Withdrawal, a Member State, the Commission, the applicant or the marketing authorization holder may bring the matter to the Committee for Medicinal Products for Human Medicinal Products, hereinafter referred to as ' the Committee `, to obtain it in accordance with the procedure laid down in Article 1 ; 32, 33 and 34.

In order to facilitate the harmonisation of the authorisation of medicinal products authorised in the Community, Member States shall forward to the Coordination Group a list of medicinal products for which harmonised production sumes are to be compiled for the coordination group.

The coordination group shall draw up a list on the basis of the Member States ' proposals and shall forward it to the Commission.

The Commission or a Member State may, in consultation with the Agency and, taking into account the views of the interested parties, decide to allow the products concerned to refer to the Committee in accordance with paragraph 1. 1.

Article 31

The Member States, the Commission, the applicant or the holder of a marketing authorisation shall, in exceptional cases where the interests of the Union are concerned, take up the matter to the committee in order to obtain it in accordance with the procedure laid down in Articles 32, 33 and 34, before a decision is taken on an application, suspension or withdrawal of a marketing authorization or any other change in a marketing authorisation which is required.

If the submission of the issue of the Committee is a consequence of the evaluation of information from pharmacovigilance of an approved medicinal product, the matter is referred to the Committee on Risk Assessment in the field of medicinal products, and Article 107j (2). 2 may apply. The Committee on Risk Assessment shall make a recommendation in accordance with the procedure laid down in Article 32. The final recommendation shall be forwarded to the Committee for Medicinal Products for Human Medicinal Products or to the Coordination Group, and the procedure laid down in Article 107k shall apply.

However, where urgent measures are considered necessary, the procedure laid down in Article 107i 107k shall apply.

The Member State concerned or the Commission shall state clearly the question referred to the Committee for processing and shall inform the applicant or holder of the marketing authorization accordingly.

The Member States, the applicant or the holder of the marketing authorization shall send the Committee all available information on the matter in question.

2. If the submission of the Committee concerns a range of medicinal products or a therapeutic group, the Agency may restrict the procedure to certain parts of the authorisation.

In such cases, Article 35 shall apply only to the medicinal products concerned if they are subject to the marketing authorisation procedure referred to in this chapter.

ARTICLE 32

Where reference is made to the procedure laid down in this Article, the Committee shall examine the case submitted to the Committee, subject to a reasoned opinion within 60 days of the submission of the case.

However, in the cases submitted to the Committee pursuant to Articles 30 and 31, the Committee may extend this period within 90 days, taking into account the views expressed by the applicant or holders of the marketing authorization.

In the case of urgency, the Committee may lay down a shorter period of time.

The Committee shall appoint one of its members to report for examination. The Committee may also appoint independent experts to advise it on certain matters. When the Committee designates experts at the same time, it defines their tasks and sets a time limit for the execution of it.

Before the Committee shall deliver its opinion, the applicant or the marketing authorization holder shall be able to submit written or oral comments within a time limit such as that of the Member State.

The opinion of the Committee shall be accompanied by the draft of the product sume and the label and package leaflet.

If the committee considers it appropriate, it may call on any other person to present information on the matter at which it is processed.

The Committee may suspend the time limit referred to in paragraph 1. 1 in order to allow the applicant or holder of the marketing authorization to prepare its observations.

4. The Agency shall immediately inform the applicant or holder of the marketing authorization where the Committee determines in its opinion :

a) the application does not meet the approval criteria ; or

b) that the product summary, as proposed by the applicant or the marketing authorization holder in accordance with Article 11, should be amended, or

c) the authorisation should be subject to certain conditions, that is to say, conditions considered essential for a safe and efficient use of the medicinal product, including pharmacovigilance, or

d) that a marketing authorisation should be suspended, changed or revoked.

Within 15 days of receipt of the opinion, the applicant or the marketing authorization holder may notify the Agency in writing that he wishes to review the decision. In such cases, the applicant or the holder of the marketing authorization shall send the Agency a detailed justification for his request within 60 days of receipt of the opinion.

Within 60 days of receipt of the reasons for the request, the Committee shall review its opinion in accordance with Article 62 (2). Paragraph 4 of Regulation (EC) No 2, 726/2004. The findings of the Committee concerning the request shall be attached to the evaluation report referred to in paragraph 1. 5 in this Article.

The Agency shall send this to the Member States, the Commission and the applicant or holder of the marketing authorization together with a report on the evaluation of the medicinal product to the Member States, the Commission and the applicant, or the holder of the marketing authorization, together with a report on the evaluation the reasons for its conclusions.

Where an opinion supports the issue or extension of a marketing authorisation, the opinion shall be attached to the following documents :

a) a draft of the product sume, cf. Article 11

b) the conditions for the granting of the authorization as referred to in paragraph 1. 4 (c)

c) particulars of any recommended conditions or limitations for the safe and efficient use of the medicinal product ;

d) proposal for labelling and package leaflet.

Article 33

Within 15 days of receipt of the opinion, the Commission shall prepare a draft of the decision to be taken on the application, in the interests of Community law.

If, pursuant to the draft decision, a marketing authorisation shall be issued, they shall be added to the provisions of Article 32 (2). The documents referred to in the second subparagraph of paragraph 5 of Annex.

If the draft decision is exceptionally not in accordance with the opinion of the Agency, the Commission shall, in accordance with the opinion of the Agency, make a detailed account of the reasons for the differences.

The draft decision shall be sent to the Member States and the applicant or holder of the marketing authorization.

Article 34

1. The Commission shall at last take a decision, in accordance with and within 15 days of the completion of the procedure referred to in Article 121 (1). 3.

2. the Rules of Procedure of the Standing Committee set up by Article 121 (1). 1 shall be adapted to take account of the responsibilities of the tasks incumreable under this chapter.

These adjustments shall include the following :

a) Apart from the cases referred to in Article 33 (2), The opinion of the Committee on 3 shall be a written statement.

b) Each Member State shall have a period of 22 days to forward to the Commission its written comments on the draft decision. However, if the decision is a matter of urgency, the President may set a shorter time period, depending on the urgency of the matter. Apart from exceptional circumstances, the time limit shall not be less than five days.

c) Each Member State may lodge a reasoned request in writing that the draft decision shall be taken up in a plenary sitting of the Standing Committee.

If, in the Commission's opinion, written comments from a Member State shall raise important new scientific or technical matters which are not affected by the opinion of the Agency, the chairman shall interrupt the procedure and send the application back to : The Agency for further consideration.

The Commission shall adopt the necessary implementing provisions for this paragraph in accordance with the procedure referred to in Article 121 (1) 2.

The third paragraph of paragraph 3. This Decision shall be forwarded to all Member States and shall be notified to the holder of the marketing authorization or the applicant for information. The Member States concerned and the reference Member State shall issue the marketing authorization or make any changes to the marketing authorization which may be required to comply with the decision within 30 days of the date on which it has been made ; this has been announced and shall refer to it in relation to the decision. They shall inform the Commission and the Agency thereof.

Article 35

1. Any application by the holder of the marketing authorization holder to amend a marketing authorisation granted under the provisions of this Chapter shall be submitted to all Member States which have previously approved the medicinal product concerned.

2. In cases where the Commission is subject to arbitration, the procedure provided for in Articles 32, 33 and 34 shall apply mutatis mutilated to changes in marketing authorisations.

Article 36

(Exgo).

Article 37

Articles 35 and 36 shall apply mutatis muth to medicinal products approved by Member States on the basis of a opinion delivered by the Committee pursuant to Article 4 of Directive 87 /22/EEC before 1. January 1995.

Article 38

1. The Agency shall publish an annual report on the application of the procedures laid down in this Chapter and shall forward this report to the European Parliament and the Council to the information provided for.

2. At least every 10 years the Commission shall publish a report on the experience gained in applying the procedures described in this chapter and proposes all the amendments which may be necessary to improve these procedures. The Commission shall forward this report to the European Parliament and the Council.

Article 39

Article 29 (2). Articles 4, 5 and 6, and 30 to 34, shall not apply to homeopathic medicinal products referred to in Article 14.

Articles 28 to 34 shall not apply to homeopathic medicinal products referred to in Article 16 (3). 2.

SECTION IV

MANUFACTURE AND IMPORTATION

Article 40

1. Member States shall take all appropriate measures to ensure that the manufacture of medicinal products in their territory is conditional upon the possession of a permit. Manufacturing authorisation is required, even though the medicinal products produced are intended for export.

The second paragraph of paragraph 1. 1 authorisation is required both for the complete and partial production, and for the division, wrapping and presentation of the processes. However, such authorization shall not be required for processing, splitting or presentation, provided that these processes are carried out solely for the purpose of retail supply by pharmaceutical products in a pharmacy or other persons who are, in other cases, in the case of : the law of the Member States is permitted to carry out the processes referred to.

The third paragraph of paragraph 3. The authorisation shall also be required for imports from third countries to a Member State, and for that purpose, this section and Article 118 shall apply to such imports as they apply in the same way as they apply in the manufacture.

4. Member States shall introduce the information relating to it in the provisions of paragraph 1 of this Article. 1 authorisation in the EU database referred to in Article 111 (1). 6.

ARTICLE 41

In order to obtain the manufacturing authorization, the applicant shall demonstrate that he shall meet at least the following conditions :

a) specify the medicinal products and pharmaceutical forms to be produced and / or imported, as well as the place of their manufacture and / or control ;

b) for the production or import of them, premises, technical equipment and control facilities suitable and adequate and satisfying the legal requirements of the State concerned, both in terms of manufacture and control, as well as for : the storage of the medicinal products, and taking into account the provisions of Article 20 ;

c) have at your disposal at least one person qualified by the expert in accordance with Article 48.

The applicant shall provide the applicant with proof that he meets these requirements.

Article 42

1. The competent authority of the Member State shall not grant a decision to grant a decision only after having secured a study by its representatives, that the particulars provided for in Article 41 are correct.

2. In order to ensure compliance with the conditions laid down in Article 41, authorization may be attached to certain conditions imposed on it either by its issue or at a later date.

3. The authorization shall apply only to the rooms specified in the application and only to the medicinal products and pharmaceutical forms referred to in the same application.

Article 43

Member States shall take all appropriate measures to ensure that the processing authorization procedure does not take longer than 90 days from the date of receipt of the application by the competent authority.

Article 44

Where the holder of the manufacturing authorization requests the amendment of one of the products referred to in Article 41 (1). The information referred to in paragraph 1 (a) and (b) may not last longer than 30 days in the case of this request. This period may be extended in exceptional cases to 90 days.

Article 45

The competent authority of the Member State shall, by the competent authority of the Member State, require further information in respect of the experts referred to in Article 41 and in respect of the expert person referred to in Article 48 ; when the competent authority does ; use of this option shall be suspended in accordance with Articles 43 and 44 of the above time until such time as the additional information required is provided.

ARTICLE 46

The holder of the manufacturing authorization shall be obliged to at least :

a) have the staff meeting the legal requirements applicable in the Member State concerned, both in terms of production and control ;

b) to supply the authorized medicinal products only in accordance with the legislation of the Member States concerned ;

c) however, inform the competent authorities in advance of any change he may wish to make in one of the particulars provided for in Article 41 ; however, the competent authorities shall be informed forthwith in the event of unforeseen replacement of the information in : the expert person referred to in Article 48 ;

d) to allow the representatives of the competent authorities of the Member State concerned to access his premises at all times ;

(e) to enable the expert person referred to in Article 48 to perform his task, in particular by providing all necessary means for his disposal ;

(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use exclusively active substances produced in accordance with good manufacturing practice of active substances and distributors ; compliance with good use of the active substances in the case of active substances. The holder of the manufacturing authorization checks in this connection that the manufacturer and distributors of active substances comply with good manufacturing practice and good distribution practices by carrying out audits on the manufacturer and distributors of the manufacturing and distribution sites of the active substances. The holder of the manufacturing authorization shall check either this compliance itself or, without prejudice to the liability of the person concerned as specified in this Directive, by means of a unit with which the person in question has concluded an agreement.

The holder of the manufacturing authorization shall ensure that the formulants are suitable for use in medicinal products by determining what appropriate good manufacturing practices. This shall be determined on the basis of a formalised risk assessment in accordance with the guidelines applicable, cf. Article 47 (4). 5. This risk assessment shall take account of the requirements according to other appropriate quality systems as well as the origin of the aid victims and their intended use as well as previous cases of quality defects. The holder of the manufacturing authorization shall ensure that the appropriate manufacturing practice has thus established the appropriate good manufacturing practice. The holder of the manufacturing authorization shall document the measures taken in accordance with this paragraph ;

g) inform the competent authority and the marketing authorization holder, if he is aware of the fact that medicinal products subject to his production permit are or suspect to be falsified, regardless of whether these medicines are subject to the authorization ; were deployed in the legal supply chain or by illegal means, including illegal sales by services of the information society ;

(h) verifying that operators, importers or distributors from which he is taking active substances, are registered to the competent authority of the Member State in which they are established ;

i) to check the authenticity and quality of the active substances and the assignation.

Article 46a

1. In this Directive, the manufacture of active substances used as raw materials, complete or partial manufacture and importation of an active substance used as raw material (as defined in Annex I, 1. Part, nr. Section 3.2.1.1 (b)) and the various processes for the division, wrapping and presentation in advance of its use in a medicinal product, including rewrapping and labelling carried out by an engrotor of raw materials.

The Commission may amend paragraph 1. 1 in order to adapt it to scientific and technical progress. Such a measure, which aims to amend non-essential provisions of this Directive, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 121 (1). 2a.

Article 46b

Member States shall take appropriate measures to ensure that the manufacture, import and distribution in their territory of active substances, including the active substances for export, comply with good manufacturing practice and good ; the distribution practices of active substances.

2. The active substances may be imported only if the following conditions are met :

a) the active substances have been produced in accordance with standards of good manufacturing practice, which are at least equivalent to the standards laid down by the Union, cf. Article 47 (4). 3, and

b) the active substances shall be accompanied by a written confirmation by the competent authority of the exporting third country on the following :

In. that the standards of good manufacturing practice applicable to the factory in which the exported active substance has been manufactured shall be at least equivalent to the standards laid down in the Union, cf. Article 47 (4). 3

(ii) the plant which has been manufactured shall be subject to regular, strict and transparent control and effective enforcement of good manufacturing practice, including repeated and unannounced inspection visits, in order to ensure that : the level of protection of public health at least equivalent to that in the Union ; and

iii. the exporting third country, in the case of observations relating to non-compliance, shall immediately transmit to the Union the information that such findings are made.

This written confirmation shall not affect the obligations laid down in Article 8 and in Article 46 (f).

3. the requirement of paragraph 1 of this Article. Paragraph 2 (b) shall not apply where the export country is listed in the list referred to in Article 111b.

The requirement of paragraph 4 of this Article. Point 2 (b) may, in exceptional cases, and where necessary to guarantee the availability of medicinal products, shall be waisted by any Member State for a period not exceeding the validity of the good manufacturing practice of a Member State, after inspection visits have been found that a factory producing an active substance for export complies with the provisions of Article 47 (3). 3, determined principles and guidelines for good manufacturing practice. Member States which avase themselves of the possibility of such a derogation shall notify the Commission thereof.

ARTICLE 47

Principles and guidelines for good manufacturing practice for medicinal products, cf. Article 46 (f) shall be adopted in the form of a Directive ; this measure, which aims to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121 (1). 2a.

The guidelines laid down in accordance with these principles and guidelines shall be issued by the Commission and shall be reviewed, where necessary, on the basis of technical and scientific developments.

The Commission shall adopt, by means of delegated acts, in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c of the principles and guidelines referred to in Article 46 (f), and Article 46b, the manufacturing practices of active substances.

The principles governing the good distribution practices of the active substances referred to in Article 46 (f), first subparagraph shall be adopted by the Commission in the form of guidelines.

The Commission shall adopt guidelines for the formalised risk assessment referred to in the second subparagraph of Article 46 (f) to the establishment of the appropriate good manufacturing practice for formulants.

Article 47a

The precautionary measures referred to in Article 54 (o) must not be removed or covered in whole or in part, unless the following conditions are met :

a) before the holder of the manufacturing authorization is wholly or partially removes or covers such safeguards, he shall check the authenticity of the medicinal product and that the wrapper is unbroken ;

b) the holder of the manufacturing authorization shall comply with Article 54 (o), by replacing these security measures with security measures corresponding to the original, in the case of the possibility of checking the authenticity of the medicinal product, identification and documenting the unbroken packing of the medicinal product. Such replacement shall be carried out without opening the internal packaging defined in Article 1 (2), 23.

The security measures shall be considered equal to the original if :

a) comply with the requirements laid down in accordance with Article 54a (3). 2, adopted delegated acts, and

b) are as effective as regards the control of authenticity and the identification of medicinal products and the provision of evidence that the packaging is unbroken ;

c) the replacement of safety measures shall be carried out in accordance with the applicable good manufacturing practices for medicinal products, and

d) the replacement of safety measures shall be carried out under the supervision of the competent authority.

2. The holders of manufacturing permits, including those engaged in business as referred to in paragraph 1. The following shall be regarded as protractors and shall therefore be liable for damages in the cases and under the conditions laid down in Directive 85 /374/EEC.

Article 48

Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization at all times has at least one expert person who satisfies the conditions laid down in Article 49 and who is in particular responsible for : the performance of the tasks defined in Article 51.

2. If the holder of the authorization meets the conditions laid down in Article 49, he may himself assume it in paragraph 1. 1 responsibility.

ARTICLE 49

Member States shall ensure that the expert person referred to in Article 48 fulfils the provisions of paragraph 1. The requirements for qualifications referred to in 2 and 3.

2. The qualified person shall possess a certificate of qualifications, certificate or other certificate of qualification for a university study or a study to be recognized by that Member State as equivalent to that of at least four years ; in theory and practical training, in one of the following scientific disciplines : pharmaci, medical science, chemistry, chemistry, pharmaceutical chemistry and technology, and biology.

However, the minimum duration of university law may be three and a half years if it is followed by a theoretical and practical training, completed with a degree at university level, of at least one year, and a period of at least one year and a time of traineas ; at least six months in a pharmacy that is open to the public.

If, at the same time, there are two university training courses or two studies which, by the Member State concerned, have two studies, one of which extends over four years and the second more than three years, the certificate shall be regarded as the certificate, or other qualification evidence of the three-year university education or training recognised as equivalent to that in order to meet the requirements referred to in the second subparagraph, in the case of diplomas, certificates or others ; the qualification of the two studies of the State concerned shall be recognised as having the same qualification ; value.

The studies shall include theoretical and practical training, which shall include at least the following basic subjects :

-WHAT? (Does not concern the Danish version).

-WHAT? general and inorganic chemistry,

-WHAT? organic chemistry,

-WHAT? analytical chemistry,

-WHAT? pharmaceutical chemistry, including pharmacovigilance,

-WHAT? commonplace and used biochemistry (medical),

-WHAT? physiology

-WHAT? microbiology,

-WHAT? Pharmacology

-WHAT? Pharmaceutical technology

-WHAT? toxicology,

-WHAT? pharmacocognosi (recording of the composition and effects of active substances in natural products of plant or animal origin).

The teaching of these subjects shall be given in such a way that the person concerned is able to fulfil the obligations specified in Article 51.

To the extent that certain diplomas, certificates or other evidence of qualification referred to in this paragraph do not satisfy the criteria laid down in this paragraph, the competent authorities of the Member State shall ensure that the person concerned shall prove to be proof of : adequate knowledge of the subjects in question.

3. The expert must have a practical experience for at least two years in one or more companies with a manufacturing permit comprehensive qualitative analysis of medicinal products, quantitative analysis of active substances and the necessary tests and checks to be carried out ; safeguarding the quality of medicinal products.

The duration of the practical experience may be short-cut by one year if the university training extends over at least five years and by a year and a half if the study extends over at least six years.

Article 50

1. A person who, in a Member State, shall exercise the establishment referred to in Article 48 at the time of the implementation of Directive 75 /319/EEC without complying with the provisions of Article 49, shall continue to exercise this exercise, Company.

2. The holder of an examination certificate, certificate or other qualification certificate of completed university study or a study carried out by the Member State concerned as equivalent to that in a scientific discipline which qualifies ; the person concerned to exercise the company referred to in Article 48, in accordance with the legislation of this State, may, once he has started his training before the 21. In May 1975, it shall be deemed to be eligible for the duties referred to in Article 48, provided that he prior to the 21 of the Member States referred to in Article 48 shall be taken. In May 1985 for at least two years directly under the management of the persons referred to in Article 48, a supervisory organization for the manufacture and / or qualitative and quantitative analysis of the active substances and the tests and controls necessary for the purposes of this Directive are carried out and the checks required for to ensure the quality of the medicinal products in one or more undertakings which have obtained a manufacturing permit.

When the person concerned has obtained the practical experience referred to in the first subparagraph, before the 21. In the case of May 1965, an extra year of practical experience is required to provide for the conditions referred to in the first subparagraph, and this additional practical experience must be achieved immediately before the exercise of these activities.

ARTICLE 51

Member States shall take all appropriate measures to ensure that the competent person referred to in Article 48, notwithstanding his relationship with the holder of the manufacturing authorization, shall be subject to the procedures referred to in Article 52, responsible for the monitoring of :

a) that any batch of medicinal products produced in the Member State concerned has been manufactured and checked in accordance with the laws in force in that Member State and in accordance with the authorization of the marketing authorization ; approved conditions

b) that any separate batch of medicinal products imported from third countries, whether produced in the Community, in a Member State has been subjected to a full qualitative analysis, a quantitative analysis of at least all of the products in the Community ; active substances and any other test or control necessary to ensure the quality of the medicinal products in accordance with the conditions laid down by the marketing authorization notification.

The expert person referred to in Article 48 shall ensure that the safety measures referred to in Article 54 (o) are placed on the packaging of medicinal products intended for the market in the Union.

Parties of medicinal products, which are thus inspected in a Member State, shall be exempted from the abovementioned controls where they are placed on the market in another Member State, accompanied by the control evidence, signed by the expert person.

2. In cases where medicinal products are imported from a third country and the Community has taken appropriate measures with the exporting country to ensure that the manufacturer of the medicinal product uses standards for good manufacturing practice, which are at least equivalent to those of the medicinal product ; by the Community, and in order to ensure that the standards referred to in paragraph 1 are applied. The first subparagraph of point (b) of the first subparagraph of the exporting country may be exemplified by the qualified person in charge of carrying out this control.

3. In all cases, and in particular when the medicinal product is offered for sale, the qualified person in a particular file or equivalent document shall certify that each consignment of each consignment complies with the provisions of this Article ; the corresponding document must be updated as the work processes are concluded and made available to the representatives of the competent authorities for a period conforming to the provisions of the Member State in question, however ; At least for five years.

Article 52

Member States shall ensure, by means of appropriate administrative measures or in the case of professional behaviour, that the person in accordance with Article 48 complies with its obligations.

Member States may provide for the temporary suspension of this person if an administrative or disciplinary procedure is initiated against him in the case of dereliction of duty.

Article 52a

1. Importers, protractors and distributors of active substances established within the Union shall record their business with the competent authority of the Member State in which they are established.

2. The registration form must include at least the following information :

i) the name or business name and fixed address,

(ii) Indication of the active substances to be imported, manufactured or distributed ;

(iii) information on premises and technical equipment to be used for their activities.

Paragraph 3. 1 persons shall submit the registration form to the competent authority within 60 days prior to the planned start of their activities.

4. The competent authority may, on the basis of a risk assessment, decide to carry out an inspection visit. Where the competent authority within 60 days of receipt of the registration form, the competent authority shall inform the applicant that a inspection visit will be carried out, the establishment shall not commence before the competent authority has notified the competent authority ; the applicant that he may start his business. If the competent authority does not within 60 days of receipt of the registration form, the applicant has informed the applicant that an inspection visit may be carried out, the applicant may start the establishment.

The fifth paragraph of paragraph 5. 1 each year each year shall forward to the competent authority the changes which have taken place in relation to the information given in the registration form. Any change which may affect the quality or safety of the active substances being produced, imported or distributed must be communicated immediately.

Paragraph 6. 1 persons referred to in the second place of their operations. In January 2013, the registration form shall be provided to the competent authority not later than 2. March, 2013.

The Member States shall adopt the information given in accordance with the provisions of this Article. 2, in the European Union database referred to in Article 111 (1). 6.

This Article shall be without prejudice to Article 111.

Article 52b

Article 2 (1) or Article 2 (1). Member States shall take the measures necessary to prevent the use of medicinal products entering the Union without prejudice to the market in the EU market if there is sufficient reason for the use of the market in the EU market, but not to be marketed on the market in the EU market ; suspect the falsified medicinal products concerned.

2. In order to establish what is necessary, as mentioned in paragraph 1 of this Article, The Commission may, by means of delegated acts in accordance with Article 121a, and subject to the conditions laid down in Articles 121b and 121c, the Commission may adopt measures to supplement paragraph 1 of this Article. First, on the basis of the criteria to be taken into account, and the monitoring to be carried out in the assessment of the potentially falsified nature of medicinal products entered into the Union, but not on the market.

ARTICLE 53

The provisions of this Title shall also apply to homeopathic medicinal products.

SECTION V

LABELLING AND PACKAGE LEAFLET

ARTICLE 54

Any medicinal product must be provided on the outer packaging or, where such a non-exigent material is not available on the internal packaging, with the following information :

a) the name of the medicinal product, followed by strength and pharmaceutical form, and, where appropriate, indication of whether the medicinal product is intended for infants, children or adults. If the product contains up to three active substances, the international community name (INN) must be specified or, if such a does not exist, the common name.

b) the composition, expressed through a qualitative and quantitative indication of the active substances per year ; dose unit or, depending on the form of entry, for a particular volume or weight, by the use of the common names ;

c) pharmaceutical form and content by weight, volume or dosiunit,

d) list of excipients which have a recognised effect and which are laid down in the detailed instructions published in accordance with Article 65. However, if there are injections prepares, a preparation for local use or an eye agent, all substances must be mentioned :

(e) the method of use and the method of administration. The packaging of the packaging for the indication of the prescribed dosage shall be made available ;

(f) a special warning that the medicinal product must be kept out of reach for children.

g) a special warning if such an instrument is necessary for the medicinal product concerned ;

(h) indication of the last date of use in clear language (month/year) ;

i) special storage conditions, if applicable,

j) any special precautions concerning the disposal of unused medicinal products or waste derived from medicinal products, and a reference to existing appropriate collection systems ;

c) the name and address of the marketing authorization holder and, where applicable, the name of the representative appointed by the holder.

I) the marketing authorization number ;

m) the batch number,

n) in the case of non-prescription medicinal products, the use of which is intended for use.

o) in the case of medicinal products other than radioactive medicinal products, referred to in Article 54a (1). 1, security measures that allow wholesalers and persons authorized to supply medicinal products to the public that :

-WHAT? verify the authenticity of the medicinal product ; and

-WHAT? to identify individual packs,

-WHAT? as well as a device which allows for the possibility of checking whether the outer packaging has been broken.

Article 54a

1. Receptionable medicinal products must bear the safety measures referred to in Article 54 (o) unless they are included in a list in accordance with the procedure laid down in paragraph 1. 2 (b) of this Article.

Non-prescription-only medicinal products shall not bear the safety measures referred to in Article 54 (o) unless they are included in a list in accordance with the procedure laid down in paragraph 1. in the case of paragraph 2 (b) of this Article, after an assessment has been detected, there is a risk of falsification.

2. The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, measures to supplement Article 54 (o), with the aim of defining the detailed rules ; for the safety measures referred to in Article 54 (o).

These delegated acts shall lay down the following :

a) the characteristics and technical specifications of the unique identifier for the safety measures referred to in Article 54 (o), which enable the verification of the authenticity and identification of the medicinal products to be taken into account, and identification of individual packages. Where the security measures are established, due account shall be taken of their cost effectiveness

b) lists of medicinal products or categories of medicinal products which, in the case of prescription-only medicines, must not prejudice the security measures and, where they are non-prescription-only medicine, shall be provided for in Article 54 (o) ; safety precautions. These lists shall be drawn up, taking into account the risk and risk resulting from falsification of falsification of medicinal products or categories of medicinal products. To this end, a minimum of the following criteria shall be used :

In. price and quantity of the medicinal product,

(ii) the number and frequency of the previous cases of counterfeit medicinal products reported in the Union and in third countries, and hitherto in the case of the number and frequency of such cases ;

iii. the specific characteristics of the medicinal products concerned,

Oh, my. the seriousness of the suffering the medicinal products are intended for processing ;

Oh. other potential public health risks,

c) procedures for the procedure laid down in paragraph 1 4 notification of the Commission and a system for quick evaluation and decision on these information for the purpose of the application of point (b) ;

d) the arrangements for the supervision of the security measures referred to in Article 54 (o), which are carried out by the proverbial, wholesalers, pharmacists and persons authorized to supply medicinal products to the public ; and competent authorities. Such arrangements shall allow the authenticity of each of the medicinal products supplied to the medicinal products referred to in Article 54 (o) and to determine the extent of that control. When drawing up these arrangements, special characteristics must be taken into account in the supply chain in Member States and on the need to ensure that the impact of control measures on certain actors in the supply chains is : proportionate proportionate

(e) the provisions relating to the establishment, management and availability of the data storage system, which shall include information on the safety measures referred to in Article 54 (o), which enable the authenticity and identification of the identification of the data ; medicinal products. The cost of this data retention system shall be borne by the holders of authorisation for the manufacture of medicinal products equipped with the security measures.

For the adoption of the measures referred to in paragraph 1. The Commission shall, as a minimum, take due account of the following conditions :

a) the protection of personal data in accordance with EU law ;

b) the legitimate interests of protecting the information of commercial confidentiality ;

c) the ownership and confidentiality of data resulting from the application of security measures ; and

d) cost-effectiveness of the measures.

The national competent authorities shall inform the Commission of non-prescription-only medicinal products for which they consider that there is a risk of falsification, and can inform the Commission of medicinal products for which they consider that there is no risk in the criteria set out in paragraph 1. (b) 2 (b).

Member States may, with a view to reimbursement or pharmacovigilance, extend the scope of the unique identifier referred to in Article 54 (o) to cover all medicinal products which are receptionable or refundable.

For the purposes of reimbursement, pharmacovigilance or medicinal product pharmacology, Member States may use the information provided for in the data memory system referred to in paragraph 1. Paragraph 2 (e) of this Article shall be subject to :

For the purpose of patient safety, Member States may extend the scope of the device referred to in Article 54 (o) to check whether the outer packaging has been broken to cover any medicinal product.

ARTICLE 55

1. The internal packaging must, with the exception of those referred to in paragraph 1, shall be taken. 2 and 3 shall be provided with the information provided for in Article 54.

2. are the internal packaging contained in an outer packaging designed in accordance with the requirements of Articles 54 and 62, when they have the form of blister packs, the following information shall be provided with at least :

-WHAT? Name of the medicinal product as determined in accordance with Article 54 (a) ;

-WHAT? the name of the marketing authorization holder ;

-WHAT? date of use,

-WHAT? the batch number.

3. Small internal packaging of which it is impossible to indicate the information provided for in Articles 54 and 62 shall be provided with at least the following information :

-WHAT? Name of the medicinal product as determined in accordance with Article 54 (a), and, where appropriate, administration route.

-WHAT? method of use

-WHAT? date of use,

-WHAT? the batch number,

-WHAT? content expressed in weight, volume or doses.

ARTICLE 56

The information referred to in Articles 54, 55 and 62 shall be so legible that they are easily legible, easily understood and impossible to delete.

Article 56a

Name of the medicinal product, cf. Article 54 (a) shall also be indicated in blunder on the packaging. The marketing authorization holder shall ensure that the package leaflet at the request of patients ' s associations are made available in formats suitable for the blind and the fungable.

Article 57

By way of derogation from Article 60, Member States may require certain conditions relating to the labelling of the medicinal product to be fulfilled, which shall allow :

-WHAT? construction of the price of the medicinal product,

-WHAT? the provision of provisions for reimbursement from the health bodies ;

-WHAT? the introduction of provisions for the provision of the medicinal product to the patient in accordance with Title VI,

-WHAT? authenticity and identification in accordance with Article 54a (3). 5.

In the case of medicinal products approved in accordance with Regulation (EC) No (EC) No, In Article 65 of this Directive, Member States shall follow the detailed instructions provided for in Article 65 of this Article in the application of this Article.

ARTICLE 58

The packaging of any medicinal product must include a package leaflet, unless all information required by Articles 59 and 62 is directly on the outer or internal packaging.

ARTICLE 59

1. The package leaflet shall be drawn up in accordance with the product summary. It shall contain the following particulars in the order below :

a) Identification of the medicinal product :

In. Name of the medicinal product, followed by strength and pharmaceutical form, and, where appropriate, the indication of whether it is intended for infants, children or adults. The common name must be specified if the medicinal product contains only one active substance and if its name is a distinguished name.

(ii) The Pharmako-therapeutic category or operation, drawn up easily understandable to the patient.

b) Therapeutic indications.

c) Conduct of the information to which the patient must be informed prior to the introduction of the medicinal product :

In. contraindications,

(ii) appropriate prudential rules during the use ;

iii. medicinal interaction and other forms of interaction (e.g. alcohol, tobacco, food) which may, where appropriate, affect the effects of the medicinal product ;

Oh, my. special warnings.

d) The necessary and usual information for the correct application, in particular :

In. dosage,

(ii) use and, where necessary, the method of administration

iii. the frequency of use, where necessary, where necessary, indication of when the medicinal product may or should be used ;

and, where appropriate, according to the nature of the medicinal product :

Oh, my. the duration of the treatment if it is to be limited ;

Oh. precautions in the case of an overdose (e.g. description of symptoms and emergency measures),

We. measures in the case of a transfer of one or more doses,

Vii. where necessary, an indication of the risk of the termination of treatment

viii. an explicit request to consult the doctor or pharmacist, if necessary, to clarify the means of use of the medicinal product.

(e) a description of adverse reactions which may occur in the normal use of the medicinal product, and, where appropriate, countermeasures ;

(f) A reference to the last date of application, as indicated on the packaging, including :

In. a warning against any overrun of this date ;

(ii) special storage conditions, if applicable ;

iii. any notice of certain visible signs of impairment, if any,

Oh, my. the composition, expressed through a complete qualitative indication (in active substances and formulants), as well as a quantitative indication of the active substances, in the form of the common names, in the form of any form in which the medicinal product is available ;

Oh. the wrapping and weight of the weight, volume or doses of any medicinal product ;

We. the name and address of the marketing authorization holder and, where appropriate, the name of its representatives in the Member States ;

Vii. the name and address of the manufacturer.

g) A list of approved names in each of the Member States where the medicinal product has been approved in accordance with Articles 28 to 39 under different names in the Member States concerned.

(h) The date that the package leaflet was last modified.

For medicinal products listed in Article 23 of Regulation (EC) No 2. The list shall be added to Article 726/2004 ' This medicinal product shall be subject to supplementary supervision `. This communication shall follow in accordance with Article 23 of Regulation (EC) No 2, The black symbol referred to in 726/2004 shall be followed by an appropriate standard explanation.

In the case of all medicinal products, a standard form is added by which patients are expressly requested to report any suspected side effects to their physician, pharmacies or health experts or directly to the products referred to in Article 107a (2). the national spontaneous reporting system referred to in paragraph 1 and specify the various ways to be used for reporting (electronic reporting, reporting to a postal address or other reporting method) in accordance with the said procedure ; with Article 107a (s). 1, second subparagraph.

2. the construction of information as referred to in paragraph 1. 1 (c) shall :

a) take into account the particular characteristics of certain users (children, pregnant women or breastfeeding women, older people, persons with particular pathology),

b) where appropriate, mention the possible effects of treatment on the ability of car services or machinery control ;

c) contain a list of excipients, which it is necessary to know in order to be able to use the medicinal product correctly and risk, which are covered by the detailed instructions published in accordance with Article 65.

3. The package leaflet shall reflect the results of collaboration with patients target groups to ensure that they are easily legible, clear and user-friendly.

4. Not later than 1. In January 2013, the Commission shall submit to the European Parliament and the Council an evaluation report on current deficiencies in the product summary and package leaflet, with proposals on how to improve the need for patients and health-care workers. If necessary, the Commission shall submit proposals to the Commission on the basis of the report and, after consulting the relevant parties concerned, to improve the readability, layout and content of these documents.

ARTICLE 60

Member States may not prohibit or impede the placing on the market of medicinal products on their territory for reasons attributable to the labelling or package leaflet, if this meets the requirements of this Title.

ARTICLE 61

1. One or more models of the outer and internal packaging and the draft package leaflet shall be submitted to the competent authorities, at the same time as the application for marketing authorization. In addition, the competent authority shall have the results of the evaluations carried out in cooperation with patients ' target groups.

2. The competent authorities shall not oppose the placing on the market of medicinal products when labelling or package leaflet satisfies the requirements of this Title and when they are in accordance with the information specified in the summary of the product ; properties.

3. Any draft modification of an element of the labelling or package leaflet covered by this section and which is not in the summary of the product characteristics shall be submitted to the competent authorities responsible for the purposes of the summary of the product. the marketing authorisation issue. If the competent authorities have not objemed to the draft amendment within 90 days of the submission of the application, the applicant may make the changes to that effect.

4. The fact that the competent authorities have not objexpressed to the marketing of a medicinal product in accordance with paragraph 1. 2 or against a modification of the labelling or the package leaflet. 3, shall be without prejudice to the responsibility of the manufacturer of the marketing authorization holder and the marketing authorization holder.

Article 62

The outer packaging and the package leaflet may bear signs or pictograms for the explanation of some of the information referred to in Article 54 and 59 (5). 1, as well as other information which is compatible with the summary of the product characteristics and which may be useful to the patient, with the exclusion of any element which may have a character in advertising.

Article 63

The information referred to in Articles 54, 59 and 62 shall be drawn up in the official language or languages of the Member State in which the medicinal product is placed on the market.

The provision of the first subparagraph shall not preclude the fact that this information may be drawn up in several languages, provided that the same information is given in all languages.

For certain medicinal products for rare diseases, the information referred to in Article 54 may be replaced by the official language of one of the Community ' s official languages.

2. The package leaflet shall be legible and drawn up in terms that are clear and comprehensible and thus enable users to act appropriately, if necessary, with the help of health-care professionals. The package leaflet shall be legible in the official language or languages of the Member State in which the medicinal product is placed on the market.

The first subparagraph shall not preclude the need for the package leaflet to be printed in several languages, provided that the same information is given in all the languages used.

3. Provided that the competent authority shall take the measures which it considers necessary to protect human health, it may grant a derogation from the requirement that certain information should appear on the labelling and package leaflet, medicinal products where the medicinal product concerned is not intended to be delivered directly to the patient, or if there are serious problems concerning the availability of the medicinal product. It may also provide a full or partial derogation from the requirement that the labelling and the package leaflet shall be written in the official language or languages of the Member State in which the medicinal product is placed on the market.

Article 64

If the provisions of this paragraph are not provided, the competent authorities of the Member States may not, after the party concerned have failed to comply with a recommendation, suspend marketing authorization until the medicinal product's labelling and the inclusion of the medicinal product are not taken into force ; package leaflet has been brought into line with the requirements of this Title.

Article 65

The Commission shall draw up and publish in consultation with the Member States and the interested parties with detailed instructions concerning in particular :

a) the drafting of certain specific warnings related to certain categories of medicinal products ;

b) the specific requirements for the use of medicinal products for small-purchase medicinal products,

c) the legibility of the information given on the labelling and package leaflet ;

d) the methods for the identification of medicinal products and certificates of authenticity ;

(e) the list of excipients intended to be indicated on the labelling of medicinal products, and the manner in which these aid substances are to be indicated ;

(f) harmonised rules for the implementation of Article 57.

Article 66

1. The outer packaging and container of medicinal products containing radionuclides must be labelled in accordance with the provisions relating to transport safety for radioactive substances as laid down by the International Atomic Energy Agency. In addition, the labelling must satisfy the provisions of paragraph 1 Two and three.

2. The label on the shielding shall include the information set out in Article 54. In addition, the label shall indicate an explanation of the codes used in the vial / ampule used, where applicable, indicating the amount of radioactivity per caption. dose or per. vial / ampule at a specified time and by the number of capsules or, as far as liquid is concerned, the number of millilitres in the container.

3. The vial / ampule must be marked with the following information :

-WHAT? the name or code of the medicinal product, including the name or chemical symbol of the radionucliid in question ;

-WHAT? batch identification and expiry date ;

-WHAT? the international symbol of radioactivity,

-WHAT? the name and address of the manufacturer,

-WHAT? the amount of radioactivity, cf. paragraph 2.

Article 67

The competent authority shall ensure that the packaging of radioactive medicinal products, radionucliid generators, radionucliid-kits or radionukleid-precursors contains a detailed package leaflet. The text on this package shall be drawn up in accordance with Article 59. In addition, the note shall contain information on the prudential rules which the user or the patient must observe during preparation and the introduction of the medicinal product, and special safeguards in the case of disposal of the packaging and its unused ; content.

ARTICLE 68

Without prejudice to Article 69, homeopathic medicinal products shall be labelled in accordance with the provisions of this Title and shall bear a clear and legible writing on their homeopathic nature.

ARTICLE 69

1. The label and any leaflet for the medicinal products referred to in Article 14 (1). In addition, in addition to the description ' homeopathic medicinal product ', the following information must be shown in addition to the description of the term ' homeopathic medicinal product ` :

-WHAT? the scientific name of the tribe / tribes followed by the dilution degree in the use of the symbols of the pharmacopoeia used as referred to in Article 1 (2), 5 ; if the homeopathic medicinal product consists of several tribes, the scientific name of the tribes may be given a distinguished name on the labelling.

-WHAT? the name and address of the holder of the registration and, where appropriate, on the manufacturer ;

-WHAT? the method of use and, where necessary, the method of administration ;

-WHAT? indication of the last date of use in clear languages (month, year),

-WHAT? pharmaceutical form,

-WHAT? the contents of the sales sheet,

-WHAT? any special prudential rules to be observed in the storage unit ;

-WHAT? a special warning if the medicinal product requires it ;

-WHAT? the batch number,

-WHAT? registration number,

-WHAT? homeopathic medicinal product, if therapeutic indications are not certified ;

-WHAT? a recommendation to the user to see a doctor if the symptoms do not disappear.

Paragraph 2, notwithstanding paragraph 1 Member States may require the Member States to apply certain provisions on labelling, which allow the possibility of :

-WHAT? price of the medicinal product,

-WHAT? conditions for reimbursement from the health insurance.

SECTIONS WE

CLASSIFICATION OF MEDICINAL PRODUCTS

Article 70

Once the competent authorities authorise the placing on the market of a medicinal product, they shall be classified as :

-WHAT? a prescribed medicinal product,

-WHAT? a non-conscription medicinal product.

The authorities shall use this purpose in accordance with the provisions of Article 71 (1). 1, stated criteria.

The competent authorities may provide for sub-categories for the medicinal products which can be provided only on prescription. In that case, they refer to the following classification :

a) (Does not concern the Danish version)

b) medicinal products for which a special prescription is required,

c) prescription-only medicines for limited supply, which only specific groups can prescribe.

ARTICLE 71

1. The prescription for medicinal products is required when they :

-WHAT? directly or indirectly may present a danger, even in normal use, if they are used without medical supervision, or

-WHAT? often and to a large extent applied under abnormal circumstances, and this directly or indirectly may be a danger to health, or

-WHAT? it contains substances or preparations containing these substances whose effect and / or adverse reactions are absolutely necessary to investigate further, or

with certain exceptions, has been prescribed by a doctor to be submitted enterally.

2. When Member States determine the sub-category of medicinal products for which a special prescription is required, the following shall be taken into account :

-WHAT? the medicinal product contains a non-exempt quantity of a substance classified as a narcotic or psychotropic substance in accordance with the international conventions (such as the UN Conventions of 1961 and 1971), or

-WHAT? the medicinal product may in abnormal use be linked to serious risk of drug abuse, causing drug addiction or to cause abuse in criminal activity ; or

-WHAT? the medicinal product contains a substance which, because it is new or has specific features, that a safeguard measure may be taken into account in the second indent of the said group.

Member States shall determine the sub-category of medicinal products for which a prescription for restricted extradition is required shall take account of :

-WHAT? the medicinal product is because of its pharmacological properties, because it is a new product, or in the interests of public health, reserved for treatments which can only be carried out in a hospital environment ; or

-WHAT? the medicinal product shall be used for the treatment of diseases to be diagnosed in a hospital environment or in institutions with appropriate diagnostic agents, whereas the import of the medicinal product and the further patient treatment may be carried out outside the hospital ; or

-WHAT? the medicinal product is intended for patients in outpatient care, but its use may cause very serious adverse reactions, which requires a prescription, where appropriate, by a specialist and a special supervision during the treatment.

4. A competent authority may derogate from the application of paragraph 1. 1, 2 and 3 in respect of :

a) the maximum single dose or the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging, and / or

b) other conditions of use which it has specified.

5. If a competent authority does not classify a medicinal product in one of the products referred to in Article 70 (4), The sub-category referred to in paragraph 2 shall nevertheless take account of the categories referred to in this Article. The criteria for determining whether a medicinal product is to be classified in the category of medicinal products that can only be prescribed on prescription are provided for in the case of 2 and 3.

Article 72

The non-concierable medicinal products are the medicinal products that do not meet the criteria as set out in Article 71.

Article 73

The competent authorities shall draw up a list of medicinal products whose extradition requires a prescription for their territory, where necessary with the indication of classification category. They shall update this list annually.

Article 74

Where new information comes to the knowledge of the competent authorities, these shall be re-examined and, where appropriate, the classification of a medicinal product in application of the criteria set out in Article 71.

Article 74a

Where a modification of the classification of a medicinal product has been approved on the basis of significant clinical or clinical trials, the competent authority shall take no account of the results of the first change in a period of one year after the approval of the first amendment ; the examination of an application by another applicant or holder of a marketing authorisation for a change to the classification of the same substance.

Article 75

Each year, the Member States shall notify the Commission and the other Member States of the amendments they have made to the list referred to in Article 73.

SECTIONS VII

Wholessnegotiation and dissemination of medicinal products

ARTICLE 76

Without prejudice to Article 6, Member States shall take appropriate measures to ensure that medicinal products are subject to only medicinal products for which marketing authorisation has been issued in accordance with Community law.

In the case of wholesandrosnegotiation and storage, the medicinal product shall be subject to a marketing authorisation in accordance with Regulation (EC) No 2, The Directive shall be 726/2004 or by the competent authority of a Member State in accordance with this Directive.

3. a distributor that does not have the marketing authorization holder and who imports a medicinal product from another Member State shall inform the holder of the marketing authorization and the competent authority of the Member State to which the medicinal product is to : import whether or not its intention to import the medicinal product concerned. In the case of medicinal products for which no authorisation has been granted under Regulation (EC) No 2. The competent authority shall be notified to the competent authority without prejudice to any additional procedures provided for in the legislation of this Member State and without prejudice to fees to the competent authority for the treatment of the notification.

4. On the subject of medicinal products for which a licence has been issued under Regulation (EC) No (EC) No, The distributor shall inform the holder of the marketing authorization and the Agency in accordance with paragraph 1 of this Article. 3. A fee shall be paid to the Agency in order to verify that the conditions laid down in EU legislation concerning medicinal products and the marketing authorization are complied with.

Article 77

1. Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the authorisation of the person in question in the possession of a licence to carry out activities such as the wholesale wholesale, the places in which the authorization is valid.

2. when persons authorized or authorised to supply medicinal products to the consumer may also exercise angeal activities under national law, they shall be subject to the provisions laid down in paragraph 1. 1 Permission granted.

3. Possession of a manufacturing authorization shall also permit the negotiation of a gros for the medicinal products covered by this authorisation. Possession of a licence to carry out activities such as a medical wholesaler does not exempt the obligation to be authorised to manufacture and to comply with the provisions laid down for this purpose, even when production or the import is done as a secondary occupation.

Member States shall provide the information on the information referred to in paragraph 1. the authorisations referred to in Article 111 (1), as referred to in Article 111 (1). At the request of the Commission or by a Member State, the Member States shall provide all useful information relating to the individual authorisations granted pursuant to this Article. 1.

5. The responsibility for carrying out the control of persons authorised to carry out the activities of the medicinal wholesalers, as well as for the inspection of the premises of the person concerned, shall be the responsibility of the Member State which has issued the premises on the premises ; its territory.

The Member State which has issued it in paragraph 1. Paragraph 1 shall suspend this or withdraw the authorization if the conditions for the authorisation are no longer present. It shall immediately inform the other Member States and the Commission thereof.

7. Estiner a Member State that the holder of a permit granted by another Member State in accordance with paragraph 1. 1 or no longer fulfils the conditions for the authorisation, it shall immediately inform the Commission and the Member State concerned. The latter Member State shall take the necessary measures and shall notify the Commission and the former Member State of the decisions it has taken and the reasons for it.

ARTICLE 78

Member States shall ensure that the procedure for the examination of the authorization procedure does not extend more than 90 days from the date on which the competent authority of the Member State concerned receives the application.

The competent authority may, where appropriate, require the applicant to submit all necessary information on the conditions of authorisation. Where the competent authority relies on this option, it shall be suspended in paragraph 1. 1 fixed period until such time as the additional information requested has been notified.

Article 79

In order to obtain the negotiating authorisation, the applicant shall at least meet the following requirements :

a) he must have appropriate and adequate premises and facilities and adequate equipment and equipment so that the medicinal products can be stored and supplied properly ;

b) he has to have qualified staff, in particular, a designated person responsible for complying with the conditions laid down in the legislation of the Member State concerned ;

c) he must undertake to fulfil the duties incumcable to him pursuant to Article 80.

Article 80

In order to obtain the negotiating authorisation, the applicant shall at least meet the following requirements :

a) to allow inspecting personnel to premises, facilities and equipment referred to in Article 79 (a) at all times ;

b) to desupply the supplies of medicinal products from persons who are in possession of a negotiated authorization, or which are exempt under Article 77 (1). 3

c) supplying medicinal products only to persons who are either in possession of a bargaining permit or as authorized by the Member State concerned to supply medicinal products to the consumer ;

ca) verify that the susceptible medicinal products were not falsified by verifying the security measures on the outer packaging, in accordance with the requirements of the provisions of Article 54a (1). 2, delegated acts

d) have prepared an emergency plan to ensure effective implementation of a withdrawal from the market by order of the competent authorities or by means of cooperation with the manufacturer of the medicinal product concerned or the marketing authorization holder ; for the medicinal product mentioned,

(e) keep records which may be available in the form of purchase and sales invoices or in the form of computer-based data or in any other form, and which, for all the received, sent or mediated medicinal products, contain at least the following : information :

-WHAT? date

-WHAT? Name of the medicinal product,

-WHAT? received, submitted or disseminated quantity ;

-WHAT? the name and address of the supplier or the recipient, as appropriate, where appropriate ;

-WHAT? the number of medicinal products concerned, at least in the case of medicinal products supplied with the safety measures referred to in Article 54 (o) ;

(f) make available to the competent authority referred to in point (e) for a period of five years for inspection purposes ;

g) comply with the principles and guidelines laid down in Article 84 for good distribution practices.

(h) have a quality system with a description of areas of responsibility, workflows and risk management measures linked to their activities ;

i) promptly notify the competent authority and, where appropriate, the marketing authorization holder, on medicinal products they receive or receive offered and which they identify as counterfeit or suspect to be falsified.

If the medicinal product has been received from another wholesaler, the holder of the wholesale distribution authorization for the purposes of point (b) shall check that the supplier wholesaler complies with the principles and guidelines of good distribution practice. This includes checking whether the supplier wholesaler is the holder of an angel negotiating licence.

If the medicinal product has been received from the manufacturer or importer, the holder of the wholes-bargaining authorization shall verify that the manufacturer or importer is the holder of a manufacturing authorization.

Where the medicinal product has been received through dissemination, the holders of the wholessing authorization shall check that the intermediaries concerned comply with the requirements laid down in this Directive.

Article 81

In the case of supplies of medicinal products to pharmacists and persons authorised or authorised to supply medicinal products to the consumer, Member States may not impose the consent of persons who have been granted permission to negotiate in another Member State ; obligations, such as public service obligations, which are more stringent than those they impose on individuals who themselves have authorised to operate a similar form of activity.

The holder of a marketing authorisation for a medicinal product and the distributors of the medicinal product concerned in actual market in a Member State shall ensure, within the framework of their responsibility, the appropriate and continued delivery of this medicinal product to pharmacies, and persons authorized to supply medicinal products in such a way that the needs of patients in the Member State concerned are covered.

The detailed rules for the application of this Article shall also be justified in the protection of public health and shall be proportionated to the objective of such protection in accordance with the provisions of the Treaty, in particular the provisions of the provisions of the Treaty ; on free movement of goods and competition.

Article 82

For all supplies of medicinal products to a person authorized by the Member State to supply medicinal products to the consumer, the wholesalers shall be authorised to provide the necessary supporting documents for :

-WHAT? date

-WHAT? the name and form of the medicinal product,

-WHAT? quantity supplied,

-WHAT? the name and address of the supplier and the recipient,

-WHAT? the number of the medicinal product, at least in the case of medicinal products supplied with the security measures referred to in Article 54 (o).

Member States shall take the appropriate measures to ensure that persons authorised or authorised to supply medicinal products to consumers are able to provide information to enable the following chain of action to be followed ; distribution stages which each medicinal product has been through.

Article 83

The provisions of this Title shall not preclude the application of stricter provisions on wholessnegotiation procedures for a Member State :

-WHAT? of narcotic or psychotropic substances in its territory ;

-WHAT? of medicinal products derived from blood ;

-WHAT? of immunological medicinal products,

-WHAT? of radioactive medicinal products.

ARTICLE 84

The Commission shall publish guidelines for good distribution practices. It shall be used for this purpose by the Committee for Medicinal Products for Medicinal Products for Medicinal Products, as well as by Council Decision 75 /320/EEC (*) established medicinal products.

(*) OJ L 147, 9.6.1975, p. 23.

Article 85

The provisions of this Title shall apply to homeopathic medicinal products.

Article 85a

Article 76 and Article 80 (c) shall not apply to wholessnegotiation of medicinal products to third countries. In addition, Article 80 (b) and (ca) shall not apply when a medicinal product is received directly from a third country but not imported. The requirements referred to in Article 82 shall apply to the provision of medicinal products to persons in third countries who have the right or the right to supply medicinal products to the public.

Article 85b

1. Pager that mediate medicinal products shall ensure that the medicated medicinal products are subject to a marketing authorisation issued under Regulation (EC) No 2. Directive 726/2004 or by the competent authorities of a Member State in accordance with this Directive.

Persons providing medicinal products must have a fixed address and contact information in the Union in order to ensure accurate identification, localisation and communication, and to enable the supervision of the competent authorities to monitor their activities.

The requirements of Article 80 (d) (i) shall apply mutatis mucous use to the dissemination of medicinal products.

2. only persons registered by the competent authority of the Member State in which they have a fixed address, cf. paragraph 1, mediate medicinal products. These people shall state at least their name, company name and fixed address for registration. They shall inform the competent authority of any modification thereof without unnecessary delay.

People who are medicated on drugs and who started their business before the 2nd. In January 2013, a register shall be registered by the competent authority no later than 2. March, 2013.

The competent authority shall establish the information referred to in the first subparagraph in a public record.

The guidelines referred to in Article 84 must contain specific provisions for dissemination.

This Article shall be without prejudice to Article 111. The inspection visits referred to in Article 111 shall be carried out under the responsibility of the Member State in which the person who is medicinal products is registered.

If a person who mediate medicinal products is not subject to the requirements of this Article, the competent authority may decide to remove the person concerned from the provisions of paragraph 1. paragraph 2. The competent authority shall inform the person concerned thereof.

SECTION VIIA

DISTANCE SELLING TO THE PUBLIC

Article 85c

The Member States shall ensure that the distance selling of medicinal products to the public is offered to the public by means of services provided for in the information society in the information society of the information society in the information society in the information society of the information society shall be provided in the information society ; The information society as defined in Directive 98 /34/EC of the European Parliament and of the Council of 22. June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and rules on information society services ; 28) , under the following conditions :

a) the natural or legal person who provides medicinal products has the right or the right to provide medicinal products to the general public, including in distance selling, in accordance with national law of the Member State where they are established ;

b) the person referred to in (a) has, as a minimum, notified to the Member State in which the person is established, the following information :

In. the name or business name and fixed address of the place of business from which these medicinal products are delivered ;

(ii) the date of the beginning of the undertaking to offer the distance selling of medicinal products to the general public by means of the information society ;

iii. the address of the website used for this purpose, and any relevant information necessary for identification of this site ;

Oh, my. where appropriate, the classification in accordance with Title VI of the medicinal products offered to the public by means of distance selling via services in the information society.

Information will be updated if necessary

c) the medicinal products comply with the national legislation of the Member State of destination in accordance with Article 6 (1). 1

d) without prejudice to the information requirements laid down in Directive 2000 /31/EC of the European Parliament and of the Council of 8. June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Single Market (the 'Directive on electronic commerce') 29) , contains the website that provides the medicinal product (s), as a minimum :

In. the contact information of the competent authority or the authority designated pursuant to (b) ;

(ii) a hyperlink to the one in paragraph 1. 4 referred to in the Member State of establishment,

iii. the one in paragraph 1. 3 the joint logo, clearly placed on each side of the website which relates to the distance selling of medicinal products to the public. The common logo must include a hyperlink for the construction of the person on the one in paragraph 1. 4 (c), list referred to.

Member States may, with justification for the protection of public health, introduce conditions for retail sales in their area of distance marketing of medicinal products to the public through services in the information society.

3. A common logo must be established which is recognisable throughout the Union and, at the same time, making it possible to identify the Member State in which the person offering the distance selling of medicinal products to the general public is established. The logo shall be clearly positioned on websites providing medicinal products to the general public in distance selling in accordance with paragraph 1. 1 (d).

The Commission must, in order to harmonise the way in which the common logo works, adopt implementing acts relating to :

a) the technical, electronic and cryptographic requirements for the control of the authenticity of the common logos ;

b) the design of the common logo.

These implementing acts must, if necessary, be amended in order to take account of technical and scientific developments. The implementing acts shall be adopted in accordance with the procedure referred to in Article 121 (1). 2.

4. Each Member State shall establish a website that contains at least the following :

a) information on the existing national legislation applicable to the provision of medicinal products to the general public by means of distance marketing by services in the information society, including information on the differences between Member States when it comes to classification ; of medicinal products and the conditions for delivery of such products ;

b) information on the purpose of the common logo ;

c) the list of persons offering the distance selling of medicinal products to the public via services in the information society in accordance with paragraph 1. 1 and addresses of their websites

d) background information on the risks associated with the illegal supply of medicinal products to the public through services in the information society.

This site must contain a hyperlink to the item in paragraph 1. 5 related website.

5. The Agency shall establish a website that provides for the application of the provisions of paragraph 1. The information referred to in paragraph 4 (b) and (d), information on applicable EU legislation concerning falsified medicinal products, as well as hyperlinks to the websites of the Member States, cf. paragraph 4. The Agency ' s website shall explicitly mention that the websites of the Member States contain information about persons authorised or entitled to provide medicinal products to the public via distance-selling via services in the information society in the information society ; Member State concerned.

Subject to Directive 2000 /31/EC and the requirements of this Title, Member States shall take the necessary measures to ensure that other persons other than those referred to in paragraph 1. Paragraph 1, which provides the public with medicinal products for distance selling in the information society and operates in their territory, will be subject to effective, proportionate and dissuasive sanctions.

Article 85d

Without prejudice to the powers of the Member States, the Commission shall, in cooperation with the Agency and the competent authorities of the Member States, provide information campaigns aimed at the general public of the dangers of falsified medicinal products. These campaigns must increase consumers 'awareness of the dangers of medicinal products delivered illegally by distance selling to the public by services in the information society, and on the feature of the common logo, Member States' websites and the Agency ' s activities ; Web site.

TITLE (II)

ADVERTISING

ARTICLE 86

For the purposes of this Title, ' advertising of medicinal products ` means any form of information-seeking establishment, a customer search or shelf-life which aims to promote the prescribed, supply, sale or consumption of medicinal products ; this includes in particular :

-WHAT? public advertising of medicinal products,

-WHAT? advertising of medicinal products for persons empowered to prescribe or supply medicinal products ;

-WHAT? visits by the pharmaceutical consultants to persons empowered to prescribe or supply medicinal products ;

-WHAT? the supply of samples,

-WHAT? incitement to prescribe or extraditing medicinal products by providing, offering or promising pekunirites, or benefits in kind of kind, except when the true value of which is not insignificant ;

-WHAT? sponsorship of advertising meetings taking part of persons empowered to prescribe or supply medicinal products ;

-WHAT? sponsorship of scientific congresses in which persons are entitled to prescribe or supply medicinal products, and in particular the maintenance of these persons for transport and residence in this context.

2. This section shall not apply to :

-WHAT? the labelling and package leaflet covered by the provisions of Section V,

-WHAT? correspondence, where appropriate, accompanied by a document of non-advertising nature necessary to answer a specific question of a specific medicinal product,

-WHAT? specific information and documentation concerning f. Exes. changes in the packaging, warnings to adverse reactions as part of the pharmacovigilance and the sales tax and price lists provided they do not contain any information on the medicinal products ;

-WHAT? information on health and disease in humans, insofar as it is not directly or indirectly referred to in a medicinal product ;

Article 87

Member States shall prohibit any form of advertising of a medicinal product for which no marketing authorisation has been granted under Community law.

2. All details in an advertisement for a medicinal product shall be consistent with the information given in the summary of the product characteristics.

3. Advertising for a medicinal product :

-WHAT? furnishing the rational use of the medicinal product by presenting it objectively and without exaggerating its properties ;

-WHAT? must not be deceptive.

Article 88

1. Member States shall prohibit advertising to the general public for medicinal products :

a) there are prescription-only, in accordance with Title VI ;

b) containing psychotropic or narcotic substances, as defined in international conventions, such as the UN Conventions of 1961 and 1971.

2. Advertising to the public is permitted for medicinal products which, by virtue of their composition and purpose, are intended to be used without the prior medical diagnosis, prescription or without medical supervision of the treatment, but of : required by reference from the pharmacy.

Member States may prohibit advertising to the general public in their territory to grant access to eligible medicinal products.

4. the tender in paragraph 1. Paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.

The prohibition in paragraph 5. Paragraph 1 shall apply unless otherwise provided for in Article 14 of Directive 89 /552/EEC.

6. Member States prohibit the industry from carrying out direct distribution of medicinal products to the public in advertising.

TITLE VIIIa

INFORMATION AND ADVERTISING

Article 88a

Before the expiry of three years from the date of entry into force of Directive 2004 /726/EC, the Commission shall submit, after consultation with patients, doctor and pharmacists, Member States and other interested parties, the European Parliament and the Council, report on the current practice in the field of information, including, inter alia, the Internet, and the associated risks and benefits for patients.

Following an analysis of the above data, the Commission shall, where appropriate, draw up a proposal for an information strategy that ensures good, objective, reliable and advertising information on medicinal products and other treatments, and shall deal with the issue of the responsibility which, shall be the source of information.

ARTICLE 89

Without prejudice to Article 88, any public advertisement for a medicinal product shall :

a) is designed in such a way as to clearly identify the nature of the advertising and the product as a medicinal product ;

b) include, at least :

-WHAT? the name of the medicinal product and the common name, where the medicinal product contains only one active substance,

-WHAT? the information necessary for the proper use of the medicinal product,

-WHAT? an express and indelible invitation to read carefully the instructions given in the case of the package leaflet or on the outer packaging.

2. Member States may provide that advertising to the general public for any medicinal product may be in any way. 1 may be limited to the name of the medicinal product or the international common name provided that such a name exists or the trade mark when the commercial is intended solely to serve as a reminder.

Article 90

Public advertisements for a medicinal product must not contain details which :

a) gives the impression that it is superfluous to consult a doctor or to have a surgical intervention, in particular by quotation or recommendation of treatment by the Commission. correspondence

b) suggests that the effects of the medicinal product are safe, are without side effects and may be better or as good as the effect of another treatment or medicinal product ;

c) suggests that the general well-being of the target may be improved through the use of the medicinal product,

d) suggests that the general well-being of the target person may be reduced if he does not use the medicinal product ; this prohibition shall not apply to vaccination campaigns as referred to in Article 88 (1). 4

(e) exclusively or principally addressed to children,

(f) refers to a recommendation from researchers, medical persons or persons who, even though they are neither scientists or medical people, in the power of their ability to encourage the consumption of medicinal products ;

g) equating the medicinal product with a foodstuff, a cosmetic product or other consumer product ;

(h) indicates that the safety of the medicinal product or its effectiveness is due to the fact that it is a natural substance,

i) in the case of a description or detailed production of the presumes, the target person may lead to the wrong diagnosis,

j) on an excessive, frightening or misleading manner referring to a statement on health,

c) on an excessive, alarming or deceptive way, the use of visual posts of changes in the human body caused by disease or lesions, or of an impact of a medicinal product on the human body or parts thereof.

Article 91

1. Any advertising of medicinal products intended for persons empowered to prescribe or supply medicinal products shall include :

-WHAT? the relevant information which is compatible with the summary of the product characteristics ;

-WHAT? the supply classification of the medicinal product.

Member States may also require this advertising to include the selling price or the indicative price for the various packages and the conditions for reimbursement through the health insurance.

2. Member States may provide that advertising of a medicinal product intended for persons empowered to prescribe or extradites this medicinal product, notwithstanding paragraph 1, may be advertided. 1 may be limited to the name of the medicinal product or the international common name provided that such a name exists or the trade mark when the commercial is intended solely to serve as a reminder.

Article 92

1. all information relating to a medicinal product to be sent to persons empowered to prescribe or supply this medicinal product shall be at least in the light of the products referred to in Article 91 (1). 1, mentioned information and indicate the date on which it was produced or last amended.

2. All the information in the information referred to in paragraph 1 1 mentioned material must be accurate, current, verifiable and sufficiently detailed to the consignee to form a personal opinion on the therapeutic value of the medicinal product.

The third quotes, tables and other illustrations obtained from medical journals or scientific works which are used in the provisions of paragraph 1. 1 the information material referred to shall be disloyal, and the exact source must be reported.

Article 93

1. The medicinal product consultants shall have adequate training for the company they are working for and possess the necessary technical knowledge so that they can provide as precise and complete information as possible on the medicinal products they are available ; prefato.

During each visit, the pharmaceutical consultants shall, for each of the medicinal products listed, give the person who visits, or make to his outline a summary of the characteristics of the product, which, if the Member State ' s legislation, permit it to be supplemented with the information on prices and reimbursement conditions referred to in Article 91 (1). 1.

3. Medicinal consultants shall provide the one in Article 98 (3). The scientific service referred to in paragraph 1 shall provide all information on the use of the medicinal products for which they are seeking to facilitate the sale of, in particular the information they receive on adverse reactions from those of whom they have paid visits.

ARTICLE 94

1. In the promotion of the sale of medicinal products to persons empowered to prescribe or hand over the medicinal products concerned, it is prohibited to provide, offer or promise these persons shall be eligible, pekuniamy benefits or benefits in kind of kind, unless they are of insignificant value and are in the practice of the practice of the doctor-or the pharmacist.

2. Representation in connection with promotional events for medicinal products must always be strictly limited to the main purpose of the meeting and must not include other people other than health professionals.

3. Persons empowered to prescribe or supply medicinal products shall not ask for or receive any of the services prohibited under paragraph 1. Paragraph 1, or which is contrary to paragraph 1, 2.

4. The measures or commercial practices which in the Member States apply to prices, merit margins and discounts shall not be affected by paragraph 1. One, two and three.

Article 95

The provisions of Article 94 (1). 1, non-direct or indirect representation in the event of purely professional and scientific arrangements ; such representation must always be strictly limited to the scientific purpose of the event ; it may not include : Other than health professionals.

Article 96

1. Free samples for persons empowered to prescribe medicinal products shall be provided in exceptional circumstances and in the following conditions :

a) only a limited number of samples of each medicinal product should be provided for each year of each authorized person,

b) each supply of samples requires that the authorized person has submitted a written, dated and signed request ;

c) in the cases of persons supplying samples, an appropriate system must be introduced for the implementation of the checks and the determination of liability ;

d) each sample must not be larger than the minimum gasket marketed,

(e) each sample must wear the "free medicine test for sale" or any other inscribe of equivalent significance ;

(f) each sample must be accompanied by a copy of the summary of the product characteristics ;

g) the tests on medicinal products containing psychotropic or narcotic substances in accordance with international conventions, such as the UN Convention of 1961 and 1971, must not be extradite.

2. Member States may further restrict the distribution of samples of certain medicinal products.

Article 97

Member States shall ensure that adequate and effective means of control of advertising for medicinal products are available. Any such means, which may be based on a system of prior control, must in any case include legal provisions whereby persons or organisations which, in accordance with national law, have a legitimate interest in the establishment of a decommissioned ; the prohibition of a commercial commercial which is incompatible with this paragraph may bring the subject of the right to a prohibition on the advertisement concerned or to bring the case to an administrative body responsible for deciding whether or not to take a decision on : Complains or to initiate appropriate prosecution.

2. Within the limits of the provisions referred to in paragraph 1. The provisions of this Article shall apply to the courts or administrative bodies, provided that they consider that such measures are necessary in the interests of all the interests concerned and in particular of the interests of society :

-WHAT? to provide for the setting of misleading advertising or to initiate appropriate legal proceedings in order to impose an invitation to such advertising ;

or

-WHAT? prohibit such advertising or to initiate appropriate legal proceedings in order to ensure that the misleading advertising is prohibited, provided that it has not yet reached the public, but its publication is imminent, even if there is no proof of any evidence ; in the face of the fact that there is actually a loss or damage, or that there is a question of presets or negligence on the part of the advertisement.

Member States shall take the provision of the provisions of paragraph 1. 2 the measures referred to may be taken as part of an accelerated procedure, either with a preliminary effect or with a definitive effect.

It shall be for each Member State to decide which of the two options referred to in the first subparagraph of paragraph 1 shall be chosen.

4. Member States may, in order to remove the aftermath of a misleading advertising imposed on a final decision, shall apply the courts or administrative authorities to :

-WHAT? to call for this decision to be made public, either in its entirety or in deductions and in a form which the court or authorities consider appropriate ;

-WHAT? to require further publication of an enrichment. Paragraph 1-4 does not preclude the use of voluntary checks on advertising for medicinal products by independent bodies, which may also examine complaints where a procedure has been established for such bodies in addition to those referred to in paragraph 1. 1 of the legal and administrative procedures provided for.

ARTICLE 98

1. The holder of the marketing authorization shall establish within its activities a scientific service which is responsible for providing information about the medicinal products placed on the market by the undertaking.

2. The marketing authorization holder shall :

-WHAT? ensure that a copy of all of the undertaking ' s advertisements, together with an indication of the recipients, the distribution and the date of the first distribution, shall be made available to the authorities or bodies responsible for the purpose of the operation ; checks on advertising of medicinal products, or forwarded to them ;

-WHAT? ensure that the advertising of medicinal products for medicinal products is in accordance with the requirements of this Title ;

-WHAT? verifies that the pharmaceutical consultants employed by the company shall have appropriate training and comply with the obligations imposed on them in accordance with Article 93 (1). 2 and 3

-WHAT? gives the authorities or bodies responsible for conducting checks on the advertising of medicinal products, the information and the assistance they are requesting for the exercise of their powers ;

-WHAT? ensure that decisions taken by the authorities or bodies responsible for carrying out the control of advertising of medicinal products are complied with immediately and fully.

3. Member States shall not prohibit the marketing authorization holder by one or more undertakings designated by this undertaking for the marketing of medicinal products.

Article 99

Member States shall take the appropriate measures to ensure that the provisions of this Title are implemented and shall in particular lay down the penalties to be applied in the event of a breach of the provisions adopted in the implementation of : this section.

Article 100

Advertising for the measures referred to in Article 14 (2). The provisions of homeopathic medicinal products referred to in this Title shall be subject to the provisions of this Title, except for Article 87 (2) ; 1.

However, only those referred to in Article 69 (2) shall apply. The information referred to shall be used in advertising for such medicinal products.

TITLE IX

PHARAOVIGILANCE

CHAPTER 1

General provisions

Article 101

In order to be able to carry out their pharmacovigilance missions and participate in the Union's pharmaceutical monitoring activities, Member States shall apply a pharmacovigilance system.

The medicinal product monitoring system shall be used to gather information on the risks to the health or public health of patients associated with medicinal products. This information shall concern, in particular, adverse reactions to persons resulting from the use of the medicinal product in accordance with the marketing authorization and any use outside the terms of the marketing authorization and side effects associated with occupational exposure.

2. Using the provisions of paragraph 1 (2). The pharmacovigilance referred to by the Member States shall carry out a scientific evaluation of all information, consider the possibility of risk inimming and prevention, and shall take legislative measures in respect of : marketing authorization, if necessary. They shall review the pharmacovigilance system regularly and report the results to the Commission by 21. September 2013, and then every two years.

3. Each Member State shall designate a competent authority for the performance of pharmacovigilance.

4. The Commission may ask the Member States to participate, under the coordination of the Agency, in international harmonisation and the standardisation of technical measures in the field of pharmacovigilance.

ARTICLE 102

Member States :

a) take all appropriate measures to encourage patients, doctors, pharmacists and other health professionals to report suspected adverse reactions to the national competent authority ; with a view to the taking of these tasks, the competent authorities may, where appropriate, be capable of taking the appropriate action ; the involvement of consumer organisations, patient organisations and organisations representing health professionals ;

b) promotes patient reporting through the availability of alternative reporting formats in addition to web-based formats ;

c) take all necessary measures to obtain accurate and verifiable data for the scientific evaluation of the reported adverse reactions ;

d) ensure that the general public receives important information on concerns based on pharmacovigilance relating to the use of medicinal products, via publication on the web portal and via other public information channels, if necessary ;

(e) shall ensure, by means of the collection of information and, where necessary, by monitoring of reports on suspected adverse reactions, that all necessary measures are taken to identify all biological medicinal products prescribed, supplied or sold ; in their territory and which are the subject of a report on suspected adverse reactions, taking due account of the name of the medicinal product (in accordance with Article 1 (2), 20) and batch number

(f) shall take the necessary measures to ensure that a holder of a marketing authorization that does not comply with the conditions laid down in this Title shall be subject to penalties which are effective, proportionate and proportionate to the grooves of the infringement ; dissuasive.

For the purposes of applying the first subparagraph (a) and (e), Member States may impose special obligations on doctors, pharmacists and other health professionals.

Article 103

A Member State may delegate tasks assigned to it pursuant to this Title to another Member State if it is authorised by written authorization. A Member State may not represent more than one Member State.

The delegating Member State shall inform the Commission, the Agency and other Member States in writing, concerning the delegation. The delegating Member State and the Agency shall publish such information.

ARTICLE 104

1. for the purpose of the taking of its pharmacovigilance duties, the holder of the marketing authorization shall use a pharmacovigilance system corresponding to the pharmacovigilance of the relevant Member State in Article 101 (1). 1.

2. Using the provisions of paragraph 1 (2). 1 the pharmacovigilance referred to by the holder of the marketing authorization shall be subject to scientific evaluation, to consider the possibility of risk inimming and prevention and shall take appropriate measures if necessary.

The marketing authorization holder shall carry out a periodic review of its pharmacovigilance system. He places a note on the most important results of the revision in the master file for the pharmacovigilance system and shall ensure, on the basis of the audit findings, that a plan for appropriate corrective measures shall be prepared and implemented. Once the corrective measures have been implemented in full, the note can be removed.

3. As part of the pharmacovigilance system, the holder of the marketing authorization shall :

a) have at all times a person who is sufficiently qualified to be available to be responsible for pharmacovigilance,

b) lead and at the request of a master file for the pharmacovigilance system,

c) use a risk management system for each medicinal product ;

d) monitor the result of the risk inimming measures included in the risk-management systems or as conditions in the marketing authorization pursuant to Article 21a, 22 or 22a ;

(e) update the risk management system and monitor pharmacovigilance data to determine whether there are new or changed risks, or whether there are changes in the relationship between benefits and risks of medicinal products.

The qualified person referred to in point (a) of the first subparagraph shall be a resident and carry out its work within the Union and shall be responsible for the establishment and operation of the pharmacovigilance system. The holder of the marketing authorization shall forward the name and contact information of the expert person to the competent authority and the Agency.

Notwithstanding the provisions of paragraph 1, The competent authorities of the Member States may request that a contact person be appointed for pharmacovigilance issues at national level, which shall report to the experts responsible for pharmacovigilance.

Article 104a

Paragraph 1, subject to the provisions of paragraph 1 of this Article. 2, 3 and 4 of the marketing authorization shall be holders of marketing authorisations issued before 21. July 2012 as an exception to Article 104 (1). Paragraph 3 (c) shall not be subject to the requirement to apply a risk management system for each medicinal product.

2. The national competent authority may impose an obligation on the holder of a marketing authorisation to use a risk management system, cf. Article 104 (1). 3 (c), if there are concerns concerning the relationship between the benefits and risks of an approved medicinal product. In this context, the national competent authority shall also impose an obligation on the marketing authorization holder to present a detailed description of the risk-management system he intends to adopt for the medicinal product concerned.

The submission of such obligations shall be informed in writing and shall contain a time frame for the submission of the detailed description of the risk management system.

3. The competent authority of the national competent authority shall provide the holder of the marketing authorization to submit written comments concerning the obligation to impose the obligation within a time limit to be fixed by the competent authority if the holder of : the marketing authorization shall request that effect within 30 days of receipt of the written notification of the obligation.

On the basis of written comments made by the holder of the marketing authorization holder, the national competent authority shall withdraw the obligation or confirm it. Where the national competent authority confirms the obligation, the marketing authorization shall be amended accordingly, so that the measures to be contained in the risk-management system are subject to conditions for placing the marketing authorization on the market ; referred to in Article 21a (a).

Article 105

The management of funds allocated to activities related to pharmacovigilance, the functioning of communications networks and market surveillance shall be monitored continuously by the national competent authorities to ensure their independence ; the exercise of mentioned pharmaceutical monitoring activities.

Paragraph 1 shall not preclude the fact that the national competent authorities shall charge the holders of marketing authorisations for the execution of these activities by the competent national authorities, provided that they are strictly guaranteed for their independence ; the exercise of mentioned pharmaceutical monitoring activities.

CHAPTER 2

Transparency and communication

Article 106

Each Member State shall establish and manage a national web portal for medicinal products, which shall be in the context of the European web portal on medicinal products created in accordance with Article 26 of Regulation (EC) No 2. 726/2004. Through the national web portals for medicinal products, Member States shall make at least the following information publicly available :

a) public evaluation reports, accompanied by summaries thereof,

b) product summaries and leaflets ;

c) the aggrection of risk management plans for medicinal products approved in accordance with this Directive ;

d) the list of medicinal products, cf. Article 23 of Regulation (EC) No, 726/2004

(e) information on the various ways in which health workers and patients may report suspected adverse reactions to medicinal products to the competent national authorities, including the web-based structured forms referred to in Article 25 of Regulation (EC) No, 726/2004.

Article 106a

1. The marketing authorization holder is intended to publish information on concerns based on pharmacovigilance on the use of a medicinal product and, at the same time, at the same time as or before its publication shall inform the competent national competent authority, the Agency and the Commission thereof.

The holder of the marketing authorization shall ensure that information to the public is presented in an objective and not misleading manner.

2. Unless the early publication is required for the protection of public health, Member States, the Agency and the Commission shall inform each other at least 24 hours before the publication of information on concerns based on : pharmaceutical surveillance.

3. For the active substances in medicinal products approved in several Member States, the Agency shall be responsible for coordinating national security communications by national competent authorities and sets timetables for the publication of information.

Coordinated by the Agency Member States shall make every reasonable effort to reach agreement on a joint communication on the security of the medicinal product and a timetable for their communication. The Committee on Risk Assessment shall advise on the request of the Agency for these security notifications by the Agency for the Evaluation of Medicinal Products.

4. When the Agency or national competent authorities shall publish the information referred to in paragraph 1. The information on personal or commercially confidential shall be omitted, unless the disclosure of such information is necessary for the protection of public health.

CHAPTER 3

Registration, reporting and evaluation of pharmacovigilance data

Section 1

Recording and reporting of suspected adverse reactions

Article 107

1. The holder of the marketing authorization shall record all suspected adverse reactions in the Union or in third countries that he is aware of, whether they are reported spontaneously by patients or health-care professionals or whether they are found in connection with an examination of the marketing authorization.

The holder of the marketing authorization shall ensure that these reports are available in one place within the Union.

Notwithstanding the first subparagraph, the suspected adverse reactions detected in a clinical trial, in accordance with Directive 2001 /20/EC, shall be recorded.

2. The holder of the marketing authorization shall not refuse to deal with reports of suspected adverse reactions to which patients and health-care professionals submit electronic or other appropriate ways.

3. The holder of the marketing authorization shall electronically transmit to the database and the data referred to in Article 24 of Regulation (EC) No (3). The holder of the marketing authorization. 726/2004 ("Eudravigilance database") knowledge of the incident shall be known within 15 days of the marketing authorization holder.

The marketing authorization holder shall electronically submit information on all non-serious presumed adverse reactions established within the Union within 90 days of the marketing authorization holder knowledge of the incident.

In the case of medicinal products containing the active substances referred to in the list of publications monitored by the Agency pursuant to Article 27 of Regulation (EC) No 2, 726/2004, the marketing authorization holder is not subject to a requirement to report to the Eudravigilance database of the supposed adverse reactions recorded in the medical literature indicated in the list, but he shall supervise all the second medical literature and report all suspected side effects.

4. The marketing authorization holder shall be required to establish procedures for obtaining accurate and verifiable data for the use of the scientific evaluation of reported adverse reactions. He shall also obtain the following information on these reports and report updates to the Eudravigilance database.

5. The marketing authorization holder shall cooperate with the Agency and the Member States on tracing of the duplication of the presumed adverse reactions.

Article 107a

1. Each Member State shall record all suspected adverse reactions that have been identified in its territory, as health professionals and patients have pointed out. In order to comply with the provisions of Article 102 (c) and (e), Member States shall involve, where appropriate, patients and health-care professionals in the follow-up on all reports received by them.

Member States shall ensure that reports of such adverse effects may be transmitted by means of the national web portals on medicinal products or in a different way.

In the case of reports of a marketing authorisation holder, Member States may include the marketing authorization holder in the follow-up on the reports in the case of the territory of which the alleged adverse reaction occurred.

3. Member States shall cooperate with the Agency and the holders of marketing authorisations for tracing of the presumed adverse reactions of a double alert.

4. Not later than 15 days after receipt of the reports referred to in paragraph 1. 1 on serious suspected side effects shall be sent by the Member States via electronic route to the Eudravigilance database.

No later than 90 days after receipt of the reports referred to in paragraph 1. 1 transmitting by electronic means the non-serious suspected side effects of the Eudraids database.

The holder of the marketing authorization shall have access to such reports via the Eudraids database.

5. Member States shall ensure that reports of suspected adverse reactions as a result of drug-related malfunction, which they are aware of, are made available to the Eudravigilance database and for the authorities, bodies, organisations and / or institutions which are ; responsible for patient safety in the Member States. They shall also ensure that all responsible authorities for medicinal products in the Member States are informed of all suspected adverse reactions to which any other authority in the Member States are aware. These reports shall be appropriately identified in the provisions laid down in Article 25 of Regulation (EC) No 2, The forms shall be 726/2004.

The individual Member States shall not impose additional obligations on the holder of the marketing authorization holder with regard to the reporting of suspected adverse reactions, unless justified on the basis of results of pharmacovigilance activities.

Section 2

Periodic security alerts

Article 107b

1. The marketing authorisations holders shall submit periodical, updated safety reports for the Agency which contain :

a) summaries of information relevant to the assessment of the benefits and risks of the medicinal product, including the results of all studies containing an analysis of the potential consequences for the marketing authorization ;

b) a scientific evaluation of the relationship between the benefits and risks of the medicinal product,

c) all information on the quantity of sales of the medicinal product and all information on the length of the medicinal product for the marketing authorization holder, including an estimate of the size of a population exposed to the medicinal product.

The evaluation referred to in (b) shall be based on all available information, including information from clinical trials, in the case of non-approved indications and populations.

The periodical, updated security reports will be sent electronically.

The Agency shall make the provisions referred to in paragraph 1. the security reports referred to in paragraph 1 shall be made available to the competent national authorities, the members of the Committee on Risk Assessment, in the field of medicinal products, the Committee for Medicinal Products for Human Medicinal Products and the Coordination Group, by means of it in Article 25a of Regulation (EC) No, Archive 726/2004.

3. As an exception to paragraph 1. 1 the marketing authorisation holder of a medicinal product shall be subject to the marketing authorization. Article 10 (1). 1, or Article 10a, and the holder of records for a medicinal product, cf. Articles 14 or 16a, submitted periodical, updated safety reports for such a medicinal product in the following cases :

a) where such an obligation is established as a condition of the marketing authorization in accordance with Article 21a or Article 22, or

b) where they are requested by a competent authority on the basis of concerns concerning pharmacovigilance data or as a result of a lack of periodic, updated security reports concerning an active substance following the issue of : marketing authorization. The evaluation reports relating to the required periodic, updated security reports shall be sent to the Committee on Risk Assessment in the field of Medicinal Products, which takes a position on whether there is a need for a single evaluation report for all marketing authorisations for medicinal products containing the same active substance and, if so, shall inform the Coordination Group or the Committee for Medicinal Medicinal Products for Human Use for the purpose of applying the procedures laid down in Article 107c (2). 4, and Article 107e.

Article 107c

1. The frequency of the presentation of the periodical, updated security reports shall be specified in the marketing authorization.

The date of presentation in accordance with the frequency specified shall be calculated from the marketing authorization date.

2. The marketing authorizations issued before the 21. July 2012, and for which projections of progress and dates for the periodic safety reports which have been updated are not provided as a condition of the marketing authorization, they shall submit to periodic safety reports in : conforms to the second subparagraph of another presentation, or other presentation dates, to be determined in the marketing authorization or decided in accordance with paragraph 1. 4, 5 or 6.

Periodic safety reports shall be submitted to the competent authorities as soon as it is requested, or in accordance with the following :

a) if a medicinal product is not yet placed on the market, at least six months after the marketing authorization, and until the medicinal product is marketed,

b) a medicinal product has been marketed, at least every six months after the first two years after the first marketing year, for the following two years and every three years thereafter.

Paragraph 3 shall also apply to medicinal products approved only in one Member State and on what paragraph 1. 4 shall not apply.

4. If medicinal products for which various marketing authorisations have been issued, the same active substance or combination of active substances contains the same active substance, the frequency and dates of the periodic table, updated, updated ; safety reports resulting from the application of paragraph 1. 1 and 2 are amended and coordinated so that a single assessment may be carried out within the framework of a procedure for the division of labour around periodic, updated safety reports and a reference date for an EU reference date from which : the production dates shall be calculated.

This harmonized presentation of the reports and the EU reference date may be determined after consultation with the Committee on Risk Assessment in the Evaluation of Medicinal Products :

a) either by the Committee for Medicinal Products for Human Medicinal Products, where at least one of the marketing authorisations for medicinal products containing the active substance in question is issued following the centralised procedure laid down in Chapter 1 of Title II of Regulation (EC) No 2. 726/2004

b) or, in other cases, the coordination group other than those referred to in (a).

The Agency shall publish the harmonized frequency of attuned frequency of safety reports as provided for in the first and second subparagraphs of this Annex. The holder of a marketing authorisation shall, in accordance with this, submit an application for a change to the marketing authorization.

For the purposes of paragraph 5. 4 is the reference date of the EU reference date for medicinal products containing the same active substance or the same combination of active substances, one of the following :

a) the date of the first marketing authorisation in the Union of a medicinal product containing this active substance, or the combination of active substances,

b) if the date set out in (a) cannot be determined, the earliest of the known dates for marketing authorisations for medicinal products containing this active substance or the combination of active substances.

6. holders of marketing authorisations may, for one of the following reasons, request the Committee for Medicinal Products for Human Medicinal Products or the Coordination Group to establish the EU reference date or change the frequency of the presentation of the relevant periodic table ; security reports :

a) on public health,

b) in order to avoid overlapping assessments,

c) in order to achieve international harmonisation.

Such requests shall be submitted in writing and duly substantiated. After consulting the Committee on Risk Assessment in the Evaluation of Medicinal Products, the Committee on Medicinal Products for Medicinal Products or Coordination Group shall be dissumed by the Committee on Medicinal Products. In the event of a change to the reference dates or the frequency of the periodic table, updated security reports, the Agency shall publish a notification thereof. The marketing authorisation holders shall submit an application for a change to the marketing authorization.

7. The Agency shall publish a list of EU reference dates and the frequency of presentation of the periodical, updated safety reports via the European web portal on medicinal products.

All changes to the presentation dates and the frequency of the projections of the periodic, updated safety reports which are specified in the marketing authorization as a result of the application of paragraph 1. 4, 5 and 6, shall enter into force six months after their publication.

Article 107d

The national competent authorities shall assess the periodic, updated security reports to determine whether there are new or changed risks or whether there are changes in the relationship between the benefits and risks of medicinal products.

Article 107e

1. An assessment of the periodic, updated safety reports for medicinal products approved in several Member States shall be carried out, and in the cases referred to in Article 107c (3). 4, 5 and 6, for all medicinal products containing the same active substance or the same combination of active substances, and for which an EU reference date and the provision of presentation for the periodic safety reports have been updated.

This assessment shall be made by one of the following :

a) a Member State designated by the Coordination Group if none of the marketing authorisations concerned have been issued in accordance with the centralised procedure laid down in Chapter 1 of Title II of Regulation (EC) No 2. 726/2004

b) a Rapporteur which the Committee on Risk Assessment has designated, if at least one of the marketing authorisations concerned has been issued following the centralised procedure laid down in Chapter 1 of Title II of Regulation (EC) No (EC) No (EC) No (EC) No (EC) No (EC) No (EC) No (EC) 726/2004.

In selecting a Member State pursuant to the second subparagraph of subparagraph (a), the coordination group shall take account of the operation of a Member State as a reference Member State in accordance with Article 28 (1). 1.

2. Member State or report shall draw up an evaluation report within 60 days of receipt of the periodic safety notification report and shall forward it to the Agency and the Member State concerned. The Agency shall forward the report to the holder of the marketing authorization.

Within 30 days of receipt of the assessment report, the Member State and the marketing authorisation holder may make comments to the Agency and to the report or Member State.

3. not later than 15 days after receipt of the items referred to in paragraph 1. The observations referred to in paragraph 2 shall update the report by the rapporteur or the Member State concerned, taking into account the comments made and shall forward it to the Committee on Risk Assessment in the field of medical surveillance. The Committee on Risk Assessment shall adopt the evaluation report with or without further amendments at its subsequent meeting and issued a recommendation. The recommendation shall set out the deviant positions and the reasons for it. The Agency shall store the assessment report adopted and the recommendation in accordance with Article 25a of Regulation (EC) No 2, 726/2004, archive and forward them both to the marketing authorization holder.

Article 107f

Following the assessment of the periodic, updated security reports, the national competent authorities shall consider whether measures are required for the marketing authorization for the medicinal product concerned.

They retain, alter, suspend or revoke marketing authorization.

Article 107g

1. In the case of a single assessment of the periodic, updated security reports, which recommend measures for more than one marketing authorisation, cf. Article 107e (2). 1 and which do not include a marketing authorisation granted under the centralised procedure laid down in Chapter 1 of Title II of Regulation (EC) No 2. 726/2004, the Coordination Group shall examine the Group of Coordination within 30 days of receipt of the report by the Committee on Risk Assessment in the Medical Commission, the report and establish a position on the conservation, modification, suspension or withdrawal of the marketing authorisations concerned, including a time limit for the implementation of the determined position.

2. When the Member States represented in the Coordination Group agree on the measures to be taken, the President shall register that there is agreement and shall forward the agreed position to the marketing authorization holder and Member States. Member States shall adopt the necessary measures for the conservation, modification, suspension or revocation of the relevant marketing authorisations in accordance with the implementation timetable laid down in the position.

In the event of a change, the holder of the marketing authorization shall, within the framework of the time established, make a proper request for amendments to the national competent authority. The request must contain an updated product summary and an updated package leaflet.

If consensus cannot be reached, the position adopted by the majority of the Member States in the coordination group has been agreed, to the Commission, which applies the procedure laid down in Articles 33 and 34.

Deviates the position of the Member States that are represented in the coordination group when agreeing, or the opinion of the majority of the Member States from the recommendation of the Committee on Risk Assessment in the Evaluation of Medicinal Products ; the coordination group shall adopt a detailed explanation of the scientific basis for the differences, with the recommendation, in detail.

3. In the event of a single assessment of the periodic, updated security reports, which recommend measures for more than one marketing authorisation, cf. Article 107e (2). 1 and which includes at least one marketing authorisation issued following the centralised procedure laid down in Chapter 1 of Title II of Regulation (EC) No 2. 726/2004, the Committee for Medicinal Products for Medicinal Products shall examine the report within 30 days of receipt of it from the Committee on Risk Assessment in the Evaluation of Medicinal Products and shall adopt an opinion on the conservation, modification, suspension or suspension of the provisions of the Community ; withdrawal of the relevant marketing authorisations, including a timetable for the implementation of the opinion.

Deviates the opinion of the Committee on Human Medicinal Products from the recommendation of the Committee on Risk Assessment in the Evaluation of Medicinal Products, the Committee for Medicinal Products for Human Medicinal Products, its opinion, a detailed explanation of it ; scientific basis for the differences, together with the recommendation.

On the basis of the opinion of the Committee on Medicinal Products Medicinal Products, cf. paragraph 3, the Commission shall adopt :

a) a decision addressed to the Member States on the measures to be taken in the field of marketing authorisations issued by Member States and affected by the procedure laid down in this Section, and

b) where it is stated in the opinion that legislative measures relating to the marketing authorization are required, a decision amending, suspension or revocation of the marketing authorisations granted under it ; centralised procedure as laid down in Chapter 1 of Title II of Regulation (EC) No, The procedure laid down in this Section shall be 726/2004 and affected by the procedure laid down in this Section.

Articles 33 and 34 of this Directive shall apply to the adoption of the decision in the first subparagraph (a) and on its implementation in the Member States.

Article 10 of Regulation (EC) No Article 726/2004 shall apply to the decision referred to in the first subparagraph of point (b). If the Commission adopits such a decision, it may also adopt a decision addressed to the Member States pursuant to Article 127a of this Directive.

Section 3

Signal detection

Article 107h

With regard to medicinal products approved in accordance with this Directive, the competent authorities shall take the following measures in cooperation with the Agency :

a) monitor the outcome of the risk measures which are included in the risk management plans and the conditions referred to in Article 21a, 22 or 22a ;

b) evaluate the updating of the risk management system,

c) monitor the data contained in the Eudravigilance database to determine whether there are new or changed risks and whether these risks affect the relationship between benefits and risks.

2. The evaluation of the Risk Assessment Board in the field of Medicinal Products shall carry out initial analysis and prioritisation of signals of new or altered risks or changes in the relationship between benefits and risks. If the Committee considers that the follow-up action may be necessary, the assessment of these signals and agreement shall be carried out as regards the possible follow-up action in respect of the marketing authorisation within a time frame which is proportionate to : the scale and severity of the issue.

3. The Agency and the national competent authorities and the holder of the marketing authorization shall inform each other of any new or altered risks or changes in the relationship between benefits and risks.

Member States shall ensure that the holders of marketing authorisations inform the Agency and the national competent authorities if new or modified risks or changes in the relationship between benefits and risks are detected.

Section 4

EU-emergency procedure

Article 107i

A Member State or, where appropriate, the Commission shall initiate the procedure in accordance with this Section when an emergency procedure is considered necessary as a result of the evaluation of data from pharmacovigilance activities, to inform the others ; Member States, the Agency and the Commission in one or more of the following cases :

a) if it is considering suspending or revoking a marketing authorisation ;

b) in the case of a ban on the extradition of a medicinal product,

c) if it is considering rejecting the renewal of a marketing authorisation

d) where the marketing authorization holder is informed that, due to the concerns relating to safety, it has stopped the marketing of a medicinal product has taken steps to withdraw a marketing authorization or intend to : do it

(e) if it considers it necessary to have a new countersign, a reduction in the recommended dose or a restriction of the indications.

The Agency shall examine whether concerns related to safety relate to medicinal products other than those covered by the information, or whether it is common to all medicinal products belonging to the same committee or therapeutic group.

Where the medicinal product concerned has been approved in more than one Member State, the Agency shall inform without undue delay the one which initiated the procedure for the outcome of this investigation and the procedures provided for in Articles 107j and 107k shall apply. If that is not the case, then the Member State concerned shall itself be concerned with the concerns relating to safety. The Agency or, where appropriate, the Member State shall inform the holders of the marketing authorisation concerning the opening of the procedure.

Subject to the provisions of this Article, 2. 1 and 107j and 107k may a Member State, where it is necessary for the protection of public health, to act quickly, suspend marketing authorization or prohibit the use of the medicinal product in question in its territory until : a final decision has been taken. It shall inform the Commission, the Agency and the other Member States within the following working day, of the reasons for it.

The Commission may, at any time in the course of the procedure laid down in Article 107j and 107k, ask the Member States in which the medicinal product is authorized to take interim measures immediately.

Where the scope of a procedure laid down in accordance with paragraph 1 shall be adopted. Paragraph 1 shall apply to medicinal products approved in accordance with Regulation (EC) No ; Under this Section, the Commission may, at any time during the procedure, take interim measures in the course of these marketing authorisations, at any time during the procedure under this Section.

The information referred to in this Article may concern individual medicinal products or a range of medicinal products or a therapeutic group.

If the Agency finds that concerns relating to safety relate to more medicinal products than those covered by the information, or that it is common to all medicinal products belonging to the same committee or therapeutic group, it shall extend to the same Committee ; the scope of the procedure in accordance with that.

Where the scope of a procedure initiated pursuant to this Article relates to a range of medicinal products or a therapeutic group, the medicinal products approved in accordance with Regulation (EC) No (EC) No (EC) No (EC) No (EC) No (EC) No (EC) No The procedure is 726/2004, which belongs to this committee or group.

5. At the time of information, cf. paragraph 1, the Member State shall make available to the Agency all relevant scientific information it has at its disposal and its assessments.

Article 107j

1. After receipt of information, cf. Article 107i (3). 1, the Agency shall publish via the European portal on medicinal products, a communication that a procedure has been initiated. In parallel with this, Member States may publish in their national web portals for medical safety to publish a communication that a procedure has been initiated.

This communication describes the questions submitted to the Agency in accordance with Article 107i and the medicinal products concerned and, where necessary, the active substances concerned. It contains information about the right of the holders of a marketing authorisation, health professionals and the public have to submit to the Agency the information relevant to the procedure and to explain how such information may be available ; is presented.

2. The Committee on Risk Assessment shall assess the questions which have been submitted to the Agency in accordance with Article 107i. The report shall work closely with the rapporteur appointed by the Committee for Medicinal Products for Human Medicinal Products or the reference Member State for the medicinal product concerned.

For the purpose of this assessment, the holder of a marketing authorisation may make written comments.

If the urgency of the matter allows for this, the Committee on Risk Assessment may hold public consultations when the Committee considers it to be appropriate for justified reasons for the extent and severity of safety concerns. The hearings shall be held in accordance with the detailed rules laid down by the Agency and communicated through the European Web portal for medicinal products. The communication shall include detailed provisions concerning participation in consultations.

In the case of public consultations, due consideration shall be given to the therapeutic effect of the medicinal product.

The Agency shall, in consultation with the parties concerned, rules for the procedure concerning the organisation and implementation of public consultations in accordance with Article 78 of Regulation (EC) No 2. 726/2004.

If a holder of a marketing authorization or other person who wants to submit information has confidential information relevant to the relationship, he may ask to be allowed to submit this information to the Committee. for the Risk Assessment in a non-public consultation.

The Committee on the Evaluation of Medicinal Products for the Evaluation of Medicinal Products within 60 days of the date of submission of the information shall be subject to a reasoned recommendation, taking due account of the therapeutic effect of the medicinal product. The recommendation shall set out the deviant positions and the reasons for it. The Committee on Risk Assessment may, in an urgent case and on a proposal from its chairman, set a shorter period of time. Recommendation must contain one or more of the following conclusions :

a) there is no need for further assessments or measures at EU level ;

b) the marketing authorization holder should carry out further assessment of the data and shall follow up the results of this assessment ;

c) Whereas the marketing authorization holder should sponsor a security survey post-marketing authorization and follow up on the results of this study ;

d) the Member States, or the marketing authorization holder, should initiate risk inimal measures ;

(e) the marketing authorization should be suspended, withdrawn or not renewed ;

(f) the marketing authorization should be changed.

For the purposes of applying the first subparagraph, point (d), the recommendation shall specify the recommended risks inimming measures and any conditions or limitations to be applied to the marketing authorization.

If, as referred to in point (f) of the first subparagraph, it is recommended to amend or add information to the product summary or package leaflet, the recommendation must contain proposals on how the text of such a change or add should be formulated, and where : in the product summary, the labelling, or the package leaflet, the text must be affixed.

Article 107k

1. Excludes the scope of the procedure as determined in accordance with Article 107i (1). 4, not marketing authorisations issued following the centralised procedure laid down in Chapter 1 of Title II of Regulation (EC) No 2 ; 726/2004, the coordination group shall process the coordination group within 30 days of receipt of the recommendation of the Committee on Risk Assessment, in the Evaluation of Medicinal Products, the recommendation and establishes a position on the conservation, modification, suspension, revocation or refusal of renewal of the relevant marketing authorisations, including a timetable for the implementation of the determined position. The coordination group may, where necessary, to establish a position and, on the proposal of its President, establish a shorter period of time.

2. When the Member States represented in the Coordination Group agree on the measures to be taken, the President shall register that there is agreement and shall forward the determined position to the marketing authorization holder and Member States. Member States shall adopt the necessary measures for the conservation, modification, suspension, revocation or rejection of the marketing authorisation in question in accordance with the implementation timetable laid down in the position.

In the event of an agreement on a change, the marketing authorisation holder shall, within the framework of the established implementation schedule, provide a proper request for a change to the national competent authority. The request must contain an updated product summary and an updated package leaflet.

If consensus cannot be reached, the position adopted by the majority of the Member States in the coordination group has been agreed, to the Commission, which applies the procedure laid down in Articles 33 and 34. Notwithstanding Article 34 (2), Paragraph 1 shall apply the procedure referred to in Article 121 (1). 2, however, use.

Deviates the position of the Member States represented in the coordination group, or the opinion of the majority of Member States represented in the Coordination Group, from the recommendation of the Committee on Risk Assessment, within Medicinal monitoring, the coordination group shall adopt its position or the opinion of the majority opinion in a detailed explanation of the scientific basis for the differences with the recommendation.

3. Excludes the scope of the procedure as determined in accordance with Article 107i (1). 4, at least one marketing authorization issued in accordance with the centralised procedure laid down in Chapter 1 of Title II of Regulation (EC) No 2 ; The Committee on Medicinal Products for Medicinal Products shall be treated within 30 days of receipt of the recommendation of the Committee on Risk Assessment in the Evaluation of Medicinal Products, the recommendation and adopts an opinion on the conservation, modification, suspension, withdrawal or revocation of the renewal of the marketing authorisations concerned. The Committee for Medicinal Products for Human Use may, where necessary, to adopt the opinion and, on the proposal of its President, to agree to a shorter period.

Deviates the opinion of the Committee on Human Medicinal Products from the recommendation of the Committee on Risk Assessment in the Evaluation of Medicinal Products, the Committee for Medicinal Products for Human Medicinal Products, its opinion, a detailed explanation of it ; scientific basis for the differences, together with the recommendation.

On the basis of the opinion of the Committee on Medicinal Products Medicinal Products, cf. paragraph 3, the Commission shall adopt :

a) a decision addressed to the Member States on the measures to be taken in the field of marketing authorisations issued by Member States and affected by the procedure laid down in this Section, and

b) where it is stated in the opinion that legislative measures are required, a decision on modification, suspension, revocation or rejection of the renewal of the marketing authorisation granted under Regulation (EC) No 2 ; The procedure laid down in this Section shall be 726/2004 and affected by the procedure.

Articles 33 and 34 of this Directive shall apply to the adoption of the decision in the first subparagraph (a) and on its implementation in the Member States. Notwithstanding Article 34 (2), Paragraph 1 of this Directive shall apply to the procedure referred to in Article 121 (1). 2, however, use.

Article 10 of Regulation (EC) No Article 726/2004 shall apply to the decision referred to in the first subparagraph of point (b). Notwithstanding Article 10 (2), The provisions of Article 87 (2) of this Regulation shall apply to paragraph 2 of the Regulation. 2, however, use. If the Commission adopits such a decision, it may also adopt a decision addressed to the Member States pursuant to Article 127a of this Directive.

Section 5

Publication of ratings

Article 107l

The Agency shall publish the final conclusions of the assessments, recommendations, opinions and decisions referred to in Article 107b-107k, via the European portal on medicinal products.

CHAPTER 4

Monitoring of safety examinations for marketing authorization

Article 107m

1. This Chapter shall apply to non-intervention security examinations according to the authorisation of the placing on the market, whether voluntarily or as a result of the placing on the market, either voluntarily or as a result of the marketing authorization holder ; Commitment in accordance with Article 21a or 22a, involving the collection of safety information from patients or health-care professionals.

2. This Chapter does not affect national requirements and EU requirements concerning the safeguarding of well-being and rights for participants in non-intervention security examinations according to the authorisation of marketing.

3. The studies are not carried out if the use of a medicinal product is thus promoted.

4. Remuneration for health professionals who have participated in non-intervention security surveys, subject to marketing authorisation, shall be limited to compensation for the time spent and expenditure incurred.

The national competent authority may require the marketing authorization holder to present the Protocol and the progress reports for the competent authorities of the Member State in which the investigation is carried out.

6. No later than 12 months after completion of the data collection, the holder of the marketing authorization shall send the final report to the competent authorities of the Member State in which the investigation has been completed.

7. During the implementation of a survey, the holder of the marketing authorization holder shall monitor the data obtained and examines their impact on the relationship between the benefits and risks of the medicinal product concerned.

All new information which could affect the assessment of the relationship between the advantages and risks of the medicinal product shall be notified to the competent authorities of the Member State in which the medicinal product has been approved in accordance with Article 23.

The obligation on the second subparagraph shall not affect the information on the findings of the marketing authorization holder, by means of the periodic, updated security reports as defined in Article 107b.

Article 107n-107q shall apply only to the measures referred to in paragraph 1. the examinations referred to in Article 21a or 22a, which are carried out in accordance with an obligation.

Article 107n

1. Before carrying out a study, the marketing authorisation holder shall submit a draft protocol to the Committee on Risk Assessment in the field of medicinal products, except where the investigations are carried out only in one Member State, which requires the investigation to be carried out in accordance with Article 22a. In the case of such examinations, the marketing authorization holder shall submit a draft protocol to the national competent authority of the Member State in which the investigation is carried out.

2. Within 60 days following the date of submission of the Protocol, the national competent authority or the committee shall issue the following :

a) a written approval of the protocol,

b) a reasoned written objection which explains in detail the reasons for the objection if the national competent authority or the Committee on Risk Assessment and the Evaluation of Medicinal Products shall find that :

In. the implementation of the study shall promote the use of a medicinal product

(ii) the examination is designed in such a way that the objectives of the investigation are unreachable, or

c) a written notice to the holder of the marketing authorization for the study to be a clinical trial subject to Directive 2001 /20/EC.

3. The study can only be initiated when the national competent authority or the Committee on Risk Assessment in the field of medical surveillance has given its written approval.

If an approval has been issued, cf. paragraph Point (a) of the marketing authorization holder shall send the Protocol to the competent authorities of the Member States in which the investigation is carried out, after which the examination may commence in accordance with the approved Protocol.

Article 107o

Following the commencement of a study, any significant changes to the Protocol shall be submitted to the national competent authority or to the Committee on Risk Assessment in the field of medical surveillance. The national competent authority or the Committee on Risk Assessment shall evaluate the amendments and inform the holder of the marketing authorization for his approval or objection. The holder of the marketing authorization shall inform the Member States of the implementation of the investigation.

Article 107p

1. Following the completion of the study, the final survey report shall be submitted to the national competent authority or to the Committee on Risk Assessment within 12 months of the completion of the collection of data ; unless the national competent authority or the Committee on Risk Assessment and the Evaluation of Medicinal Products shall be subject to a derogation from the competent authority of the Medical Agency.

2. The marketing authorization holder shall assess whether the results of the study have consequences for the marketing authorization and, if necessary, submit an application for a change to the marketing authorization to the national competent authorities.

3. together with the final survey report, the holder of the marketing authorization holder shall electronically summarate the results of the examination to the national competent authority or to the Committee on Risk Assessment, in the case of Medical surveillance.

Article 107q

On the basis of the results of the examination and having heard the marketing authorization holder of the marketing authorization, the Committee on Risk Assessment may make reasoned recommendations concerning the marketing authorization. The recommendations shall set out the deviant positions and the reasons for it.

2. If any recommendations concerning amendments, suspension or revocation of a medicinal product approved by the Member States pursuant to this Directive, shall lay down the Member States that are represented in : the Group of the Coordination Group, a position on the matter, taking into account the provisions of paragraph 1. 1 the recommendation and the establishment of a timetable for the implementation of the established position.

When the Member States represented in the Coordination Group agree on the measures to be taken, the President shall register that there is agreement and shall forward the agreed position to the marketing authorization holder and Member States. Member States shall adopt the necessary measures to amend, suspend or revoke the marketing authorisation in question in accordance with the implementation timetable laid down in the position.

In the event of an agreement on a modification, the holder of the marketing authorization shall, within the framework of the time established, make a proper request for a change to the national competent authority. The request must contain an updated product summary and an updated package leaflet.

The Holding shall be published on the European web portal on medicinal products created in accordance with Article 26 of Regulation (EC) No 2. 726/2004.

If consensus cannot be reached, the position adopted by the majority of the Member States in the coordination group has been agreed, to the Commission, which applies the procedure laid down in Articles 33 and 34.

Deviates the position of the Member States represented in the coordination group when agreeing on, or the opinion of the majority of the Member States represented in the coordination group, from the recommendation of the Committee on Economic and Social Affairs and Cooperation, Risk assessment in the field of Medicinal Products shall be accompanied by a detailed explanation of the scientific basis for the differences, with the recommendation, on the basis of its position or the opinion of the majority.

CHAPTER 5

Implementation, delegation and guidelines

Article 108

In order to harmonise the performance of the pharmacovigilance activities in this Directive, the Commission shall adopt implementing measures for the following areas on which pharmacovigilance activities are laid down in Article 8 (2). 3, and Articles 101, 104, 104a, 107, 107a, 107b, 107h, 107h, 107n and 107p.

a) content of the master file for the pharmacovigilance system and the marketing authorisation holder's maintenance of this file ;

b) the minimum requirements for the quality assurance system of the competent authorities of the national competent authorities and the marketing authorisation holder for the execution of pharmaceutical monitoring activities ;

c) the use of internationally recognized terminology, formats and standards recognised at international level for the execution of pharmacovigilance activities ;

d) the minimum requirements for monitoring the data contained in the Eudravigilance database in order to determine whether there are any new or changed risks ;

(e) format of and the content of the electronic transmission of suspected adverse reactions from Member States and the marketing authorization holder ;

(f) format and content of electronic periodic, updated security reports and risk management plans ;

g) format of protocols, summary and final survey reports for the studies on marketing authorisation ;

These measures must take account of the international harmonisation work in the field of pharmacovigilance and, where necessary, be revised to take account of technical and scientific developments. These measures shall be adopted in accordance with the regulatory procedure referred to in Article 121 (1). 2.

Article 108a

In order to facilitate the execution of pharmaceutical monitoring activities in the Union, the Agency shall draw up the Agency, in cooperation with the competent authorities and other interested parties :

a) guidelines for the good pharmacovigilance of both competent authorities and the holders of marketing authorisations ;

b) scientific guidelines for the impact studies on the marketing authorization.

Article 108b

The Commission shall publish a report on the execution of the Member States ' pharmacovigilance tasks by 21. July 2015 and then every three years.

TITLE X

SPECIAL PROVISIONS CONCERNING MEDICINAL PRODUCTS DERIVED FROM BLOOD OR PLASMA FROM HUMAN BEINGS

ARTICLE 109

For the tapping and testing of human blood and plasma, the Directive 2002//98/EC of the European Parliament and of the Council of the European Parliament and of the Council of 27 January 2003 laying down standards for the quality and safety of collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001 /83/EC (30) use.

Article 110

Member States shall take the necessary measures to achieve self-sufficiency in the Community with blood and plasma from human beings. To this end, they shall promote the voluntary and unpaid donation of blood and plasma and shall take the necessary measures to encourage the production and use of products obtained from such blood or plasma from human beings ; derive from the voluntary and unpaid donation of blood or plasma. They shall inform the Commission of the measures taken.

SECTION XI

SUPERVISION AND PENALTIES

Article 111

1. In cooperation with the Agency, the competent authority of the Member State concerned shall ensure during inspection visits, where necessary, unannounced and, where appropriate, request an official laboratory for the control of medicinal products or a laboratory which is to be carried out ; designated for this purpose, to carry out random checks that the requirements relating to medicinal products are complied with. This cooperation consists in the exchange of information with the Agency on both planned and inspection visits. Member States and the Agency shall cooperate on the coordination of inspection visits to third countries. The inspection visits shall include, but not limited to, the visits referred to in paragraph 1. 1a-1f referred to.

Subsiders in the Union or in third countries and wholesalers from medicinal products are made subject to repeated inspection visits.

1b. The competent authority of the Member State concerned shall have a monitoring system covering inspection visits at appropriate intervals, based on risk, importers, importers, or distributors of active substances that are at home ; their territory, and an effective follow-up on that.

The competent authority may, where it considers that there are grounds for non-compliance with the legal requirements laid down in this Directive, including principles and guidelines for good manufacturing practice and good distribution practice, cf. Article 46 (f), and Article 47, make inspection visits to the premises of :

a) protractors or distributors of active substances resident in third countries ;

b) assists or importers of formulants.

(b) 1c (s). The inspection visits referred to in 1a and 1b may also be carried out in the Union and in third countries on the occasion of a Member State, the Commission or the Agency.

1D may also be subject to inspection visits to the holders of marketing authorisations and intermediaries of medicinal products.

1e. In order to verify that information is submitted to obtain a certificate of conformity, the bodies of the European Pharmacopoeia shall be capable of complying with the standardization of nomenclature and standards of quality as referred to in the Convention on the subject of the Convention ; the preparation of a European Pharmacopoeia (European Directorate for Medicinal Products) to apply to the Commission or to the Agency and to request such inspection visits if the source of the material in question is subject to a monograph in it. European Pharmacopoeia.

1f, the competent authority of the Member State concerned may pay inspection visits to an undertaking producing the starting materials of specific request from the establishment.

The following inspection visits shall be carried out by representatives of the competent authorities, who shall be empowered to :

a) make inspection visits to the manufacturing and commercial departments of establishments producing medicinal products, active substances or excients, and in any laboratories that have been assigned to the holder of the manufacturing authorization ; inspection tasks pursuant to Article 20 ;

b) take samples, inter alia, for the purpose of an independent analysis in an official laboratory for the control of medicinal products or a laboratory designated by a Member State for that purpose ;

c) examine any documents relating to inspection visits subject to the subject matter of the inspection visits by Member States on 21. The provisions in May 1975 which limit access to it in the case of descriptions of the manufacturing method

d) carry out the inspection of premises, inventories, documents and master file for the pharmacovigilance of the holders of marketing authorisations and in any undertakings by the holder of the marketing authorization holder to carry out the tasks ; in Section IX.

The inspections shall be carried out in accordance with the guidelines set out in Article 111a.

Member States shall take all appropriate measures to ensure that the manufacturing processes used in the manufacture of immunological medicinal products are duly checked and that the homogeneity between the parties shall be maintained at all times.

3. The competent authority shall draw up each of the provisions referred to in paragraph 1. the inspection visits referred to in paragraph 1 shall be a report on the conformity of the principles and guidelines laid down in Articles 47 and 84 for good manufacturing practice and good distribution practices to the extent that they are relevant in the individual case ; cases, or whether the marketing authorization holder complies with the requirements set out in Section IX.

The competent authority, which carried out the inspection, shall inform the inspected unit of the contents of the reports.

Before the adoption of this report, the competent authority shall give the affected inspected unit the opportunity to make observations.

Without prejudice to any agreements concluded between the Union and third countries, a Member State, the Commission or the Agency may require a manufacturing establishment in a third country to submit to an inspection visit as provided for in this Article.

5. No later than 90 days after an inspection visit referred to in paragraph 1. 1 certificates of good manufacturing practice or good distribution practice, depending on the specific case, shall be issued to the unit inspected if the findings of the visit are that the person concerned complies with the principles laid down in EU law ; and guidelines for good manufacturing practice or good distribution practices.

If the inspection visit has been made in connection with the procedure for certification of conformity with the monograph of the European Pharmacopoeia, a certificate must be issued.

The Member States are allowing the attestations of good manufacturing practice and good distribution practice, the introduction into an EU database which the Agency manages on the Union's behalf. in accordance with Article 52a (1). 7, Member States shall also introduce information in this database concerning the registration of importers, protractors and distributors of active substances. The database must be publicly available.

7. is the conclusion of an inspection visit as referred to in paragraph 1. (b) 1g (a), (b) and (c), or the conclusion of an inspection visit to a distributor of medicinal products or the active substances or the manufacture of ancillants, that the inspected unit is not complying with the requirements and / or those of the EU right ; Whereas the principles and guidelines of good manufacturing practice and good distribution practice shall be introduced in the information provided for in paragraph 1. 6 related to the EU database.

8. If the conclusion of an inspection visit referred to in paragraph 1 shall be drawn up, (b) 1g (d) is that the marketing authorization holder does not follow the pharmacovigilance system as described in the master file for pharmacovigilance and in paragraph IX, shall make the holder of the competent authority of the Member State concerned of : the marketing authorization shall be aware of these deficiencies and provide the opportunity to make observations.

The Member State concerned shall, in such case, inform the other Member States, the Agency and the Commission.

The Member State concerned shall, where appropriate, take the necessary measures to ensure that a holder of a marketing authorisation is imposed on penalties which are effective, proportionate and dissuasive to the gross inflexibility of the infringement ; effect.

Article 111a

The Commission shall adopt the guidelines for the principles applicable to inspection visits as referred to in Article 111.

In cooperation with the Agency, Member States shall establish the form and content of the authorisation referred to in Article 40 (1). Article 77 (1) and 77 (1). 1, of the reports referred to in Article 111 (1), 3, of the certificates of good manufacturing practice and of the certificates of good distribution practice referred to in Article 111 (1). 5.

Article 111b

1. At the request of a third country, the Commission shall assess whether the existing regulatory framework in force relating to active substances exported to the Union and the respective control and enforcement activities shall ensure a level of protection of : The public health of the Union. If this is the case, the Commission shall decide to perform the third country on a list of the evaluation shall consist of a review of relevant documentation and, unless there are arrangements, as referred to in Article 51 (1). 2 of this Directive covering this area of activity-shall also include a review on the place of the regulatory system of the third country and, where necessary, an observation inspection of one or more plants in the third country, where there are manufactured active substances. In this assessment, particular account shall be taken of :

a) the country ' s rules on good manufacturing practice ;

b) how periodically inspections are carried out to verify compliance with good manufacturing practice ;

c) the effectiveness of the enforcement of good manufacturing practices ;

d) where periodically and quickly the country shall provide information on the manufacturing of active substances which do not comply with the requirements.

2. The Commission shall adopt the implementing acts necessary for the application of the provisions of paragraph 1 of this Article. (1) (a)-(d). These implementing acts shall be adopted in accordance with the procedure referred to in Article 121 (1 2.

3. The Commission shall periodically check the conditions set out in paragraph 1. One has been fulfilled. The first inspection shall take place no later than three years after the country has been included in the list in accordance with paragraph 1. 1.

4. The Commission shall carry out the evaluation and checks provided for in paragraph 1. 1 and 3, in cooperation with the Agency and the competent authorities of the Member States.

ARTICLE 112

Member States shall take all appropriate measures to ensure that the marketing authorisation holder and the holder of the manufacturing authorization where the holder of the manufacturing authorization is satisfied that the medicinal product and / or the constituent parts and the stock market are carried out ; the intermediate products in the manufacture of the products referred to in Article 8 (3). Article 3 (h) shall be used as a basis for marketing authorization.

Article 113

For the purposes of implementing Article 112, Member States may require the production of the immunological medicinal products and medicinal products derived from human blood or human plasma to submit a competent authority copies of all the products, proof of verification signed by the qualified person in accordance with Article 51.

Article 114

1. A Member State may, in the event that it considers it necessary for reasons of public health, to require the marketing authorization holder to :

-WHAT? live vaccines,

-WHAT? immunological medicinal products used in the primary immunosation of children or other groups exposed to hazards ;

-WHAT? immunological medicinal products used in the context of public immunotarisation programmes ;

-WHAT? or immunological medicinal products which are new or produced by new or modified technology or which have the nature of the news for a given manufacturer during a transitional period normally determined by the marketing authorization ;

before placing on the market, samples from each lot of the bulbs and / or the medicinal product for testing in an official Medicinal Control Laboratory or a laboratory designated by a Member State for that purpose, unless the competent authority, the competent authority of another Member State in the context of a batch produced in that Member State has previously examined the party in question and declared that it complies with the approved specifications. Member States shall ensure that such tests are completed within 60 days of receipt of the samples.

The competent authorities may, where a Member State ' s legislation lays down provisions to this effect for public health, require that the marketing authorisation holder for medicinal products derived from blood or plasma from human beings, before placing on the market, samples from each lot of the bulbs and / or the finished product to be tested in an official Medicinal Control Laboratory or a laboratory designated by a Member State for that purpose unless the competent authorities : authorities in another Member State have already investigated the party concerned ; and stated that it is in accordance with the approved specifications. Member States shall ensure that such tests are completed within 60 days of receipt of the test.

Article 115

Member States shall take all necessary measures to ensure that the production and purification processes used in the manufacture of medicinal products on the basis of human blood or human plasma are duly checked, and that they are continuously monitored ; ensure uniformity between the parties and, to the extent the technological stand allows, the absence of specific viral contamination. The manufacturer must therefore communicate to the competent authorities the method used to restrict or remove the pathogenicity which may be transmitted through medicinal products derived from blood or plasma from human beings. To this end, the competent authorities may submit samples of bulk goods and / or medicinal products for testing in a state laboratory or a laboratory designated for this purpose, either during the examination of the application in accordance with Article 19 or after the marketing authorisation issue.

Article 116

The competent authorities shall suspend, withdraw or modify the marketing authorization if it is evaluated, either that the medicinal product is harmful or that it is without therapeutic effect or that the ratio between benefits and risks is not favourable ; or that it does not have the quantitative and qualitative composition. Therapeutic effect shall be considered to be missing if it is estimated that therapeutic results cannot be achieved with the medicinal product.

The marketing authorization may also be suspended, withdrawn or amended if the information referred to in Article 8 (10) or (11) of the case is incorrect or has not been amended in accordance with Article 23, or the conditions under Articles 21a, 22 or 22a have not been met or if the checks provided for in Article 112 have not been carried out.

The second subparagraph of this Article shall also apply in cases where the manufacture of the medicinal product is not carried out in accordance with the information given in accordance with Article 8 (2). the provisions of Article 3 (d) or (3) (d) or in respect of which checks shall not be carried out in accordance with the methods described in Article 8 (1). (3) (h).

ARTICLE 117

Without prejudice to the measures provided for in Article 116, Member States shall take all appropriate measures to ensure that the supply of a medicinal product is prohibited and that it is withdrawn from the market if it is assessed that :

a) the medicinal product is harmful, or

b) the therapeutic effect of the medicinal product is missing ; or

c) the relationship between benefits and risks is less favourable, or

d) the medicinal product does not have the qualitative and quantitative composition of the product, or

(e) the checks on the medicinal product and / or the components and intermediate products at the time of production have not taken place, or any other requirement or other obligation in connection with the issue of the manufacturing authorization has not been fulfilled.

The competent authority may limit the prohibition on extradition and withdrawal from the market to only each batch of consignment, against which an objection has been raised.

3. The competent authority may, in the case of a medicinal product for which extradition has been banned, or withdrawn from the market in accordance with paragraph 1. In exceptional circumstances, the provision of the medicinal product for patients already treated with the medicinal product in question during a transitional period permit the extradition of the medicinal product.

Article 117a

1. Member States must have a system designed to prevent the fact that medicinal products suspected of being a health hazard are to be used to the patient.

The second paragraph of paragraph 2. 1 the system shall cover the reception and handling of information on suspected counterfeit medicines and the presumed quality defects of medicinal products. The system shall also cover withdrawal of medicinal products on the pretext of holders of marketing authorisations or withdrawal of medicinal products from the market by national competent authorities of all relevant actors in : the supply chain both in and out of normal working hours. The system must also allow the possibility of withdrawal of medicines from patients who have received such medicinal products, if necessary with the assistance of health professionals.

3. If the medicinal product concerned is suspected of posing a serious risk to public health, the competent authority of the Member State in which the medicinal product first was identified immediately gives a prompt warning to all Member States and all : operators in the supply chain in the Member State concerned. In the event of such medicinal products to be taken to patients, public communications shall be issued without delay within 24 hours to withdraw these medicines from the patients. These notifications shall contain sufficient information on the presumed quality deficiency or forgery and the risks involved.

4. Member States shall give the date of the 22. July, 2013, the Commission shall notify the Commission of the details of their respective national systems as referred to in this Article.

Article 118

1. The competent authority shall suspend or withdraw the authorization for a category of preparations or all when one of the conditions laid down in Article 41 shall no longer be complied with.

2. The competent authority may, in addition to the measures set out in Article 117, either suspend the production or import of medicinal products from third countries or suspend or revoke the manufacturing authorization for a category of : preparations or all, as the provisions of Articles 42, 46, 51 and 112 are not complied with.

Article 118a

Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all necessary measures to ensure the implementation of these penalties. The penalties shall be effective, proportionate and dissuasive to the conditions of abuse.

These penalties shall not be less than those applicable to infringements of the same nature and meaning of national legislation.

The second paragraph of paragraph 1. The rules laid down shall, in particular, be directed at :

a) the manufacture, distribution, dissemination, import and export of counterfeit medicines and the distance selling of counterfeit medicines to the public through services in the information society ;

b) failure to comply with the provisions of this Directive on the production, distribution, import and export of active substances ;

c) failure to comply with the provisions of this Directive on the use of formulants.

The penalties shall take, where appropriate, the risk of human health that falsification of medicinal products constitutes.

3. Member States shall give the Member State of the second In January 2013 the Commission shall notify the Commission of the provisions adopted pursuant to this Article and shall forthwith notify any amendments to those provisions.

By the 2nd. In January 2018, the Commission shall submit to the European Parliament and the Council a report giving a summary of the Member States ' implementing measures in relation to this Article, together with an assessment of the effectiveness of these measures.

Article 118b

Member States shall organise meetings with the participation of patients and consumer organisations and, where necessary, Member State law enforcement officials, in order to disseminate public information on the measures taken in the field of : prevention and enforcement, in order to combat the falsification of medicinal products.

Article 118c

For the purposes of this Directive, Member States shall take the necessary measures to ensure cooperation between the competent authorities for the medicinal products and the customs authorities.

Article 119

The provisions of this Title shall apply to homeopathic medicinal products.

SECTION XII

STANDING COMMITTEE

Article 120

The Commission shall adopt amendments which may be necessary in order to adapt Annex I to scientific and technical progress. These measures, which are intended to amend non-essential provisions of this Directive, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 121 (1). 2a.

ARTICLE 121

The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Medicinal Products, hereinafter referred to as ' the Standing Committee ', when it adjusts the directives on the removal of technical barriers to trade in medicinal products for technical progress.

2. When reference is made to this paragraph, Articles 5 and 7 of Decision 1999 /468/EC shall apply, cf. its Article 8.

The period laid down in Article 5 (1). 6, in Decision 1999 /468/EC shall be set at three months.

When reference is made to this paragraph, Article 5a (2) shall apply. 1-4, and Article 7 of Decision 1999 /468/EC, cf. its Article 8.

3. When reference is made to this paragraph, Articles 4 and 7 of Decision 1999 /468/EC shall apply, cf. its Article 8.

The period laid down in Article 4 (1). 3, in Decision 1999 /468/EC shall be set at one month.

4. The Rules of Procedure of the Standing Committee are published.

Article 121a

1. The Commission shall be given the power to adopt the delegated acts referred to in Article 22b, 47, 52b and 54a for a period of five years from the 20. January, 2011. The Commission shall report on the delegated powers within six months before the end of the five-year period. The delegation of powers shall automatically be extended for periods of the same duration, unless the European Parliament or the Council revokes the delegation pursuant to Article 121b.

As soon as the Commission adopts a delegated act, it shall inform the European Parliament and the Council thereof.

3. The requirements for the adoption of delegated acts shall be given to the Commission on the conditions laid down in Articles 121b and 121c.

Article 121b

At any time, the delegation of powers referred to in Article 22b, 47, 52b and 54a may be revoked at any time by the European Parliament or the Council.

2. The institution which initiated an internal procedure in order to determine whether the delegation of powers must be recalled shall endeavour to give the other institution and the Commission informed in reasonable time prior to the final decision ; shall be taken and indicate at the same time the delegated powers that may be subject to revocation, as well as the possible justification for this.

3. The decision to withdraw shall bring an end to the delegation of the powers set out in the decision in question. It shall have effect immediately or at a later date which will be specified in the decision. It does not affect the validity of the delegated acts that have already entered into force. It shall be published in the Official Journal of the European Union.

Article 121c

1. The European Parliament or the Council may object to a delegated act within two months of the notification.

The period of time may be extended by two months on the initiative of the European Parliament or the Council.

2. does not have the European Parliament or the Council at the end of the paragraph in paragraph 1. The period referred to in paragraph 1 shall be published in the Official Journal of the European Union, and shall enter into force on the date laid down herein.

The delegated act may be published in the Official Journal of the European Union and shall enter into force before the expiry of the deadline, if both the European Parliament and the Council have communicated to the Commission that they do not intend to object.

Parliament, or the Council, shall, within the time referred to in paragraph 1, be made The period referred to in paragraph 1 shall not apply to a delegated act. The institution which objects to the delegated act states the reasons for it.

TITLE XIII

GENERAL PROVISIONS

ARTICLE 122

1. Member States shall take all appropriate measures to ensure that the competent authorities concerned exchange relevant information in order to ensure that the conditions for the issue of the conditions laid down in Articles 40 and 77 are concerned ; permits, of the provisions referred to in Article 111 (1). 5, certificates and marketing authorisations shall be complied with.

On the basis of reasoned request, Member States shall electronically transmit to the Member States in accordance with Article 111 The reports to the competent authorities of another Member State or to the Agency shall be referred to as referred to.

3. Conclusions in accordance with Article 111 (1). 1 shall apply throughout the Community.

Where a Member State, in exceptional circumstances and for reasons relating to public health, cannot accept the conclusions of inspection visits as referred to in Article 111 (1). 1, it shall forthwith inform the Commission and the Agency thereof. The Agency shall inform the Member States concerned.

If the Commission is informed of such divergent views, it may, in consultation with the Member States concerned, request the inspection authority which made the first inspection visit to carry out a new one ; the inspector may be accompanied by the inspector ; two other inspectors from Member States that are not party to the dispute.

Article 123

1. Each Member State shall take all appropriate measures to ensure that decisions on marketing authorisation, denial or revocation of marketing authorization, on cancellation of a decision to refuse or recall ; marketing authorisation, the prohibition of supply and withdrawal from the market, as well as the reasons for it, shall immediately be brought to the Agency ' s knowledge.

2. The holder of the marketing authorization shall immediately inform the Member States concerned of any measures he has taken to suspend the sale of or to withdraw the medicinal product from the market, and to indicate the reasons for the sale of the medicinal product ; where this relates to the effectiveness of the medicinal product or the protection of public health. Member States shall ensure that such information is immediately brought to the attention of the Agency.

3. Member States shall ensure that adequate information on measures referred to in paragraph 1 shall be taken. 1 and 2, and which may affect public health in third countries, shall immediately be notified to the World Health Organisation, with a copy to the Agency.

4. The Agency shall publish each year a list of medicinal products for which marketing authorization has been refused, revoked or suspended for which extradition has been banned or withdrawn from the market.

Article 124

Member States shall give each other the necessary information, in particular the information provided for in Articles 122 and 123, in order to ensure the quality and harmlessness of homeopathic medicinal products manufactured and marketed in the Community.

ARTICLE 125

Any of the decisions referred to in this Directive by the competent authorities of the Member States must be carefully substantiated.

The decision must be notified to the applicant, specifying the legal redress, in accordance with the applicable law and the time limits accordingly.

Decisions to grant or revoke a marketing authorisation shall be made available to the public.

Article 126

The marketing authorization may only be refused, suspended or revoked on the grounds referred to in this Directive.

Any decision on the suspension of the manufacture or importation of medicinal products from third countries, the prohibition of supply and withdrawal of a medicinal product from the market may only be taken with the reasons referred to in Articles 117 and 118.

Article 126a

1. If there is no marketing authorization or an application is not available for treatment for a medicinal product approved in another Member State in accordance with this Directive, a Member State may, where it is entitled to do so, may, public health, authorise the placing on the market of the medicinal product concerned.

When a Member State makes use of this option, it shall adopt the measures necessary to comply with the requirements of this Directive, in particular those referred to in Title V, VI, VIII, IX and XI. Member States may decide that the provisions of Articles 63, paragraphs 1 and 2 shall not apply to medicinal products approved in accordance with paragraph 1. 1.

3. A Member State must, before giving such a marketing authorisation :

a) inform the holder of the marketing authorization in the Member State in which the medicinal product concerned is approved, on the consideration of issuing a marketing authorisation for the medicinal product concerned under this Article ;

b) where appropriate, request the competent authority of the Member State concerned to submit a copy of the evaluation report referred to in Article 21 (1). 4, and of the marketing authorization applicable to the medicinal product concerned, the competent authority of the Member State concerned shall, within 30 days of receipt of the request, submit a copy of the request, the evaluation report and the marketing authorization for the medicinal product concerned.

4. The Commission shall establish a public register of the medicinal products approved pursuant to paragraph 1. Member States shall inform the Commission of the marketing authorisations to a medicinal product which is granted or ceases pursuant to paragraph 1. 1, including the name or business name of the holder of the permit and his residence. The Commission shall make the necessary changes to the medicinal product register and make the register available on the Commission's website.

5. The Commission shall submit to 30. April 2008, the Council and the European Parliament will have a report on the application of this provision in order to table the necessary amendments.

Article 126b

In order to ensure independence and transparency, Member States shall ensure that employees of the competent approval authorities, rapporteurs and experts who are involved in the authorisation and surveillance of medicinal products have no economic or other economic or other, interests of the pharmaceutical industry, which could be involved in their impartiality. These individuals emits a declaration every year on their economic interests.

In addition, the Member States shall ensure that the competent authority is making its own and its own internal rules of procedure, meeting agendas and meeting minutes accompanied by the decisions taken, poll results and explanations of vote, including minority opinion, publicly available.

Article 127

At the request of the manufacturer, the exporter or the competent authority of the exporting third country, Member States shall certify that a manufacturer of medicinal products is in possession of the manufacturing authorization. For the issue of such certificates, the following conditions must be complied with :

a) Member States shall take into account the current administrative provisions in force within the World Health Organisation ;

b) in the case of medicinal products intended for export and already authorised in their territory, they shall present a summary of product characteristics as approved in accordance with Article 21.

2. If the manufacturer is not in possession of a marketing authorization, he shall be required to make it to the authorities responsible for issuing it in paragraph 1. The certificate referred to in paragraph 1 shall submit an explanation of the reasons for which such authorization is not available.

Article 127a

When a medicinal product is approved in accordance with Regulation (EC) No, The Committee on Medicinal Products for Human Use in its opinion refers to the recommended conditions or restrictions pursuant to Article 9 (2). Point (c) (c) (c) (c) (c) (c) (c) (c) (c) (c), (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (

Article 127b

Member States shall ensure that appropriate arrangements are made for the collection of medicinal products not used or not where the last period of use has been exceeded.

SECTION XIV

FINAL PROVISIONS

Article 128

Directive 65 /65/EEC, 75 /318/EEC, 75 /318/EEC, 75 /319/EEC, 89 /342/EEC, 89 /343/EEC, 89 /343/EEC, 92 /25/EEC, 92 /26/EEC, 92 /27/EEC, 92 /28/EEC and 92 /73/EEC, as amended by the Directives listed in Annex II, part A, shall be repealed, without prejudice to the obligations of the Member States ; in respect of the deadlines set out in Annex II, Part B, shall be affected.

References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex III.

Article 129

This Directive shall enter into force on the twentith day following that of its publication in the Official Journal of the European Communities.

ARTICLE 130

This Directive is addressed to the Member States.


Appendix 2

PARLIAMENT OF THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2001 /82/EF

of 6. November 2001

laying down a Community code of veterinary medicinal products

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION HAVE-

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee 1) ,

After the procedure laid down in Article 251 of 2) , and

in the following considerations :

(1) (7) Council Directive 81 /851/EEC of 28. September 1981 on the approximation of the laws of the Member States relating to veterinary 3) , Council Directive 81 /852/EEC of 28. September 1981 on the approximation of the laws of the Member States relating to analytical, toxicological pharmacological and clinical standards and requirements for the testing of veterinary medicinal products ; 4) , Council Directive 90 /677/EEC of 13. December 1990 on the extension of the scope of Directive 81 /851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products ; 5) and Council Directive 92 /74/EEC of 22. September 1992 on the extension of the scope of Directive 81 /851/EEC on the approximation of legislation on veterinary medicinal products and laying down additional provisions for homeopathic veterinary medicinal products ; 6) have, on several occasions, been subject to extensive changes. The directives should therefore be codified and assembled in a single text so that their provisions can be clearly and rationalised.

(2) All provisions relating to the production and distribution of veterinary medicinal products should be the primary purpose of protecting public health.

(3) This objective should, however, be achieved by means of funds that cannot hinder the development of the industry and the trade in medicinal products within the Community.

(4) To the extent that Member States already have certain laws, regulations or regulations on veterinary medicinal products, these differ from one another in respect of the essential principles. They appear inhibitory to the trade in medicinal products within the Community and therefore has an immediate effect on the functioning of the internal market.

(5) It is therefore important that these obstacles be removed. To this end, the approximation of the provisions in question is necessary.

(6) For the purposes of public health and the free movement of veterinary medicinal products, it is necessary for the competent authorities to have all relevant information on authorized veterinary medicinal products in the form of approved summaries relating to the products of the products ; properties.

(7) With the exception of medicinal products falling within the Community ' s centralised authorisation procedure established by Council Regulation (EEC) No (EC) No (EEC) No No 2309/93 of 22. July 1993 establishing Community procedures for the authorisation and supervision of human and veterinary medicinal products and the establishment of a European Medicines Evaluation Agency ; 7) whereas, in principle, a marketing authorisation issued by a competent authority in a Member State should be recognised by the authorities in the other Member States, except where there is a weighing reason for assume that the approval of the person concerned should be accepted ; veterinary medicinal products may present a danger to human or animal health or to the environment. If there is a dispute between Member States concerning the quality, safety or efficacy of a veterinary medicinal product, a scientific evaluation of the matter at Community level should be carried out in order to reach a single decision on : The question of the dispute, which must be binding on the Member States concerned. The decision should be adopted by means of a rapid procedure that ensures close cooperation between the Commission and the Member States.

(8) In order to do this, a Committee on Veterinary Medicinal Products should be set up subject to the European Medicines Evaluation Agency set up by Regulation (EEC) No 2. 2309/93.

(9) This Directive constitutes only one stage of the achievement of the objective of the free circulation of veterinary medicinal products. In the light of experience gained, in particular in the Committee on Veterinary Medicinal Products, new measures will prove necessary for the elimination of continued existing barriers to free circulation.

(10) Feed medicinal products do not fall within the scope of this Directive, but it is, both for economic reasons and for public health, to prohibit the use of non-authorised medicinal products for the manufacture of : Feed medicinal products.

(11) The harmfulness and therapeutic effect can only be examined in context and only a relative significance, evaluated in the current state of science and taking into account the provision of the medicinal product. The documents and information to be attached to the marketing authorisation application shall demonstrate that the benefits associated with the effectiveness outweigh the potential risks. In the event of a negative outcome, the application shall be refused.

(12) Allowance for marketing should be refused if the therapeutic effect of the medicinal product is either lacking or inadequate, and the concept of therapeutic effect must be understood as the vocal effect of the projetor.

(13) The authorisation for placing on the market should also be refused if the wait time the specified waiting period is insufficient to eliminate the health hazard that the residues constitute.

(14) Before authorizing the placing on the market of an immunological veterinary medicinal product, the manufacturer must be able to demonstrate that he will be in a position to ensure uniformity between the manufacturing parties.

(15) The competent authorities should have the power to prohibit the use of an immunological veterinary medicinal product if the immunological response of treated animals will be disruptive in the implementation of national or Community programmes ; diagnosis, control or eradication of animal diseases.

(16) First and foremost, the users of homeopathic medicinal products should clearly be informed that these are homeopathic medicinal products, just as they should have sufficient certainty for their quality and safety.

(17) The provisions on the production and supervision and supervision of homeopathic veterinary medicinal products should be harmonized in order to permit the placing on the market throughout the Community of safe medicinal products of good quality.

(18) In view of the special characteristics of the homeopathic medicinal products, such as their weak concentration of the active components, and the difficulty of applying the traditional statistical methodology for clinical trials on them, one should be introduced ; specially, simplified registration arrangements for traditional homeopathic medicinal products placed on the market without therapeutic indication and in a pharmaceutical form and a dosage which does not pose a risk to the animal.

(19) For homeopathic veterinary medicinal products placed on the market with information on therapeutic indication or in a form which may present risks related to the expected therapeutic effect, the normal rules for authorisation should be subject to authorization ; the marketing of veterinary medicinal products is used. However, when these medicinal products are intended for use on pet animals and exotic animals, Member States should be able to use special rules for the evaluation of the results of the tests to determine the safety and efficacy of these medicinal products ; subject to the notification by the Commission of these rules.

(20) In order to protect human and animal health better and avoid unnecessary duplication in the processing of applications for veterinary medicinal products for veterinary medicinal products, Member States should systematically prepare evaluation reports for : each veterinary medicinal product they approve and, on request, exchange these reports. A Member State should also be able to suspend the processing of an application for marketing authorisation, which is for treatment in another Member State, in order to recognise the decision of the latter Member State.

(21) In order to facilitate the reproduction of veterinary medicinal products and avoid the repeated checks carried out in a Member State to be repeated in another Member State, the minimum requirements for the production and import of veterinary medicinal products should be applied to veterinary medicinal products from the veterinary medicinal products ; third countries and the issue of equivalent authorisations.

(22) The quality of veterinary medicinal products produced in the Community should be guaranteed by ensuring that the principles of good manufacturing practice for these medicinal products are required, regardless of their final uses.

(23) Measures should be taken to ensure that distributors of veterinary medicinal products are authorized by the Member States and carry out the necessary records.

(24) Standby and regulatory requirements for the implementation of veterinary medicinal products as an effective means of monitoring these and, in order to protect public health, the free movement of veterinary medicinal products may facilitate the free movement of veterinary medicinal products if they lay down ; common rules for the execution of the tests and the design of the journal shall allow the competent authorities to make a statement on the basis of consistent tests and in accordance with common criteria, and thus contribute to the imposition of divergent assessments.

(25) It should be given more accurately in which cases it is not necessary to present the results of pharmacological and toxicological studies or clinical trials in order to obtain authorisation for the marketing of a veterinary medicinal product, which, in the case of the Member of the Commission, must : essential goods correspond to an innovative medicinal product, while ensuring that innovative companies are not disadvantaged. In the general interest, however, it should be avoided that tests on animals are repeated, unless absolutely necessary.

(26) Following the establishment of the internal market, specific checks on the quality of veterinary medicinal products imported from third countries may be waiving only if the Community has taken appropriate measures to ensure that the necessary checks are carried out ; exported in the exporting country.

(27) In order to guarantee that it is safe to continue to use veterinary medicinal products, it is necessary to ensure that the medicinal products monitoring systems in the Community are continually adapted to take account of scientific and technical progress.

(28) In the interests of the protection of public health, relevant data on adverse reactions in people in the use of veterinary medicinal products should be collected and evaluated.

(29) Medicinal monitoring systems should take account of the current data on a lack of effect.

(30) In addition, the collection of information on adverse reactions caused by the use other than the prescribed, studies of whether the withdrawal period is sufficient and of potential environmental problems contribute to improving normal control of the fact that : the veterinary medicinal products are used appropriately.

(31) It is necessary to take account of changes that are the result of international harmonisation of definitions, terminology and technological development in the field of pharmacovigilance.

(32) The increased use of electronic means of communication on the side effects of veterinary medicinal products marketed in the Community is intended to gather all information on adverse reactions in a single place, while ensuring that : the information shall also be provided to the competent authorities of all Member States.

(33) It is in the Community's interest to ensure that there is consistency between the monitoring systems for veterinary medicinal products for centrally authorized medicinal products and the monitoring systems for medicinal products approved by other procedures.

(34) Marketing authorisations holders should be actively responsible for the ongoing pharmacovigilance of the veterinary medicinal products they are placing on the market.

(35) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999 /468/EC of 28. in June 1999 laying down the procedures for the exercise of implementing rules conferred on the Commission 8) .

(36) In order to improve the protection of public health, it is necessary to establish that foodstuffs must not be derived from animals used for clinical trials in veterinary medicinal products unless a maximum level is provided for ; residues of the medicinal product concerned in accordance with Council Regulation (EEC) No 2, 2377/90 of 26. June 1990 laying down a common procedure for the establishment of maximum residue limits for veterinary medicinal products in animal foodstuffs 9) .

(37) The Commission should be empowered to adopt the necessary amendments to Annex I in order to adapt it to scientific and technical progress.

(38) This Directive should not affect the obligations of the Member States in respect of the deadlines for transposition of the Directives listed in Annex II, Part B,

ISSUED THE FOLLOWING DIRECTIVE :

SECTIONS IN

DEFINITIONS

ARTICLE 1

For the purposes of this Directive :

1) (The case).

2) Veterinary medicinal product :

a) any substance or combination of substances presented as a suitable means of treatment or prevention of animal diseases ; or

b) any substance or combination of substances which may be used for or given to animals for the purpose of either re-establishing, altering or influencing physiological functions by carrying out a pharmacological, immunological or metabolic effect, or provide a medical diagnosis.

3) (The case).

4) Stof

any substance, irrespective of its origin, as this may be :

-WHAT? human, such as :

human blood and human blood preparations.

-WHAT? animal, such as :

micro-organisms, whole animals, parts of bodies, animal sects, toxins, extracts extracted by extraction, blood preparations ;

-WHAT? vegetable, for example :

micro-organisms, plants, parts of plants, plant varieties, extracts extracted from the extraction ;

-WHAT? chemical, as for example :

basic substances, natural chemical substances, and chemical preparations, obtained by conversion or synthesis.

5) Mixture for feed medicinal products

any veterinary medicinal product prepared in advance for the purpose of the subsequent manufacture of feed medicinal products.

6) Feed medicinal products

any mixture of one or more veterinary medicinal products and one or more feedingstuffs prepared before their marketing and intended for no processing to animals on account of their health or preventive characteristics or other, of their characteristics as referred to in point 2.

7) Immunological veterinary medicinal product

a veterinary medicinal product which is submitted to animals in order to evoke active or passive immunity or to determine the degree of immunity.

8) Homeopathic veterinary medicinal product :

A medicinal product obtained from substances called homeopathic tribes, following a homeopathic manufacturing method described in the European Pharmacopoeia or in the absence thereof, in the pharmacopoeias currently officially in the Member States. A homeopathic veterinary medicinal product may contain several active substances.

9) Holding Time :

Necessary period during normal regulatory use and in accordance with the provisions of this Directive must be observed from the final treatment of the animal with the veterinary medicinal product for this animal to be used in the manufacture of foodstuffs, in order to protect : public health by ensuring that such foodstuffs do not contain residues that exceed the maximum levels of residues of active substances as determined in accordance with Regulation (EEC) No (EEC) No (EEC) No (EEC) No (EEC) No ; 2377/90.

10) Side effects :

A harmful and unintended response to a veterinary medicinal product which enters into doses normally used for the purpose of prevention, diagnosis or treatment of disease or for resettlement, alteration or exposure to a physiological physiological order function.

11) People's side effects

a harmful and unintended reaction, which enters into humans after exposure to a veterinary medicinal product.

12) Serious adverse reaction :

a side effect which is lethal, life-threatening, or causes significant invalidity or incapacity for incapacity, is a congenital abnormal or birth injury or resulting in persistent or prolonged symptoms in the treated animal.

13) Unexpected side effect

a side effect whose nature, severity or outcome is not mentioned in the summary of the product characteristics.

14) Periodical, updated security reports

the periodic reports which contain the registrations referred to in Article 75.

15) Post-Marketing Surveys

pharmaco-epidemiological enquiry or clinical trials carried out in accordance with the conditions laid down in the marketing authorization and carried out in order to identify and examine a safety hazard in connection with an approved approval ; veterinary medicinal product.

16) Unprescribed use

the use of a veterinary medicinal product which is not in accordance with the summary of the product characteristics, including the misuse and serious abuse of the preparation.

17) Wholessnegotiation with veterinary medicinal products

any action involving the purchase, sale, import and export or any other commercial transaction with veterinary medicinal products, be it to be of economic benefit or not, except for :

-WHAT? the supply of veterinary medicinal products to which he himself has produced,

-WHAT? the retail sale of veterinary medicinal products by persons authorized to do so in accordance with Article 66.

17a) The representative of the marketing authorization holder :

The person, commonly referred to as the local representative designated by the marketing authorization holder, to represent this person in the Member State concerned.

18) Agency

The European Medicines Agency established by Regulation (EC) No, 726/2004 10) .

(19) Risk of the use of the medicinal product :

-WHAT? any risk associated with the quality, safety and effiance of the veterinary medicinal product on animal or human health ;

-WHAT? any risk of undesirable effects on the environment.

20) Relationship between benefits and risks :

Evaluation of the positive therapeutic effects of veterinary medicinal products in relation to the risk of adverse effects as described above.

21) Expensive ecept :

Any prescription for veterinary medicinal products prescribed by a qualified expert with the power to do so in accordance with applicable national law.

(22) Name of veterinary medicinal product :

The name may be either a distinguished name that must not be confused with the common name, a common name, or a scientific name with an addition of a brand name or the name of the marketing authorization holder.

23) Common name :

The international community name recommended by the World Health Organization, or if such a non-standard common name does not exist.

24) Strength :

The content of active substances, expressed in quantities per year ; Dosing unit, volume unit or weight unit according to the dosage form.

25) Inner packaging :

It shall keep, or any other form of packaging, directly connected with the medicinal product.

26) Outer packaging :

The packaging of the packaging of the internal packaging.

27) Labelling :

The information on the internal or outer packaging of the internal packaging.

28) Entry note :

The information note to the user that contains information to the user and who is following the medicinal product.

TITLE II

SCOPE OF APPLICATION

ARTICLE 2

This Directive shall apply to veterinary medicinal products, including premixtures for feed medicinal products to be placed on the market in the Member States and which are either manufactured in an industrial field or by the use of an industrial process.

2. In case of doubt as to whether a product from a total assessment of its properties may be subject to the definition of ' veterinary medicinal product ' and the definition of a product falling under the other Community legislation, this Directive shall apply : use.

3. Notwithstanding paragraph 1. The provisions of this Directive shall apply to active substances used as raw materials as laid down in Articles 50, 50a, 51 and 80, and in addition to certain substances which may be used as a veterinary medicinal product, and which provides for the metabolizing of metabolites. antiinfectious antiparasitic, antiinflammatory, hormonal or psychotropic properties to the extent set out in Article 68.

ARTICLE 3

1. This Directive shall not apply to :

a) feed medicinal products as defined in Council Directive 90 /167/EEC of 26. March 1990 laying down the conditions for the preparation, marketing and use of feed medicinal products in the Community 11)

b) inactivated immunological veterinary medicinal products obtained from pathogenic organisms and antigens extracted from an animal or a livestock unit and used for the treatment of this animal or livestock in the same place ;

c) veterinary medicinal products, produced from radioactive isotopes ;

d) additives, as provided for by Council Directive 70 /524/EEC of 23. November 1970 concerning additives in feedingstuffs 12) which are mixed feedingstuffs and forage feedingstuffs in accordance with the conditions laid down in that Directive, and

(e) without prejudice to Article 95 medicinal products for veterinary use, intended for research or development.

However, feeding medicinal products referred to in subparagraph (a) may be made only on the basis of premixtures to feed medicinal products approved in accordance with this Directive.

2. Without prejudice to the provisions governing possession, ordination, extradition and submission of veterinary medicinal products, this Directive shall not apply to :

a) medicinal products prepared in a pharmacy following the veterinary centre for a particular animal or a small group of animals commonly referred to as the magic of the products ;

b) medicinal products prepared in a pharmacy in accordance with the requirements of a pharmacopoeia and are intended for direct extradition to the final user, commonly referred to as official medicinal products.

ARTICLE 4

1. Member States may provide that this Directive does not apply to non-inactivated immunological veterinary medicinal products derived from pathogenic organisms and antigens derived from an animal or a livestock unit and used for the treatment of this Directive ; the animal or livestock unit in the same place.

2. Member States may, on their own territory, in the case of veterinary medicinal products intended exclusively for aquarium fish, ornamental birds, letterings, terrors, small-order, ferrets and celery rabbits, derogate from the provisions of Article 5 to 8, provided that they are subject to the provisions of Article 5 (8) ; Whereas the medicinal products in question do not contain substances whose application requires veterinary checks and the necessary measures are taken to prevent abuse of the medicinal products in question to other species.

TITLE III

MARKETING

CHAPTER 1

Marketing Permission

Article 5

1. No veterinary medicinal product may be placed on the market in a Member State without the authorisation of the placing on the market in accordance with this Directive, or authorised thereto in accordance with Regulation (EC) No (EC) No (EC) No ; 726/2004.

When a medicinal product has obtained a first authorisation under the first subparagraph, any additional species, strengths, medicinal products, management paths, package sizes, and any change and extension, must also have a permit in accordance with the first subparagraph or is subject to the original marketing authorisation. All of these marketing authorisations shall be deemed to belong under the same comprehensive marketing authorisation, in particular with regard to the application of Article 13 (1). 1.

2. The marketing authorization holder shall be responsible for the marketing of the medicinal product. The issuer of a representative shall not exempt the marketing authorization holder on his legal responsibility.

ARTICLE 6

1. The placing on the market of a veterinary medicinal product for submission to one or more food-producing animals shall not be authorised unless the pharmacologically active substances contained in the medicinal product are listed in Annex I, II, or III to Regulation (EEC) No, 2377/90.

2. The marketing authorization holder or, where appropriate, the competent authorities shall, where it is justified as a result of a modification of the Annexes to Regulation (EEC) No 2, Directive 2377/90, initiating all necessary measures to amend or revoke the marketing authorization no later than 60 days after the date of publication of the said amendment to the said Regulation in the Official Journal of the European Union.

3. Notwithstanding paragraph 1. 1 may be a veterinary medicinal product containing pharmacologically active substances not listed in Annexes I, II or III to Regulation (EEC) No 2 ; 2377/90 is hereby approved for the specific animals of the Hestlep, which, in accordance with Commission Decision 93 /623/EEC of 20, shall be approved. October 1993 on an identification document (passport) to accompany registered equidae ; 13) and Commission Decision 2000 /68/EEC of 22. December 1999 amending Decision 93 /623/EEC and on the identification of equidae for breeding and production of production 14) have been declared unfit for slaughter for human consumption. Such veterinary medicinal products shall not contain any active substances listed in Annex IV to Regulation (EEC) No 2, 2377/90, or calculated for processing state, cf.. the approved summary of product characteristics for which a veterinary medicinal product is permitted for the animals of the Hestaste.

Article 7

Where the state of health requires, a Member State may authorise the marketing or treatment of animals with veterinary medicinal products authorised by another Member State in accordance with the provisions of this Directive.

ARTICLE 8

In the event of serious epizootic diseases, Member States may temporarily authorise the use of immunological veterinary medicinal products without marketing authorization if there is no suitable medicinal product and after they have notified the Commission ; on the detailed conditions of use.

The Commission may use the option provided for in the first subparagraph, where it is expressly provided for by Community provisions concerning certain serious epizootic diseases.

A Member State may, where an animal is the subject of imports from or exported to a third country and subject to specific mandatory health rules, authorise the use of an immunological veterinary medicinal product for the animal in question, even though there is, in this case, Member States have not been granted authorisation for the marketing of this medicinal product, but it has been approved under the legislation of the third country concerned. Member States shall take all necessary measures for the control of imports and the use of such immunological medicinal products.

Article 9

No veterinary medicinal product may be given to animals without marketing authorization, unless it relates to the testing of veterinary medicinal products as referred to in Article 12 (1). Article 3 (j), approved by the competent national authorities, after notification of this or authorization, in accordance with the applicable national legislation.

Article 10

Member States shall take the necessary measures to ensure that, in a Member State, when there is no veterinary medicinal product approved for the treatment of a state of non-food-producing animal, the competent veterinarian may be responsible for the veterinary medicinal product, exceptionally, under his direct, personal responsibility for the treatment of the animals in question, in particular in order to avoid any unacceptable suffering, use :

a) a veterinary medicinal product which, in the Member State concerned, has been approved by the present Directive or in force of Regulation (EC) No 2, 726/2004 for another species or animal species, but for another condition, or

b) if the medicinal product referred to in (a) does not exist, either :

In. a medicinal product for human use, as in the Member State concerned, through the European Parliament and Council Directive 2001 /83/EC, or in force of Regulation (EC) No (EC) No (EC) No 149/EC. 726/2004, or

(ii) in accordance with specific national measures, a veterinary medicinal product which, in another Member State, has been approved by the present Directive to the same animal species or to another animal species and to the condition of the species concerned or to another ; state, or

c) if the medicinal product referred to in point (b) does not exist and with the limitations of the legislation of the Member State concerned, a veterinary medicinal product prepared in order to be commissioned by a person authorized by a person authorized to do so ; subject to national law.

The veterinarian may submit the medicinal product in person, or to allow someone else to do so under his responsibility.

Notwithstanding Article 11, the provisions of paragraph 1 shall apply. Paragraph 1 shall also apply to the treatment of animals of the hectare, provided that such animals comply with Commission Decision 93 /623/EEC and 2000 /68/EC shall be declared unfit for slaughter for human consumption.

Article 11 (3) or Article 11, the Commission shall establish a list of substances which are essential for the treatment of animals of the hectare, and for which the withdrawal period shall be at least six months in accordance with the control procedure in Decision 93 /623/EEC and 2000 /68/EF.

This measure, which aims to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

Article 11

Member States shall take the necessary measures to ensure that, in a Member State, when there is no veterinary medicinal product approved for the treatment of a condition of a food-producing species, the veterinary veterinarian may, exceptionally, under his direct personal responsibility, in particular in order to avoid unacceptable suffering, the animals in question on a particular holding shall be treated with :

a) a veterinary medicinal product which, in the Member State concerned, has been approved by the present Directive or in force of Regulation (EC) No 2, 726/2004 to another animal species or to the same animal species, but to another condition, or

b) if the medicinal product referred to in point (a) does not exist :

In. a medicinal product for human use, as in the Member State concerned, in force of Directive 2001 /83/EC or Regulation (EC) No 2 ; 726/2004, or

(ii) a veterinary medicinal product which, in another Member State, has been approved by the present Directive to the same animal species or to other food-producing animal species and to the condition of the species concerned, or to other conditions, or

c) where there is no veterinary medicinal product as referred to in (b), with a veterinary medicinal product which is prepared in accordance with a veterinarian empowered by a person authorized to do so in accordance with national law and with the restrictions imposed ; the legislation of the Member State concerned.

The veterinarian may submit the medicinal product in person, or to allow someone else to do so under his responsibility.

Paragraph 1 shall apply where the pharmacologically active substances of the medicinal product are listed in Annexes I, II or III to Regulation (EEC) No 2. 2377/90, and in the case of an appropriate detention period, the veterinarian shall determine the appropriate withdrawal period.

If the medicinal product is not given a detention period for the species concerned, the specified withdrawal period shall not be shorter than :

-WHAT? 7 days for eggs

-WHAT? 7 days for milk

-WHAT? 28 days for the meat of poultry and mammals, including fat and offal

-WHAT? 500 grasdays for fish meat.

However, the Commission may change these specific detention times. These measures, which are intended to amend non-essential provisions of this Directive, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

3. The wait time referred to in paragraph 1 shall be that of the third paragraph. The second subparagraph shall be zero when it is a homeopathic veterinary medicinal product, provided that the active substance is included in Annex II to Regulation (EEC) No 2. 2377/90.

4. In the case of the animal doctor's treatment in accordance with paragraph 1, 1 and 2, this shall keep records of all relevant information including the date of examination of the animals, indication of the owner, the number of animals treated, the prescribed medicinal products, the doses of treatment, the duration of treatment, and the duration of the examination ; recommended retication times. The veterinarian must keep these records at the disposal of the competent authorities for at least five years.

5. Member States shall take, without prejudice to the other provisions of this Directive, all necessary measures for the purposes of import, negotiation, supply and information on the medicinal products which they allow for use in the submission of food-producing animals in accordance with paragraph 1 ; paragraph 1 (b) no. (ii).

Article 12

1. In order to obtain a marketing authorisation for a veterinary medicinal product which does not fall within the scope of the procedure covered by Regulation (EC) No 2, The application shall be submitted to the competent authority of the Member State concerned in the Member State concerned.

In the case of veterinary medicinal products intended for one or more animal species intended for food production if pharmacologically active substances for the species or animal species have not yet been included in Annexes I, II or III to Regulation ; (EEC) No In the case of a valid application for the fixing of maximum residue levels in accordance with the abovementioned Regulation, a valid application for a marketing authorisation shall be applied for marketing authorization. The marketing authorisation application may not be submitted within six months of the application for the fixing of maximum residue levels.

For the provisions referred to in Article 6 (2). However, the veterinary medicinal product referred to in paragraph 3 may, however, be subject to the marketing authorisation application without a valid application in accordance with Regulation (EEC) No 2, 2377/90. The scientific evidence which is necessary to demonstrate the quality, safety and efficuse of the veterinary medicinal product, cf. paragraph 3.

2. A marketing authorisation may be issued only to an applicant established in the Community.

3. The documentation attached to the application for marketing authorization shall include all administrative information and all scientific and technical material which may demonstrate the quality, safety and effimentation of the veterinary medicinal product. This documentation must be provided in accordance with Annex I and in particular include the following information :

a) the name or business name and place of residence or registered office of the person responsible for the placing on the market of the person concerned and, where appropriate, for the manufacturer or the manufacturer or the persons concerned and the places where the manufacture is to be carried out ;

b) name of the veterinary medicinal product,

c) the qualitative and quantitative composition of all the constituents of the veterinary medicinal product, including the international common name recommended by the World Health Organisation, provided that such a common name for the medicinal product is present, or the chemical name,

d) description of the manufacturing method,

(e) therapeutic indications, counterindications and adverse reactions ;

(f) the dosage of the various animal species for which the veterinary medicinal product is determined, the method of medicinal products, administration and method, and the proposed shelf life of the animal ;

g) Indication of any precautionary and precautionary measures to be taken in the storage of the veterinary medicinal product, in the treatment of animals, and in the disposal of waste products, and the risks which may be taken, as appropriate ; the veterinary medicinal product may offer the health of the environment and human, animal and plant health ;

(h) indication of the withdrawal period for medicinal products intended for food-producing animal species ;

i) the description of the control methods used by the manufacturer,

j) the results of :

-WHAT? (physicochemical, biological or microbiological) Pharmaceutical tests

-WHAT? safety studies and the studies for residues,

-WHAT? pre-clinical and clinical trials,

-WHAT? studies that assess the risks to which the medicinal product may imply the environment. The impact must be examined, and it is considered in specific cases to introduce specific provisions to limit it.

c) a detailed description of the pharmacovigilance system and, where appropriate, the risk management system which the applicant intends to introduce ;

I) a product sume in accordance with Article 14, a model of the internal packaging and the outer packaging of the veterinary medicinal product and the package leaflet in accordance with Articles 58 to 61 ;

m) a document stating that the manufacturer is authorized to manufacture veterinary medicinal products in his country of origin ;

n) the resides of any authorisation for the placing on the market of the veterinary medicinal product concerned in another Member State or in a third country, together with a list of Member States in which an application for authorisation has been submitted in accordance with Whereas this Directive is for consideration, the product type of product concerned, as proposed by the applicant in accordance with Article 14 or approved by the competent authority of the Member State in accordance with Article 25, and the resides of the proposed package leaflet and the details of the product, information on the refusal of authorization, whether in the Community or in the Community, a third country, and the reasons for them. All of this information shall be updated regularly ;

o) proof that the applicant has a qualified person responsible for pharmacovigilance and the equipment necessary to report on any supposed side effect in the Community or a third country ;

p) in the case of veterinary medicinal products intended for one or more food-producing species and whose pharmacologically active substances for the species of animal or animal species have not yet been included in Annexes I, II or III ; to Regulation (EEC) No, Directive 2377/90, a certificate for the submission of a valid application for the fixing of maximum residue levels for the Agency in accordance with the abovementioned Regulation.

Documents and information relating to the results of tests, studies and trials referred to in subparagraph (j) shall be accompanied by detailed and critical summarymecs drawn up in accordance with Article 15.

ARTICLE 13

Article 12 (1) or Article 12 (1). the applicant shall not be obliged to submit, without prejudice to the laws relating to the protection of industrial and commercial property, to present the results of tests for residues, studies for residues or of the protection of the products concerned ; clinical or clinical trials, if he can prove that the medicinal product is a generic version of a reference medicinal product which, in accordance with Article 5, has been or has been approved for at least eight years in a Member State or in the Community.

A generic veterinary medicinal product which has obtained approval pursuant to this provision may not be placed on the market before the ten-year period following the initial marketing authorisation for the reference medicinal product has expired.

Paragraph 1 shall also apply where the reference medicinal product has not been approved in the Member State in which the application for the generic medicinal product has been lodged. In such cases, the applicant shall indicate in the application form the name of the Member State in which the reference medicinal product is or has been approved. At the request of the competent authority of the Member State in which the application has been lodged, the competent authority of the other Member State shall, within one month, forward confirmation that the reference medicinal product has been or has been approved, and the full composition of the reference product and, where appropriate, the relevant documentation.

In the case of veterinary medicinal products intended for fish and bees or other species designated by the Commission, the ten-year period shall be extended, cf. the second paragraph, however, to 13 years.

This measure, which aims to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

2. For the purposes of this Article :

-WHAT? ' Reference medicinal product ` means a medicinal product approved in accordance with Article 5 and in accordance with Article 12 ;

-WHAT? ' generic medicinal product ` means a medicinal product which has the same qualitative and quantitative composition of active substances and the same medicinal product as the reference medicinal product, and if the equivalence of the reference medicinal product is shown by appropriate ; bioavailability studies. The different salts, esters, ethotes, isomers, mixtures of isomers, complexes, or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in the properties of safety and / or effect. If this is the case, the applicant shall provide further information that proves that the various salts, esters or derivatives of an active substance are safe and / or effective. Various oral medicinal products with immediate release shall be regarded as having the same medicinal product as one. The applicant may be exemplify from carrying out bioavailability studies if he is able to demonstrate that the generic medicinal product meets the relevant criteria as defined in the relevant detailed guidelines.

3. If the veterinary medicinal product is not covered by the definition of a generic medicinal product in paragraph 1, 2 (b) or bioequivalence cannot be detected in the case of bioavailability studies, or in the case of changes, in relation to the reference medicinal product, of the active substances, the therapeutic indications, the strength, the medicinal product or the administration road shall be presented by the results of the relevant safety surveys, studies on residues and pre-clinical trials.

4. If a biological veterinary medicinal product corresponding to a biological reference veterinary medicinal product does not satisfy the conditions laid down in the definition of a generic medicinal product, in particular because of differences resulting from the raw material or because the manufacturing processes for the biological medicinal product and the biological reference product are different, shall be submitted to the results of appropriate pre-clinical or clinical trials in relation to these conditions. The additional data to be submitted shall in respect of nature and quantity meet the relevant criteria set out in Annex I and the relevant detailed guidelines. The results of other tests and tests from the case of the reference box shall not be submitted.

5. For veterinary medicinal products intended for one or more food-producing animal species and containing a new active substance, which is the 30one. In April 2004, the period of 10 years shall be extended in respect of the period of 10 years. The second subparagraph of the marketing authorization for any extension of the marketing authorization to another food-producing species shall be subject to a year, if approved no later than five years after the issuing of the original marketing authorization.

However, this period may not exceed 13 years in total for a marketing authorisation, which relates to at least four food-producing animals.

The ten-year period may be extended to eleven, twelve or thirteen years for a veterinary medicinal product intended for a food-producing animal if the marketing authorization holder has also originally applied for the fixing of : maximum residue levels for the animal species covered by the authorization.

6. The implementation of the necessary studies and experiments for the application of paragraph 1. 1-5 and the resulting practical requirements are not considered to be in breach of the rights of patents and additional protection certificates for medicinal products.

Article 13a

Article 12 (1) or Article 12 (1). the applicant shall not be obliged to submit, without prejudice to the legislation relating to the protection of industrial and commercial property, to present the results of tests for residues, studies for residues or of ; clinical or clinical trials, if this can prove that the active substances which are part of the veterinary medicinal product have been found in the Community of a minimum of 10 years in the Community for at least 10 years and have been recognised as effective and sufficiently effective ; ensure in accordance with the requirements of Annex I, in which case the applicant shall submit ; relevant bibliographic scientific evidence.

2. The Evaluation Report, published by the Agency, following an evaluation of an application for the fixing of maximum residue levels in accordance with Regulation (EEC) No 2, In the appropriate way, it is appropriate to use scientific evidence, particularly as regards the security investigations.

3. If an applicant makes use of scientific evidence in order to obtain a permit for a food-producing animal species and in the same way as regards the same medicinal product, new residues in accordance with the provisions of Regulation (s) are submitted to the Commission ; (EEC) No Whereas 2377/90 and new clinical trials in order to obtain a permit for a different food-producing species, third parties may not refer to such studies and tests within the framework of Article 13 for a period of three years after the date of the date ; the grant of the authorisation for which the studies have been granted.

Article 13b

In the case of veterinary medicinal products containing active substances forming part of the composition of approved veterinary medicinal products, which have not been combined for therapeutic purposes, in accordance with the provisions of Article 12 (2), The first subparagraph (j), (3) (j), shall be presented, where necessary, of the results of the safety examinations, of studies for residues and new clinical or clinical trials in relation to the new combination, without the need to provide, however, documentation concerning each active substance.

Article 13c

The holder of a marketing authorisation may authorise the use of the pharmaceutical documentation, safety examinations, the studies on residues, the preclinical and clinical trials, following the authorisation of this authorisation. in the case of the veterinary medicinal product concerned, in view of the examination of a subsequent application for a veterinary medicinal product with the same qualitative and quantitative composition of active substances and the same pharmaceutical form.

Article 13d

Notwithstanding Article 12 (2), the applicant shall not be obliged to submit, in exceptional circumstances, of the immunological veterinary medicinal products, to present the results of certain studies of the species for which the medicinal product is intended for the purposes of which the medicinal product is available ; studies for justified reasons cannot be carried out, in particular because of other Community provisions.

ARTICLE 14

Product trisuction shall include the following information in this order :

1) the name of the veterinary medicinal product, followed by strength and medicinal products ;

2) the qualitative and quantitative composition of the active substances and formulants, which are to be familiar with a view to the sound use of the veterinary medicinal product, in the common name or chemical designation ;

3) pharmaceutical form,

4) Clinical particulars

4.1. species intended for the preparation,

4.2. the applications for use of the species for which the preparation is intended ;

4.3. contraindications,

4.4. special warnings for each animal species, the medicinal product is intended for :

4.5. special precautions, including special precautions, as the person dealing with animals with the medicinal product must follow ;

4.6. adverse reactions (frequency and severity),

4.7. use during drainness, milk production or egg production ;

4.8. medicamentelle interactions and other interactions ;

4.9. dosage and administration road,

4.10. overdosage (if any symptoms, emergency treatment, antitoxin),

4.11. the time of detention for the various food products, including food, without detention periods.

5) pharmacological properties,

5.1. Pharmaco-dynamic properties

5.2. Pharmaco-kinetic properties

6) Pharmaceutical information :

6.1. list of formulants,

6.2. essential inequities

6.3. the durability, where appropriate, after the reconstitution of the medicinal product or after the opening of the package for the first time ;

6.4. special storage precautions,

6.5. the nature and composition of the internal packaging,

6.6. where appropriate, special measures to be taken for the disposal of unused veterinary medicinal products or waste resulting from the use of these products ;

7) holder of the marketing authorization ;

8) marketing authorisation number / number,

9) the date of the first authorisation or renewal of the authorization ;

10) the date of text change.

In the case of approvals provided for in Article 13, it is not necessary to include those parts of the product summary of the reference medicinal product which refers to therapeutic indications or dosage instructions which are still subject to patent law ; at the time when the generic medicinal product is placed on the market.

Article 15

1. The applicant shall ensure that the detailed and critical summarms referred to in Article 12 (2) shall be provided. The other technical or professional qualifications referred to in the second subparagraph shall be drawn up and signed by persons with the necessary technical or professional qualifications before they are submitted to the competent authorities.

2. Persons with the items in paragraph 1 The technical or professional qualifications referred to in Article 13a (1) must be subject to any technical or professional qualifications. The bibliographic scientific evidence referred to in Annex I shall be mentioned in accordance with Annex I.

3. a short food description for the products referred to in paragraph 1. 1 the persons referred to shall be annexes to the detailed and critical resumes of the person referred to in paragraph 1.

CHAPTER 2

Special provisions for homeopathic veterinary medicinal products

Article 16

1. Member States shall ensure that the homeopathic veterinary medicinal products manufactured and marketed in the Community are registered or approved in accordance with Articles 17, 18 and 19, excluding veterinary medicinal products, registered or approved in comply with national legislation at the latest by 31. December 1993. Articles 32 and 33 (3). In the case of homeopathic medicinal products recorded in accordance with Article 17, use is applicable to homeopathic medicinal products.

Member States shall introduce a special simplified registration procedure for the homeopathic veterinary medicinal products referred to in Article 17.

Without prejudice to Article 10, homeopathic veterinary medicinal products under the responsibility of a veterinarian may be presented to non-producing goods producing animals.

Notwithstanding Article 11 (4), Member States shall permit, during the responsibility of a veterinarian, homeopathic veterinary medicinal products intended for food-producing animal species and whose active substances are listed in Annex II to Regulation (EEC) No 2 ; 2377/90. Member States shall take appropriate measures to monitor the use of homeopathic veterinary medicinal products which, in another Member State, have been registered or approved by this Directive for the same animal species.

Article 17

Paragraph 1, subject to the provisions of Regulation (EEC) No 2, Whereas 2377/90 on the fixing of maximum residue levels in respect of pharmacologically active substances intended for food-producing animals is used only for a particularly simplified registration procedure for homeopathic products ; veterinary medicinal products which satisfy all the following conditions :

a) the administration road is as described in the European Pharmacopoeia or to the pharmacopoeias currently having official status in the Member States ;

b) there are no special therapeutic indications on the label or in the information on the veterinary medicinal product ;

c) the dilution degree must ensure that the medicinal product is harmless. In particular, it must not contain more than one part per 10,000 of the basic tincture.

Where new scientific information is available, the provisions of the first subparagraph (b) and (c) may be adapted to the Commission. These measures, which are intended to amend non-essential provisions of this Directive, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

In the registration process, Member States shall establish a classification for the supply of the medicinal product.

2. The criteria and procedural rules laid down in Chapter 3 of the derogation Article 25 shall apply mutatis muted to the special, simplified registration procedure for homeopathic veterinary medicinal products referred to in paragraph 1. 1, however, not on the proof of therapeutic effect.

Article 18

The special, simplified application for registration may include a range of medicinal products obtained from the same homeopathic strain (s). The application shall be accompanied by the following documents, in particular, in order to demonstrate the pharmaceutical quality of these medicinal products and the uniformity of the particulate produced by the parties :

-WHAT? the homeopathic stock (s) of the scientific name or other designation of a pharmacopoeia, stating the different administration methods, pharmaceutical forms and dilution degrees to be recorded ;

-WHAT? evidence of the description of the manufacture and control of the tribe (tribes), which shall prove the homeopathic nature of the homeopathic veterinary medicinal product in the case of homeopathic veterinary medicinal products containing biological substances, a description of the necessary precautions to prevent any pathogen,

-WHAT? the documentation for the production and control of each pharmaceutical form and the description of the methods of dilution and potent preparation,

-WHAT? the authorisation to manufacture the medicinal products concerned,

-WHAT? copies of any registrations or approvals for the same medicinal products in other Member States ;

-WHAT? one or more models of the outer and internal packaging of the medicinal products to be recorded.

-WHAT? information concerning the shelf life of the medicinal product.

-WHAT? recommended withdrawal time accompanied by all necessary information.

Article 19

1. Other homeopathic veterinary medicinal products other than those referred to in Article 17 (2). 1, shall be approved in accordance with Articles 12, 13a, 13b, 13c, 13d and 14.

2. A Member State may, in its territory, introduce or retain special provisions concerning safety studies, pre-clinical and clinical trials of homeopathic veterinary medicinal products intended for pet animals or non-food-producing products ; exotic species, which are not covered by Article 17 (1). Paragraph 1, in accordance with the principles and the special practices applicable to homeopathy in this Member State. In such cases, the Member State shall inform the Commission of the special rules in force.

Article 20

This Chapter shall not apply to immunological veterinary medicinal products.

The provisions of Titus VI and VII shall also apply to homeopathic veterinary medicinal products.

CHAPTER 3

Experation of the marketing authorisation issue

Article 21

Member States shall take all appropriate measures to ensure that the issue of a marketing authorisation procedure does not exceed 210 days from the time of the submission of a valid application.

Where the marketing authorisations for the same veterinary medicinal product are requested in more than one Member State, applications must be submitted in accordance with Articles 31-43.

2. If a Member State ascertains that an application for the marketing of the same medicinal product is already under consideration in another Member State, it shall refuse to examine the application and shall inform the applicant that Articles 31 to 43 shall apply, use.

Article 22

Where a Member State in accordance with Article 12 (1), Whereas Article 3 (3) (n) shall be informed that another Member State has approved a veterinary medicinal product subject to an application for marketing authorisation in the Member State concerned, if the application has not been submitted in accordance with the authorization, with Articles 31-43.

Article 23

In the treatment of an application in accordance with Article 12 (13d), the competent authority of the Member State shall :

1) verify that the material provided is in accordance with Article 12 to 1 and examine whether the conditions for the granting of marketing authorisation have been met ;

2) have the possibility of allowing the veterinary medicinal product, its raw materials and, where necessary, its intermediates and other constituents to verify an official Medicinal Control Laboratory or a laboratory designated by a Member State for that purpose ; and ensure that the control methods used by the manufacturer and described in the application material in accordance with Article 12 (1). the first subparagraph of paragraph 3 (i) is satisfactory ;

3) in the same way, in particular in consultation with the national reference laboratory or the EFReference Laboratory, that the analysis method for the detection of residues proposed by the applicant in accordance with Article 12 (2) shall be ensured. 3 (j), second indent, is satisfactory ;

4) where appropriate, require the applicant to supplement the material with additional information on the points referred to in Article 12-13d. Where the competent authority makes use of this option, the time limits laid down in Article 21 shall be suspended until such time as the additional information required is provided. The time limits shall also be suspended during the time provided for in the event of the applicant to give an explanation of oral or written explanation.

ARTICLE 24

Member States shall take all the necessary provisions to ensure that :

a) the competent authorities shall ensure that the manufacturing and the products of veterinary medicinal products from third countries are in a position to carry out their production in accordance with the provisions of Article 12 (2). the information referred to in Article 12 (2) shall be subject to the information contained in the material referred to in Article 12 (3) (d), or 3 (i)

b) Whereas the competent authorities may, in duly substantiated cases, grant the production and the authorisation of veterinary medicinal products from third countries to allow certain parts of the manufacture and / or the checks provided for in (a) by third parties in such a way as to ensure that, in such cases, such checks are carried out ; the competent authorities ' control shall also be carried out in such undertakings as well.

ARTICLE 25

1. The authorization of the marketing authorization shall send the competent authority to the holder of the product to be notified of the product suction approved.

2. The competent authority shall take all necessary measures to ensure that the information relating to the veterinary medicinal product, including the labelling and package leaflet, is in accordance with the information approved in the product summary at : the marketing authorization issue or later.

3. The competent authority shall immediately make the marketing authorization together with the product summary of any veterinary medicinal product which it has approved, accessible to the public.

4. The competent authority shall draw up an evaluation report and observations relating to the results of the results of the pharmaceutical tests, safety examinations, the studies on residues and the pre-clinical and clinical trials ; clinical trials of the veterinary medicinal product concerned.

The Evaluation Report shall be updated as soon as new information is available for evaluation of the quality, safety or effiination of the veterinary medicinal product concerned.

The competent authority shall, without delay, make the evaluation report accompanied by the explanatory statement of its opinion directly accessible to the public after removing any information of commercial confidentiality.

Article 26

1. The marketing authorisation may be made subject to the marketing authorization holder on the internal and / or external packaging and on the package leaflet, provided that it is required, other important information for the protection or protection of the products ; health, including special precautions to be observed during use and other warnings resulting from the provisions of Article 12 (2). Article 13 (3) (j) and 13-13d ' s studies and studies or the experience gained from the use of the veterinary medicinal product after it has been placed on the market.

2. (Repeared).

3. In exceptional circumstances and after consultation with the applicant, the issuance of the authorisation may be made subject to the introduction of specific mechanisms, in particular with regard to the safety of the veterinary medicinal product, by the competent authorities, any event related to the application and of the measures to be taken. Such authorisation shall be issued only by objective and verifiable reasons. Continuation of the marketing authorisation shall depend on a renewed annual assessment of these conditions.

ARTICLE 27

1. The holder of the authorization shall, in the case of the marketing authorization, for the marketing authorization referred to in Article 12 (2). Whereas, (3) (d) and (i), take account of scientific and technical progress and to introduce the necessary changes for the production of the veterinary medicinal product and inspected according to normally recognised ; scientific methods.

These amendments shall be subject to approval by the competent authority of the Member State concerned.

2. The competent authority may require the applicant or the marketing authorization holder to supply substances in sufficient quantities to carry out checks for the detection of the residues of the products concerned. veterinary medicinal products.

The holder of the marketing authorization shall assist with its technical expertise, at the request of the competent authority, in order to make it easier for the national reference laboratory designated pursuant to Council Directive 96 /23/EC of 29. April 1996 on the control measures to be implemented for certain substances and residues thereof in live animals and their products ; 15) the implementation of the analytical procedure for the detection of residues of veterinary medicinal products.

3. The holder of the authorisation shall immediately forward new information to the competent authority if they may involve any amendments to the information and documents referred to in Article 12 (1). 3, 13, 13a, 13b, and 14 or in Annex I.

The holder of the authorisation shall in particular be obliged to notify the competent authority without delay of any prohibition or restriction imposed by the competent authorities of the countries in which the veterinary medicinal product is placed on the market and on the other new information which could affect the assessment of the relationship between the benefits and risks of the veterinary medicinal product concerned.

In order to ensure that the relationship between the benefits and risks is to be assessed, the competent authorities may at any time request the marketing authorization holder to provide information which proves that the relationship between benefits and risks should be provided ; continues to be favorable.

4. (Repeared).

5. The holder of the marketing authorization shall immediately inform the competent authorities of any intended change in the particulars or documents referred to in Article 12 to 1 or to the Member States.

Article 27a

Where a marketing authorisation is issued, the holder of the marketing authorization shall inform the competent authority of the Member State which issued the authorisation, when the marketing of the veterinary medicinal product is actually started in this ; Member States, taking into account the different approved presentations.

The holder shall also inform the competent authority if the veterinary medicinal product is temporarily or permanently no longer placed on the market in the Member State. Such notification shall, unless exceptional circumstances exist, take place at least two months before the interruption of the placing on the market.

At the request of the competent authority, in particular as part of pharmacovigilance, the holder of the marketing authorization shall submit to the competent authority all information on the quantity of sale to the veterinary medicinal product and all the information he is in possession of the length of the ordinal.

Article 27b

The Commission shall adopt appropriate arrangements for the treatment of amendments to the conditions of marketing authorisations issued in accordance with this Directive.

The Commission shall adopt these arrangements in an implementing Regulation. This measure, which aims to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

Article 28

1. The marketing authorization shall be valid for five years, cf. however, paragraph 1 4 and 5.

2. The authorization may be renewed after five years on the basis of a reassessment of the relationship between benefits and risks.

To this end, the marketing authorization holder shall provide a consolidated list of all documents submitted in respect of quality, safety and efficacy, including all the changes introduced after the issuance of : the marketing authorization, at least six months before the validity of this expires in accordance with paragraph 1. The competent authority may, at any time, require the applicant to submit the documents indicated.

3. A marketing authorisation which has been renewed has unlimited validity, unless the competent authority for justified reasons relating to pharmacovigilance shall decide to renew it for another five-year period in accordance with paragraph 1. 2.

4. If a permit does not actually lead to the placing on the market of the authorised veterinary medicinal product in the issuing Member State, the authorization shall be suspended at the latest three years after the issue has been issued.

If an approved veterinary medicinal product previously placed on the market in the Member State which has issued the authorisation shall no longer be placed on the market in this Member State for three consecutive years, the authorisation shall be disposed of to this medicinal product.

Under exceptional circumstances and in the interests of human or animal health, the competent authority may derogate from paragraph 1. 4 and 5. Such deviations must be duly justified.

ARTICLE 29

The authorization shall be without prejudice to the responsibility of general rule of law, which is the responsibility of the manufacturer and, where appropriate, the marketing authorization holder.

Article 30

The marketing authorization shall be refused if the documentation submitted to the competent authorities is not in accordance with Articles 12 to 13d and 15.

The marketing authorization shall also be refused if it checks on the provisions of Articles 12 and 13 (3). 1, the documents and information listed are clear ;

a) the assessment of the relationship between the advantages and risks of the veterinary medicinal product by regulatory purposes is negative, taking into account in particular the benefits of animal health and welfare and consumer safety where the application relates ; veterinary medicinal products for zootechnical purposes ; or

b) the veterinary medicinal product does not have therapeutic effect or the therapeutic effect of the medicinal product of the applicant to be inadequate for the animal species which must be the subject of treatment, or

c) the veterinary medicinal product does not have the qualitative and quantitative composition of the veterinary medicinal product, or

d) the withdrawal period indicated by the applicant is insufficient to provide for food produced from treated animals not containing residues which may be a danger to the health of the consumer, or is not sufficiently substantiated ; or

(e) that the labelling or package leaflet proposed by the applicant is not in accordance with this Directive, or

(f) the veterinary medicinal product is offered for sale to an application which is prohibited under other Community provisions.

However, as long as Community legislation in this field continues to be prepared, the competent authorities may refuse to authorize the placing on the market of a veterinary medicinal product if necessary to ensure the protection of : public health, consumer or animal health.

The applicant or holder of the marketing authorization shall be responsible for the correct operation of the documents and data.

CHAPTER 4

Procedure for mutual recognition and decentralised approval procedures

Article 31

1. A coordination group shall be established for examination of all questions relating to marketing authorisations to a veterinary medicinal product for two or more Member States, in accordance with the procedures laid down in this Chapter. The Agency shall provide the secretariat for the coordination group.

2. The Coordination Group shall consist of a representative of each Member State, which is appointed for a period of three years. The members of the Coordination Group may accompany the experts.

3. The Coordination Group shall draw up its own rules of procedure, which shall enter into force after the Commission has delivered a favourable opinion. The rules shall be published.

ARTICLE 32

1. In order to obtain a marketing authorisation for a veterinary medicinal product in more than one Member State, the applicant shall submit an application based on an identical documentation in the Member States concerned. The documentation attached to the application for marketing authorization shall include all administrative information and the scientific and technical material referred to in Articles 12 to 14. The documentation submitted shall include a list of the Member States covered by the application.

The applicant shall ask one of these Member States to function as a reference Member State and to draw up an evaluation report on the veterinary medicinal product in accordance with paragraph 1. Two or three.

The evaluation report shall, where appropriate, contain an analysis in accordance with Article 13 (1). Article 13a (5) or Article 13a (1) 3.

2. If, at the time of submission of the application, a marketing authorisation has already been issued to the veterinary medicinal product concerned, the Member States concerned shall recognise the authorisation granted by the reference Member State. To this end, the holder of the marketing authorization shall request the reference Member State to draw up an evaluation report or, if appropriate, update the existing evaluation report. The reference Member State shall draw up or update the evaluation report within 90 days of receipt of the valid request for this purpose. The approved evaluation report, the approved product sume, the approved labelling and the approved package leaflet shall be forwarded to the Member States concerned and the applicant.

3. If, at the time of submission of the application, no marketing authorization for the veterinary medicinal product concerned, the applicant shall request the reference Member State to draw up a draft evaluation report, a draft of the draft report ; product sume and a draft of the labelling and package leaflet.

The reference Member State shall draw up these drafts within 120 days of receipt of the valid request and shall forward them to the Member States concerned and the applicant concerned.

4. Within 90 days of receipt of the documents referred to in paragraph 1. The Member States concerned shall approve the evaluation report, product summary and the labelling and package leaflet, and notify the reference Member State accordingly. The latter shall register a consensus, terminate the procedure and shall inform the applicant accordingly.

5. No later than 30 days after an agreement has been established, all Member States in which an application has been submitted pursuant to paragraph 1. 1, a decision that corresponds to the evaluation report, product summary, and the labelling and package leaflet, as approved.

Article 33

1. If a Member State, because of a potential serious risk to human or animal health or to the environment, cannot approve the evaluation report, product summary, labelling or package leaflet within the time limit laid down in Article 32 (1). 4, shall forward a detailed justification for this to the reference Member State, the other Member States concerned and the applicant. The disputed points shall immediately be submitted to the Group of Coordination.

Where a Member State in which an application has been submitted, refers to the justifications referred to in Article 71 (1). The Member State concerned shall no longer be regarded as a Member State concerned with regard to this chapter.

The Commission shall adopt guidelines setting out the definition of a potential serious risk to human and animal health or the environment.

3. In the coordination group, all of the measures referred to in paragraph 1 shall be The Member States shall be as concerned as possible in order to reach agreement on the measures to be taken. They shall give the applicant the opportunity to express his views orally or in writing. If the Member States reach agreement within 60 days from the date of notification of the disputed points in the coordination group, the Member State of reference shall record the agreement, the procedure shall complete and notify the Member State of the Agreement ; the applicant accordingly. Article 32 (1). 5, apply.

4. If the Member States do not reach agreement within the limit of 60 days, the Agency shall be informed immediately for the purposes of applying the procedure laid down in Articles 36, 37 and 38. A detailed description of the disputed questions and the reasons for the disunity to the Agency shall be submitted. The applicant shall have a copy of that information.

5. as soon as the applicant has been informed that the matter has been submitted to the Agency, he shall immediately send this of a copy of the information referred to in Article 32 (2). The information and documents referred to in the first subparagraph are the first subparagraph.

In the first paragraph of paragraph 6. The Member States which have approved the evaluation and product summary of the reference Member State may, at the request of the applicant, permit the placing on the market of the veterinary medicinal product at the request of the Member State, without waiting for the result of the product referred to in Article 36 ; fixed procedure. In such a case, the authorisation shall not prejudice the outcome of this procedure.

Article 34

1. is a veterinary medicinal product subject to several applications for marketing authorisation submitted under Articles 12 to 14, and has adopted the Member States ' different decisions concerning the approval, suspension or withdrawal of such authorisation, a Member State, the Commission or the holder of the marketing authorization may bring the matter to the Committee for Veterinary Medicinal Products, hereinafter referred to as ' the Committee `, to obtain it in accordance with the procedure laid down in Articles 36, 37 and 38.

2. In order to facilitate the harmonisation of veterinary medicinal products authorised in the Community and to improve the impact of Articles 10 and 11, Member States shall transmit to the Member States no later than 30. In April 2005, a list of medicinal products for which harmonised product sumes shall be drawn up for the coordination group.

The Coordination Group shall draw up a list of medicinal products on the basis of the Member States ' proposals and shall forward it to the Commission.

The medicinal products listed in this list are subject to paragraph 1. 1 in accordance with the timetable laid down in cooperation with the Agency.

The Commission shall determine the final list and schedule in consultation with the Agency and after consultation with the interested parties.

Article 35

Member States or the Commission, or the applicant or the holder of a marketing authorisation, in particular cases where Community interest is concerned, the matter shall be referred to the Committee in order to obtain it in accordance with the procedure laid down in Article 1. before a decision is taken on an application, suspension or withdrawal of a marketing authorisation or any other change in the conditions for a marketing authorisation which is required, in particular : taking into account information gathered pursuant to Title VII.

The Member State concerned or the Commission shall state clearly the question referred to the Committee for processing and shall inform the applicant or holder of the marketing authorization accordingly.

The Member States and the applicant or the marketing authorization holder shall forward all available information to the Committee on the matter in question.

2. If the submission of the Committee concerns a range of medicinal products or a therapeutic group, the Agency may restrict the procedure to certain parts of the authorisation.

In such cases, Article 39 shall apply only to those medicinal products where they are subject to the marketing authorisation procedure referred to in this chapter.

Article 36

Where reference is made to the procedure laid down in this Article, the Committee shall examine the case submitted to the Committee, subject to a reasoned opinion within 60 days of the submission of the case.

However, in the cases submitted to the Committee pursuant to Articles 34 and 35, the Committee may extend this period of 90 days, taking into account the views expressed by the holders of marketing authorisations affected.

In the case of urgency, the Committee may lay down a shorter period of time.

The Committee shall appoint one of its members to report for examination. The committee may also appoint independent experts to advise it on certain matters. When the Committee appoints such experts, it shall define their tasks and set a time limit for the execution of such experts.

Before the Committee gives its opinion, the applicant or the marketing authorization holder shall be able to submit written or oral observations within a time limit which it lays down.

The opinion of the Committee shall be accompanied by the draft of the product sumes and the package of products for labelling and package leaflet.

If the committee considers it appropriate, it may call on any other person to present information on the matter at which it is processed.

The Committee may suspend the time limit referred to in paragraph 1. 1 in order to allow the applicant or holder of the marketing authorization to prepare its observations.

4. The Agency shall immediately inform the applicant or holder of the marketing authorization if the Committee in its opinion states :

-WHAT? the application does not meet the approval criteria ; or

-WHAT? that the product summary, as proposed by the applicant or the marketing authorization holder in accordance with Article 14, should be amended, or

-WHAT? the authorisation should be subject to certain conditions, that is to say, conditions which are considered essential to a safe and efficient use of the veterinary medicinal product, including pharmacovigilance, or

-WHAT? that a marketing authorisation should be suspended, changed or revoked.

Within 15 days of receipt of the opinion, the applicant or the marketing authorization holder may notify the Agency in writing that he wishes to review the decision. In such cases, he shall send the Agency a detailed justification for his request within 60 days of receipt of the opinion.

Within 60 days of receipt of the reasons for the request, the Committee shall review its opinion in accordance with Article 62 (2). The second subparagraph of the second subparagraph of Regulation (EC) No 2 : 726/2004. The findings of the Committee concerning the request shall be attached to the evaluation report referred to in paragraph 1. 5 in this Article.

5. not later than 15 days after the adoption of the Committee ' s final opinion, the Agency shall forward to the Member States, the Commission and the applicant or the marketing authorization holder, together with a report, with a statement of the evaluation of : the veterinary medicinal product and the reasons for its conclusions.

Where an opinion supports the issue or extension of a marketing authorisation, the opinion shall be attached to the following documents :

a) Whereas, in accordance with Article 14, a draft of the product sumes referred to in Article 14 shall reflect the differences in the veterinary conditions laid down in the Member States ;

b) any conditions for the granting of the authorization as referred to in paragraph 1. 4

c) details of any recommended conditions or limitations with regard to the safe and efficient use of the veterinary medicinal product ; and

d) proposal for labelling and package leaflet.

Article 37

Within 15 days of receipt of the opinion, the Commission shall prepare a draft of the decision to be taken on the application, in the interests of Community law.

Where, pursuant to the draft decision, a marketing authorisation shall be issued, the documents referred to in Article 36 (3) shall be anneoi; The second paragraph of the second paragraph of Annex.

If the draft decision is exceptionally not in accordance with the opinion of the Agency, the Commission shall, as an Annex, attach a detailed account of the reasons for the differences.

The draft decision shall be forwarded to the Member States and the applicant or holder of the marketing authorization.

Article 38

1. The Commission shall at last take a decision, in accordance with and within 15 days of the completion of the procedure referred to in Article 89 (1). 3.

2. the Rules of Procedure of the Standing Committee set up by Article 89 (1). 1 shall be adapted to take account of the responsibilities of the tasks incumreable under this chapter.

These adjustments shall include the following :

-WHAT? in writing.-Apart from the cases referred to in the third subparagraph of Article 37, the Standing Committee shall deliver in writing.

-WHAT? each Member State shall have a period of 22 days to send the Commission its written comments concerning the draft decision. However, if the decision is a matter of urgency, the President may set a shorter time period, depending on the urgency of the matter. Aside from exceptional circumstances, the time limit shall not be less than five days.

-WHAT? each Member State shall have the possibility to submit in writing of the request that the draft decision be taken up in a plenary sitting of the Standing Committee.

When the written comments from a Member State, in accordance with the opinion of a Member State, raise important new scientific or technical matters which are not affected by the opinion of the Agency, the chairman shall interrupt the procedure and send the application back to : The Agency for further consideration.

The Commission shall adopt the necessary implementing provisions for this paragraph in accordance with the procedure referred to in Article 89 (3) 2.

The third paragraph of paragraph 3. The decision referred to in paragraph 1 shall be forwarded to all Member States and shall be notified to the applicant or holder of the marketing authorization for information. The Member States concerned and the reference Member State shall issue the marketing authorization or make any changes to the marketing authorization which may be required to comply with the decision within 30 days of the date of the authorization ; that this has been announced and it refers to the decision. They shall inform the Commission and the Agency thereof.

Article 39

1. Any application by the marketing authorization holder to amend a marketing authorisation granted under the provisions of this Chapter shall be submitted to all the Member States which have previously approved the marketing authorisation ; veterinary medicinal product.

The Commission shall adopt these measures in the form of an implementing Regulation. This measure, which aims to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

2. In cases where the Commission is submitted to a arbitration procedure, the procedure laid down in Articles 36, 37 and 38 shall apply mutatis mutilated to changes in marketing authorisations.

Article 40

1. a Member State considers it necessary to modify the conditions of a marketing authorisation granted under the provisions of this Title, or to suspend or withdraw it in order to protect human or animal health ; or the environment shall, without delay, bring the matter to the Agency forthwith to obtain it in accordance with the procedures laid down in Articles 36, 37 and 38.

Article 35 of the provisions of Article 35 may, in exceptional circumstances, when considering human or animal health or to the environment, it is necessary to act quickly until a final decision has been adopted, to suspend marketing and the use of the medicinal product concerned in their territory. They shall inform the Commission and the other Member States no later than the following working day of the reasons.

ARTICLE 41

Articles 39 and 40 shall apply mutatis muth to veterinary medicinal products approved by Member States on the basis of the opinion of the Committee given in accordance with Article 4 of Directive 87 /22/EEC before 1. January 1995.

Article 42

1. The Agency shall publish an annual report on the application of the procedures laid down in this Chapter and shall forward this report to the European Parliament and the Council to the information provided for.

2. At least every 10 years the Commission shall publish a report on the experience gained in applying the procedures described in this chapter and proposes all the amendments which may be necessary to improve these procedures. The Commission shall forward this report to the European Parliament and the Council.

Article 43

Article 33 (1). 4, 5 and 6, and Articles 34 to 38 shall not apply to homeopathic veterinary medicinal products referred to in Article 17.

Articles 32 to 38 shall not apply to homeopathic veterinary medicinal products referred to in Article 19 (1). 2.

SECTION IV

MANUFACTURE AND IMPORTATION

Article 44

Member States shall take the necessary measures to permit the manufacture of veterinary medicinal products in their territory to be subject to authorisation. This licence shall be required, even though the veterinary medicinal products produced are intended for export.

The second paragraph of paragraph 1. 1 authorisation is required both for the complete and partial production, and for the division, wrapping and presentation of the processes.

However, such authorization shall not be required for processing, splitting or presentation, provided that these processes are carried out solely for the purpose of retail supply by pharmaceutical products in a pharmacy or other persons who are, in other cases, in the case of : the law of the Member States is permitted to carry out the processes referred to.

The third paragraph of paragraph 3. Paragraph 1 shall also be required for imports from third countries to a Member State, and for that purpose, this section and Article 83 shall apply to such imports in the same way as they apply in the manufacture of such imports.

Member States shall take the necessary measures to ensure that veterinary medicinal products imported in their territory from third countries and which are intended for another Member State shall be accompanied by a copy of the provisions referred to in paragraph 1. 1 mentioned permission.

4. Member States shall send a copy of the manufacturing authorization referred to in paragraph 1. 1 to the Agency. The Agency shall establish that information in the Community database referred to in Article 80 (1). 6.

Article 45

In order to obtain the manufacturing authorization, the applicant shall demonstrate that he shall meet at least the following requirements :

a) specify the veterinary medicinal products and pharmaceutical forms to be produced and / or imported, as well as the place of their production and / or control ;

b) for the production or introduction of the premises, technical equipment and control facilities suitable and adequate and satisfying the legal requirements of the Member State concerned, both in terms of the production and control of the Member State concerned, in the case of the storage of medicinal products, all taking into account Article 24 ;

c) have at your disposal at least one person qualified by the expert in accordance with Article 52.

The applicant shall provide the applicant with proof that he meets these requirements.

ARTICLE 46

1. The competent authority of the Member State concerned shall not give the manufacturing authorization until such time as a check carried out by its representatives, that the particulars provided for in Article 45 are correct.

2. In order to ensure compliance with the conditions laid down in Article 45, certain obligations may be attached to the authorization, either by its issuance or at a later date.

3. The authorization shall apply only to the premises specified in the application, as well as for the veterinary medicinal products and pharmaceutical forms referred to in the same application.

ARTICLE 47

Member States shall take all appropriate measures to ensure that the case handling of the manufacturing authorization does not exceed 90 days from the date of receipt of the application by the competent authority.

Article 48

If the holder of the manufacturing authorization requests the amendment of one of the products referred to in Article 45 (2), The information referred to in paragraph 1 (a) and (b) may not last longer than 30 days in the case of this request. This period may be extended in exceptional cases to 90 days.

ARTICLE 49

The competent authority of the Member State shall, by the competent authority of the Member State, require further information in respect of the information referred to in Article 45 and, as regards the expert person referred to in Article 52, when the competent authority does ; use of this option shall be suspended in accordance with Articles 47 and 48 until such time as the additional information required has been provided.

Article 50

The holder of the manufacturing authorization shall be obliged to at least :

a) have the staff meeting the applicable legal requirements of the Member State concerned, both in terms of manufacture and control ;

b) to supply the authorized veterinary medicinal products only in accordance with the legislation of the Member States concerned ;

c) inform the competent authorities in advance of any change he may wish to make in one of the particulars provided for in Article 45, however, in the case of unforeseen replacement of the information provided for in Article 45, in the case of the competent authorities. Article 52 referred to in Article 52 ;

d) to enable representatives of the competent authorities of the Member State concerned to access his premises at any time ;

(e) to enable the qualified person referred to in Article 52 to perform its task, in particular by providing all necessary means at his disposal ;

(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and use only active substances such as raw materials produced in accordance with the detailed rules of the good manufacturing practice of raw materials ;

g) to keep precise records of all veterinary medicinal products supplied to him, including samples, in accordance with the legislation of the country of destination. At least the following information shall be recorded for each transaction, whether it is for payment or not :

-WHAT? date

-WHAT? name of the veterinary medicinal product,

-WHAT? quantity supplied,

-WHAT? the name and address of the beneficiary

-WHAT? the batch number.

Such records shall be kept at the disposal of the competent authorities for at least three years.

Article 50a

1. In this Directive, the manufacture of active substances used as raw materials, complete or partial manufacture or import of an active substance used as raw material as defined in Annex I, 2. part, section C, and the various processes for splitting, wrapping or presentation prior to its application in a veterinary medicinal product, including the wrapping and the use of a new labelling, by means of a reseller of raw materials.

2. The Commission shall adopt any amendments which may be necessary in order to adapt the provisions of paragraph 1. 1 to scientific and technical progress.

These measures, which are intended to amend non-essential provisions of this Directive, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

ARTICLE 51

The principles and guidelines for the good manufacturing practice of veterinary medicinal products referred to in Article 50 (f) shall be adopted by the Commission in the form of a Directive addressed to the Member States. These measures, which are intended to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

Detailed guidelines, in accordance with the said principles, are published by the Commission and reviewed, as necessary, in order to take account of scientific and technical progress.

The principles of good manufacturing practice referred to in Article 50 (f) of active substances used as raw materials shall be adopted in the form of detailed guidelines.

The Commission shall also publish guidelines on the form and content of the authorization referred to in Article 44 (1). 1, the reports referred to in Article 80 (1). 3, and the certificate of good manufacturing practice referred to in Article 80 (3). 5.

Article 52

Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization at all times has at least one expert person satisfying the conditions laid down in Article 53 and which are in particular responsible for : the performance of the tasks defined in Article 55.

2. If the holder of the authorization fulfils the conditions laid down in Article 53, he may himself assume it in paragraph 1. 1 responsibility.

ARTICLE 53

Member States shall ensure that the expert person referred to in Article 52 (2) shall be subject to the provisions of Article 52 of the Commission. Paragraph 1 shall satisfy the provisions of paragraph 1. 2 and 3 of this Article are entitled to qualifications.

2. The expert must possess a certificate of qualifications, certificate or other certificate of qualification for a university study or a study to be recognized by the Member State concerned, including at least four years of theoretical work ; and practical training in one of the following scientific disciplines : pharmaci, medical science, chemistry, chemistry, pharmaceutical chemistry and technology, and biology.

However, the minimum duration of the university studio may be three and a half years if it is followed by a theoretical and practical training, completed with a degree at university level, of at least one year and a minimum practicable period of at least one year ; Six months in a pharmacy that's open to the public.

If, at the same time, there are two university training courses or two studies which, by the Member State concerned, have two studies, one of which extends over four years and the second more than three years, the certificate shall be regarded as the certificate, or other qualification evidence of the three-year university education or training recognised as equivalent to that for the purpose of meeting the requirements referred to in the first subparagraph, in so far as the diplomas, certificates or others are carried out ; the qualification of the two studies of the State concerned shall be recognised as having the same qualification ; value.

The studies shall include theoretical and practical training, which shall include at least the following basic subjects :

-WHAT? Experimental Physics

-WHAT? general and inorganic chemistry,

-WHAT? organic chemistry,

-WHAT? analytical chemistry,

-WHAT? pharmaceutical chemistry, including pharmacovigilance,

-WHAT? commonplace and used biochemistry (medical),

-WHAT? physiology

-WHAT? microbiology,

-WHAT? Pharmacology

-WHAT? Pharmaceutical technology

-WHAT? toxicology,

-WHAT? pharmacocognosi (recording of the composition and effects of active substances in natural products of plant or animal origin).

The teaching of these subjects shall be given in such a way that the person concerned is able to fulfil the obligations specified in Article 55.

To the extent that certain diplomas, certificates or other qualifications certificates referred to in the first subparagraph do not satisfy the criteria laid down in this paragraph, the competent authorities of the Member State shall ensure that the person concerned in these subjects shall be responsible for the marketing of the relevant provisions ; proof of adequate knowledge as regards the production and control of veterinary medicinal products.

3. The qualified person shall have a practical experience for at least two years in one or more companies with a manufacturing permit comprehensive qualitative analysis of medicinal products, quantitative analysis of active substances and the necessary tests and checks ; to ensure the quality of medicinal products.

The duration of the practical experience may be short-cut by one year if the university training extends over at least five years and by a year and a half if the study extends over at least six years.

ARTICLE 54

1. a person operating in the Member State referred to in Article 52 (2). The person concerned at the time of the implementation of Directive 81 /851/EEC, without meeting the qualifications referred to in Article 53, is qualified to continue to perform this activity in the Community.

2. The holder of an examination certificate, certificate or other qualification certificate of completed university study or a study carried out by the Member State concerned as equivalent to that in a scientific discipline which qualifies ; the person concerned to exercise the company referred to in Article 52, in accordance with the legislation of this State, may, once he has started training before the 9. October 1981-shall be deemed to be eligible for the duties referred to in Article 52 in this Member State, provided that he prior to the 9. In October 1991, for at least two years directly, under the management referred to in Article 52, a supervisory authority for the production and / or qualitative and quantitative analysis of the active substances and the tests and controls necessary for the operation of the persons concerned are carried out ; in order to ensure the quality of veterinary medicinal products, in one or more undertakings which have obtained a manufacturing authorization.

When the person concerned has obtained the practical experience referred to in the first subparagraph, before the 9. In the case of October 1971, an extra year of practical experience is required to provide for this additional practical experience to be achieved immediately before the exercise of those activities.

ARTICLE 55

1. Member States shall take all appropriate measures to ensure that Article 52 referred to in Article 52, notwithstanding his dealings with the holder of the manufacturing authorization, within the framework of the procedures referred to in Article 56 ; responsible for the monitoring of :

a) that any batch of veterinary medicinal products produced in the Member State concerned has been manufactured and checked in accordance with the laws in force in that Member State, and in accordance with the notification of : marketing authorization approved conditions ;

b) that any separate batch of veterinary medicinal products imported from third countries, whether produced in the Community, in a Member State has been subjected to a full qualitative analysis, a quantitative analysis of at least all active substances ; substances and any other test or control necessary to ensure the quality of veterinary medicinal products in accordance with the conditions laid down in the communication of the marketing authorization.

Parties of veterinary medicinal products, which are thus inspected in a Member State, shall be exempted from the control referred to above when they are placed on the market in another Member State, accompanied by the control evidence, signed by the expert person.

2. In cases where veterinary medicinal products are imported from a third country and the Community has taken appropriate measures with the exporting country to ensure that the manufacturer of the veterinary medicinal product uses standards of good manufacturing practice, which : at least equal to the standards established by the Community and to ensure that the standards referred to in paragraph 1 are applied. The first subparagraph of point (b) of the first subparagraph of the exporting country may be exemplified by the expert person in order to exercise that control.

3. In all cases and in particular when the veterinary medicinal products are offered for sale, the qualified person in a given journal or equivalent document shall certify that each consignment of the consignment complies with the provisions of this Article, this Article shall be the subject of this Article ; the file or the corresponding document shall be updated as the work processes are concluded and made available to the representatives of the competent authorities for a period conforming to the Member State in question ; provisions, however, for at least five years.

ARTICLE 56

Member States shall ensure, by means of appropriate administrative measures or in the case of professional behaviour, that the person in accordance with Article 52 complies with its obligations.

Member States may provide for the temporary suspension of this person if an administrative or disciplinary procedure is initiated against him in the case of dereliction of duty.

Article 57

The provisions of this Title shall apply to homeopathic veterinary medicinal products.

SECTION V

LABELLING AND PACKAGE LEAFLET

ARTICLE 58

1. The internal and outer packaging of the veterinary medicinal products must, except where they are covered by Article 17 (1). 1, shall be approved by the competent authorities. The packaging must be provided with the following easily legible information, which shall be in accordance with the information and documents submitted pursuant to Articles 12 to 13d and the product summary :

a) the name of the medicinal product followed by strength and pharmaceutical form. The common name shall be included where the medicinal product contains only one active substance and, where the name is a specific name,

b) the qualitative and quantitative composition of active substances specified per ; either unit or the weight of a given quantity or weight, in the application of common names ;

c) the manufacturer ' s batch number,

d) the marketing authorization number ;

(e) the name or business name and place of residence or registered office of the marketing authorization holder and for the representative to be appointed by the holder of the marketing authorization holder ;

(f) the animal species for which the veterinary medicinal product is determined and the method of use and, where necessary, the way in which it is in charge. The packaging of the packaging for the indication of the prescribed dosage shall be made available ;

g) the retention time of veterinary medicinal products for the treatment of food-producing animal species for all species concerned and for the various food-producing species (meat and meat offal, eggs, milk and honey), including for foodstuffs, Holding Time

(h) indication of the last use date in clear language ;

i) special storage precautions, if any, where appropriate ;

j) any special precautions concerning the disposal of unused medicinal products or waste originating from veterinary medicinal products, and a reference to existing appropriate collection systems ;

c) where appropriate, in accordance with Article 26 (2), 1, tendering information

I) the words ' for veterinary use ', or in the case of the medicinal products referred to in Article 67, the words ' for veterinary use shall require veterinarian ' s right to be delivered,

2. The amount of the suspension form and the content of the weight, volume or dosiunit of content need only be specified on the outer packaging.

In the case of the qualitative and quantitative composition of active substances in veterinary medicinal products, the provisions of Annex I shall apply, 1. Part A, Section A, shall apply to the provisions of paragraph 1. The information referred to in (b) shall be 1.

4. You, pursuant to paragraph 1, The information referred to in paragraph 1 (f) to (l) shall be required on the outer packaging and the container in the language or languages used in the country where the medicinal product is placed on the market.

5. Member States may, in the case of medicinal products for which a marketing authorisation has been granted under Regulation (EC) No (EC) No (EC) No, Whereas 726/2004, authorise or require that the outer packaging be provided with supplementary information as regards the holding, possession, sale or any security measures provided that such information is not in breach of Community law or marketing authorization and do not have the nature of advertising.

This additional information shall be provided in a blue framework so that they are clearly separated from the information referred to in paragraph 1. 1.

ARTICLE 59

The information referred to in Article 58 (3) shall be as regards the ampuller. 1, shall be applied to the outer packaging. The internal packaging, however, only has to be provided with the following information : the holder, however, only needs to be provided with the following information :

-WHAT? name of the veterinary medicinal product,

-WHAT? the quantity of active substances,

-WHAT? the route of administration

-WHAT? the manufacturer ' s batch number,

-WHAT? the last used date

-WHAT? the words ' for veterinary use `.

2. In the case of other less internal packaging units other than ampoules containing only one dose, and on which it is impossible to apply the products referred to in paragraph 1. Article 58 (1) shall apply to Article 58 (1). 1, 2 and 3, only for the outer packaging.

Three, as referred to in paragraph 1. The information on the outer packaging and of the internal packaging of the information shall be written in the language or languages used in the country in which the medicinal product is placed on the market.

ARTICLE 60

If there is no outer packaging, the particulars must be provided for the outer packaging, cf. Articles 58 and 59 shall be marked on the packaging of the internal packaging.

ARTICLE 61

1. The package of veterinary medicinal products must include a package leaflet, unless all of the information required in this Article is indicated on the internal and outer packaging. Member States shall take the necessary measures to ensure that the package leaflet relates only to the veterinary medicinal product, as it has been added.

The package leaflet shall be written in a readily understood language in the official language or languages of the Member State in which the medicinal product is placed on the market.

The first subparagraph shall not preclude the entry of the package leaflet in several different languages, provided that the same information is given in all languages.

The competent authorities may waive the requirement for certain information to be shown on the label and the package leaflet for certain veterinary medicinal products and that the package leaflet shall be read in the official language or languages of the Member State in which : the veterinary medicinal product shall be placed on the market when the veterinary medicinal product concerned has only been submitted by a veterinarian.

2. The competent authorities shall approve the package leaflet. It shall contain at least, in this order, the following information, which shall be in accordance with the information and documents presented in accordance with Articles 12 to 13d and with the approved product sume :

a) the name or business name and place of residence or registered office of the marketing authorization holder and, where appropriate, for the manufacturer and, where appropriate, on the representative of the marketing authorization holder ;

b) the name of the veterinary medicinal product, followed by strength and pharmaceutical form. The common name is included if the medicinal product contains only one active substance and if the name is a distinguished name. If the medicinal product is approved in accordance with the procedure laid down in Article 31 to 43 under different names in the Member States concerned, a list of the approved names for each Member State shall be given.

c) therapeutic indications,

d) counterindications and adverse reactions to the extent such information is necessary for the use of the veterinary medicinal product ;

(e) the animal species for which the veterinary medicinal product is determined, dosage in relation to these species, the scope of application, including the route of administration and, where appropriate, indications of proper use ;

(f) the waiting period, even if this is nil, for veterinary medicinal products given to food-producing animals ;

g) special storage precautions, if any,

(h) where appropriate, in accordance with Article 26 (2), 1, tendering information

i) special precautions, where appropriate, for the disposal of unused medicinal products or waste originating from medicinal products.

Article 62

If the provisions of this paragraph are not kept, the competent authorities of the Member States may not suspend or revoke the marketing authorization without the result of a call to the right person.

Article 63

The requirements of the Member States relating to the conditions governing the delivery to the public, whether the indication of the prices of veterinary medicinal products and industrial property rights are not affected by the provisions of this Title.

Article 64

Paragraph 1, without prejudice to paragraph 1. 2, homeopathic veterinary medicinal products must be labelled in accordance with the provisions of this Title and on the label, with clear and legible writing, the words ' homeopathic medicinal product for veterinary use `.

2. The label and any package leaflet to the medicinal products referred to in Article 17 (1). In a very visible manner, the words ' homeopathic veterinary medicinal products without approved therapeutic indications ` shall be carried out in a very visible manner and shall contain only the following information :

-WHAT? the scientific name of the tribe / tribes followed by the dilution degree in the use of the symbols of the pharmacopoeia used as referred to in Article 1 (2), 8) If the homeopatical veterinary medicinal product consists of several tribes, the scientific name of the tribes may be given a specific name on the labelling of the products ;

-WHAT? the name and address of the marketing authorization holder and, where appropriate, on the manufacturer ;

-WHAT? the method of use and, where necessary, the method of administration ;

-WHAT? indication of the last date of use in clear language (month/year) ;

-WHAT? type of discourse,

-WHAT? the contents of the sales sheet,

-WHAT? any special prudential rules to be observed in the storage unit ;

-WHAT? target species

-WHAT? a special warning if the medicinal product requires it ;

-WHAT? the manufacturer ' s batch number,

-WHAT? registration number.

SECTIONS WE

POSSESSION, NEGOTIATION AND DELIVERY OF VETERINARY MEDICINAL PRODUCTS

Article 65

Member States shall take the necessary measures to ensure that the wholes-use of veterinary medicinal products is made subject to authorisation, and to ensure that the time involved in the processing of an application for authorisation does not exceed 90 days ; calculated from the day on which the competent authority receives the application.

Member States may exempt the delivery of small quantities of veterinary medicinal products from one retailer to another from the definition of wholessnegotiation.

2. In order to obtain the negotiated authorization, the applicant must have personnel with technical qualifications, suitable and adequate premises and suitable and adequate equipment meeting the requirements of the Member State in question for storage and storage ; management of veterinary medicinal products.

3. The holder of the negotiated authorization shall keep and store accurate records, which shall include at least the following information :

a) date

b) the precise indication of the veterinary medicinal product,

c) the manufacturer ' s batch number, the last date of use,

d) quantities received or supplied ;

(e) name and address of supplier or recipient.

At least once a year an accurate review shall be carried out in which the inventory and unridged medicinal products are to be compared with stock inventory and a report on any inconsistencies.

Such inventory shall be kept at the disposal of the competent authorities for at least three years.

The holder of a negotiated authorisation shall hold an emergency plan to ensure effective implementation of any measure to withdraw a medicinal product from the market, which shall be carried out under the order of the competent authorities ; or in cooperation with the manufacturer of the medicinal product concerned or the marketing authorization holder.

4. Member States shall take the necessary measures to ensure that wholesalers only provide veterinary medicinal products for persons authorized to retailer in accordance with Article 66, or to other persons who are duly duly duly authorised ; permit to receive veterinary medicinal products from wholesalers.

5. a distributor who does not have the marketing authorization holder and who imports a medicinal product from another Member State shall inform the holder of the marketing authorization and the competent authority of the importing Member State that he intends to : perform this import. With regard to products not issued under Regulation (EC) No, The competent authority shall be informed by the competent authority, subject to additional procedures provided for in the legislation of that Member State.

Article 66

Member States shall take the necessary measures to ensure that the retail sale of veterinary medicinal products is carried out only by persons authorized by the law of the Member State concerned to carry out such sales.

2. Any person who, in accordance with paragraph 1, 1 authorised to negotiate veterinary medicinal products, for all prescription veterinary medicinal products, to keep an exact record, and for all persons in and outbound transactions, the following information shall be recorded :

a) date

b) the precise indication of the veterinary medicinal product,

c) the manufacturer ' s batch number,

d) quantities received or supplied ;

(e) name and address of supplier or recipient ;

(f) the name and address of the veterinarian, if any, and copies of the prescription.

At least once a year an accurate examination shall be carried out in which the inline and exit medicinal products should be reconciled with inventory and a report on any inconsistencies.

Such records shall be kept at the disposal of the competent authorities for five years.

3. Member States may authorize in their territory veterinary medicinal products intended for food-producing animals and which require the veterinary record, either by or under the supervision of a registered person who, in accordance with the national system, legislation has the appropriate qualifications in order to be able to carry out inventories and submit a report. Member States shall inform the Commission of relevant provisions of national law. This provision shall not apply to the supply of veterinary medicinal products to oral or to enteral treatment of bacterial infections.

4. (Repeared).

Article 67

Without prejudice to more stringent Community rules or national rules for the supply of veterinary medicinal products and in order to protect human and animal health, veterinary medicinal products are required for the release of the following veterinary medicinal products to the public :

a) medicinal products for which official restrictions on delivery or use are applicable, f. Exes.

-WHAT? limitations on the implementation of the relevant UN Conventions concerning the illegal trade in euphoria and psychotropic substances ;

-WHAT? limitations on the basis of Community rules,

aa) veterinary medicinal products intended for food-producing animals.

Member States may, however, provide for derogations from this requirement in accordance with the criteria laid down by the Commission. This measure, which aims to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

Member States may continue to apply national provisions either up to :

-WHAT? the date of application of a decision adopted in accordance with the first subparagraph, or

-WHAT? 1. January 2007, provided that such a decision has not been adopted before 31 December. December 2006

b) medicinal products for which the veterinarian is required to take special precautions to avoid any unnecessary risk of :

-WHAT? the species for which the preparation is calculated ;

-WHAT? the person who brings the animal to the medicinal product,

-WHAT? the environment,

c) medicinal products intended for the treatment of disease flows, which require an accurate prior diagnosis or may cause effects which make it difficult or intervened in subsequent diagnoses or treatments ;

d) official preparation, as described in Article 3 (1). 2 (b) intended for food-producing animals.

Member States shall take all necessary measures to ensure that, in the case of medicinal products which are only prescribed on prescription, the prescribed and supplied quantity shall be limited to what is necessary for the treatment in question ; Processing mode.

In addition, a prescription for a prescription for new veterinary medicinal products containing an active substance in the case of use in veterinary medicinal products has been approved for less than five years.

ARTICLE 68

Member States shall take the necessary measures to ensure that only persons authorised in accordance with their national law are in possession of or possess veterinary medicinal products or substances which may be used as such ; veterinary medicinal products, which offer metabolites, antiinfectious antiparasitarian, antiinflammatory, hormonal or psychotropic properties.

2. Member States shall establish a register of traders and resellers who are authorised to lay down active substances which may be used in the manufacture of veterinary medicinal products with the products referred to in paragraph 1. 1 mentioned properties.

Such persons shall keep accurate records of all the transactions of substances which may be used in the manufacture of veterinary medicinal products and in control checks to keep those records available to the competent authorities for at least three years.

3. The Commission shall adopt any amendments to the list of substances referred to in paragraph 1. 1.

These measures, which are intended to amend non-essential provisions of this Directive, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

ARTICLE 69

Member States shall ensure that a person who owns or is responsible for food-producing animals may prove to have been purchased and stored in veterinary medicinal products or to have treated such animals for a period of five years after the treatment has been carried out ; including cases where the animal has been slaughtered during the five-year period.

They may, inter alia, require records to be kept containing at least the following information :

a) date

b) name of the veterinary medicinal product,

c) quantity,

d) the name and address of the supplier of the medicinal product,

(e) indication of the animals treated.

Article 70

By way of derogation from Article 9 and subject to Article 67, Member States shall ensure that veterinarians who perform services in another Member State may include small quantities which do not exceed the daily need of veterinary medicinal products other than the immunological, veterinary medicinal products when these medicinal products are not authorized in the Member State in which the service is provided (hereinafter referred to as the host Member State), and treat animals with such animals, provided that :

a) the competent authorities of the Member State in which the veterinarian is established have given the marketing authorisation referred to in Articles 5, 7 and 8,

b) veterinary medicinal products are transported by the veterinarian of the original packaging ;

c) Whereas veterinary medicinal products for the treatment of food-producing animals have the same qualitative and quantitative composition of active substances such as medicinal products authorized in the host Member State in accordance with Articles 5, 7 and 8 ;

d) a veterinarian who provides services in a host Member State shall familial himself with good veterinary practice in the Member State concerned and ensure that the wait time indicated on the labelling of the veterinary medicinal product concerned shall be observed, unless he is satisfied ; whereas, with fairness, it is likely to be aware that, according to good veterinary practice, the host Member State should be required to have a longer wait time ;

(e) the veterinary medicinal product does not supply veterinary medicinal products to persons who own or are responsible for the animals treated in the host Member State unless it is permitted in such cases to the veterinary medicinal product, in such a case, for the veterinary medicinal products ; animals he has to deal with, and only the small quantities of the medicinal product necessary to complete the treatment of the animals concerned ;

(f) the veterinarian has precise records of the treated animals, the diagnosis, the veterinary medicinal products, the dose of the dose, the duration of the treatment, and the time taken to the practised amount of waiting. Such records shall be kept at the disposal of the host Member State ' s competent authorities for at least three years ;

g) the Committee and the quantity of veterinary medicinal products which the veterinarian compades does not exceed what is required in good veterinary practice in order to meet daily needs.

ARTICLE 71

1. If there are no specific Community provisions relating to the use of immunological veterinary medicinal products for the eradication or eradication of animal diseases, a Member State may prohibit the manufacture of any Member State in accordance with national law. the import, possession, sale, supply and / or use of immunological veterinary medicinal products throughout or part of its territory, if it is established ;

a) the treatment of animals with the medicinal product interferes in the implementation of a national diagnosis, control or eradication of diseases of animals or makes it difficult to confirm that live animals or foodstuffs or other, products obtained from treated animals are not contaminated ;

b) that the disease to which the medicinal product is intended to provoke immunity from the medicinal product is virtually non-occurring in the area concerned.

The Member State may also refuse to grant a marketing authorisation in accordance with a decentralised procedure as specified in Articles 31-43.

The competent authorities of the Member States shall inform the Commission of each time the provisions of paragraph 1. 1 shall be applied.

SECTIONS VII

PHARAOVIGILANCE

Article 72

Member States shall take all appropriate measures to encourage the notification of suspected adverse reactions to veterinary medicinal products to the competent authority.

Member States may lay down specific requirements for veterinarians and other healers in connection with the reporting of suspected serious or unexpected side effects and adverse reactions to humans.

Article 73

In order to ensure that appropriate and harmonized decisions on veterinary medicinal products authorised in the Community are adopted, taking into account information on suspected adverse reactions to veterinary medicinal products at normal conditions of use, compose : Member States shall monitor veterinary medicinal products. This system shall collect information useful for the surveillance of veterinary medicinal products, in particular the side effects of animals and people, and to carry out a scientific evaluation of such information.

This information shall be compared with the available information on the sale and prescribing of veterinary medicinal products.

Member States shall ensure that the relevant information collected by this system shall be transmitted to the other Member States and to the Agency. The information shall be recorded in the database referred to in Article 57 (3) The second subparagraph of paragraph 1 (k) of Regulation (EC) No (EC) No, The database and may constantly be consulted by all the Member States and must be made available immediately to the public.

The system also takes account of the information available on the non-anticipated effect, not prescribed use, study of the extent to which the withdrawal period is sufficiently long and of potential environmental problems related to use ; of the preparation, interpreted in accordance with the advice of the Commission, as set out in Article 77 (2) ; 1 which could have an impact on the evaluation of the pros and cons of the medicinal products.

Article 73a

The management of funds allocated to activities related to pharmacovigilance, the functioning of communications networks and market surveillance shall be monitored continuously by the competent authorities to ensure their independence.

Article 74

The marketing authorization holder shall continue to have a suitable qualified expert in pharmacovigilance at its disposal.

This expert person shall be resident in the Community and shall be responsible for :

a) the establishment and operation of a system ensuring that all information on suspected adverse reactions reported to the company ' s employees, including sales staff and consultants, gathers and regimen so that they are at least one place in the Community ;

b) the drawing up of the records referred to in Article 75 to the competent authorities in the form they may lay down, in accordance with the provisions of Article 77 (2). 1, mentioned instructions

c) ensuring that any requests from the competent authorities on the provision of additional information for the assessment of the benefits and risks of a veterinary medicinal product are answered promptly and fully, including information on the sale of the sale ; is, or how many prescriptions have been issued for the veterinary medicinal product concerned,

d) the transmission to the competent authorities of any information relevant to the assessment of the pros and cons of a veterinary medicinal product, including relevant information on surveillance surveys after the marketing of the veterinary medicinal product.

Article 75

1. The holder of the marketing authorization shall keep detailed records of all suspected adverse reactions which show in the Community or a third country.

Except where exceptional circumstances are available, this information shall be communicated to you in the form of a report pursuant to the instructions provided for in Article 77 (2). 1.

2. The marketing authorization holder shall record all suspected serious adverse reactions and adverse reactions to humans in the use of veterinary medicinal products, which shall be notified to him, and immediately and in any case within 15 days of the following : the receipt of this information shall report them to the competent authority of the Member State in whose territory they have shown.

The marketing authorization holder shall also record all suspected serious adverse reactions and adverse reactions to humans in the use of veterinary medicinal products to which he is reasonably presumed to be aware of, and without delay, not later than 15 days after receipt of this information, report them to the competent authority of the Member State in whose territory they have shown.

3. The holder of the marketing authorization shall ensure that all suspected serious adverse reactions, adverse reactions to humans and any presumption of transfers via veterinary medicinal products of infections which have proven in the territory of a third country ; immediately and no later than 15 days after receipt of the information, shall be reported in accordance with the provisions of Article 77 (2). The Member States shall be available to the Agency and the competent authorities of the Member States in which the veterinary medicinal product is approved.

The fourth paragraph of paragraph 4. 2 and 3 the marketing authorization holder shall, in the case of veterinary medicinal products covered by Directive 87 /22/EEC, or have undergone the marketing authorisation procedures laid down in Articles 31 and 32 of this Directive, or medicinal products which have undergone the procedures laid down in Articles 36, 37 and 38 of this Directive further ensure that all suspected adverse adverse reactions and suspected adverse reactions in humans showing in the Community are reported, so that : the information is available to the reference Member State or to : competent authority designated as a reference Member State. The reference Member State shall take responsibility for the investigation and follow-up of such adverse reactions.

5. Unless other requirements are laid down as a condition for the notification of the marketing authorization, or subsequently, as specified in the guide referred to in Article 77 (2), 1, the records shall be presented to the competent authorities in the form of periodic, updated security reports as soon as it is requested, or at least every six months after the issuing of the authorization, and until marketing commencement. Periodic, updated security reports shall be submitted as soon as it is requested, or at least every six months in the first two years after the first marketing year and once a year for the following two years. This shall be submitted to the reports every three years or as soon as the request is requested.

The periodic safety notification report shall include a scientific evaluation of the relationship between the benefits and risks of the veterinary medicinal product.

6. The Commission may amend paragraph 1. Five on the basis of experience gained.

These measures, which are intended to amend non-essential provisions of this Directive, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

7. After the marketing authorization has been issued, the holder may request a change to the periods referred to in paragraph 1 of this Article. 5, in accordance with the procedure laid down in Commission Regulation (EC) No (EC) No ; 1084/2003 16) .

8. The holder of the marketing authorization shall not, without prior or at the same time, inform the competent authority of information relating to veterinary pharmacovigilance in connection with the approved veterinary medicinal product.

In any case, the holder of a marketing authorisation shall ensure that such information is presented in an objective and not misleading manner.

Member States shall take the necessary measures to ensure that a holder of a marketing authorization that does not comply with these conditions shall be imposed on penalties which are effective, proportionate and have, dissuasive.

ARTICLE 76

1. The Agency shall establish in cooperation with the Member States and the Commission with a computerised network to facilitate the exchange of pharmacovigilance information relating to veterinary medicinal products placed on the market in the Community so that the competent authorities may have : the information at the same time.

Paragraph 2 of the provisions of paragraph 2. The network shall ensure that the Member States, in accordance with the provisions of Article 77 (3), shall ensure that notifications are transmitted ; 1, mentioned instructions on suspected serious adverse reactions and adverse reactions to humans who have taken place within their territory shall be made available to the Agency and to the other Member States within 15 days of the notice.

3. Member States shall ensure that reports of suspected serious adverse reactions and adverse reactions to human beings which have taken place within 15 days of notification shall be made available for : holder of the marketing authorization.

Article 77

1. In order to facilitate the exchange of information on pharmacovigilance in the Community, the Commission shall draw up, in consultation with the Agency and the Member States and the parties concerned, a detailed guidance in the collection, control and presentation of records ; adverse reactions, including technical requirements for electronic exchange of information on veterinary pharmacovigilance, in accordance with internationally recognized terminology.

The marketing authorization holder shall use the veterinary terminology approved at international level to submit a list of adverse reactions to the veterinary terminology approved at international level.

The Commission shall publish this guidance, which takes account of the international harmonisation work in the field of pharmacovigilance.

2. in the interpretation of the definitions referred to in Article 1 (2), 10 to 16, and the principles laid down in this Title shall refer to the marketing authorization holder and the competent authorities for the guidance referred to in paragraph 1. 1.

ARTICLE 78

1. If a Member State as a result of the surveillance data for veterinary medicinal products is considered to suspend, revoke or modify a marketing authorisation to limit the indications or the addensation, to modify dosage, add one contraindications or add a new precautionary rule, it shall immediately inform the Agency, the other Member States and the marketing authorization holder.

2. If, in order to protect human or animal health, it is necessary to act quickly, the Member State concerned may suspend marketing authorization to a veterinary medicinal product, provided that the Agency, the Commission and the other Member States shall be notified thereon at the latest on the following day.

3. When the Agency has been notified in accordance with paragraph 1. 1 or 2, it shall deliver its opinion as soon as possible, taking into account the urgency of the matter.

The Commission may, on the basis of this opinion, request the Member States in which the veterinary medicinal product is placed on the market to take interim measures immediately.

Final measures shall be adopted in accordance with the procedure referred to in Article 89 (3) 3.

Article 79

The Commission shall adopt any amendments which may be necessary in order to update the provisions of Article 72 to 78, in order to take account of scientific and technical progress.

These measures, which are intended to amend non-essential provisions of this Directive, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

TITLE (II)

MONITORING AND PENALTIES

Article 80

1. The competent authority of the Member State concerned shall ensure that, if necessary, inspection visits and, where appropriate, request an official laboratory for the control of medicinal products or a laboratory designated for this, for the purpose of carrying out random checks that the requirements concerning veterinary medicinal products are complied with.

The competent authority may also pay unannounced inspection visits to the promoters of active substances used as raw materials for veterinary medicinal products, or the marketing authorization holder, if justified by the holder of the authorization ; the requirements referred to in Article 51 have not been complied with. Such inspection visits may also take place at the request of a Member State, the Commission or the Agency.

In order to verify the information submitted to obtain a certificate of conformity with regard to the monograph of the European Pharmacopoeia, the body may be able to standardise nomenclature and standards of quality as referred to in the Convention on the subject of a certificate of conformity ; the preparation of a European Pharmacopoeia, 17) (The European Directorate of Medicinal Products for Medicinal Products) to the Commission or to the Agency and to request such inspection visits if the raw material concerned is subject to a monograph of the European Pharmacopoeia.

The competent authority of the Member State concerned may pay inspection visits to a manufacturing manufacturing maker at the request of the manufacturer himself.

These inspections shall be carried out by representatives of the competent authorities, who shall have the authority to :

a) make inspection visits to the manufacturing and trading establishments and the laboratories of the manufacturing authorization by the holders of the manufacturing authorization to have received control tasks pursuant to Article 24 ;

b) take samples, inter alia, for the purpose of an independent analysis in an official laboratory for the control of medicinal products or a laboratory designated by a Member State for that purpose ;

c) be aware of all documents relating to the subject matter of the inspection visits, subject to the provisions of the Member States on 9. October 1981, which restricts access to it for the description of the manufacturing method,

d) carry out the inspection of premises, inventories and documents of holders of marketing authorisations and in the case of promoters who have been assigned the marketing authorization holder to perform the operations referred to in Title VII, and in particular Articles 74 and 75 ; activities.

The Member States shall take all measures necessary to ensure that the processes used in the manufacture of immunological veterinary medicinal products are fully validated and guarantee uniformity between the manufacturing parties.

3. The representatives of the competent authority shall draw up after each of the items referred to in paragraph 1. the inspection report referred to in paragraph 1 shall report on the application of the principles and guidelines of good manufacturing practice referred to in Article 51, or, where appropriate, the requirements laid down in Title VII have been complied with. The content of these reports shall be notified to the manufacturer or holder of the marketing authorisation concerned by the inspection visit concerned.

Without prejudice to any agreements concluded between the Community and a third country, a Member State, the Commission or the Agency may require that a third country be subject to an inspection visit as referred to in paragraph 1. 1.

5. No later than 90 days after an inspection visit referred to in paragraph 1. Paragraph 1 shall issue a certificate of good manufacturing practice to the manufacturer, if the conclusion of the visit is to comply with the principles and guidelines laid down in Community law in the case of good manufacturing practice.

If the inspection visit has been made at the request of the European Pharmacopoeia, a certificate of compliance shall be issued for the monograph.

The Member States shall allow the attestations of good manufacturing practice to be introduced into a Community database administered by the Agency on behalf of the Community.

7. If the conclusion of an inspection visit referred to in paragraph 1 shall be drawn up, 1 is that the manufacturer does not comply with the principles and guidelines laid down in Community legislation in the case of good manufacturing practice, this information shall be put in the case referred to in paragraph 1. 6 related to the Community database.

Article 81

Member States shall take all appropriate measures to ensure that the marketing authorization holder and, where appropriate, the holder of the manufacturing authorization shall demonstrate that the veterinary medicinal product and / or the marketing authorization is carried out ; the components and intermediate products, in the preparation of the methods used for placing the marketing authorization on the market.

2. for the implementation of paragraph 1. Member States may require the holders of the marketing authorization for the immunological veterinary medicinal products to be submitted to the competent authorities of any verification evidence signed by the expert in accordance with Article 55.

The holder of the marketing authorization for immunological veterinary medicinal products must ensure that there are representative samples of each batch of veterinary medicinal products in storage sufficient at least until the latest date of use and on request, promptly present them to the competent authorities.

Article 82

When a Member State in order to protect human or animal health considers it necessary, it may require that the marketing authorization holder of an immunological veterinary medicinal product before it is put into circulation, shall send samples of the particulates of the medicinal product ; the preparation in bulk and / or of the medicinal product for the control of an official pharmacolaboratory testing laboratory.

2. The marketing authorization holder shall, at the request of the competent authorities, provide the products referred to in paragraph 1 as soon as possible. The tests referred to in Article 81 (1) shall be as specified ; 2, as referred to as inspection certificates.

The competent authority shall inform all the other Member States of the authorization of the veterinary medicinal product and the European Directorate of Medicinal Products (EDQM) that it intends to check the parties or the party concerned.

The competent authorities of another Member State may, in such cases, not apply the provisions of paragraph 1. 1.

3. The laboratory responsible for inspection must be examined in accordance with the provisions of Article 81 (1). The verification certificates referred to above shall repeat all the analyses carried out by the manufacturer on the finished product, at the tests given in accordance with the relevant provisions in the documentation for the marketing authorization application.

The list of analyses to be repeated by the laboratory responsible for the control may be limited to the most necessary if this is to be agreed between all the Member States concerned and, where appropriate, in consultation with the European Directorate for European Directorates ; Pharocious quality (EDQM).

in the case of immunological veterinary medicinal products subject to a marketing authorisation pursuant to Regulation (EC) No (EC) No, The list of analyses to be repeated by the laboratory responsible for the checks can be carried out only after a positive opinion from the Agency.

4. The results of the analyses shall be approved by all the Member States concerned.

Except in cases where the Commission is informed that a longer time limit is required to carry out the analyses, Member States shall ensure that the examination is completed within 60 days of the date of receipt of the tests.

Within the same period, the competent authority shall forward the results of these analyses to the other Member States concerned, the European Directorate-Quality of Medicinal Products, the marketing authorization holder and, where appropriate, the manufacturer.

Where a competent authority finds that a batch of an immunological veterinary medicinal product is not in conformity with the manufacturer ' s verifier or the specifications set for the marketing authorization, it must take all the necessary checks, the measures necessary to the marketing authorization holder and, where appropriate, the manufacturer and inform the other Member States where the veterinary medicinal product concerned has been approved.

Article 83

The competent authorities of the Member States shall suspend, withdraw, withdraw, or modify the marketing authorization if it is assessed :

a) Whereas the assessment of the relationship between the advantages and risks of the veterinary medicinal product by regulatory purposes is negative, taking into account in particular the benefits of animal health and welfare, and the benefits and safety of consumers when : the authorisation concerns veterinary medicinal products for zootechnical purposes ;

b) the veterinary medicinal product is without therapeutic effect on the animal species which is the subject of treatment ;

c) the medicinal product does not have the quantitative and qualitative composition of the product,

d) the wait time specified is insufficient to the fact that foodstuffs obtained from the treated animal do not contain residues which may be a danger to the consumer ' s health ;

(e) the veterinary medicinal product is offered for sale to an application which is prohibited under other Community provisions.

(f) the information contained in the documentation pursuant to Articles 12 to 13d and 27 is incorrect ;

g) the one in Article 81 (1). The checks have not been carried out

The competent authorities may, as long as Community legislation in this field is prepared, refuse to grant marketing authorization to a veterinary medicinal product if necessary to ensure the protection of public health, consumers ' ; or animal health.

2. The marketing authorization may be suspended, withdrawn, withdrawn, or modified if it is assessed :

a) the information provided for in Article 12-13d in the dossier has not been amended in accordance with Article 27 (1). 1 and 5

b) all new data referred to in Article 27 (2) have not been submitted to the competent authorities. 3.

ARTICLE 84

Without prejudice to the provisions of Article 83, Member States shall take all appropriate measures to prohibit the provision of the veterinary medicinal product and shall be withdrawn from the market if it proves that :

a) the assessment of the relationship between the advantages and risks of the veterinary medicinal product by regulatory purposes is negative, taking into account in particular the benefits of animal health and welfare and the benefits of consumer safety ; and health, where the authorisation relates to veterinary medicinal products for zootechnical purposes ;

b) the veterinary medicinal product is without therapeutic effect on the animal species which is the subject of treatment ;

c) the veterinary medicinal product does not have the qualitative and quantitative composition,

d) the wait time indicated is insufficient to the presence of foodstuffs obtained from the treated animal not containing residues which may be a danger to the consumer ' s health ;

(e) the one in Article 81 (1). The checks have not been carried out, or that other requirements and obligations relating to the issue of the manufacturing authorization are not met.

The competent authority may limit the supply supply and revocation of the market to cover only the manufacturing parties against which an objection has been raised.

Article 85

1. The competent authority of a Member State shall suspend or withdraw the authorization for a category of products or to all of them when one of the conditions laid down in Article 45 no longer observed.

2. The competent authority of a Member State may, in addition to taking the measures provided for in Article 84, either to suspend the production or import of veterinary medicinal products from third countries or to suspend or revoke the provisions of Article 84 ; the manufacturing authorization for a category of preparations or all, where the provisions concerning the production or importation of third countries are not complied with.

Member States shall prohibit advertising to the public in respect of veterinary medicinal products, which :

a) Whereas, pursuant to Article 67, only available on prescription is available ;

b) contain psychotropic or euphoria substances such as those referred to in the UN Conventions of 1961 and 1971.

ARTICLE 86

The provisions of this Title shall apply to homeopathic veterinary medicinal products.

Article 87

Member States shall take appropriate measures to encourage veterinarians and other interested professionals to inform the competent authorities of any adverse reaction to a veterinary medicinal product.

TITLE IX

STANDING COMMITTEE

Article 88

The Commission shall adopt any amendments which are necessary for the adaptation of Annex I to technical progress.

These measures, which are intended to amend non-essential provisions of this Directive, shall be adopted in accordance with the regulatory procedure with the supervision referred to in Article 89 (1). 2a.

ARTICLE 89

1. The Commission shall be assisted by a Standing Committee on Veterinary Medicinal Products for Adaptation to Technical Progress of the Directives on the removal of technical barriers to the trade in veterinary medicinal products, hereinafter referred to as ' the Standing Committee `.

2. When reference is made to this paragraph, Articles 5 and 7 of Decision 1999 /468/EC shall apply, cf. its Article 8.

The period laid down in Article 5 (1). 6, in Decision 1999 /468/EC shall be set at three months.

When reference is made to this paragraph, Article 5a (2) shall apply. 1-4, and Article 7 of Decision 1999 /468/EC, cf. its Article 8.

3. When reference is made to this paragraph, Articles 4 and 7 of Decision 1999 /468/EC shall apply, cf. its Article 8.

The period laid down in Article 4 (1). 3, in Decision 1999 /468/EC shall be set at one month.

4. The Rules of Procedure of the Standing Committee shall be published.

TITLE X

GENERAL PROVISIONS

Article 90

Member States shall take all appropriate measures to ensure that the competent authorities concerned exchange relevant information, in particular to ensure that the requirements laid down for the authorisations referred to in Article 44 referred to in Article 80 shall be ensured, paragraph 5, certificates or marketing authorisations shall be complied with.

On the basis of reasoned request, Member States shall immediately forward the provisions of Article 80 (3) The reports to the competent authorities of another Member State shall be referred to.

The conclusions of the measures referred to in Article 80 (3). The inspections carried out by inspectors from the Member State concerned shall be valid throughout the Community.

However, where a Member State is exceptionally not in favour of the health or animal health of a Member State, in exceptional circumstances, the conclusions of an inspection carried out in accordance with Article 80 (2) are not in exceptional cases. 1, this Member State shall immediately inform the Commission and the Agency. The Agency shall inform the Member States concerned.

Where the Commission is informed of these weighty considerations, it may, after consulting the Member States concerned, request that the inspector from the competent supervisory authority carry out a new inspection. This inspector may be accompanied by two inspectors from Member States that are not party to the dispute.

Article 91

1. Each Member State shall take all appropriate measures to permit decisions on the marketing authorisation and any decision on refusal of refusal or withdrawal of such authorisation, on the cancellation of a decision on refusal of refusal, or the marketing authorisation revocation, the prohibition of extradition and the withdrawal of the market, together with the reasons for it, shall immediately be brought to the Agency ' s knowledge.

2. The holder of the marketing authorization shall immediately inform the Member States concerned of any measures he takes in respect of the suspension of the placing on the market or withdrawal of the veterinary medicinal product from the market ; in the case of the efficacy of this medicinal product or the protection of public health, the reasons for this shall be so. Member States shall ensure that such information is brought to the attention of the Agency.

3. Member States shall ensure that adequate information on measures taken pursuant to paragraph 1 shall be taken. 1 and 2, which may affect health protection in third countries, shall immediately be notified to the relevant international organisations and that a copy of the notification shall be made to the Agency.

Article 92

Member States shall provide each other with each other the information necessary, in particular the information provided for in Articles 90 and 91, to ensure the quality and safety of homeopathic veterinary medicinal products manufactured and marketed in the Community.

Article 93

At the request of the manufacturer or the exporter of veterinary medicinal products, or the competent authority of an importing third country, Member States shall certify that the manufacturer is in possession of the manufacturing authorization. For the purpose of issuing such certificates, the following conditions must be complied with :

a) the Member States must take into account the relevant administrative provisions of the World Health Organisation ;

b) in the case of veterinary medicinal products intended for export, which are already permitted in their territory, the Member States shall submit the summary of the product characteristics, as approved in accordance with Article 25 or, where such, does not exist, a corresponding document.

2. If the manufacturer is not in possession of a marketing authorization, he shall be required to issue the manufacturer in the first paragraph of paragraph 1. The competent authorities shall give the competent authorities a statement as to why there is no marketing authorization.

ARTICLE 94

The decisions taken by the competent authorities of the Member States must not be taken with any other reasons other than the reasons set out in this Directive, and shall be justified in detail.

The decisions shall be communicated to the person concerned, providing information on the legal basis of the complainment and the deadline for the implementation of the complaint.

Decisions to grant or revoke a marketing authorisation shall be made available to the public.

Article 95

Member States shall not permit food from animals that have been used for clinical trials unless the competent authorities have set an appropriate detention period. Such withdrawal time shall be either :

a) at least equal to the one referred to in Article 11 (1). 2, possibly combined with a safety factor that takes account of the nature of the substance tested ; or

b) where maximum residue levels have been set for residues in accordance with Regulation (EEC) No 2 ; Directive 2377/90, ensuring that this maximum limit is not exceeded in the food concerned.

Article 95a

Member States shall ensure that appropriate arrangements are established for the collection of veterinary medicinal products not used or where the final application has been exceeded.

Article 95b

When a veterinary medicinal product is to be approved in accordance with Regulation (EC) No 726/2004, and the Scientific Committee referred to in its opinion, it refers to the recommended conditions or restrictions in respect of the safe and efficient use of the veterinary medicinal product in : pursuant to Article 34 (1). The provisions of Article 4 (4) (d) of that Regulation shall be adopted by a Decision to the Member States, in accordance with the procedure laid down in Articles 37 and 38 of this Directive, on the implementation of these conditions or restrictions.

SECTION XI

FINAL PROVISIONS

Article 96

Directives 81 /851/EEC, 81 /852/EEC, 90 /677/EEC and 92 /74/EEC, as amended by the Directives listed in Annex II, Part A, shall be repealed, without prejudice to the obligations of the Member States concerning the transposition limits laid down in Annex II, Part B.

References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex III.

Article 97

This Directive shall enter into force on the twentith day following that of its publication in the Official Journal of the European Communities. (Thrown into force 18/12 2001, Schultz, red. ).

ARTICLE 98

This Directive is addressed to the Member States.

Official notes

1) The commotion contains provisions that implement parts of Directive 2001 /83/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community code of medicinal products for human use, the Official Journal of the European Communities. L 311, s. Last amended by Directive 2010 /84/EU of the European Parliament and Council Directive 2010 /84/EU of 15. December 2010, EU Official Journal, nr. L 348, s. Directive 74, and the European Parliament and Council Directive 2011 /62/EC of 8. June 2011, EU Official Journal, nr. In 174, s. Directive 74, and parts of Directive 2001 /82/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community code of veterinary medicinal products, the EC Official Journal of 2001, no. L 311, s. Regulation (1), as last amended by Regulation (EC) No 2 of the European Parliament 596/2009 of 18. June 2009, EU-Official Journal 2009, nr. In 188, s. 14.

1) OJ C 368, 20.12.1999, p. 3.

2) Opinion of the European Parliament July 2001 (not yet published in the Official Journal) and Decision of the Council of 27. September 2001.

3) OJ No 22, 9.2.1965, p. 369/65. Directive as last amended by Directive 93 /39/EEC (OJ L 214, 24.8.1993, p. TWENTY-TWO.

4) OJ L 147, 9.6.1975, p. 1. Directive as last amended by Commission Directive 1999 /83/EC (OJ L 243, 15.9.1999, p. 9).

5) OJ L 147, 9.6.1975, p. 13. Directive as last amended by Commission Directive 2000 /38/EC (OJ L 139, 10.6.2000, p. TWENTY-EIGHT.

6) OJ L 142, 25.5.1989, p. 14.

7) OJ L 142, 25.5.1989, p. 16.

8) OJ L 181, 28.6.1989, p. 44.

9) OJ L 113, 30.4.1992, p. 1.

10) OJ L 113, 30.4.1992, p. 5.

11) OJ L 113, 30.4.1992, p. 8.

12) OJ L 113, 30.4.1992, p. 13.

13) OJ L 297, 13.10.1992, p. 8.

14) OJ L 214, 24.8.1993, p. 1. The Regulation has been amended by Commission Regulation (EC) No 2. 649/98 (OJ L 88, 24.3.1998, p. 7).

15) OJ L 265, 5.10.1984, p. 1. The directive has been repealed with effect from 13. 5. Directive 2000 /43 / Euratom Directive 97 /43 / Euratom (OJ L 180, 9.7.1997, p. TWENTY-TWO.

16) OJ L 246, 17.9.1980, p. 1. Directive as last amended by Directive 84 /467/EEC (OJ L 265, 5.10.1984, p. (4), repealed with effect from 13.5.2000 by Directive 96 /29/EC (OJ L 314, 4.12.1996, p. 20).

17) OJ L 250, 19.9.1984, p. 17. Directive as amended by Directive 97 /55/EC (OJ L 290, 23.10.1997, p. 18).

18) OJ L 298, 17.10.1989, p. 23. Directive as amended by Directive 97 /36/EC (OJ L 202, 30.7.1997, p. 60).

(19) OJ L 184, 17.7.1999, p. 23.

20) OJ L 324, 10.12.2007, p. 121.

21) OJ L 136, 30.4.2004, p. 1.

(22) OJ L 121, 1.5.2001, p. 34.

23) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 2 ; 1901/2006 (EUT L 378, 27.12.2006, p. 1).

24) OJ L 207, 30.7.1986, p. 1.

25) OJ L 210, 7.8.1985, p. 29. Directive as last amended by Directive 1999 /34/EC of the European Parliament and of the Council (OJ L 141, 4.6.1999, p. 20).

26) OJ L 18, 22.1.2000, p. 1.

27) OJ L 262, 14.10.2003, p. 22.

28) OJ L 204, 21.7.1998, p. 37.

29) OJ L 178, 17.7.2000, p. 1.

(30) The EUT L 33 of 8.2.2003, p. 30.

1) OJ C 75, 15.3.2000, p. 11.

2) Opinion of the European Parliament of 3 July 2001 (not yet published in the Official Journal) and Decision of the Council of 27. September 2001.

3) OJ L 317, 6.11.1981, p. 1. Directive as last amended by Commission Directive 2000 /37/EC (OJ L 139, 10.6.2000, p. TWENTY-FIVE.

4) OJ L 317, 6.11.1981, p. 16. Directive as last amended by Commission Directive 1999 /104/EC (OJ L 3, 6.1.2000, p. 18).

5) OJ L 373, 31.12.1990, p. 26.

6) OJ L 297, 13.10.1992, p. 12.

7) OJ L 214, 24.8.1993, p. 1. The Regulation has been amended by Commission Regulation (EC) No 2. 649/98 (OJ L 88, 24.3.1998, p. 7).

8) OJ L 184, 17.7.1999, p. 23.

9) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No, 1274/2001 (OJ L175, 28. 6. 2001, s. 14).

10) OJ L 136, 30.4.2004, p. 1.

11) OJ L 92, 7.4.1990, p. 42.

12) OJ L 270, 14.12.1970, p. 1. Regulation as last amended by Regulation (EC) No, 1756/2002 (OJ L 265, 3.10.2002, p. 1).

13) OJ L 298, 3.12.1993, p. 45. Directive as amended by Commission Decision 2000 /68/EC (OJ L 23, 28.1.2000, p. 72.

14) OJ L 23, 28.1.2000, p. 72.

15) OJ L 125, 23.5.1996, p. 10. Regulation as amended by Regulation (EC) No 2 ; 806/2003 (OJ L 122, 16.5.2003, p. 1). '

16) The EUT L 159, 27.6.2003, p. 1.

17) OJ L 158, 25.6.1994, p. 19.