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

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Overview (table of contents)



Annex 1



European Parliament and Council Directive 2001/83/EC





Annex 2



European Parliament and Council Directive 2001/82/EC



The full text of the Decree on the National Board of Health's tasks in connection with different application procedures, cooperation procedures on pharmacovigilance and the procedures for voldgiftssager1)

Pursuant to section 9, paragraph 3, article 17, paragraph 3, section 34, no. 5 and 6, and section 56 (1), (2). point of law No. 1180 of 12. December 2005 on medicinal products, as amended by Act No. 605 of 18. June 2012, fixed: § 1. The Executive order implementing the procedural sections of the European Parliament and Council Directive 2001/83/EC on the Community code relating to medicinal products, as amended most recently by the European Parliament and of the Council directive 2010/84/EC and European Parliament and Council directive 2011/62/EU, and of European Parliament and Council Directive 2001/82/EC on the Community code relating to veterinary medicinal products, as amended most recently by the European Parliament and of the Council Regulation (EC) No 1782/2003. 596/2009.

(2). A merging of the European Parliament and Council Directive 2001/83/EC on the Community code relating to medicinal products, as amended most recently by the European Parliament and of the Council directive 2010/84/EC and European Parliament and Council directive 2011/62/EU, is included as annex 1 to this notice.

(3). A merging of the European Parliament and Council Directive 2001/82/EC on the Community code relating to veterinary medicinal products, as amended most recently by the European Parliament and of the Council Regulation (EC) No 1782/2003. 596/2009, included as annex 2 to this order.

§ 2. The health protection agency is the competent authority in accordance with European Parliament and Council Directive 2001/83/EC on the Community code relating to medicinal products, as amended most recently by the European Parliament and of the Council directive 2010/84/EC and European Parliament and Council directive 2011/62/EU.

§ 3. The health protection agency is the competent authority in accordance with European Parliament and Council Directive 2001/82/EC on the Community code relating to veterinary medicinal products, as amended most recently by the European Parliament and of the Council Regulation (EC) No 1782/2003. 596/2009.

(2). Relating to articles 10, 11, 66, (3) and 37 of the Executive order on Annex 2 is the National Board of health, however, no jurisdiction authority.

(3). For the purposes of article 66 (1) of annex 2 of the Executive order is competence shared between the National Board of health and the Food Agency, since Food Agency is the competent authority for the dispensing and sale of medicines through veterinarians.

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

(2). Executive Order No. 476 of 24. May 2006 on the Danish Medicines Agency's tasks related to different application procedures are hereby repealed.

The Ministry of health and prevention, the 1. August 2012 Astrid Krag/Dorthe Eberhardt Søndergaard



Annex 1 European Parliament and Council Directive 2001/83/EC

of 6. November 2001

establishing a Community code relating to medicinal products for human use

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION

having regard to the Treaty establishing the European Community, and in particular article 95,

having regard to the proposal from the Commission,

having regard to the opinion of the Economic and Social Committee1),

in accordance with the procedure referred to in article 2512), and

on the basis of the following considerations:

(1) Council Directive 65/65/EEC of 26. January 1965 on the approximation of legislation on medical specialiteter3), Council Directive 75/318/EEC of 20. May 1975 on the approximation of the laws of the Member States relating to standards and regulations relating to analytical, pharmacotoxicological and clinical investigations of medical specialiteter4), Council Directive 75/319/EEC of 20. May 1975 on the approximation of legislation on medical specialiteter5), Council Directive 89/342/EEC of 3. May 1989 extending the scope of Directive 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins, serums and allergener6), Council Directive 89/343/EEC of 3. May 1989 extending the scope of Directive 65/65/EEC and 75/319/EEC and laying down additional provisions for the radioactive lægemidler7), Council Directive 89/381/EEC of 14 May 1991. June 1989 extending the scope of Directive 65/65/EEC and 75/319/EEC on the approximation of laws relating to proprietary medicinal products and laying down special provisions for medicinal products derived from blood or plasma from mennesker8), Council Directive 92/25/EEC of 31 March 1992. March 1992 on the wholesale distribution of medicinal lægemidler9), Council Directive 92/26/EEC of 31 March 1992. March 1992 concerning the classification in connection with the dispensing of medicinal lægemidler10), Council Directive 92/27/EEC of 31 March 1992. March 1992 on the labelling and package leaflets for medicinal lægemidler11), Council Directive 92/28/EEC of 31 March 1992. March 1992 on the advertising of medicinal lægemidler12) 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 laws relating to pharmaceutical preparations and laying down additional provisions on homeopathic lægemidler13) has on several occasions been subjected to extensive changes. Directives should therefore be codified and brought together in a single text, so that their provisions can clearly and rationally.

(2) all the provisions concerning the manufacture, distribution and use of medicinal products must have as a main purpose to protect the public health.

(3) However, This objective must be attained by means which will not inhibit the development of the pharmaceutical industry and trade in medicinal products within the community.

(4) Differences between certain national provisions, in particular between provisions relating to medicinal products, not including substances and combinations of substances that serve as food, feed or cosmetic articles, inhibitory to the trade in medicinal products within the community and thus have a direct impact on the functioning of the internal market.

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

(6) in order to settle the remaining differences, should be laid down on the control of medicinal products and detailed outlines for the tasks incumbent on the competent authorities of the Member States to ensure compliance with legal.

(7) the concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other and have only a relative significance, there must be assessed taking into account how far science has been reached, and what the drug is to be used for. The documentation and the information that must accompany the application for marketing authorisation, it must demonstrate that the benefits connected with efficiency, outweighs the potential risks.

(8) standards and protocols for conducting trials of medicinal products are an effective means of control of these and thus also for the protection of public health and can facilitate the movement of drugs, where laying down common rules for their implementation, as well as the compilation of dossiers and applications processing.

(9) experience has shown that it will be reasonable to an even greater extent to clarify the cases where it is not required to present the results of toxicological and pharmacological tests or clinical trials with a view to marketing authorisation of a medicinal product which is essentially similar to a medicinal product authorized, subject to should be avoided, to innovative businesses are put at a disadvantage.

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

(11) All the Member States the adoption of the same standards and regulations will make it possible for the competent authorities to give its opinion on the basis of uniform tests and on the basis of common criteria and will therefore help to prevent differences in assessment.

(12) With the exception of pharmaceuticals, which come under the community's centralised authorisation procedure introduced by Council Regulation (EEC) No 2377/90. 2309/93 of 22. July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for lægemiddelvurdering14), should an authorisation to market a medicinal product issued by a competent authority in a Member State shall be recognised by the authorities of the other Member States unless there are serious grounds for supposing that the authorisation of the medicinal product concerned may present a risk to public health. In the event of disagreement between Member States about the quality, safety or efficacy of the medicinal product, a scientific evaluation should be made of the issue at the community level, and the scientific assessment should lead to a single decision on the contentious issue, which should be binding for the Member States concerned. Decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States.

(13) for this purpose, a Committee for proprietary medicinal products falling within the scope of the European Agency for the evaluation of medicinal products established by Regulation (EEC) No 2377/90. 2309/93.


(14) whereas this directive is an important step in the implementation of the objectives in the context of the free movement of medicinal products. It may, however, prove necessary in the light of experience gained and in particular in the above Committee for proprietary medicinal products, to be able to adopt new measures with a view to abolish yet existing obstacles to free movement.

(15) in order better to protect public health and avoid unnecessary duplication of work in connection with the processing of applications for marketing authorisations for medicinal products, Member States should systematically prepare assessment reports in respect of each medicinal product they approve, and upon request exchange such reports. A Member State should be able to suspend the examination of an application for marketing authorisation for treatment in another Member State for the purpose of recognising the latter Member State decision.

(16) following the establishment of the internal market can only renounced, specific controls to guarantee the quality of medicinal products imported from third countries, if the community has taken appropriate measures to ensure that the necessary controls are carried out in the exporting country.

(17) it is necessary to adopt specific provisions for immunological, homeopathic, radiopharmaceuticals and medicinal products derived from blood or plasma from humans.

(18) in setting the rules for radiopharmaceuticals, account should be taken of Council Directive 84/466/Euratom of 3. September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or behandlinger15). There should also be taken of Council Directive 80/836/Euratom of 15. July 1980 amending the directives laying down the basic standards for the health protection of the general public and workers against the dangers arising from ionising stråling16), whose aim is to prevent the workers or patients exposed to a dose of ionizing radiation, and in particular article 5 (c)), which required prior authorization for the addition of radioactive substances in the manufacture of medicinal products as well as for the importation of such medicinal products.

(19) the community fully supports the efforts of the Council of Europe to promote voluntary unpaid blood and plasma for the purpose of community self-sufficiency in blood products and to ensure respect for ethical principles in trade in therapeutic substances of human origin.

(20) provisions aimed at ensuring the quality, safety and efficacy of medicinal products derived from human blood and plasma, should find the same apply to public and private undertakings as well as on blood and plasma imported from third countries.

(21) in view of homeopathic medicinal products for specific characteristics, such as their weak concentration of active principles and the difficulty of applying the traditional statistical methodology for clinical trials for them, provision should be made for a simplified registration system for homeopathic medicinal products placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not and poses a risk to the patient.

(22) the anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method of production, may provide, as regards registration and marketing authorization shall be treated with homeopathic medicines.

(23) first and foremost, should the users of homeopathic medicinal products with a very clear indication of the case of homeopathic medicines, like they should have sufficient guarantees of their quality and safety.

(24) the provisions concerning the manufacture of, as well as the control and supervision of homeopathic medicinal products must be harmonized to permit the marketing throughout the community of safe medicinal products of good quality.

(25) For homeopathic medicinal products marketed with information about therapeutic effects or in a form which may present risks in connection with the expected therapeutic effect, the usual rules of marketing authorizations in respect of medicinal products used. In particular, Member States with a tradition of homeopathy should be able to apply particular rules for the evaluation of the test results 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 to prevent the checks carried out in one Member State is repeated in another Member State, should be laid down as minimum requirements for manufacture and imports from third countries, as well as the issuance of the necessary permits.

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

(28) Before an authorization to market an immunological medicinal product or a medicinal product derived from blood or plasma from humans, the manufacturer must demonstrate he is able to guarantee the uniformity between the parties. As regards medicinal products derived derived from human blood or plasma, he shall also, to the extent the State of the art makes it possible to prove that there is no specific viralkontamination.

(29) the conditions for supplying medicinal products to the public should be harmonized.

(30) in this respect, intra-Community travellers the right to lead a reasonable quantity of medicinal products, as they have been in a legal manner for personal use. It must also be possible for a person who is resident in a Member State, to receive a reasonable amount of drugs for personal use from another Member State.

(31) Furthermore, required pursuant to Regulation (EC) No 1782/2003. 2309/93 for certain medicines a community marketing authorization. In this respect, there should be a classification in connection with the dispensing of the medicinal products for which there must be such a marketing authorisation. There should therefore be laid down criteria that should be used as a basis for the decisions to be taken by the community.

(32) it is therefore appropriate, as a first step be a harmonisation of the principles which should underlie classification in connection with the dispensing of medicinal products in the community or in the Member State concerned, on the basis of the principles already established in this field by the Council of Europe, as well as in the harmonization work done by the United Nations with regard to narcotic drugs and psychotropic substances.

(33) the provisions relating to classification in connection with the dispensing of medicinal products, shall not affect the provisions of Member States ' social security schemes for reimbursement or payment for prescription drugs.

(34) Many activities related to the wholesale distribution of medicinal products for human use will be able to cover several Member States simultaneously.

(35) the entire distribution chain, from the manufacture or import of medicines in the community for their extradition to the consumer, should be subject to control, in order to ensure that medicines are stored, transported and handled in suitable conditions. The provisions to be adopted for this purpose, will make it considerably easier to pull defective products from the market and will allow for a more effective fight against counterfeiting.

(36) all persons who operate wholesale trade in medicinal products must be in possession of a special authorization. This requirement should not, however, include pharmacists and persons authorized to supply medicinal products to the public, and which only takes care of this task. It is, however, out of consideration for the control of pharmaceutical products as a whole required that pharmacists and persons authorized to supply medicinal products to the public, keep records of contracted items.

(37) it is appropriate for the authorisation should apply certain basic requirements, compliance with which it is the responsibility of the Member State to verify. Each Member State must recognize permits issued by the other Member States.

(38) Certain Member States impose on wholesalers who supply medicinal products to pharmacists and persons authorized to supply medicinal products to the public certain public service obligations. Member States should be able to apply those obligations on wholesalers established within their territory. They should also be able to use them on wholesalers in other Member States, provided that they do not impose more stringent obligations than those they impose on their own wholesalers, and to the extent that they may be justified on grounds of public health protection and are proportionate to the objective relating to this protection.

(39) the provisions as to how the labelling must be made, and how the package leaflet shall be designed, should be clarified.

(40) the provisions relating to patient information should ensure a high level of protection for consumers in order to make it possible for them to use medicines correctly on the basis of full and comprehensible information.

(41) the marketing of medicinal products whose labelling and package leaflet has been prepared in accordance with the provisions of this directive should not be prohibited or impeded on grounds relating to their labelling or the package leaflet.

(42) this directive should not affect the implementation of the measures taken pursuant to Council Directive 84/450/EEC of 10. September 1984 on the approximation of the laws and regulations of the Member States concerning misleading reklame17).


(43) all Member States have also adopted specific measures concerning the advertising of medicinal products. These measures differ from Member State to Member State. The differences have an impact on the functioning of the internal market, since an advertisement issued in one Member State can 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 of the Member States concerning the pursuit of television-radiospredningsvirksomhed18) contains a prohibition of television advertising for medicinal products available only on prescription in the Member State within whose jurisdiction the broadcaster falls. This principle should also apply to other media.

(45) Public advertising of non-prescription medicines will, if they are excessive and not sufficiently well thought through, could have an impact on public health. In so far as such advertising is permitted, they should therefore meet certain essential criteria to be determined.

(46) in addition, should the free distribution of samples for advertising purposes to the public shall be prohibited.

(47) the pharmaceutical commercials, which caters to persons qualified to prescribe or supply medicinal products, helps to inform these persons. Such advertising should be subject to strict conditions and an effective control on the basis, among other things, in the work that has been done within the framework of the Council of Europe.

(48) advertising of medicinal products should be subject to appropriate and effective control. It would be appropriate to let the control mechanisms established by Directive 84/450/EEC, serve as a model.

(49) medical sales representatives play an important role in promoting the sale of pharmaceutical products. There should therefore be imposed on them certain obligations, including the obligation to give the person in whom visited, a summary of the product characteristics.

(50) persons qualified to prescribe medicinal products must be able to perform these functions objectively without being influenced by direct or indirect financial incentives.

(51) Free medical samples should, under certain restrictive conditions could be released to persons qualified to prescribe or supply medicinal products so that they can familiarize themselves with new drugs and get some experience in the use of them.

(52) The persons qualified to prescribe or supply medicinal products must have access to neutral and objective information about the medicinal products which are available on the market, but is the responsibility of the Member States to take appropriate measures in this regard depending on their specific situation.

(53) Each undertaking which manufactures or imports medicinal products should set up a system which can ensure that all the information given about a drug, is in accordance with the conditions approved for its use.

(54) in order to ensure that it remains safe to use drugs, it is necessary to ensure that 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 have been a result of international harmonisation of definitions, terminology and technological developments in pharmacovigilance.

(56) the increasing use of electronic networks for the transmission of information on adverse reactions to medicinal products marketed in the community, aims to provide the competent authorities the opportunity to get the information at the same time.

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

(58) holders of marketing authorisations should be proactively responsible for ongoing pharmacovigilance of the medicinal products they place 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 June 1999. June 1999 laying down the procedures for the exercise of implementing powers conferred on the Kommissionen19).

(60) the Commission should be authorised to adopt the necessary changes 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 concerning the deadlines for transposition of the in annex II, part B, directives listed

HAS ADOPTED THIS DIRECTIVE:

TITLE I

DEFINITIONS

Article 1

For the purposes of this directive: 1) (repealed).



2) medicinal product:



– Any substance or combination of substances presented as an appropriate means for the treatment or prevention of disease in humans



  or



– Any substance or combination of substances which may be used in or administered to human beings with a view either to restoring, or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.



3) fabric:



  any substance, regardless of its origin, since this can be:



– human, as for example:



  human blood and preparations of human blood



– animal, as for example:



  micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood substances derived preparations



– vegetable, as for example:



  micro-organisms, plants, parts of plants, vegetable secretions, substances obtained by extraction



– chemical, as for example:



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



3A) active ingredient:



  any substance or mixture of substances intended to be used in the manufacture of a drug, and that by entering into the production of this becomes an active ingredient of the medicinal product concerned, who must exercise a pharmacological, immunological or metabolic action, with a view to restoring, or affect physiological functions or to making a medical diagnosis.



3B excipient:



  any component of a drug other than the active substance and its packaging.



4) immunological medicinal product:



  any medicinal product consisting of vaccines, toxins, serums or allergen products:



– vaccines, toxins and serums shall cover in particular:



i. agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine



II. products used for diagnosing immunity modes, such as tuberculin and tuberculin PPD, toxins for the Schick and Dick applied tests, brucellin;



III. agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin.



b. "allergen product" is a medicine as a aims to identify or induce a specific acquired alteration in the immunological response to an allergenic substance.



4A) advanced therapy medicinal product:



  a product as defined in article 2 of European Parliament and Council Regulation (EC) No 1782/2003. 1394/2007 of 13. November 2007 on medicines for advanced terapi20).



5) homeopathic medicinal product:



  Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the currently has official status in the Member States. A homeopathic medicinal product may contain several active substances.



6) radiopharmaceutical:



  any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose.



7) radionuclide generator:



  any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by Elution or by any other method and used in a radiopharmaceutical.



8) Kit:



  any preparation to be reconsitituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration.



9) radionuclide precursor:



  any other radionuclide produced for the radio-labelling of another substance prior to administration.



10) medicinal products derived from blood or plasma from people:



  medicinal products which are prepared industrially by public or private enterprises on the basis of blood components; These drugs include, in particular, albumin, clotting factors and immunoglobulins of human origin.



11) adverse reaction:



  a harmful and unintended response to a drug.



12) serious adverse reaction:



  an adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.



13) unexpected adverse reaction:



  an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.



14) (discontinued).



15) post-authorisation safety study for marketing:




  any inquiry relating to an authorised medicinal product, which is conducted with the aim of identifying, characterising or quantifying a safety hazard, confirm the drug's safety profile or measure the effectiveness of risk management measures.



16) abuse of medicinal products:



  persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological Effets.



17) wholesale distribution of medicinal products:



  all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. This company exercised together with manufacturers or their depositories, importers, other wholesalers or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned.



17A) Dissemination of medicinal products:



  all activities in connection with the sale or the purchase of medicinal products, with the exception of wholesale distribution, which does not include the physical handling and consisting of negotiating independently on behalf of another legal or natural person.



18) public service obligations:



  the obligation imposed upon the respective wholesalers, to continuously to guarantee a range of medicinal products which meet the needs within a specific geographic area, and to ensure the delivery of the products requested at very short notice within the whole of the territory concerned.



18A representative of the marketing authorisation holder):



  The person, commonly referred to as the local representative, designated by the marketing authorisation holder to represent him in the Member State concerned.



19) Prescription



  a prescription for medicines, issued by a health care professional who is empowered.



20) name of the medicinal product:



  A name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name, together with a trade mark or the name of the holder of the marketing authorisation.



21) Common name:



  the name recommended by the World Health Organization International common name or, if one does not exist, the usual common name.



22) strength of the medicinal product:



  the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.



23) Inner packing:



  the container or any other form of packaging that is in direct contact with the medicinal product.



24) outer packaging:



  the packaging, which surrounds the inner packaging.



25) labelling:



  the information affixed to the inner or the outer packaging.



26) (does not concern the English version).



  the leaflet containing information for the user which accompanies the medicinal product.



27) Agency:



  The European Medicines Agency established by Regulation (EC) No 1782/2003. 726/200421).



28) Risk by the use of the medicinal product:



-any risk relating to the quality, safety and efficacy of the medicinal product for the patient's health or public health



-any risk of undesirable effects on the environment.



28A) the relationship between benefits and risks:



  An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks described in (i); 28), first indent.



28B) risk management system:



  a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions and activities.



28 c) risk management plan:



  a detailed description of the risk management system.



28d) pharmacovigilance system:



  a system in which the marketing authorisation holder and the Member States to carry out the tasks and responsibilities provided for in Title IX, and the aim of which is to monitor the safety of approved drugs and detect changes in the relationship between benefits and risks.



28E) pharmacovigilance system Master file for:



  a detailed description of the pharmacovigilance system, as the holder of the marketing authorisation in respect of one or more authorised medicinal products.



29) traditional herbal medicinal product:



  Any herbal medicinal product that fulfils the conditions laid down in article 16a, paragraph 1.



30) herbal medicinal product:



  Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or a composition of one or more such herbal substances and one or more such herbal preparations.



31) herbal substances:



  All mainly whole, fragmented or cut plants, plant parts, algae, fungi or mosses, as contained in the untreated, usually dried, but possibly also fresh-form. Certain exudates that have not undergone a special treatment, is also regarded as herbal substances. A precise definition of herbal substances include the plant part used and the botanical name according to the binomial system (genus, species, variety and author).



32) herbal preparations:



  Preparations obtained by treating herbal substances by extraction, distillation, pressing, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, squeezing juices and processed exudates.



33) falsified medicinal product:



  Any medicinal product with an incorrect description of:



– its identity, including its packaging and labelling, its name or its composition, with regard to any of the ingredients, including excipients, and the strength of these constituents



– its origin, including its manufacture, its manufacturing country, its country of origin or the holder of the marketing authorisation therefor, or



– its history, including records and documents related to the channels of distribution used.



This definition does not include unintentional quality defects and shall be without prejudice to infringements of intellectual property rights.

SECTION II

The SCOPE of the

Article 2

1. This Directive shall apply to medicinal products for human use, which is to be marketed in the Member States, and which are either manufactured industrially or by means of an industrial process.

2. In the event of doubt as to whether a product on the basis of an overall assessment of its properties can be included in the definition of medicinal product and the definition of a product falling under other Community legislation, this Directive shall apply.

3. Notwithstanding paragraph 1 of this article and article 3, nr. 4, the provisions of title IV of this Directive shall apply to the manufacture of medicinal products which are solely intended for export, and on intermediate products, active substances and excipients.

4. Paragraph 1 shall not affect article 52b and 85a.

Article 3

This Directive shall not apply to: 1) medicinal products prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula)



2) any medicinal product prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the pharmacy in question (commonly known as the Officinal)



3) medicinal products intended for research and development trials, but without prejudice to the European Parliament and of the Council Directive 2001/20/EC of 4. April 2001 on the approximation of the laws of the Member States ' laws, regulations and administrative provisions relating to the application of good clinical practice in the conduct of clinical trials on medicinal products for human brug22).



4) intermediate products intended for further processing by an authorized manufacturing



5) radionuclides in the form of sealed sources.



6) whole blood, plasma or blood cells of human origin, except for plasma which is produced using an industrial process.



7) advanced therapy medicinal products as defined in Regulation (EC) No 1782/2003. 1394/2007, which are manufactured in non routine basis in accordance with 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 prescription on a tailored drug to a single patient.



  The manufacture of such drugs must be approved by the competent authority of the Member State. Member States shall ensure that any national requirements relating to traceability and pharmacovigilance and the in this issue said specific quality standards are equivalent to those laid down at Community level in respect of advanced therapy medicinal products in respect of which approval is required in accordance with European Parliament and Council Regulation (EC) No 1782/2003. 726/2004 of 31. March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European lægemiddelagentur23).

Article 4

1. This directive does not contain derogations from the Community rules relating to the radiation protection of persons undergoing medical examination or treatment, or from the Community rules relating to the basic standards for the health protection of the general public and workers against the dangers of ionizing radiation.


2. This Directive shall apply without prejudice to Council decision 86/346/EEC of 25. June 1986 accepting on behalf of the community the European Agreement on the exchange of therapeutic substances of human oprindelse24).

3. the provisions of this Directive shall be without prejudice to Member States ' authorities either as regards the setting of prices for 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 not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products as contraceptives or abortifacients. Member States shall communicate to the Commission the provisions of national law in question.

5. This directive and all regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of, or produced from such cells, for reasons which are not listed in the aforementioned Community legislation. Member States shall inform the Commission of the relevant national legislation. The Commission shall make this information publicly available in a directory.

Article 5

1. A Member State may, in accordance with the legislation in force and to fulfil special needs, grant derogations from the provisions of this directive as regards medicinal products which have been delivered in accordance with an order made in good faith and unsolicited, and are manufactured in accordance with instructions from health-care professionals, empowered thereto on their personal and direct responsibility for a particular patient.

2. Member States may temporarily authorise the extradition of a non-approved drug, if the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation, which can cause damage.

3. Without prejudice to the provisions of paragraph 1, Member States may lay down provisions to ensure that marketing authorisation holders, manufacturers and health professionals are not subject to civil or administrative liability with regard to any consequences that may result from the use of a drug outside the authorised indications or from the use of an unauthorised medicinal product, when such use is recommended or required by a competent authority in the case every suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation, which can cause damage. These provisions shall apply, irrespective of whether or not national or Community authorisation.

4. Product liability pursuant to in Council Directive 85/374/EEC of 25. July 1985 on the approximation of the laws of the Member States by law, regulation or administrative provisions laid down on the produktansvar25) are not covered by paragraph 3.

TITLE III

MARKETING

CHAPTER 1

Marketing authorisation

Article 6

1. No medicinal product may be placed on the market in a Member State, without prejudice to the competent authority of the Member State has granted a marketing authorisation in accordance with this directive, or have been issued permits in accordance with Regulation (EC) No 1782/2003. 726/2004, read in conjunction with Regulation (EC) No 1782/2003. 1394/2007.

When a medicinal product has been given an initial marketing authorisation in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes and pack sizes as well as all changes and extensions also have a permit in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered to come under the same overall marketing authorisation, in particular for the purposes of article 10, paragraph 1.

1. the marketing authorisation holder is responsible for the placing on the market of the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility.

2. The authorisation referred to in paragraph 1 shall also be required for radionuclide generators, kits and radionuclide precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals.

Article 7

A marketing authorization shall not be required for radiopharmaceuticals prepared at the time of use by a person or an institution which, in accordance with national law, is authorized to use such medicinal products in an approved hospital or similar. and as the exclusive use of authorized radionuclide generators, kits, or radionukleidpræcursorer in accordance with the manufacturer's instructions.

Article 8

1. in order to obtain a marketing authorisation, which are not covered by a procedure established by Regulation (EEC) No 2377/90. 2309/93, an application shall be submitted to the competent authority of the Member State concerned.

2. A marketing authorization may only be granted to an applicant established in the community.

3. the application shall be accompanied by the following particulars and documents submitted in accordance with Annex i: (a)) name or business name and permanent address or seat of the applicant and, where appropriate, of the manufacturer



(b)) name of the medicinal product.



c) qualitative and quantitative particulars of all the constituents of the medicinal product, including international non-proprietary name (INN) recommended by the World Health Organization, where such a single name for the medicinal product exists, or a reference to the chemical name (title).



CA) Assessment of the risks posed by the medicinal product might pose to the environment. The impact must be assessed, and in particular cases introduced specific provisions in order to limit it.



d) description of manufacturing method



e) therapeutic indications, contra-indications and side-effects



f) posology, pharmaceutical form, method and route of expected shelf life.



g) reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, when given to patients and for the disposal of waste products, together with an indication of potential risks presented by the medicinal product for the environment.



h) description of the control methods employed by the manufacturer.



HA) a written confirmation that the manufacturer of the medicinal product by conducting audits, see. Article 46,



  (f)), has verified that the manufacturer of the active substance has complied with the principles and guidelines of good manufacturing practice. The written confirmation must contain a reference to the date of the audit, and a statement that the outcome of the audit confirms that the manufacturing process complies with the principles and guidelines of good manufacturing practice.



I) Results of:



-pharmaceutical (physico-chemical, biological or microbiological) tests



-pre-clinical (toxicological and pharmacological) tests



– clinical trials.



IA) a summary of the applicant's pharmacovigilance system which includes the following elements:



-proof that the applicant is in possession of a qualified person responsible for pharmacovigilance



– the name of the Member States in which the qualified person resides and carries out its work



– the expert's contact information



– a statement signed by the applicant that he or she has the necessary means to carry out the tasks and responsibilities provided for in Title IX



– a reference to the place where the master file for the pharmacovigilance system must be kept



IAA) the flood risk management plan that describes the risk-management system which the applicant will introduce for the medicinal product in question, as well as a summary thereof,



IB) A declaration to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC.



j) A summary of product characteristics in accordance with article 11, as well as a model of the outer packaging with the information referred to in article 54, and of the immediate packaging with the information referred to in article 55, together with a package leaflet in accordance with article 59.



k) a document showing that the manufacturer is authorised to manufacture medicinal products in its home country



l) copies of the following:



– authorisation for placing on the market of the medicinal product in another Member State or in a third country, a summary of safety data, including the information contained in the periodic safety update reports, where available, such alerts and reports of suspected adverse reactions, together with a list of those Member States in which an application for a marketing authorisation submitted in accordance with this directive is under examination



– product characteristics 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 proposed in accordance with article 59 or approved by the competent authority of the Member State in accordance with article 61



– details of any decisions on refusal of the marketing authorisation, be it in the European Union or in a third country and the reasons for these.



m) a copy of any designation of the medicinal product as a drug for a rare disease in accordance with European Parliament and Council Regulation (EC) No 1782/2003. 141/2000 of 16. December 1999 on orphan medicinal products sygdomme26), accompanied by a copy of the Agency's opinion on the matter.



n) (discontinued).




  Documentation and information about results for in the first subparagraph, point (i)), provided for pharmaceutical, pre-clinical and clinical trials must be accompanied by detailed summaries in accordance with article 12.

The risk management system referred to in the first subparagraph) (iaa), must be proportionate to the identified risks and the potential risks of the medicinal product and the need for safety data, after that has been authorized 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, paragraph 1, shall submit an application for authorisation to market a radionuclide generator also contain the following information: – a general description of the system as well as a detailed description of the components of the system which may affect the composition or quality of the daughter nucleid preparation



– qualitative and quantitative description of the eluate or the sublimate.

Article 10

1. Notwithstanding the provisions of article 8, paragraph 3, point (i)), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant is not required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised in accordance with article 6 in at least eight years in a Member State or in the community.

A generic drug, which has received approval pursuant to this provision shall not be placed on the market before the ten-year period after the initial marketing authorisation of the reference medicinal product has expired.

Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the application for the generic medicinal product is lodged. In this case, the applicant must specify in the application form the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is lodged, the competent authority of the other Member State within one month to forward a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation.

The period laid down in the second subparagraph shall be extended to a maximum of 10 years 11 years if the holder of the marketing authorisation in the course of the first eight years of this ten-year period achieves an authorisation for one or more new therapeutic indications, as by the scientific assessment carried out with a view to approving them, are deemed to constitute a significant clinical benefit in comparison with existing therapies.

2. for the purposes of this article: (a) ' reference medicinal product ' shall mean) a medicinal product authorised under article 6 and in accordance with article 8



(b)) ' generic medicinal product ' shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. Is this the case, applicants shall supply any further information showing that the different salts, esters or derivatives of an authorised active substance is safe and/or effective. Various oral dosage forms with immediate release is considered one and the same pharmaceutical form. The applicant can be exempted from conducting bioavailability studies, if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.

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

4. where a biological medicinal product which is similar to a reference biological product does not meet the conditions set out in the definition of generic medicinal products, in particular due to differences as raw materials or because the manufacturing processes of the biological medicinal product and the reference product are different, the results of appropriate pre-clinical tests or submission of clinical trials relating to these conditions. The additional data to be submitted, shall, with respect to the nature and quantity of the satisfy the relevant criteria in Annex i and the related detailed guidelines. The results of other tests and trials from the reference medicinal product's dossier shall not be provided.

5. In addition to the provisions of paragraph 1 shall be granted in cases where the application concerns a new indication for a well-known drug, data protection in a non-cumulative period of one year, provided that there has been significant pre-clinical tests or clinical trials relating to the new indication.

6. The implementation of the necessary studies and trials with a view to the application of paragraphs 1 to 4 and the consequential practical requirements shall not be considered to be contrary to patent rights or to supplementary protection certificates for medicinal products.

Article 10a

Notwithstanding article 8, paragraph 3, point (i)), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant is not required to provide the results of pre-clinical tests or clinical trials if he can demonstrate that the active substances contained in the medicinal product have found well-established medicinal use in the medical field for at least ten years within the community, and that they are effective and sufficiently secure in relation to the conditions laid down in Annex i. In such a case be presented instead of test results a relevant bibliographic scientific evidence.

Article 10b

For medicinal products containing active substances used in medicinal products approved composition, which, however, has not been used in combination for therapeutic purposes, in accordance with article 8, paragraph 3, point (i)), presented results of new pre-clinical tests or new clinical trials relating to the new combination, but it shall not be necessary to provide documentation relating to each individual active substance.

Article 10 c

After the granting of the marketing authorisation holder may give his consent to the reference to the pharmaceutical, pre-clinical and clinical documentation contained in the file of the medicinal product, for the purpose of processing of a later application for a medicinal product which has the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.

Article 11

The summary of product characteristics shall contain the following information in this order: 1) name of the medicinal product followed by its strength and pharmaceutical form



2) The qualitative and quantitative composition in terms of the active substances and excipients must be familiar with a view on the proper use of the drug, since the general common name or chemical description shall apply



3) pharmaceutical form



4) Clinical information:



4.1. therapeutic indications



4.2. Posology and method of Administration for adults and, where necessary, for children



4.3. contraindications



4.4. Special warnings and special precautions for use and, in the case of immunological medicinal products, any special precautions to be taken by persons handling such drug and the persons administering them to patients, together with any precautions to be taken by the patient,



4.5. interaction with other medicinal products or other interactions



4.6. use during pregnancy and breastfeeding



4.7. effects on ability to drive vehicles and operate machinery



4.8. adverse reactions



4.9. overdose (symptoms, emergency procedures, antidotes)



5 pharmacological properties):



5.1. pharmacodynamic properties



5.2. pharmacokinetic properties



5.3. preclinical safety data



6) Pharmaceutical information:



6.1. list of excipients



6.2. incompatibilities



6.3. shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time



6.4. Special precautions for storage,



6.5. nature and contents



6.6. any special precautions for disposal of a used medicinal product or waste resulting from this drug



7) the holder of the marketing authorisation



8) marketing authorisation number/numbers



9) date of first authorisation/renewal of the authorisation



10) date of text change



11) in the case of radiopharmaceuticals, full details of internal radiation dosimetry.



12) in the case of radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of finished product and, where appropriate, maximum storage time during which any intermediate, as URf.eks. an eluate or the ready radiopharmaceutical meets its specifications.


With regard to authorisations in accordance with article 10, it is not necessary to include those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which teurapeutiske were still covered by patent law at the time when the generic medicine was marketed.

For the medicinal products listed in the list referred to in article 23 of Regulation (EC) No 1782/2003. 726/2004, the summary of product characteristics contain the following entry: ' this drug is subject to supplementary supervision '. This information should follow it in article 23 of Regulation (EC) No 1782/2003. 726/2004 referred to black symbol and followed by an appropriate default explanation.

For all medicinal products, the summary of product characteristics shall also contain a standard formulation with which health-care professionals expressly asked to report any suspected adverse reactions in accordance with the national system for spontaneous reporting as referred to in article 107a, paragraph 1. It must be possible to make reports in a variety of ways, including electronic transmission, in accordance with article 107a, paragraph 1, second subparagraph.

Article 12

1. the applicant shall ensure that, in article 8, paragraph 3, last paragraph, referred to the detailed summaries shall be prepared and signed by the persons who have the necessary technical or professional qualifications, which must be set out in a brief curriculum vitae, before the material, shall be submitted to the competent authorities.

2. The persons who are in possession referred to in paragraph 1, the technical or professional qualifications, to justify a possible application of Article 10a, referred to scientific bibliographical documentation on the conditions laid down in Annex i.

3. The detailed summaries shall form part of the documentation, the applicant shall submit to the competent authorities.

CHAPTER 2

Particular requirements for homeopathic medicines

Article 13

1. Member States shall ensure that homeopathic medicinal products manufactured and marketed within the community, shall be approved or registered in accordance with articles 14, 15 and 16, except medicinal products which have been registered or approved in accordance with the national legislation up to and including the 31. December 1993. In case of registrations, article 28 and article 29, paragraphs 1 to 3 shall apply.

2. Member States shall establish 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 subject to a special, simplified registration procedure: – orally or external use



– There are no specific therapeutic indications on the label or in the information about the medicinal product



– a sufficient degree of dilution to guarantee that the medicinal product is harmless; in particular it must not contain either more than one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with traditional medicine for active substances whose presence in an allopathic medicinal product results in prescription.

During registration, Member States shall draw up a classification for the dispensing of the medicinal product.

The Commission may, with regard to the new scientific knowledge to adapt the provisions of the first subparagraph, the third indent. This measure, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 121, paragraph 2a.

2. The criteria and rules of procedure referred to in article 4, paragraph 4, article 17, paragraph 1, and articles 22 to 26, 112, 116 and 125 shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic effect.

Article 15

Application for special, simplified registration may cover a series of medicinal products derived from the same homeopathic stock (s). The application be accompanied by the following documents in order in particular to demonstrate these medicines pharmaceutical quality and the manufactured batch homogeneity: – the (n) homeopathic (s) scientific name or another name of a pharmacopoeia with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered,



— documentation with description of the manufacture and control of the tribe, and justifying its/their homeopathic use, by means of an adequate bibliography



-manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentization,



– the authorization to manufacture the relevant medicinal products



– copy of any registrations or approvals for the same drugs in other Member States



-one or more mock-ups of the outer packaging and the immediate packaging of the medicinal products to be registered.



– information relating to the medicinal product durability.

Article 16

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

2. A Member State may introduce or retain in its territory specific rules for the pre-clinical and clinical trials of homeopathic medicinal products which are not covered by article 14, paragraph 1, in accordance with the principles and the specific practices that applies to homeopathy in this Member State.

In that case, the Member State concerned shall notify the Commission of the specific rules in force.

3. the provisions of title IX shall apply to homeopathic medicinal products, with the exception of those referred to in article 14, paragraph 1.

CHAPTER 2a

Specific provisions applicable to traditional herbal medicinal products

Article 16a

1. A simplified registration procedure (hereinafter ' traditional-use registration medicinal product ') is hereby established for herbal medicinal products which fulfil all the following criteria: (a)) they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for and designed for use without medical supervision for diagnosis, prescription or monitoring of treatment



(b)) they are exclusively for processing in accordance with a specified strength and Posology



(c)) the oral is for external use and/or for inhalation



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



e) data on the drug's traditional use is adequate, in particular, it is proven that the product is not harmful under normal conditions of use, and it may, on the basis of long term use and experience can be assumed to have pharmacological effects or efficacy of the medicinal product.

2. Byway of derogation from article 1, no. 30, is the presence in the herbal medicinal product of vitamins or minerals, if safety is well documented, does not preclude that the medicinal product is eligible for registration in accordance with paragraph 1, provided that the vitamins or minerals is effect supports the active plant ingredients effect with regard to the specified indications.

3. The provisions of this chapter shall not apply in cases where the competent authorities deem that a traditional herbal medicinal product fulfils the criteria for authorisation of the placing on the market in accordance with article 6 or 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 that a medicinal product may be registered as traditionally applied herbal medicinal product, the applicant shall submit an application to the competent authorities of the Member State.

Article 16 c

1. the application shall be accompanied by: a) the information and documents:



i. listed in article 8, paragraph 3, subparagraph (a))-h)) (j) and (k))



II. the results of the pharmaceutical tests referred to in article 8, paragraph 3, point (i)), second indent



III. Summary of product characteristics, without the data specified in article 11, paragraph 4



IV. in the case of formations referred to in article 1, no. 30, or article 16a, paragraph 2, the information referred to in article 16a, paragraph 1, point (e)), relating to the composition as such; If the individual active ingredients are not sufficiently known, information must also relate to the individual active ingredients



(b)) a marketing authorisation or registration of the medicinal product, which the applicant has obtained in another Member State or in a third country for the purpose of direct marketing, as well as details of any decision to deny such permission or registration, both within the community and a third country, and the reasons therefor



c) bibliographical or expert opinions, which proves that the medicinal product in question or a similar means has found medical use for at least 30 years prior to the date of the application, including at least 15 years within the community. Committee for herbal medicinal products shall draw up, at the request of the Member State where the application for traditional-use registration has been submitted, a medicinal product opinion on whether there is enough evidence that the drug or the corresponding remedy has been used over long periods of time. The Member State shall submit relevant documentation in support of the referral;



d) a bibliographic review of safety data together with an expert report and, if so required by the competent authority after a further request, the data necessary for the evaluation of medicinal product safety.

Annex I shall apply mutatis mutandis to the particulars and documents listed in (a)).


2. A corresponding product, as referred to in paragraph 1, point (c)), is characterised by having the same active ingredients, excipients used, without regard to the same or similar purpose, equivalent strength and Posology and the same or similar route of administration as the medicinal product, the application is made.

3. The requirement to document the medicinal use throughout this period of 30 years, as stated in paragraph 1 (c)), have been met, although the product's marketing has not been based on a separate permission. The requirement is also met if the number or quantity of the constituents of the medicinal product has been reduced during this period.

4. When the product has been used in the community for less than 15 years, but meets the conditions for a simplified registration, submit to the Member State where the application for traditional-use registration has been submitted, the medicinal product herbal medicinal product on behalf of the Committee for herbal medicinal products. The Member State shall submit relevant documentation in support of the submission.

The Committee shall consider whether the other criteria for a simplified registration, see. Article 16a, are fully met. If the Committee considers it possible, it shall draw up a community herbal monograph as referred. Article 16 h, paragraph 3, the Member State must take into account when making its final decision.

Article 16 d

1. Without prejudice to article 16 h, paragraph 1, the provisions of Chapter 4 of title III, mutatis mutandis, to registrations issued in accordance with article 16a, provided that: (a)) that there is prepared a community herbal monograph in accordance with article 16 h, paragraph 3, or



(b) to plant medicinal product consists of herbal substances), preparations or combinations thereof contained in the list referred to in article 16f.

2. In the case of other herbal medicines, see. Article 16a, each Member State takes when evaluating an application for traditional-use registration, take due account of registrations, herbal medicinal product issued in another Member State in accordance with this chapter.

Article 16e

1. Traditional-use registration shall be refused if the application does not herbal medicinal product is in accordance with articles 16a, 16b or 16 c or if it turns out that at least one of the following conditions are met: (a)) the qualitative and/or quantitative composition is not as declared



(b)) the indications do not comply with the requirements laid down in article 16a



c) product may be harmful under normal conditions of use



d) data on traditional use are not adequate, especially if it is not on the basis of long term use and experience it can be assumed that the product has a pharmacological effect or effect



(e)) the pharmaceutical quality is not sufficiently documented.

2. the competent authorities of the Member States shall inform the applicant, the Commission and any competent authority that requests it, about the decisions they make about the refusal of traditional-use registration and the reasons for such a drug.

Article 16f

1. Draw up a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products in accordance with the procedure referred to in article 121, paragraph 2. This list includes, with respect to each herbal substance, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional herbal medicinal product.

2. If an application for traditional-use registration, a herbal drug preparation or a combination thereof relates to a plant herbal, covered by the list referred to in paragraph 1, it is not necessary to submit the data specified in article 16 c, paragraph 1 (b)), (c)) and (d)). Article 16e (1) (c)) and (d)), shall not apply.

3. If a herbal substance, preparation or a combination thereof ceases to be included on the list referred to in paragraph 1, revoked the registrations issued pursuant to paragraph 2, relating to herbal medicinal products containing this substance, unless the particulars and documents referred to in article 16 c, paragraph 1, shall be presented within three months.

Article 16 g

1. Article 3, paragraphs 1 and 2, article 4, paragraph 4, article 6, paragraph 1, article 12, article 17, paragraph 1, article 19, 20, 23, 24, 25, 40 to 52, 70 to 85, 101 to 108b, article 111, paragraphs 1 and 3, article 112, 116, 117, 118, 122, 123, 125, article 126, paragraph 2, and article 127 of this directive as well as Commission Directive 2003/94/EC of 8. October 2003 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and investigational medicinal products for human brug27) shall apply mutatis mutandis to traditional-use registration drug pursuant to this chapter.

2. In addition to the requirements contained in articles 54 to 65, any labelling and package leaflet shall contain a statement of: (a)) that the product is a traditional herbal medicinal product for use with a particular (s) indication (s) exclusively based on use over long periods of time, and



(b)) to the user should consult a doctor if the symptoms despite use of drug, continues, or if there turns out side effects that are not mentioned in the package leaflet.

A Member State may require that the labelling and package leaflet must also contain information about that tradition.

3. In addition to the requirements laid down by article 86 to 99, any advertising of a medicinal product registered under this chapter shall contain the following statement: ' traditional herbal medicinal product for use in specified (ke) indication (s) exclusively based on the use of a long time '.

Article 16 h

1. Is hereby established a Committee for herbal medicinal products. Committee under the purview of the Agency and shall have the following powers: (a) in the case of simplified registration):



– to carry out the tasks arising from article 16C(1) and (4)



– to carry out the tasks arising from article 16 d



– to draw up a draft list of herbal substances, preparations and combinations thereof, as referred to. Article 16f, paragraph 1, and



– to establish community monographs for traditional herbal medicinal products, see. paragraph 3 of this article.



(b)) as regards marketing authorisations for medicinal herbs to establish community herbal monographs for herbal medicinal products, see. (3).



(c)) as regards referrals to the Agency under Chapter 4 of title III relating to herbal medicinal products as referred to in. Article 16a, to perform the tasks laid down in article 32.



d) where other medicinal products containing herbal substances, shall be submitted to the Agency under Chapter 4 of title III of this regulation, where appropriate, to express an opinion on the herbal substance.

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

In accordance with article 57, paragraph 2, of Regulation (EEC) No 2377/90. 2309/93 establishes the Executive Director a procedure that ensures the appropriate coordination with the Committee for medicinal products for Human use.

2. Each Member State shall appoint for a term of three years which may be renewed, one Member and one alternate to the Committee for herbal medicinal products.

The alternates shall represent and vote on behalf of absent members. Members and alternates shall be selected on the basis of their role and experience in the evaluation of herbal medicinal products and shall represent the competent national authorities.

The said Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years which may be renewed, and they have no alternates.

Such members shall be appointed by co-opting, establishes the relevant Committee (s) additional member (s)-specific complementary scientific expertise. Members, who are elected by co-opting, selected from among the experts nominated by Member States or the Agency.

The members of the said Committee may be accompanied by experts in specific scientific or technical fields.

3. the Committee for herbal medicinal products shall establish community herbal monographs for herbal medicinal products, taking into account the provisions of article 10, paragraph 1, point (a)), nr. (ii)), as well as for traditional herbal medicinal products. The said Committee shall carry out the tasks that it will be further imposed pursuant to the provisions of this chapter and other Community legislation.

When community herbal monographs have been prepared as provided in this paragraph, Member States shall take them into account in the examination of an application. If there have not yet been drawn up such a community herbal monographs, can be referred to other appropriate monographs, publications or data.

When new community herbal monographs are established, the holder of the registration takes a position on whether it is necessary to change the registration accordingly. The holder of the registration shall notify such changes to the competent authority of the Member State concerned.

Herbal monographs are published.

4. The General provisions of Regulation (EEC) No 2377/90. 2309/93 relating to the Committee for medicinal products shall apply by analogy to the Committee for herbal medicinal products.

Article 16i

No later than 30 June. April 2007, the Commission shall submit a report to the European Parliament and the Council on the implementation of the provisions of this chapter.

The report shall include an assessment on the possible extension of traditional-use registration drug to other categories of medicinal products.

CHAPTER 3

Proceedings concerning the granting of a marketing authorisation

Article 17


1. Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation are not longer than a maximum of 210 days from the submission of a valid application.

If there be issued a marketing authorisation for a medicinal product in more than one Member State submitted applications in accordance with articles 28 to 39.

2. If a Member State notes that an application for marketing authorization for the same medicinal product already under treatment in another Member State, it shall reject the application and inform the applicant of treating that article 28-39 shall apply.

Article 18

If a Member State in accordance with article 8, paragraph 3, point (l)), is informed that another Member State has authorised a medicinal product which is the subject of an application for marketing authorisation in the Member State concerned, it shall reject the application if it is not submitted in accordance with articles 28 to 39.

Article 19

When treating a in accordance with article 8, 10, 10a, 10b and 10 c application submitted to the competent authority of the Member State: 1) check the submitted material consistent with article 8 and article 10, 10a, 10b and 10 c, and examine whether the conditions for the granting of a marketing authorisation have been fulfilled



2) have the option of letting the medicinal product, its starting materials and, if appropriate, its intermediate products or other substances control by an official medicines control laboratory or a laboratory that a Member State has designated for that purpose, and to ensure that the conditions set by the manufacturer and used in the written materials described control methods, see. Article 8, paragraph 3, point (h)), is satisfactory



3), where appropriate, be able to require the applicant to supplement the material with additional information about those in article 8, paragraph 3, and article 10, 10a, 10b and 10 c, points mentioned. Where the competent authority makes use of this option, the time-limits referred to in article 17 shall be suspended until the requisite additional information has been given. These time limits shall be suspended also in that time, which in this case is given by the applicant to submit oral or written explanation.

Article 20

Member States shall take all the measures necessary in order that: (a)) the competent authorities verify that manufacturers and importers of medicinal products coming from third countries are able to carry out manufacture in compliance with the article 8, paragraph 3, subparagraph (d)), contained entries and/or to carry out controls according to the methods described in the literature, see. Article 8, paragraph 3, point (h))



(b)), the competent authorities in justified cases can provide manufacturers and importers of medicinal products coming from third countries, permission to let certain parts of the manufacture and/or of the checks provided for in point (a)) carried out by third parties; in such cases, the competent authorities shall be carried out also in the designated establishment.

Article 21

1. When the marketing authorization is issued, the competent authority of the Member State concerned shall send the holder the summary of the product characteristics as approved by that authority.

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

3. The national competent authority makes publicly available without delay the marketing authorisation together with the summary of product characteristics and package leaflet, all the conditions laid down in accordance with articles 21a, 22 and 22a, together with deadlines for the fulfilment of the conditions of each of the drugs it has approved.

4. The national competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the pharmaceutical, pre-clinical and clinical trials, the risk management system and the pharmacovigilance system relating to the medicinal product concerned. The assessment report shall be updated whenever there is new information relevant to the evaluation of the quality, safety or efficacy of the medicinal product.

The national competent authority shall without delay make the evaluation report as well as the reasons for its comments available to the public after deletion of commercially confidential nature of the information. The explanatory statement is specified separately for each indication applied for.

The public assessment report must contain a summary drafted in plain intelligible language. The summary shall contain in particular a section on the conditions for the use of the medicinal product.

Article 21a

In addition to the provisions of article 19, a marketing authorisation of a medicinal product is made conditional on the fulfilment of one or more of the following conditions: (a)) to be taken certain measures to ensure the safe use of the medicinal product, which is included in the risk management system



(b)) to be carried out in accordance with the marketing authorisation safety studies



(c) obligations for recording or reporting of) all suspected adverse reactions which are more stringent than the obligations laid down in Title IX, to be met



d) other conditions or restrictions with a view to the safe and effective use of the medicinal product must be respected



(e)) the presence of an adequate pharmacovigilance system



f) efficiency studies to be carried out after authorisation for placing on the market, if it is found that there are still concerns about certain aspects of efficacy, which can only be remedied after the medicinal product is marketed. The obligation to carry out such investigations must be based on the delegated acts adopted pursuant to Article 22b, taking into account the scientific guidelines referred to in Article 108a.

Of the marketing authorisation shall be fixed, if necessary, the deadlines for the fulfilment of these conditions.

Article 22

In exceptional circumstances and following consultation with the applicant, the marketing authorisation may be made subject to certain conditions, in particular as regards the safety of the medicinal product, the orientation of the national competent authorities of any incident relating to the application and on measures to be taken.

The marketing authorisation may be granted only for objective and verifiable reasons, if the applicant can show that he is unable to provide comprehensive information about the efficacy and safety under normal conditions of use, and shall be based on one of the grounds listed in Annex i.

The maintenance of the marketing authorisation depends on an annual reassessment of these conditions.

Article 22a

1. Following the granting of a marketing authorisation, the competent national authority may impose the holder of a marketing authorisation, the obligation to: (a)) implement a safety investigation, after that has been authorized for placing on the market, if there are concerns about the risks of an authorised medicinal product. If there are concerns with regard to the risks presented by more than one drug, encourages the national competent authority, after consultation of the Committee for risk assessment in the field of pharmacovigilance, the marketing authorisation holders concerned to conduct a post-authorisation safety study for joint marketing



b) carry out an impact study in accordance with the marketing authorisation, if the understanding of the disease or the clinical methodology shows that the previous impact assessments may need to be changed significantly. The obligation to carry out impact studies for marketing authorisation must be based on the delegated acts adopted pursuant to Article 22b, taking into account the scientific guidelines referred to in Article 108a.

The imposition of such an obligation to be duly justified, shall be notified in writing and include the purpose and the time frame for the submission and implementation of the survey.

2. The competent national authority shall provide the marketing authorisation holder to submit written observations in response to the imposition of the obligation, within a time limit which it shall fix, if the marketing authorisation holder so requests within 30 days of receipt of the written notice of the obligation.

3. On the basis of the written submissions, that the marketing authorisation holder has delivered, pulling the national competent authority the obligation back or confirms it. Where the national competent authority confirms the obligation, be amended marketing authorisation, so that the obligation will be included as a condition of the marketing authorisation, and the risk management system shall be updated accordingly.

Article 22b

1. With a view to defining the situations where the efficacy studies after marketing authorisation may be required for the purposes of this directive, articles 21a and 22a, the Commission may, by means of delegated acts in accordance with article 121a and without prejudice to the conditions laid down in article 121b and 121 c adopt measures, which complement the provisions of article 21a and 22a.

2. When adopting such delegated acts, the Commission, acting in accordance with the provisions of this directive.

Article 22 c

1. the marketing authorisation holder shall incorporate all the conditions provided for in articles 21a, 22 or 22a, in its risk management system.

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


Article 23

1. The marketing authorisation holder shall be in accordance with the marketing authorization is issued, in respect of article 8, paragraph 3, subparagraph (d)) and (h)), referred to the manufacturing and control methods, take account of scientific and technical development and introduce the changes that are necessary in order that the medicinal product is manufactured and checked in accordance with the generally accepted scientific methods.

These changes must be approved by the competent authority of the Member State concerned.

2. the consent holder shall submit without delay new information for the national competent authority, if they may involve changes to the information or documents referred to in article 8, paragraph 3, or article 10, 10a, 10b and 11, or article 32, paragraph 5, or Annex I.

The holder of the marketing authorisation is in particular obliged to immediately inform the national competent authority of any prohibition or restriction imposed by the competent authorities of the countries where the medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product concerned. The information should include both positive and negative results of clinical trials or other studies in all indications and populations, regardless of whether or not they are included in the marketing authorisation or not, as well as data on the use of the medicinal product, if such use has taken place outside the terms of the marketing authorisation.

3. the marketing authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge, including the conclusions of the assessments and recommendations published on the European medicines Web-portal established in accordance with article 26 of Regulation (EC) No 1782/2003. 726/2004.

4. For ongoing to assess the relationship between benefits and risks, the national competent authority may at any time ask the holder of the marketing authorisation to forward data demonstrating that the risk-benefit ratio remains favourable. The holder of the marketing authorisation corresponds adequate and promptly on any such request.

The national competent authority may at any time ask the marketing authorisation holder to submit a copy of the master file for the pharmacovigilance system. The marketing authorization holder shall submit the copy no later than seven days after receipt of the request.

Article 23a

After a marketing authorisation has been granted, the marketing authorisation holder shall inform the competent authority of the Member State which has granted the authorization, whether, when placing on the market of the medicinal product for human actually commences in that Member State, taking into account the various presentations authorised.

In addition, the competent authority shall inform the holder, if the medicinal product is temporarily or permanently no longer marketed in the Member State. Such notification shall, unless there are exceptional circumstances, be made at least two months before the termination of the placing on the market.

At the request of the competent authority, in particular in the context of pharmacovigilance, the marketing authorisation holder shall submit to the competent authority all information on the volume of sales of the medicinal product, and any information which he is in possession of a prescribed amount.

Article 23b

1. the Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this directive.

2. The Commission shall adopt the arrangements referred to in paragraph 1 by an implementing regulation. This measure, designed to amend non-essential elements of this directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 121, paragraph 2a.

3. At the time of the adoption of the arrangements referred to in paragraph 1, the Commission shall endeavour to make it possible to submit a single application for one or more identical changes to the terms of several marketing authorisations.

4. A Member State may continue to apply national provisions on variations applicable at the time of the entry into force of the implementing regulation on marketing authorisations, as before 1 January 2002. January 1998 was issued for drugs that only authorised in the Member State concerned. Shall be issued to a medicinal product which is the subject of a national provision in accordance with this article, after following a marketing authorisation in another Member State, the implementing regulation apply in respect of that medicinal product from that time.

5. a Member State Decides to continue to apply national provisions as referred to in paragraph 4, it shall notify the Commission thereof. There is no notification, at the latest on 20. January 2011, see the implementing regulation shall apply.

Article 24

1. The marketing authorisation shall be valid for five years, without prejudice to article. However, paragraphs 4 and 5.

2. The marketing authorisation may be renewed after five years on the basis of a re-evaluation of the relationship between benefits and risks, carried out by the competent authority of the Member State which issued the authorization.

To this end, the marketing authorisation holder shall submit to the national competent authority consolidated documentation with respect to the quality, safety and efficacy, including the evaluation of the data in the reports of suspected adverse reactions and the periodic safety update reports shall be submitted in accordance with section IX, and all variations introduced since the marketing authorization is issued, at least nine months before the validity of this expires in accordance with paragraph 1.

3. A marketing authorization, there is renewed, for an unlimited period, unless the competent national authority, on justified grounds relating to pharmacovigilance, including exposure of an insufficient number of patients for the drug, decides to proceed with one additional five-year period in accordance with paragraph 2.

4. If an authorisation does not lead to actual placing on the market of the authorised product in the issuing Member State, the authorisation will lapse within three years after its date of issue.

5. when an authorised medicinal product, having been marketed in the Member State which issued the permit, no longer be placed on the market in that Member State for three consecutive years, the authorisation for the medicinal product concerned.

6. In exceptional circumstances and in the interests of public health, the competent authority may derogate from paragraphs 4 and 5. Such derogations shall be duly substantiated.

Article 25

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

Article 26

1. The marketing authorisation shall be refused if, after verification of the scope of article 8 and article 10, 10a, 10b and 10 c particulars and documents referred to prove, either: (a)) that the relationship between benefits and risks cannot be considered as favourable, or



(b)) to the therapeutic efficacy is lacking or is insufficiently substantiated by the applicant, or



(c)) that the medicinal product does not have the specified qualitative and quantitative composition.

2. authorization shall also be refused if the documents produced in support of the application or the information does not comply with the requirements of articles 8, 10, 10a, 10b and 10 c.

3. The applicant for or holder of a marketing authorisation shall be responsible for the submitted documents and data are correct.

Article 27

1. a coordination group shall be for the purposes of the following: (a)) study of all matters related to a marketing authorisation for a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4



b) examination of issues relating to the supervision of medicinal products authorised by the Member States in accordance with articles 107 c, 107 g, 107 k, Member and 107q



c) examination of issues relating to changes to marketing authorisations granted by Member States in accordance with article 35, paragraph 1.

The Agency shall provide the Secretariat of the coordination group.

The coordination group is based in discharging of its pharmacovigilance tasks, including approval of risk management systems and monitoring of their effectiveness, for the scientific evaluation and the recommendations of the Committee for risk assessment in the field of pharmacovigilance regulation. Article 56, paragraph 1, point (aa)) of Regulation (EC) No 1782/2003. 726/2004.

2. the coordination group shall be composed of one representative of each Member State, who are appointed for a period of three years, renewable. Member States may appoint an alternate member for a period of three years, renewable. Members may, if they so wish, be accompanied by the expert.

Members of the coordination group and the expert must, when exercising their functions, apply the scientific and regulatory resources, for which the national competent authorities have at their disposal. Each national competent authority supervises the conducted studies academic level and facilitates the designated Committee members and experts ' activities.

Article 63 of Regulation (EC) No 1782/2003. 726/2004 shall apply to the coordination group as regards transparency and the independence of its members.

3. the coordination group shall adopt its rules of procedure, which shall enter into force after the Commission has acceded to it. The rules of procedure shall be made public.

4. The Executive Director of the agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the coordination group.


5. Coordination Group members shall ensure that there is appropriate coordination between the tasks of the Group and the work carried out by the competent national authorities, including the consultative bodies concerned with the marketing authorisation.

6. Except as otherwise provided in this directive, the Member States, which are represented in the coordination group, to do their utmost to reach an agreement on the measures to be taken. If no agreement can be reached, the position taken by the majority of the Member States, which are represented in the coordination group has.

7. Coordination Group members have even after completing their duties under an obligation not to disclose information of the kind covered by the obligation of professional secrecy.

CHAPTER 4

Mutual recognition procedure and decentralised authentication

Article 28

1. If desirable issued a marketing authorisation of a medicinal product in two or more Member States, the subject of an application, based on identical documents in the Member States concerned. The file must include the documentation and the information referred to in articles 8, 10, 10a, 10b, 10 c and 11. The enclosed material must contain a list of the Member States affected by the application.

The applicant shall request one Member State to act as "reference Member State" and to prepare an assessment report on the medicinal product in accordance with paragraphs 2 and 3.

2. If at the time the application is submitted, have already been granted a marketing authorisation 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 authorization shall request the reference Member State to prepare an assessment report on the medicinal product or, where appropriate, to update any existing assessment report. The reference Member State shall prepare or update the assessment report within 90 days of receipt of the valid application. The approved assessment report, the approved summary of product characteristics, the approved labelling and package leaflet shall be forwarded to the Member States concerned and to the applicant.

3. If at the time the application is submitted, the absence of a marketing authorisation for the medicinal product, the applicant shall request the reference Member State to prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet. The reference Member State shall prepare these drafts within 120 days after receipt of a valid application and shall send them to the concerned Member States and to the applicant.

4. Within 90 days after receipt of the documents referred to in paragraphs 2 and 3, the Member States concerned shall approve the assessment report, summary of product characteristics and the labelling and package leaflet and shall inform the reference Member State to this effect. The latter determines that there is a consensus, terminating 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, shall adopt, not later than 30 days after that there is established consensus a decision consistent with the approved assessment report, summary of product characteristics, labelling and package leaflet.

Article 29

1. If a Member State on grounds of a potential serious risk to public health cannot approve the assessment report, summary of product characteristics and the labelling and package leaflet within the time limit laid down in article 28, paragraph 4, it shall send a detailed statement of the reasons therefor to the reference Member State, the other Member States concerned and the applicant. The disputed points shall be submitted immediately to the coordination group.

2. the Commission shall adopt guidelines to define what is meant by a potential serious risk to public health.

3. Within the coordination group does all the Member States referred to in paragraph 1, their utmost to reach an agreement on the measures to be taken. They give the applicant the opportunity to submit its views orally or in writing. If the Member States reach an agreement within a period of 60 days from the date of notification of the disputed points, reference Member State shall record the agreement reached, terminating the procedure and shall inform the applicant accordingly. Article 28, paragraph 5, shall apply.

4. If the Member States fail to reach agreement within the period referred to in paragraph 2 at 60 days, the Agency shall be immediately informed with a view to the application of the procedure laid down in articles 32, 33 and 34. The Agency presented a detailed description of the disputed question and of the reasons for their disagreement. A copy is sent to the applicant.

5. As soon as the applicant has been informed that the matter has been submitted to the Agency, immediately send a copy of this in article 28, paragraph 1, referred to in the first subparagraph information and documents.

6. In the cases referred to in paragraph 4, the Member States which recognize the assessment report of the reference Member State, the draft summary of product characteristics and the labelling and package leaflet, at the request of the applicant, authorise the marketing of the medicinal product without waiting for the outcome of the procedure laid down in article 32. In this case, however, permission not prejudge the outcome of this procedure.

Article 30

1. Is a medicinal product subject of multiple applications for a marketing authorisation submitted in accordance with articles 8, 10, 10a, 10b, 10 c and 11, and the Member States have adopted divergent decisions concerning the authorization, suspension or withdrawal, can a Member State, the Commission, the applicant or the marketing authorisation holder may refer the matter to the Committee for medicinal products for Human use, hereinafter referred to as ' the Committee ', in order to get it treated in accordance with the procedure referred to in article 32 , 33 and 34.

2. in order to promote the harmonisation of the authorisation of medicinal products authorised in the community, Member States shall communicate each year a list of medicines for which there must be harmonised product summaries, to the coordination group.

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

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

Article 31

Member States, the Commission, the applicant for or holder of a marketing authorisation shall, in specific cases where the interests of the Union are concerned, bring the matter to the Committee in order to get it treated in accordance with the procedure laid down in articles 32, 33 and 34, before deciding on an application, a suspension or a revocation of a marketing authorisation or of any other change in a marketing authorisation which appears necessary.

If the referral of the question for the Committee is a result of the evaluation of information from pharmacovigilance of an authorised medicinal product, refer the question to the Committee for risk assessment in the field of pharmacovigilance and article 107j, paragraph 2, can be applied. The Committee for risk assessment in the field of pharmacovigilance makes a recommendation in accordance with the procedure laid down in article 32. The final recommendation will be forwarded to the Committee for medicinal products for Human use or the coordination group, and the procedure referred to in article 107 shall apply.

If it is considered necessary to take emergency measures, the procedure laid down in articles 107i to 107 k, however, apply.

The Member State concerned or the Commission shall indicate clearly which issues submitted to the Committee for consideration and shall inform the applicant or the marketing authorisation holder.

Member States, the applicant or the marketing authorisation holder shall send to the Committee all available information relating to the matter under consideration.

2. Where the referral to the Committee concerns a range of medicinal products or a therapeutic group, the Agency may limit the procedure to specific parts of the authorisation.

In that case, article 35 shall apply only to those medicinal products only if they are covered by the procedure for the marketing authorisation referred to in this chapter.

Article 32

1. where reference is made to the procedure laid down in this article, the Committee shall examine the matter and shall give its reasoned opinion within 60 days after it has received the case presented.

In the cases presented to the Committee in accordance with articles 30 and 31, the Committee may, however, extend this time limit by a maximum of 90 days, taking into account the views of the applicants or the marketing authorisation holders concerned had to make.

In urgent cases, the Committee may, on a proposal from its Chairman, lay down a shorter period.

2. To consider the matter, the Committee shall appoint one of its members to act as rapporteur. The Committee may also appoint independent experts to advise it on specific questions. When the Committee shall appoint experts, define it at the same time, their tasks and shall fix a time limit for the execution thereof.

3. before the Committee shall deliver its opinion, gives the applicant or the marketing authorisation holder to submit written or oral observations within a time limit, as this sets.

The Committee's opinion shall be accompanied by the draft summary of product characteristics and the labelling and package leaflet.

If the Committee deems it appropriate, may invite any other person to provide information about the case, it has to treat.

The Committee may suspend the time limit referred to in paragraph 1 in order to allow the applicant or the marketing authorisation holder with an opportunity to prepare its observations.

4. the Agency shall forthwith inform the applicant or the marketing authorisation holder shall, if in its opinion the Committee determines: (a) the application does not satisfy the acceptance criteria), or




(b)) to the summary of product characteristics proposed by the applicant or the marketing authorisation holder in accordance with article 11 should be amended, or



(c)) that the authorization should be made dependent on certain conditions, IE. conditions that are considered to be of vital importance for the safe and effective use of the medicinal product including pharmacovigilance, or



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

No later than 15 days after receipt of the opinion, the applicant or the marketing authorisation holder shall inform the Agency in writing that he wants the decision taken up for reconsideration. In such cases, the applicant or the marketing authorisation holder shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion.

Within 60 days following receipt of the grounds for the request, taking the Committee reconsidered its opinion in accordance with article 62, paragraph 1, subparagraph 4, of Regulation (EC) No 1782/2003. 726/2004. The Committee's conclusions concerning the request shall be annexed to the assessment report referred to in paragraph 5 of this article.

5. within 15 days after the Committee has adopted its final opinion, the Agency shall forward this to the Member States, the Commission and the applicant or the marketing authorisation holder together with a report on the evaluation of the medicinal product and stating the reasons for its conclusions.

If an opinion is favourable to the granting or extension of a marketing authorisation, the following documents shall be annexed to the opinion: (a) a draft summary of product characteristics), see. Article 11



(b)) the conditions for granting the authorization referred to in paragraph 4 (c))



(c) particulars of any) detailed recommended conditions or restrictions with a view to the safe and effective use of the medicinal product



d) draft of the labelling and package leaflet.

Article 33

No later than 15 days after receipt of the opinion, the Commission shall draw up a draft of the decision to be taken in respect of the application, taking into account Community law.

If a draft decision which envisages the granting of marketing authorization, the products shall be those specified in article 32, paragraph 5, second subparagraph, the documents referred to in that annex.

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

The draft decision shall be forwarded to the Member States and the applicant or the marketing authorisation holder.

Article 34

1. the Commission shall take a final decision in accordance with, and within 15 days after the completion of the procedure laid down in article 121, paragraph 3.

2. The rules of procedure of the Standing Committee set up by article 121, paragraph 1, be adapted to take account of the tasks incumbent upon it pursuant to this chapter.

These adaptations involves the following: (a)), with the exception of the cases referred to in article 33, paragraph 3, the Standing Committee shall be obtained in writing the opinion.



(b)), each Member State shall have 22 days to forward to the Commission his written observations on the draft decision. However, if the decision is of urgency, the President may set a shorter period, depending on how much the issue of urgency. Apart from exceptional circumstances should the deadline not be shorter than five days.



(c)), each Member State should have the opportunity to submit a reasoned request in writing that the draft decision be discussed in a plenary session of the Standing Committee.

If the written observations of a Member State, the Commission considers that raises important new scientific or technical questions that are not affected in the Agency's opinion, the procedure and the Chairman shall communicate the application back to the Agency for further consideration.

The Commission shall adopt the necessary detailed rules for the application of this paragraph in accordance with the procedure referred to in article 121, paragraph 2.

3. The decision referred to in paragraph 1 shall be transmitted to all Member States and communicated to the marketing authorisation holder or the applicant for information. The concerned Member States and the reference Member State shall grant or withdraw marketing authorisation or make the changes in the marketing authorisation, which may be necessary in order to comply with the decision within 30 days after he is notified, and refers in this connection to the decision. They shall inform the Commission and the Agency.

Article 35

1. Any application by the marketing authorization holder to vary a marketing authorization which has been granted in accordance with the provisions of this chapter shall be submitted to all the Member States which have previously authorized the medicinal product concerned.

2. In cases where the Commission is submitted to arbitration, the procedure laid down in articles 32, 33 and 34 shall apply by analogy to variations made to marketing authorizations.

Article 36

(Discontinued).

Article 37

Articles 35 and 36 shall apply by analogy to medicinal products authorised by the Member States on the basis of an opinion from the Committee, which is made in accordance with article 4 of Directive 87/22/EEC before 1 July. January 1995.

Article 38

1. The Agency shall publish an annual report on the application of the procedures set out in this chapter and shall forward this report to the European Parliament and the Council for information.

2. At least every ten years the Commission shall publish a report on the experience gained in the application of the procedures that are described in this chapter and shall propose any changes 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, paragraph 4, 5 and 6, and articles 30 to 34 shall not apply to the homeopathic medicinal products referred to in article 14.

Articles 28 to 34 shall not apply to the homeopathic medicinal products referred to in article 16, paragraph 2.

TITLE IV

MANUFACTURE AND IMPORT

Article 40

1. Member States shall take all appropriate measures to ensure that the manufacture of medicinal products within their territory subject to possession of a licence. Manufacturing authorization required, even though the manufactured medicinal products are intended for export.

2. The authorization referred to in paragraph 1 shall be required for both the full and the partial manufacture, as well as for processes of dividing up, packaging and presentation. This permission is not required for processing, splits and changes by wrapping or presentation, in so far as such operations are carried out solely for the purpose of retail supply by pharmacists in dispensing pharmacies or by other persons under the law of the Member States are authorized to perform these processes.

3. The authorization referred to in paragraph 1 shall also be required for imports from third countries into a Member State, and to this end, this section and article 118 shall apply to such imports in the corresponding extent, as they apply to the manufacture.

4. Member States shall ensure that the information related to it in paragraph 1 of this article shall be authorized in the Community database referred to in article 111, paragraph 6.

Article 41

In order to obtain the manufacturing authorization, the applicant must demonstrate that he meets the following conditions at least: (a)) specify the medicinal products and pharmaceutical forms which are to be manufactured and/or imported and also the place for their manufacture and/or control



(b)) for the manufacture or importation of them dispose of premises, technical equipment and control options that are suitable and sufficient, and complying with the legal requirements which the Member State concerned shall make, both as regards manufacture and controls as for the storage of medicinal products and taking into account the provisions of article 20



c) have at least one person who is qualified in accordance with article 48, available.

The applicant must provide the application with evidence that he satisfies these requirements.

Article 42

1. The competent authority of the Member State shall notify the manufacturing authorization only after having secured by a study carried out by its representatives, pursuant to article 41 of given information is correct.

2. In order to ensure compliance with the conditions laid down in article 41, there may be attached to the permit certain obligations imposed either by its issue or at a later time.

3. The authorization shall apply only to the premises specified in the application and only for the application listed medicinal products and pharmaceutical forms.

Article 43

Member States shall take all appropriate measures to ensure that the proceedings concerning the manufacturing authorisation will not last longer than 90 days from the date of receipt of the application by the competent authority.

Article 44

If the holder of the manufacturing authorization requests modification of one of the products listed in article 41, paragraph 1, point (a)) and (b)), the information provided, taken for the procedure relating to this request shall not exceed 30 days. In special cases, this period may be extended to 90 days.

Article 45

The competent authority of the Member State of the applicant may require further information with regard to the information gathered in accordance with article 41, as well as in respect of the qualified person referred to in article 48; where the competent authority makes use of this possibility, they shall be suspended in article 43 and 44 above, the time-limits laid down, until the required additional information has been provided.

Article 46

The holder of the manufacturing authorization is required to at least:




a) to have at its disposal personnel who, in the Member State concerned complies with the applicable legal requirements as regards both manufacture and control



(b)) only to hand over the allowable medicinal products in accordance with the laws of the Member States concerned



c) in advance to inform the competent authorities of any changes he may wish to make to any of the particulars supplied pursuant to article 41; However, the competent authorities shall be informed immediately in the event of unforeseen replacement of the qualified person referred to in article 48



(d)) at any time to give the representatives of the competent authorities of the Member State concerned access to his premises;



(e)) to enable the qualified person referred to in article 48 to carry out its task, in particular by providing all necessary resources at his disposal



f) to respect the principles and guidelines of good manufacturing practice for medicinal products and to use only active substances which have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practice for active substances. The holder of the manufacturing authorization checks in this connection, the manufacturer and distributors of medicinal substances comply with good manufacturing practice and good distribution practice, by conducting audits at the manufacturer and distributors of the active substances in the manufacturing and distribution locations. The holder of the manufacturing authorization check either this observance itself or, without prejudice to his/her responsibilities as set out in this directive through a device with which the person concerned has entered into an agreement with.



  The holder of the manufacturing authorization shall ensure that the Formulants are suitable for use in medicinal products, by defining what is appropriate good manufacturing practice. This shall be determined on the basis of a formalized risk assessment in accordance with the applicable guidelines, see. Article 47, paragraph 5. This risk assessment is done taking into account the requirements according to appropriate quality systems as well as help other substances origin and their intended use as well as the earlier case of quality defects. The holder of the manufacturing authorization shall ensure that the appropriate good manufacturing practice thus determined shall be used. The holder of the manufacturing authorization documents the measures taken pursuant to this paragraph



g) immediately to inform the competent authority and the holder of the marketing authorisation, if he becomes aware of the fact that medicinal products covered by his manufacturing authorisation, or suspected of being counterfeit, regardless of whether these medicines were distributed in the legal supply chain or with illegal means, including illegal sales through services in the information society



(h)) to verify that manufacturers, importers, or distributors, from which he wears off the active substances to be registered with the competent authority of the Member State in which they are established



in) to check the active substances and auxiliary substances, authenticity and quality.

Article 46a

1. For the purposes of this directive, manufacture of active substances used as starting materials, complete or partial manufacture and import of an active substance used as a starting material (as defined in Annex i, part 1, point 3.2.1.1 (b))), as well as the various processes in the context of splitting, wrapping and presentation prior to its use in a medicinal product, including repackaging and re-packaging or re-labelling as made by a wholesale distributor of raw materials.

2. The Commission may amend paragraph 1 in order to adapt it to scientific and technical progress. Such a measure designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 121, paragraph 2a.

Article 46b

1. Member States shall take appropriate measures to ensure that the manufacture, importation and distribution in their territory of medicinal substances, including active substances intended for export, complies with good manufacturing practice and good distribution practice for active substances.

2. Active substances may be imported only if the following conditions are met: a) the active substance is manufactured in accordance with standards of good manufacturing practice at least equivalent to those of Union established standards, see. Article 47, paragraph 3, and



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



i. that the standards for good manufacturing practices applicable at the factory where the exported active substance is manufactured, at least equivalent to those of Union established standards, see. Article 47, paragraph 3



II. that the factory, which has been responsible for the manufacture shall be subject to regular, rigorous and transparent monitoring and effective enforcement of good manufacturing practices, including repeated and unannounced inspections, in order to ensure a level of protection of public health, which is at least equal to the applicable within the Union, and



III. to the exporting third country in cases of non-compliance findings in relation to the supply of information immediately about such findings to the Union.

This written confirmation shall be without prejudice to the obligations referred to in article 8 and in article 46 (f)).

3. the requirement in paragraph 2 of this article) (b) shall not apply if the exporting country is included on the list referred to in Article 111b.

4. the requirement in paragraph 2 of this article) (b), may exceptionally, and where it is necessary to ensure the availability of medicines, be waived by any Member State for a period not exceeding the validity of the certificate of good manufacturing practice by a Member State after an inspection has found that a factory that manufactures an active substance for export compliance in article 47 (3), laid down the principles and guidelines of good manufacturing practice. Member States which avail themselves of the possibility of such a derogation, it shall notify the Commission thereof.

Article 47

The principles and guidelines of good manufacturing practice for medicinal products referred to in article 6. Article 46 (f)), shall be adopted in the form of a directive. This measure, designed to amend non-essential elements of this directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 121, paragraph 2a.

Detailed guidelines in line with these principles and guidelines issued by the Commission and revised where necessary in the light of technical and scientific progress.

The Commission shall adopt, by means of delegated acts in accordance with article 121a and without prejudice to the conditions laid down in article 121b and 121 c in article 46, point f), first subparagraph, and Article 46b referred to the principles and guidelines of good manufacturing practice for active substances.

In article 46, point f) referred to in the first subparagraph principles of good distribution practice for active substances shall be adopted by the Commission in the form of guidelines.

The Commission shall adopt guidelines in article 46, point f) referred to in the second subparagraph of formalised risk assessment for determining what is appropriate good manufacturing practice for excipients.

Article 47a

1. In article 54, point (o)), provided security measures must not be removed or covered in whole or in part, unless the following conditions are met: (a)) by the holder of the manufacturing authorization completely or partially removing or covering these security measures, he checks the authenticity of the product, and that the packaging is unbroken



(b)) the holder of the manufacturing authorization comply with article 54, point (o)), by replacing these security measures with security measures, similar to the original, as far as the possibility to verify the authenticity of the product, identifying and documenting that the drug's packaging is unbroken. Such a replacement is carried out, without opening the immediate packaging defined in article 1, no. 23.



  Security measures are considered equivalent to the original, if they:



a) complies with the requirements of the pursuant to article 54a (2) adopted delegated acts, and



(b)) are just as effective as regards the control of authenticity and identification of drugs and provision of proof that the packaging is unbroken



c) replacement of the security measures implemented in accordance with the applicable good manufacturing practice for medicinal products, and



d) replacement of security measures is conducted under the supervision of the competent authority.

2. Manufacturing authorisation holders, including those carrying out activities referred to in paragraph 1, shall be considered as phonogram producers and therefore liable for damages in the cases and under the conditions laid down in Directive 85/374/EEC.

Article 48

1. Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization has permanently and continuously at least one qualified person who fulfils the conditions laid down in article 49, and in particular is responsible for the performance of the tasks defined in article 51.

2. If the authorisation-holder personally fulfils the conditions laid down in article 49, he may himself assume the responsibility referred to in paragraph 1.

Article 49

1. Member States shall ensure that the qualified person referred to in article 48 fulfils the obligations referred to in paragraphs 2 and 3 requirements for qualifications.


2. The qualified person shall be in possession of a diploma, certificate or other evidence of a university course of study, or a course, as recognised by the Member State concerned as being equivalent thereto in a period of at least four years of theoretical and practical study in one of the following scientific disciplines: Pharmacy, medicine, veterinary science, chemistry, pharmaceutical chemistry and technology, biology.

However, the minimum duration of the University course may be three and a half years on, if it is followed by a theoretical and practical training, culminating in an examination at university level of a duration of at least one year and including a praktikanttid of at least six months in a pharmacy open to the public.

If in a Member State at the same time are two university educations or two studies, as of that State recognised as covering each other, one of which extends over four years and the other over three years, is considered the diploma, certificate or other evidence of the three-year university degree or training recognized as equivalent thereto, to meet the requirements referred to in the second subparagraph on duration , in so far as the diplomas, certificates or other evidence of formal qualifications in the two studies of that State recognised as having the same value.

The study includes theoretical and practical instruction, covering at least the following basic subjects: – (does not concern the English version).



-General and inorganic chemistry



– organic chemistry



-analytical chemistry



-pharmaceutical chemistry, including analysis of medicinal product



-General and applied Biochemistry (medical)



– Physiology



– Microbiology



— Pharmacology



-pharmaceutical technology



– Toxicology



-pharmacognosy (study of the composition and effects of the active substances of natural substances of plant and animal origin).

The teaching of these subjects must be given in such a way that the person concerned will be able to meet the obligations specified in article 51.

In so far as certain diplomas, certificates or other evidence of formal qualifications referred to in this paragraph does not meet the criteria referred to in this paragraph, the competent authorities of the Member State shall ensure that the person concerned shall submit proof of adequate proficiency in those subjects.

3. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products.

The duration of the practical experience may be reduced by one year, if the University extends over at least five years, and with a year and a half, if the Studio stretches over at least six years.

Article 50

1. A person in a Member State referred to in article 48 shall provide the person's company at the time of the implementation of Directive 75/319/EEC, without complying with the provisions of article 49, is qualified for in the community continue to exercise this activity.

2. the holder of a diploma, certificate or other evidence of completed university course of study, or a course of study, that of the Member State concerned is recognised as being equivalent thereto, within a scientific discipline that qualifies the person to carry on the activities of the person referred to in article 48 in accordance with the legislation of that State, may-when he has begun his training before the 21st century. May 1975-deemed qualified in that Member State to assume the duties of the person referred to in article 48 provided that he previously, before the 21st century. May 1985 for at least two years directly under the leadership of the person referred to in article 48 have exercised supervisory company for the manufacture and/or carried out qualitative and quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products in one or more companies which have obtained the manufacturing licence.

When the person concerned has acquired the practical experience referred to in the first subparagraph, before the 21st century. May 1965, required that an additional years of practical experience corresponding to the conditions referred to in the first subparagraph; This additional practical experience must be obtained immediately prior to the exercise of these activities.

Article 51

1. Member States shall take all appropriate measures to ensure that the qualified person referred to in article 48, without prejudice to his relationship with the holder of the manufacturing authorization, within the framework of the procedures referred to in article 52 is responsible for securing: (a)) to any party drugs that are manufactured in the Member State concerned, are produced and controlled in accordance with the legislation in force in that Member State and in accordance with the requirements of the marketing authorization at the time of notification of



(b)) to each manufactured batch of medicinal products imported from third countries, irrespective of whether it is produced in the community in a Member State have been subjected to a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation at the time of notification of the conditions laid down.

The qualified person referred to in article 48 shall ensure that the products listed in article 54, point (o)), provided security measures are placed on the packaging of medicinal products intended to be marketed in the European Union.

Lots of drugs, that is controlled in a Member State shall be exempt from the above controls when they are placed on the market in another Member State, accompanied by the control reports signed by the qualified person.

2. In cases where the medicinal products imported from a third country, and the community has taken the appropriate measures with the exporting country to ensure that the manufacturer of the medicinal product applies standards of good manufacturing practice at least equivalent to the standards laid down by the community, and to ensure that the under paragraph 1, first subparagraph, point (b)), referred to the control is carried out in the exporting country, the qualified person may be relieved of responsibility for carrying out these checks.

3. In all cases, and particularly where the medicinal products are released for sale, the qualified person in a register or equivalent document certifying that each production batch satisfies the provisions of this article; This register or equivalent document must be updated as the work processes are terminated, and made available to the competent authorities ' representatives in a period that is in accordance with the provisions of the Member State concerned, subject to a minimum of five years.

Article 52

Member States shall ensure, through appropriate administrative measures or by rules of professional conduct, to the qualified person in accordance with article 48 of its commitments.

Member States may provide for the temporary suspension of such a person, if the commencement of administrative or disciplinary proceedings against him for dereliction of duty.

Article 52a

1. Importers, manufacturers and distributors of medicinal substances, as established in the Union, register their company with the competent authority of the Member State where they are established.

2. The registration form shall contain at least the following information: i) the name or business name and permanent address



II) a statement of the active substances which should be imported, manufactured or distributed



III) information about the premises and technical equipment to be used for their business.

3. The persons referred to in paragraph 1 submits the registration form to the competent authority not later than 60 days before the scheduled start of their business.

4. The competent authority may, on the basis of a risk assessment, decide to carry out an inspection. If the competent authority within a period of 60 days following receipt of the registration form shall inform the applicant that will be carried out an inspection visit, the company does not commence until the competent authority has informed the applicant that he or she can start business. Where the competent authority within a period of 60 days following receipt of the registration form has informed the applicant that will be carried out an inspection, the applicant may commence business.

5. The persons referred to in paragraph 1 shall transmit each year to the competent authority a list of changes that have taken place in relation to the information given in the registration form. Any change that may affect the quality or safety of the active substances manufactured, imported or distributed, must be notified immediately.

6. The persons referred to in paragraph 1, which started their activities in the 2. January 2013, must have submitted the registration form to the competent authority not later than the 2. March 2013.

7. Member States shall ensure that the information given in accordance with paragraph 2 of this article, in the Community database referred to in article 111, paragraph 6.

8. This article shall be without prejudice to article 111.

Article 52b

1. Byway of derogation from article 2, paragraph 1, and without prejudice to the provisions of title VII, Member States shall take the necessary measures to prevent drugs entering the Union, but not intended to be marketed in the EU market, comes on the market, if there are sufficient grounds to suspect that such drugs are counterfeit.


2. In order to determine what necessary measures as referred to in paragraph 1 of this article, the Commission may, by means of delegated acts in accordance with article 121a and without prejudice to the conditions laid down in article 121b and 121 c, adopt measures to complement this article paragraph 1, with regard to the criteria to be taken into account, and the control to be made in the assessment of the potentially counterfeit nature of medicinal products brought into the Union, but not intended to be placed on the market.

Article 53

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

TITLE V

LABELLING AND PACKAGE LEAFLET

Article 54

Any medicinal product shall be on the outer packaging or, if one does not exist, on the immediate packaging bear the following information: a) the name of the medicinal product followed by its strength and pharmaceutical form, and, where appropriate, whether the medicinal product is intended for babies, children or adults. Where the product contains up to three active substances, the international proprietary name (INN) shall be specified, or, if one does not exist, the common name.



b) composition, expressed through a qualitative and quantitative indication of the active ingredients per dosage unit or according to the form of Administration for a particular volume, or weight, using their common names



c) the pharmaceutical form and the contents by weight, volume or dose unit



d) list of co-Formulants which has a recognised effect and included in the detailed instructions that are published pursuant to article 65. If, however, in the case of injectable preparations, a preparation for local use or an eye-remedy, all substances mentioned



(e)) the method and, if necessary, route of administration. Allocated space on packaging to indicate the prescribed dosage



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



g) a special warning, if this is necessary for the medicinal product concerned



h) expiry date, in clear terms (month/year)



in), where appropriate, special storage precautions



j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, as well as a reference to existing suitable collection systems



k) the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder.



l) marketing authorisation number



m) lot number



n) for non-prescription medicines indication of intended use.



o) for other medicines than radiopharmaceuticals, as referred to in article 54a (1) safety measures, making it possible for wholesalers and persons authorised or entitled to supply medicinal products to the public, to:



– check the authenticity of the product, and



– identify individual packs



– as well as a device that makes it possible to check whether the outer packaging has been broken.

Article 54a

1. Prescription drugs should be provided in article 54, point (o)), referred to security measures, unless they are included in a list in accordance with the procedure referred to in paragraph 2 (b)), of this article.

Non-prescription medicines must not be provided in article 54, point (o)), referred to security measures, unless the exception is included in a list in accordance with the procedure referred to in paragraph 2 (b)), of this article, after that an assessment has identified a risk of forgery.

2. the Commission shall adopt, by means of delegated acts in accordance with article 121a and without prejudice to the conditions laid down in article 121b and 121 c, measures to supplement article 54, point (o)), with the aim to lay down the detailed rules referred to in article 54, point (o)), referred to security measures.

These delegated acts should lay down the following: (a)) the characteristics and technical specifications for the unique identifier within the scope of article 54, point (o)) referred to the security measures, which allow for the control of medicines ' authenticity and identification of the individual packages. When establishing safety measures shall take due account of their cost effectiveness



b) lists of drugs or classes of drugs which, in the case of prescription drugs, not shall be provided with security measures, and, in the case of non-prescription drugs shall be those referred to in article 54, point (o)), referred to security measures. These lists must be drawn up, taking account of the risk and the risk as a result of forgery connected with drugs or categories of drugs. To this end, as a minimum, the following criteria shall apply:



in price and sales volume of the product.



II. the number and frequency of past cases of counterfeit drugs reported in the Union and in third countries and developments with regard to the number and frequency of these cases



III. the particular characteristics of the medicinal products in question



IV. the severity of the disorders, medicines intended for the treatment of



v. other potential risks to public health



c) procedures for the notification referred to in paragraph 4 of the Commission and a system for rapid evaluation of, and decision on these notifications with a view to the application of subparagraph (b))



(d)) the detailed arrangements for the checks referred to in article 54, point (o)), provided security measures carried out by manufacturers, wholesalers, pharmacists and persons authorised or entitled to supply medicinal products to the public, and by the competent authorities. These arrangements shall enable verification of the authenticity of each delivered medicines packaging bearing the in article 54, point (o)), referred to security measures, and determine the extent of this control. In drawing up these schemes must take account of the characteristics of supply chains in Member States and to the need to ensure that the impact of control measures on specific actors in the supply chain, is proportionate



(e)) the provisions concerning the creation, management and accessibility of the data storage system, which will contain information about the in article 54, point (o)), referred to security measures that enable control of the authenticity and identification of the medicinal products. The cost of this storage system must be borne by the holders of a permit for the manufacture of medicinal products, which are fitted with safety measures.

3. At the time of the adoption of the measures referred to in paragraph 2, the Commission shall take due account, as a minimum, to the following conditions: (a)) the protection of personal data in accordance with EU law



(b)) the legitimate interests in protecting information of a commercially confidential nature



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



d) cost-effectiveness.

4. The competent authorities shall inform the Commission of non-prescription drugs, for which they assess that there is a risk of counterfeiting, and wishes to inform the Commission about the drugs for which they deem that there is no risk in accordance with the criteria set out in paragraph 2 (b)).

5. Member States may, for the purpose of reimbursement or pharmacovigilance, extend the scope of the Committee referred to in article 54, point (o)), provided unique identifier to include any medicinal product which is prescription or can be refunded.

Member States may, for the purpose of reimbursement, pharmacovigilance or drug epidemiology, use the information in the data-storage system, referred to in paragraph 2 (e)), of this article.

Member States may, for the purpose of expanding the scope of the patient safety in article 54, point (o)), provided device for checking if the outer packaging has been broken, to include any medicinal product.

Article 55

1. Inner packagings shall, apart from those referred to in paragraphs 2 and 3, be provided with the information provided for in article 54.

2. Is the inner packagings in an outer packaging that is designed in accordance with the provisions laid down in articles 54 and 62, they shall, once they have the form of blister packs, be provided with at least the following information: – the name of the medicinal product as laid down in accordance with article 54, point (a))



– name of the marketing authorisation holder



– the expiry date



— the lot number.

3. Small immediate packaging units on which it is impossible to indicate the information provided for in articles 54 and 62, shall bear at least the following information: – the name of the medicinal product as laid down in accordance with article 54, point (a)), as well as, if necessary, the route of administration.



– the method



– the expiry date



— the lot number



– content, expressed in weight, volume or by number of doses.

Article 56

The information referred to in articles 54, 55 and 62, must be affixed in such a way that they are easy to read, easy to understand and impossible to delete.

Article 56a


The name of the medicinal product, in accordance with article 3. Article 54, point (a)), is also entered in Braille on the packaging. The marketing authorisation holder shall ensure that the leaflet on request from patient groups be made available in formats appropriate for the blind and visually impaired.

Article 57

Byway of derogation from article 60, Member States may require certain additional conditions concerning the labelling of the medicinal product allows: – indication of the price of the medicine



– an indication of the provisions for reimbursement from health insurance agencies



– an indication of the requirements for the extradition of the drug to the patient in accordance with Title VI of the



– identity and identification in accordance with article 54a, paragraph 5.

In the case of medicinal products authorised under Regulation (EC) No 1782/2003. 726/2004, the following Member States for the purposes of this article, in article 65 referred to in this directive for detailed instructions.

Article 58

The packaging for any medicinal product must contain a leaflet, unless all the information required in accordance with articles 59 and 62, are set directly on the outer or the inner packaging.

Article 59

1. the package leaflet shall be drawn up in accordance with the summary of product characteristics; It must contain the following information in the order listed below: a) the identification of the medicinal product:



i. the name of the medicinal product followed by its strength and pharmaceutical form, and, where appropriate, an indication of whether or not it is intended for babies, children or adults. The common name must be specified, if the medicinal product contains only one active substance and if its name is an invented name.



II. Pharmaco-therapeutic group or type of activity way, easily comprehensible for the patient.



b) therapeutic indications.



(c) A list of information), the patient should be aware of before taking the medicinal product:



i. contraindications



II. relevant precautions during use



III. medical interactions and other forms of interaction (URf.eks. alcohol, tobacco, foodstuffs) which may affect the efficacy



IV. Special warnings.



(d) the necessary and usual information) with a view to proper use, in particular:



i. dosage



II. implementation and, if necessary, route of administration



III. the frequency of administration, specifying if necessary, the medicinal product may or must be administered



  as well as, as appropriate, depending on the nature of the medicinal product:



IV. the duration of treatment, if it is to be limited



v. precautions in case of overdose (URf.eks. Description of the symptoms and emergency measures)



vi. precautions in case of skipping one or more doses



VII. where appropriate, an indication of the risk by the termination



VIII. an express invitation to possibly consult a doctor or pharmacist in order to clarify the manner in which the medicinal product is used.



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



f) a reference to the expiry date indicated on the packaging, including:



i. a warning against any breaching of this date



II. special storage precautions, if applicable



III. any warning with regard to certain visible signs of deterioration



IV. composition, expressed through a full qualitative indication (in active substances and excipients), as well as a quantitative indication of the active substances, using common names, for any form in which the medicinal product is available



v. pack size and content in weight, volume or by number of doses, for any pharmaceutical form



vi. the name and address of the marketing authorisation holder and, where applicable, the name of its representatives in the Member States



VII. the manufacturer's name and address.



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



h) the date on which the package leaflet was last revised.

For medicinal products listed on it in article 23 of Regulation (EC) No 1782/2003. 726/2004, the following shall be added to the list provided additional message ' this drug is subject to supplementary supervision '. This notification must follow it in article 23 of Regulation (EC) No 1782/2003. 726/2004 referred to black symbol and followed by an appropriate default explanation.

For all medicinal products, add a standard formulation, the rate at which patients explicitly asked to report any suspected side effects to your doctor, pharmacist or health care professional or directly to it in article 107a, paragraph 1 referred to national system for spontaneous reporting, and which specify what are the different ways that can be used for reporting (electronic reporting, reporting to a postal address or other transmission ways) in accordance with article 107a (1), second subparagraph.

2. The indication of the information pursuant to paragraph 1 (c)) shall: (a)) take account of the specific conditions applicable to certain users (children, pregnant or breastfeeding women, the elderly, persons with a special pathology)



b) mention, if appropriate, possible effects on the ability to drive vehicles or machinery control



c) contain a list of excipients, as it is necessary to have knowledge in order to be able to use the drug correctly and risk free, and which are subject to the detailed instructions that are published pursuant to article 65.

3. the package leaflet shall reflect the results of cooperation with target patient groups to ensure that it is legible, clear and easy to use.

4. No later than the 1. January 2013, the Commission shall submit an evaluation report to the European Parliament and the Council on the current deficiencies in the summary of product characteristics and package leaflet with suggestions as to how these can be improved to better meet the needs of patients and the health of persons. If necessary, the Commission shall submit, on the basis of the report and after consultation with the relevant parties concerned proposals for improving readability, layout and content of these documents.

Article 60

Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds due to the labelling or the package leaflet, if this satisfies the requirements laid down in this section.

Article 61

1. One or more mock-ups of the outer packaging and the immediate packaging as well as the draft package leaflet, shall be submitted to the competent authorities, at the same time with the application for marketing authorization. In addition, the competent authority presented the results of the evaluations that have been carried out in cooperation with patient audiences.

2. The competent authorities does not oppose the placing on the market of medicinal products where labelling or the package leaflet comply with the provisions of this title, and when they are in accordance with the particulars listed in the summary of the product characteristics.

3. Any draft amendment of an item in the labelling or the package leaflet covered by this title, and which are not connected with the summary of the product characteristics, shall be submitted to the authorities competent in respect of the granting of the marketing authorisation. If the competent authorities have not objected to the draft amendment within a period of 90 days from the filing of the application, the applicant can carry out those changes.

4. the fact that the competent authorities have not objected to the marketing of a medicinal product within the meaning of paragraph 2 or a change to the labelling or the package leaflet pursuant to paragraph 3 shall be without prejudice to the responsibilities after ordinary is the responsibility of the manufacturer and the holder of the marketing authorisation.

Article 62

The outer packaging and the package leaflet can be fitted with signs or pictograms to explain some of the information referred to in article 54 and article 59, paragraph 1 and other information compatible with the summary of the product characteristics, and that may be useful for the patient, with the exclusion of any element that may have the character of advertising.

Article 63

1. In articles 54, 59 and 62 concerning the labelling information referred to shall be worded in the official language or languages used in the Member State where the medicinal product is placed on the market.

The provision in the first subparagraph shall not preclude such information can be written in several different languages, provided that the same information must be given in all languages.

In the case of certain orphan medicinal products, the information referred to in article 54 may, on reasoned request, be drawn up in one of the official languages of the community.

2. the package leaflet must be written and be worded in terms that are clear and understandable, and thus allows users to act appropriately, when necessary with the help of health professionals. Package leaflet must be written in the official language or languages of the Member State where the medicinal product is placed on the market.

The first subparagraph shall not prevent the package leaflet can be printed in several languages, provided that the same information is given in all the languages involved.


3. Provided that the competent authority shall take such measures as it considers necessary in order to protect human health, it may grant exemption from the requirement that certain information must appear on the labelling and package leaflets for specific medicinal products, if the medicinal product concerned is not intended for released directly to the patient, or if there are serious problems regarding the availability of the drug. It can also provide full or partial exemption from the requirement that the labelling and the package leaflet must be written in the official language or languages of the Member State where the medicinal product is placed on the market.

Article 64

Compliance with the provisions of this subparagraph do not, Member States ' competent authorities, after the party concerned has failed to comply with a recommendation, may suspend the marketing authorisation of the medicinal product, until the labelling and the accompanying package leaflet has been brought into conformity with the provisions of this title.

Article 65

The Commission shall draw up and publish, in consultation with Member States and stakeholders, detailed instructions concerning in particular: (a)) the wording of certain special warnings for certain categories of medicinal products



(b)) the specific need for information with regard to over-the-counter (OTC) medicines



c) the legibility of the information listed on the labelling and package leaflet



d) methods for the identification of drugs and evidence of their authenticity



e) the list of excipients which must appear on the labelling of medicinal products and the way in which these excipients must be indicated



f) harmonised rules for the implementation of article 57.

Article 66

1. The outer packaging and the container of medicinal products containing radionuclides shall be labelled in accordance with the provisions on transport safety of radioactive substances as defined by the International Atomic Energy Agency. In addition, the labelling must comply with the provisions of paragraphs 2 and 3.

2. The label on the shielding shall include the particulars listed in article 54. In addition, on the face of the label can be found an explanation for the on the vial used codes, where appropriate with an indication of the amount of radioactivity per dose or per vial/ampoule to a specified time and the number of capsules, or, for liquids, the number of millilitres in the container.

3. The vial shall be labelled with the following information:-the name or code of the medicinal product, including the name or chemical symbol of the radionuclide in question



– identification of the lot and expiration date



– the international symbol for radioactivity



– the manufacturer's name and address



– the amount of radio activity, see. (2).

Article 67

The competent authority must ensure that the packaging of radiopharmaceuticals, radionuclide generators, radionuclide kits or radionuclide precursors contain a detailed leaflet. The text of this leaflet shall be drawn up in accordance with article 59. In addition, slip indicate the precautions that the user or the patient to be taken into account during the preparation and administration of the medicinal product and special security measures in connection with the disposal of the packaging and its unused contents.

Article 68

Without prejudice to article 69 should homeopathic medicinal products shall be labelled in accordance with the provisions of this section and carry an inscription with clear and legible font on their homeopathic nature.

Article 69

1. The labelling and package leaflet to the any medicinal products referred to in article 14, paragraph 1, and shall bear, in addition to the indication on the highly visible way of the words ' homeopathic medicinal product ' shall only be applied to the following information: – the tribe's/scientific name of the stock or stocks followed by the degree of dilution through the use of the symbols of the pharmacopoeia used as referred to in article 1, no. 5; If the homeopathic medicinal product composed of several tribes, in addition to the scientific names of the stocks indicate a brand name on the labelling.



– name and address of the holder of the registration and, where applicable, of the manufacturer



– the method and, if necessary, route of administration



– the expiry date, in clear terms (month, year)



– pharmaceutical form



– the content of sales packaging



-any special precautions to be taken by storage



– a special warning, if the drug requires it



— the lot number



-the registration number



– ' homeopathic medicinal product without approved therapeutic indications '



– a recommendation for the user to consult a doctor if the symptoms do not go away.

2. Notwithstanding paragraph 1, Member States may require the application of certain provisions of the labelling that provides a listing of: – the price of the medicine



– conditions for reimbursement from health insurance.

TITLE VI

CLASSIFICATION OF MEDICINES

Article 70

1. When the competent authorities authorises the placing on the market of a medicinal product, you must indicate its classification as: – a prescription drug



– a non-prescription drug.

The competent authority shall apply for that purpose in article 71, paragraph 1, specified criteria.

2. The competent authorities may fix sub-categories for medicinal products, which can only be dispensed on prescription. In this case, refer to the following classification: (a)) (does not concern the English version)



b) medicinal products subject to special medical prescription



c) prescription medicines to limited extradition, as only certain groups can prescribe.

Article 71

1. Required prescription medicines when they: – directly or indirectly may present a danger, even in normal use, if used without medical supervision, or



– often and to a very large extent will be used under abnormal circumstances, and this can be direct or indirect danger to human health, or



-contain substances or preparations with a basis of these substances whose effect and/or side effects it is absolutely necessary to examine in more detail, or with certain exceptions, is prescribed by a doctor in order to be submitted for parenteral use.

2. Where Member States provide for the sub-category of medicinal products subject to special medical prescription, they shall take account of the following:-the medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions (such as the United Nations conventions of 1961 and 1971), or



– medicinal product can by abnormal use be associated with serious risk of drug abuse, cause drug addiction or give rise to abuse of criminal purposes, or



-the medicinal product contains a substance which, because it is new or has special properties, as a safety measure will be regarded as part of the group referred to in the second indent.

3. Where Member States provide for the sub-category of medicinal products subject to restricted prescription dispensing, they shall take account of the following: – medicinal product is due to its pharmacological properties, because we are talking about a new product, or in order to protect public health, reserved for treatments which can only be conducted in a hospital environment, or



– medicinal product used for the treatment of diseases which must be diagnosed in a hospital environment or in institutions with adequate diagnostic products, whereas the administration of the drug and further patient treatment can be done outside the hospital, or



-the medicinal product is intended for outpatients but its use can cause very serious side effects, which require a prescription issued, where appropriate, by a specialist and a special monitoring during treatment.

4. A competent authority may waive application of paragraphs 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 drug in one of the products listed in article 70, paragraph 2, referred to subcategories, it shall nevertheless take into account the of this article, paragraphs 2 and 3, referred to criteria in determining whether any medicinal product shall be classified in the category of drugs can only be dispensed on prescription.

Article 72

The non-prescription drugs are the drugs that do not meet the criteria listed in article 71.

Article 73

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

Article 74

If new information comes to the knowledge of the competent authorities, these shall examine and, if appropriate, amend the classification of a medicinal product by applying the criteria listed in article 71.

Article 74a

Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority for a period of one year after the approval of the first modification does not take account of the results of these trials when examining an application by another applicant for or holder of a marketing authorisation for a change of classification of the same substance.

Article 75


Member States shall communicate each year to the Commission and to the other Member States the changes they have made to the list referred to in article 73.

TITLE VII

Wholesale distribution and dissemination of drugs

Article 76

1. Without prejudice to article 6, Member States shall take appropriate measures to ensure that in their territories only marketed medicinal products for which marketing authorisation has been issued in accordance with Community law.

2. In the case of wholesale distribution and storage, medicinal product shall be covered by a marketing authorisation issued in accordance with Regulation (EC) No 1782/2003. 726/2004 or by the competent authority of a Member State in accordance with this directive.

3. Any Distributor, not being the marketing authorisation holder, who imports a medicinal product from another Member State shall notify the marketing authorisation holder and the competent authority of the Member State in which the medicinal product to be imported, of its intention to import the medicinal product concerned. With regard to medicinal products which have not been issued a permit pursuant to Regulation (EC) No 1782/2003. 726/2004 shall be notified to the competent authority, without prejudice to additional procedures which may be laid down in the legislation of that Member State, and without prejudice to the fees payable to the competent authority for the processing of the notification.

4. With regard to medicinal products in respect of which a permit has been issued in accordance with Regulation (EC) No 1782/2003. 726/2004, the Distributor must also submit the notification to the holder of the marketing authorisation and the Agency in accordance with paragraph 3 of this article. I have to pay a fee to the Agency in order to verify that the conditions laid down in Community legislation on medicinal products and in the marketing authorisation have been 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 requirement that the person concerned is in possession of an authorization to engage in activity as a wholesaler in medicinal products with an indication of the places on their territory, where the permission is valid.

2. where persons authorized or entitled to supply medicinal products to the public, also can engage in wholesale business, in accordance with national legislation, they are subject to the authorization provided for in paragraph 1.

3. Possession of a manufacturing authorization shall include authorization to distribute by this permit included drugs wholesale. Possession of an authorization to engage in activity as a wholesaler in medicinal products does not exempt from the obligation to obtain permission to manufacture and to comply with the rules laid down for that purpose, nor when the manufacture or importation occurs as a secondary occupation.

4. Member States shall provide information on the authorizations referred to in paragraph 1 in the Community database referred to in article 111, paragraph 6. At the request of the Commission or a Member State, Member States shall submit all useful information on the individual licences they have issued, in accordance with paragraph 1 of this article.

5. responsibility for the implementation of the control of the persons who have been granted permission to engage in activity as a wholesaler in medicinal, as well as for the inspection of their premises, shall be the responsibility of the Member State which issued the permit for premises in its territory.

6. The Member State which issued the authorization referred to in paragraph 1, it shall suspend this or pull it back, if the conditions for authorisation are no longer present. It shall immediately inform the other Member States and the Commission thereof.

7. Where a Member State, the holder of an authorization granted by another Member State in accordance with paragraph 1, do not or no longer fulfil the conditions for authorisation, it shall inform without delay the Commission and the Member State concerned thereof. The latter Member State shall take the necessary measures and provide the Commission and the first Member State of the decisions taken and the reasons therefor.

Article 78

Member States shall ensure that the procedure for the treatment of the distribution authorization does not span 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, that he provides all necessary information on the conditions of the permission. When the competent authority avails itself of this option, suspended the time limit laid down in paragraph 1 until such time as the supplementary information requested has been granted.

Article 79

In order to obtain the distribution authorization, the applicant shall at least comply with the following requirements: (a)) he must have suitable and adequate premises and installations as well as suitable and sufficient equipment, so that the medicines can be stored and dispensed properly



(b)) he must possess a qualified staff, particularly a designated responsible person who fulfils the conditions laid down in the legislation of the Member State concerned



(c)), he must undertake to fulfil the obligations incumbent upon him under article 80.

Article 80

In order to obtain the distribution authorization, the applicant shall at least comply with the following requirements: (a)) at any time give inspecting staff access to premises, installations and equipment referred to in article 79 (a))



(b)) only diminish supplies of medicines from persons who are themselves in possession of the distribution authorization or who are exempted in accordance with article 77, paragraph 3



c) only provide drugs to people who either are themselves in possession of the distribution authorization or who, in the Member State concerned has authorized or entitled to supply medicinal products to the public



CA) verify that the drugs received are not counterfeit, by checking the security measures on the outer packaging in accordance with the requirements referred to in article 54a (2) delegated acts



d) have drawn up an emergency plan which ensures effective implementation of a withdrawal from the market ordered by the competent authorities or in cooperation with the manufacturer of the medicinal product in question or the holder of the marketing authorisation for the medicinal product



e) they must keep records either may exist in the form of purchase/sales invoices, or on computer, or in any other form, giving for any received, sent or disseminated medicines contain at least the following information:



– date



– the name of the medicinal product



– received, sent or disseminated quantity



– name and address of the supplier or consignee, as appropriate



– the number of the batch of drugs, at least for medicinal products which are supplied with the products listed in article 54, point (o)), provided security measures



f) provide the documentation referred to in point (e)) available to the competent authorities for a period of five years for inspection



g) comply with the principles laid down in article 84 and guidelines of good distribution practice.



h) have at their disposal a quality system with a description of responsibilities, workflow and risk management measures related to their business



I) without delay notify the competent authority and, where applicable, the holder of the marketing authorisation of the medicinal products which they receive or are offered, and as they identify as counterfeit or suspect of being counterfeit.

If the medicinal product is received from another wholesaler, wholesale, holders of the authorization for distribution for the purposes of point (b)) to verify that the supplier wholesaler complies with the principles and guidelines of good distribution practice. This includes checking if the supplier wholesaler is the holder of a wholesale distribution authorisation.

If the medicinal product is received from the manufacturer or importer, the holder of the authorization for distribution wholesale check that the manufacturer or importer is the holder of a manufacturing authorisation.

If the medicinal product is received through the dissemination, to be the holder of the authorization for distribution wholesale check that the relevant intermediary satisfies the requirements laid down in this directive.

Article 81

With regard to the supply of medicinal products to pharmacists and persons authorized or entitled to supply medicinal products to the public, Member States shall not impose upon persons who have obtained distribution authorisation in another Member State, obligations, inter alia. public service obligations that are more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities.

The holder of a marketing authorisation for a medicinal product and the distributors of the product, there are actually placed on the market in a Member State, within the framework of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorized to supply medicinal products so that the needs of patients in the Member State in question are covered.

The detailed rules for implementing this article should, moreover, be justified on public health protection and be proportionate to the objective of such protection, in accordance with the provisions of the Treaty, including in particular the provisions on the free movement of goods and competition.

Article 82

For all supplies of medicinal products to a person who, in the Member State concerned has authorized or entitled to supply medicinal products to the public, wholesalers with permission to enclose the required documentation for: – date




– the name of the medicinal product and the form



– delivered quantity



– the supplier and the recipient's name and address



– medicines lot number, at least for drugs that are provided with the security measures referred to in article 54, point (o)).

Member States shall take appropriate measures to ensure that persons authorized or entitled to supply medicinal products to the public are able to provide information that makes it possible to follow the chain of distribution path of every medicinal product has gone through.

Article 83

The provisions of this section shall not prevent a Member State from applying stricter provisions for wholesale distribution: – of narcotic or psychotropic substances at its area



– medicinal products derived from blood



– of immunological medicinal products



– of radiopharmaceuticals.

Article 84

The Commission shall publish guidelines on good distribution practice. It belongs to that end, the Committee for medicinal products and by Council decision 75/320/EEC (*) created the pharmaceutical Committee.

(*) OJ L 147 of 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 the wholesale distribution of medicinal products to third countries. In addition, the provisions of article 80 (b)) and ca), does not apply where a medicinal product is received directly from a third country but cannot be imported. The requirements of article 82 shall apply to the supply of medicinal products to persons in third countries authorized or entitled to supply medicinal products to the public.

Article 85b

1. Persons who disseminate medicinal products shall ensure that the brokered medicines are covered by a marketing authorisation issued in accordance with Regulation (EC) No 1782/2003. 726/2004 or by the competent authorities of a Member State in accordance with this directive.

Persons who disseminate medicinal products must have a fixed address and contact information in the Union in order to ensure an accurate identification, localization and communication as well as to enable the competent authorities to supervise their operations.

The requirements of article 80, paragraph (d))-in), shall apply mutatis mutandis to distribution of medications.

2. Only persons who are registered by the competent authority of the Member State where they have permanent address, see. paragraph 1 shall communicate the medicines. These persons shall inform, as a minimum, your name, business name and permanent address for the purpose of registration. They shall notify the competent authority of any modification thereof without unnecessary delay.

Persons providing medicines, and which started their activities in the 2. January 2013, shall register with the competent authority within the 2. March 2013.

The competent authority shall establish the information referred to in the first subparagraph, in a publicly accessible register.

3. The guidelines referred to in article 84 shall contain specific provisions concerning dissemination.

4. This article shall be without prejudice to article 111. The inspections referred to in article 111 shall be conducted under the responsibility of the Member State in which the person who conveys medicines are registered.

Meet a person who conveys medicines, not the requirements of this article, the competent authority may decide to remove the question from the register referred to in paragraph 2. The competent authority shall notify the person concerned thereof.

TITLE VIIA

DISTANCE SELLING TO THE PUBLIC

Article 85 c

1. subject to the ban on distance sales of prescription-only medicines to the general public through information society services under national legislation, Member States shall ensure that the sale of medicinal products to the public is provided through information society services as defined in European Parliament and Council Directive 98/34/EC of 22. June 1998 relating to a procedure for the provision of information in the field of technical standards and regulations as well as regulations for the information society tjenester28), subject to the following conditions: (a)) the natural or legal person, who offers medicinal products is authorized or entitled to supply medicinal products to the public, even at a distance, in accordance with the national law of the Member State in which the person is established;



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



i. name or corporate name and permanent address of the establishment from which these drugs are delivered



II. the date of commencement of the business, which consists in offering remote sale of medicinal products to the public through the services of the information society



III. the address of the Web site that is used for this purpose, and all relevant information necessary for the identification of this site



IV. where relevant, the classification pursuant to Title VI of the drugs that are offered to the public at a distance through the services of the information society.

The information is updated if necessary c) medicines complies with the national law of the Member State of destination in accordance with article 6, paragraph 1



d) without prejudice to the information requirements provided for in European Parliament and Council Directive 2000/31/EC of 8. of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the internal market (' directive on electronic commerce ') 29), contains the Web site that is providing medicines, at a minimum, the following:



i. contact information on the competent authority, or the authority designated in accordance with subparagraph (b))



II. a link to the Web site referred to in paragraph 4, the Member State of establishment



III. the Community logo referred to in paragraph 3, clearly marked on each page in the Web site relating to distance marketing of medicinal products to the public. The common logo must include a link to the construction of the person on it in paragraph 4 (c)), the list provided.

2. Member States may, on grounds relating to the protection of public health establish conditions for retail sales in their territory by means of distance selling of medicinal products to the public through the services of the information society.

3. There must be a common logo, which is recognizable throughout the Union, and which at the same time makes it possible to identify the Member State in which the person offering remote sale of medicinal products to the public, is established. The logo must be clearly placed on sites offering medicinal products to the public at a distance, in accordance with paragraph 1 (d)).

The Commission must, in order to harmonise the way in which the common logo work, adopt implementing acts relating to: (a)) the technical, electronic and cryptographic requirements for control of the joint logos authenticity



(b)) the design of the common logo.

These implementing acts shall, if necessary, be amended to take account of technical and scientific developments. Implementing acts adopted in accordance with the procedure referred to in article 121, paragraph 2.

4. Each Member State shall set up a Web site that contains, at a minimum, the following: (a)) information on applicable national legislation relating to the supply of medicinal products to the public at a distance through the services of the information society, including information that there may be differences between the Member States with regard to the classification of medicinal products and the conditions of delivery of these



b) indication of the purpose of the common logo



(c)) the list of people who offer distance marketing of medicinal products to the public through the services of the information society in accordance with paragraph 1, together with the addresses on their websites



d) background information about the risks associated with illicit supply of medicinal products to the public through the services of the information society.

This Web site must include a link to the Web site referred to in paragraph 5.

5. The Agency shall set up a Web site, which provides in paragraph 4 (b)) and (d)), referred to information, information on the acquis relating to counterfeit medicines, as well as links to Member State sites, see. (4). The Agency's Web site must explicitly mention that Member States ' Web sites contains information about persons authorised or entitled to supply medicinal products to the public via distance selling through information society services in the Member State concerned.

6. Without prejudice to Directive 2000/31/EC and the requirements set out in this title, Member States shall take the necessary measures to ensure that persons other than those referred to in paragraph 1, which offers the public medicinal products at a distance through the services of the information society, and as operating on their territory will be subject to effective, proportionate and dissuasive sanctions.

Article 85 d

Without prejudice to the powers of the Member States, implement or facilitate the Commission in cooperation with the Agency and the competent authorities of the Member States information campaigns directed at the public at large about the dangers of counterfeit medicines. These campaigns to raise consumer awareness about the dangers of drugs, supplied illegally by distance selling to the general public through the services of the information society, and about the function of the common logo, the Member States ' sites and the Agency's Web site.

TITLE VIII

ADVERTISING

Article 86

1. For the purposes of this title ' advertising of medicinal products ' means any form of information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; This includes, in particular: – advertising to the general public of medicinal products




-advertising of medicinal products to persons qualified to prescribe or supply medicinal products



– pharmaceutical consultants visits to persons qualified to prescribe or supply medicinal products



– extradition of samples



– incitement to prescribe or supply medicinal products by make, offer or promise cash benefits or benefits in kind, except if the real value of this is insignificant



– sponsorship of promotional meetings involving persons qualified to prescribe or supply medicinal products



– sponsorship of scientific congresses, in which participating persons qualified to prescribe or supply medicinal products, and in particular the holding of these individuals ' spending on transport and stay in this connection.

2. This section shall not apply to: – labelling and package leaflet as covered by the provisions of title V



-correspondance, accompanied, where appropriate, by a document of non-promotional nature, needed to answer a specific question about a particular medicinal product



– practical information and documentation relating to, for example. changes in packaging, warnings against side effects in the context of pharmacovigilance, as well as sales catalogues and price lists, provided they do not contain any information on the medicinal products



– information on health and diseases in humans, in so far as that herein, either directly or indirectly refer to a drug Article 87

1. Member States shall prohibit any advertising of a medicinal product for which marketing authorisation has not been issued in accordance with Community law.

2. All details of an advertisement for a medicinal product must match the information listed in the summary of the product characteristics.

3. The advertising of a medicinal product: – to promote the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties,



– must not be misleading.

Article 88

1. Member States shall prohibit the advertising to the general public of medicinal products which: (a)) on prescription, in accordance with Title VI of the



(b) contain psychotropic or narcotic substances) as defined in international conventions, such as the United Nations conventions of 1961 and 1971.

2. Advertising to the general public is permitted for medicinal products which, by virtue of their composition and purpose, are intended and designed to be used without prior medical diagnosis or for the prescription or without medical monitoring of treatment, but, if necessary, following guidance from the pharmacy.

3. Member States may, on their territory, prohibit the advertising to the general public for reimbursable medicines.

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

5. the prohibition in paragraph 1 shall apply, save as otherwise provided for in article 14 of Directive 89/552/EEC.

6. Member States shall prohibit the industry to make the direct distribution of medicinal products to the public for promotional purposes.

TITLE VIIIa

INFORMATION AND ADVERTISING

Article 88a

The Commission shall submit, before expiry of three years from the entry into force of Directive 2004/726/EC, following consultations with patients ' and consumers ' organisations, doctors ' and pharmacists ' associations, Member States and other stakeholders, the European Parliament and the Council a report on the current practice in the field of information, including, inter alia, via the Internet, and about the associated risks and benefits for patients.

After an analysis of the above data, the Commission shall draw up, where appropriate, proposals for an information strategy to ensure good, objective, reliable and non-promotional information on medicinal products and other treatments, and deals with the issue of the responsibility of the information source.

Article 89

1. Without prejudice to article 88, all advertising to the general public of a medicinal product: (a)) shall be designed in such a way that the message is in the nature of advertising is manifest and the product is clearly identified as a medicinal product



b) include at least:



– the name of the medicinal product, as well as the common name if the medicinal product contains only one active substance



– the information necessary for correct use of the medicinal product



– a specific and legible invitation to read carefully the instructions that are listed, as appropriate, in the package leaflet or on the outer packaging.

2. Member States may decide that the advertising to the general public of a medicinal product notwithstanding the provisions of paragraph 1 may be limited to the name of the medicinal product or the international proprietary name, where this exists, or the trademark, if it is intended solely to serve as a reminder.

Article 90

Public advertising of a medicinal product shall not contain elements which: (a)) gives the impression that it is superfluous to consult a doctor or having a surgical intervention, in particular by offer of diagnosis or recommendation of treatment by correspondence



(b)) suggests that the effect of the drug is safe, with no side effects and is better or just as good as the impact of a second treatment or another drug



c) suggests that the health of the subject can be enhanced by the use of the medicinal product



(d)) suggests that the right comfort level will be affected if he is not taking the medicine; This prohibition shall not apply to vaccination campaigns as referred to in article 88, paragraph 4



e) solely or mainly caters for children



f) refers to a recommendation by scientists, health professionals or persons who, although they are neither scientists or medical practitioners, by virtue of their reputation can encourage the consumption of medicinal products



(g)) suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;



h) suggests that the safety of the medicinal product or its effectiveness is due to the fact that in the case of a natural substance



in) by a description or detailed representation of a case history can lead målpersonen to even erroneous diagnosis



j) in improper, alarming or misleading way refers to claims of recovery



k) in improper, alarming or misleading way makes use of pictorial representations of changes in the human body caused by disease or injury, or of the impact of a medicinal product on the human body or parts thereof.

Article 91

1. Any advertising of medicinal products to persons qualified to prescribe or supply medicinal products shall include: – the relevant information that is compatible with the summary of the product characteristics



– dispensing of the medicinal product classification.

Member States may also require that this advertising includes the selling price or indicative price for the different packages and the conditions for reimbursement through health insurance.

2. Member States may decide that the advertising of a medicinal product to persons qualified to prescribe or supply this drug, notwithstanding the provisions of paragraph 1 may be limited to the name of the medicinal product or the international proprietary name, where this exists, or the trademark, if it is intended solely to serve as a reminder.

Article 92

1. All information material about a drug, as in promotional purposes, be sent to persons qualified to prescribe or supply this medicinal product must include at least the in article 91, paragraph 1, the information referred to, and specify the date on which it was drawn up or last revised.

2. All the contents of the material referred to in paragraph 1 shall be accurate, up-to-date, verifiable and sufficiently detailed for that recipient can form a personal opinion about the therapeutic value of the medicinal product.

3. Quotations, tables, and other illustrations taken from medical journals or scientific works, as used in the dossier referred to in paragraph 1, must be faithfully reproduced, and the exact source must be provided.

Article 93

1. Medical sales representatives shall have received appropriate training with the company that they work for, and be in possession of the necessary professional knowledge, so that they can provide as accurate and complete information as possible about the medicinal products which they present.

2. During every visit to medical sales representatives for each of the present together drugs provide the person in whom visited, or put at his disposition a summary of product characteristics, if the legislation of the Member State so permits, be supplemented with the information about prices and conditions for reimbursement referred to in article 91, paragraph 1.

3. Medical sales representatives shall give the Committee referred to in article 98, paragraph 1, referred to scientific service all the information regarding the application of the medicines, as they seek to promote, in particular such information about side effects, which they receive from the people with whom they have visited.

Article 94

1. By promoting the sale of pharmaceutical products in the face of persons qualified to prescribe or supply medicinal products in question, it shall be prohibited to grant, offer or promise these people prizes, cash benefits or benefits in kind, unless they are of negligible value and stand in connection with the practice of medicine or pharmacy profession.

2. Representation in connection with promotional events for medicinal products shall always be strictly limited to the main purpose of the meeting and must not be extended to persons other than health-care professionals.


3. Persons qualified to prescribe or supply medicinal products shall not solicit or receive any of the benefits which is prohibited pursuant to paragraph 1, or which is contrary to paragraph 2.

4. The measures or trade practices in Member States applies to prices, margins and discounts shall not be affected by paragraph 1, 2 and 3.

Article 95

The provisions of article 94, paragraph 1 shall not prevent the direct or indirect representation in connection with events of purely professional and scientific nature; such representation shall always be strictly limited to the main scientific objective of the event; It must not be extended to other than health professionals.

Article 96

1. Free samples to persons qualified to prescribe medicinal products must be supplied only in exceptional cases and subject to the following conditions: (a)) that must be supplied only a limited number of samples for each medicinal product each year to each qualified person



b) any supply of samples requires the authorized person has submitted a written, dated and signed request,



(c)) for those supplying samples shall maintain an adequate system for implementation of control and accountability;



d) each sample must not be larger than the smallest packaging placed on the market



e) each sample shall be marked ' free medical sample not for sale ', or any other inscription of equivalent importance



f) each sample shall be accompanied by a copy of the summary of product characteristics



g) there must be no handed out samples of medicinal products containing psychotropic or narcotic substances under international conventions, such as the United Nations Convention of 1961 and 1971.

2. Member States may further restrict the distribution of samples of certain medicinal products.

Article 97

1. Member States shall ensure that adequate and effective means exist to monitor the advertising of medicinal products. Such funds, which can be based on a system of prior control, must in any event include legal provisions under which persons or organizations regarded under national law as having a legitimate interest in obtaining an injunction against an advertisement, which is inconsistent with this section, may refer the matter to the Court with a demand to ban the concerned advertisement or refer the matter to an administrative body which have jurisdiction either to decide on complaints or to initiate appropriate legal proceedings.

2. Within the framework of the legal provisions referred to in paragraph 1, Member States shall confer upon the courts or administrative authorities powers enabling them, in cases where they deem such measures to be necessary taking into account all the interests involved and in particular the public interest:-to order the cessation of, misleading advertising, or to institute appropriate legal proceedings for an order ordered the cessation of such advertising



  or



– to prohibit such advertising, or to institute appropriate legal proceedings to get the misleading advertising is prohibited, if it has not yet been published but publication is imminent, even if no proof of actual loss or damage or of intention or negligence on the part of the advertiser.

3. Member States shall make provision for the measures referred to in paragraph 2 shall be taken in the context of an accelerated procedure either with interim effect or with definitive effect.

It is for each Member State to decide which of the two options, which are referred to in the first subparagraph, it will choose.

4. Member States may, with a view to eliminating the continuing effects of misleading advertising, there is cessation, by a final decision, confer upon the courts or administrative authorities powers enabling them: – to require publication of that decision in its entirety or in part and in such form as they deem adequate



– to require the further publication of a corrigendum. 5. paragraphs 1 to 4 shall not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies, which can also deal with complaints, if there for such bodies is provided for a procedure in addition to those referred to in paragraph 1, the judicial and administrative procedures.

Article 98

1. The marketing authorization holder shall establish within his undertaking, a scientific service in charge of information about the medicinal products which the company markets.

2. The marketing authorization holder shall: – shall ensure that a copy of all of the company's advertising, together with an information sheet with details of the recipients, the routing style and date of first distribution, made available to the authorities or bodies responsible for monitoring advertising of medicinal products, or be forwarded to these



– ensure that the company's advertising of medicinal products is in accordance with the provisions laid down in this subparagraph



– check that the company employees of medical sales representatives have appropriate training and comply with the obligations incumbent on them under article 93 (2) and (3)



– gives the authorities or bodies responsible for monitoring advertising of medicinal products, the information and assistance they request with a view to the exercise of their powers



– shall ensure that decisions taken by the authorities or bodies responsible for monitoring advertising of medicinal products, comply immediately and in full.

3. Member States shall not prohibit the co-promotion of a jointly with one or more companies nominated by this carries out promotional activities for drugs.

Article 99

Member States shall take appropriate measures to ensure that the provisions of this section shall be conducted, and shall determine in particular the sanctions, to be implemented in the event of infringement of the provisions adopted for the implementation of this subparagraph.

Article 100

Advertising within the scope of article 14, paragraph 1, referred to homeopathic medicinal products fall under the provisions of this title, with the exception of article 87, paragraph 1.

However, only the particulars provided for in article 69, paragraph 1, referred to information used in the advertising of such medicinal products.

TITLE IX

PHARMACOVIGILANCE

CHAPTER 1

General provisions

Article 101

1. in order to be able to perform their pharmacovigilance tasks and participate in the Union's pharmacovigilance activities, Member States shall apply a system of pharmacovigilance.

The pharmacovigilance system must be used to collect information about the risks to patients ' health or public health, that are associated with drugs. This information shall relate in particular to the side effects in humans as a result of the use of the medicinal product in accordance with the marketing authorisation as well as for any use outside the terms of the marketing authorisation and the side effects associated with occupational exposure.

2. Using the provided for in paragraph 1, Member States shall carry out a pharmacovigilance system scientific evaluation of all information, considering opportunities for risk minimization and prevention and take legislative measures relating to marketing authorisation, if it is necessary. They shall conduct regular audits of their pharmacovigilance system and report the results to the Commission not later than the twenty-first century. September 2013 and thereafter every two years.

3. Each Member State shall designate a competent authority for the conduct of pharmacovigilance.

4. the Commission may request Member States to participate, under the coordination of the Agency, in international harmonization and standardization of technical measures in the field of pharmacovigilance.

Article 102

Member States: (a)) shall take all appropriate measures to encourage patients, doctors, pharmacists and other healthcare professionals to report suspected adverse reactions to the competent national authority; for the purposes of carrying out these tasks can be carried out, where appropriate, the involvement of consumer organisations, patients ' organisations and organisations representing healthcare professionals



b) promotes patient reporting through provision of alternative reporting formats in addition to Web-based formats



(c)) shall take all necessary measures for the collection of accurate and verifiable data to use for the scientific evaluation of reports of suspected adverse reactions



(d)) shall ensure that the public receives vital information about concerns in a timely manner based on pharmacovigilance, relating to the application of medicines, through publication on the Web portal and through other public information channels, if necessary



e) ensures through the collection of information and, if necessary, through follow-up to reports of suspected adverse drug reactions, to take all necessary measures for the identification of all biologic drugs, prescribed, dispensed or sold on their territory which is the subject of a reported suspected adverse reactions, taking due account of the name of the medicinal product (in accordance with article 1, no. 20) and lot number



f) shall take the necessary measures to ensure that a marketing authorisation holder who does not comply with the conditions laid down in this section, penalties that are effective, proportionate and dissuasive tionate to.


Through the application of the first subparagraph, point (a)) and e), Member States may impose on doctors, pharmacists and other health-care professionals special obligations.

Article 103

A Member State may delegate tasks, it has been imposed in accordance with this section, to another Member State, if this gives written permission to do so. A Member State may not represent more than one other Member State.

The delegating Member State informs the Commission in writing, the Agency and other Member States of the delegation. The delegating Member State and the Agency shall publish such information.

Article 104

1. With a view to the fulfilment of its pharmacovigilance tasks using the marketing authorisation holder a pharmacovigilance system, which corresponds to the relevant Member State's pharmacovigilance system in article 101, paragraph 1.

2. Using the provided for in paragraph 1, system of pharmacovigilance, the marketing authorisation holder shall conduct a scientific evaluation, considering opportunities for risk minimization and prevention and take appropriate measures, if necessary.

The marketing authorisation holder shall conduct a periodic review of his pharmacovigilance system. He puts a note on the main findings of the review in the master file of the pharmacovigilance system and guarantees on the basis of audit findings that a plan of appropriate corrective measures be drawn up and implemented. When the corrective action has been fully implemented, the note can be removed.

3. As part of the pharmacovigilance system, the holder of the marketing authorization: a) have permanently and someone who is sufficiently expert at his disposal, which is responsible for pharmacovigilance,



b) lead and on request a pharmacovigilance system master file available



(c)) use a risk management system for each medicinal product



d) monitor the outcome of the risk minimisation measures contained in risk management systems, or which are laid down as conditions of the marketing authorisation pursuant to articles 21a, 22 or 22a;



e) updating 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 the benefits and risks of medicines.

The qualified person referred to in the first subparagraph, point (a)), should be resident and carry out its work in the Union and is responsible for the creation and operation of the pharmacovigilance system. The marketing authorisation holder sends the qualified person's name and contact information for the competent authority and the Agency.

4. Notwithstanding the provisions of paragraph 3, the competent authorities may request the appointment of a contact person for pharmacovigilance issues at national level, which shall report to the experts, which is responsible for pharmacovigilance activities.

Article 104a

1. without prejudice to the provisions of this article, paragraphs 2, 3 and 4, holders of marketing authorisations granted before the 21st century. July 2012, by way of derogation from article 104, paragraph 3, point (c)), will not be subject to the requirement to apply a risk management system for each medicinal product.

2. The national competent authority may require the marketing authorisation holder an obligation to apply a risk management system, see. Article 104, paragraph 3, point (c)), if there are concerns regarding the relationship between the benefits and risks of an authorised medicinal product. In this context, instructs the national authority, also the holder of the marketing authorisation the obligation to submit a detailed description of the risk-management system which he intends to introduce for the medicinal product concerned.

The imposition of such obligations must be duly justified, shall be notified in writing and include a time frame for the submission of the detailed description of the risk management system.

3. The competent national authority shall provide the marketing authorisation holder to submit written observations in response to the imposition of the obligation, within a time limit which it shall fix, if the marketing authorisation holder so requests within 30 days of receipt of the written notice of the obligation.

4. On the basis of the written submissions, that the marketing authorisation holder has delivered, pulling the national competent authority the obligation back or confirms it. Where the national competent authority confirms the obligation, the marketing authorisation shall be amended accordingly, so that the measures that must be contained in the risk management system shall be included as conditions of the marketing authorisation as referred to in article 21a) (a).

Article 105

The management of funds earmarked for activities connected with pharmacovigilance, functioning of communication networks and market surveillance shall be verified by the national competent authorities in order to ensure their independence in the exercise of the said medicinal product surveillance activities.

Paragraph 1 shall not preclude that national competent authorities charge a fee for marketing authorisation holders for the national competent authorities, the execution of these activities, provided there is strict guarantees of their independence in the exercise of the said medicinal product surveillance activities.

CHAPTER 2

Openness and communication

Article 106

Each Member State shall establish and administer a national Web portal on medicinal products, which shall be in the context of the European medicines Web-portal established in accordance with article 26 of Regulation (EC) No 1782/2003. 726/2004. Through the national Web portals on medicines makes Member States at least the following information: (a) publicly available) public assessment reports accompanied by summaries thereof



b) summaries of product characteristics and package inserts



c) summary of the flood risk management plans for medicinal products authorised in accordance with this directive



(d)) the list of medicinal products, see. Article 23 of Regulation (EC) No 1782/2003. 726/2004



e) information about the different ways in which health-care professionals and patients may report suspected adverse reactions to medicinal products for the competent national authorities, including on the Web-based structured forms referred to in article 25 of Regulation (EC) No 1782/2003. 726/2004.

Article 106a

1. As soon as the marketing authorisation holder intends to publish information about concerns based on pharmacovigilance in connection with the use of a medicinal product, and in any event at the same time as or before publication, he informs the competent national authority, the Agency and the Commission thereof.

The marketing authorisation holder shall ensure that the information presented to the public on an objective and not misleading way.

2. Unless rapid publication is required in the interests of public health protection, it shall inform the Member States, the Agency and the Commission each other at least 24 hours prior to the publication of information about concerns based on pharmacovigilance.

3. For active substances of the medicinal products authorised in more than one Member State, is the agency responsible for coordination of the national competent authorities ' security notifications and sets timetables for the publication of information.

Coordinated by the Agency, the Member States themselves make all reasonable efforts to reach agreement on a joint communication on the safety of the medicinal product and a timetable for their dissemination. The Committee for risk assessment in the field of pharmacovigilance Adviser on request from the Agency about these security messages.

4. When the Agency, or the national competent authorities shall publish the information referred to in paragraphs 2 and 3, exclude information of personal or commercially confidential nature, 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 marketing authorisation holder shall record all suspected adverse reactions within the Union or in third countries, as he gets familiar with, regardless of whether they are reported spontaneously by patients or health-care professionals, or whether it is established in connection with an investigation in accordance with the marketing authorisation.

The marketing authorisation holder shall ensure that these reports are available in one place in the Union.

Notwithstanding the first subparagraph are recorded and reported suspected adverse reactions have been observed in connection with a clinical trial, in accordance with Directive 2001/20/EC.

2. the marketing authorisation holder does not reject to deal with reports of suspected adverse reactions by patients and healthcare professionals submit electronically or in some other appropriate manner.

3. the marketing authorisation holder shall electronically forward information on all serious suspected adverse reactions that have been observed in the European Union or third countries, to the data base and the data referred to in article 24 of Regulation (EC) No 1782/2003. 726/2004 (' the Eudravigilance database '), no later than 15 days after the marketing authorisation holder has knowledge of the incident.

The marketing authorization holder shall electronically forward information about all non-serious suspected adverse reactions recorded in the Union, within 90 days after that the marketing authorisation holder has knowledge of the incident.


In the case of medicinal products containing the active substances referred to in the list of publications, as monitored by the Agency in accordance with article 27 of Regulation (EC) No 1782/2003. 726/2004, the marketing authorisation holder is not subject to a requirement to make reporting to Eudravigilance database of suspected adverse reactions which are registered in the listed medical literature, but he must monitor all other medical literature and report all suspected adverse reactions.

4. The marketing authorization holder shall be required to establish procedures for obtaining accurate and verifiable data to use for the scientific evaluation of reports of suspected adverse reactions. He must also obtain follow-up information on these alerts and report updates to the Eudravigilance database.

5. the marketing authorisation holder shall cooperate with the Agency and Member States on tracking of double reporting of suspected adverse reactions.

Article 107a

1. each Member State shall record all suspected adverse reactions which is found on its territory, and as healthcare professionals and patients have made the attention. In order to comply with the provisions of article 102) (c) and (e)), the Member States shall, where appropriate, patients and healthcare professionals in the follow-up on all alerts they receive.

Member States shall ensure that reports of such side effects can be transmitted by means of the national Web portals on medicines or otherwise.

2. with regard to the information provided by the holder of a marketing authorisation, the Member State in whose territory the alleged adverse reaction occurred, involving the holder of the marketing authorisation in the follow-up of reports.

3. Member States shall cooperate with the Agency and marketing authorisation holders on double tracking reports of suspected adverse reactions.

4. within 15 days after receipt of the reports referred to in paragraph 1 about serious suspected adverse reactions, Member States shall send reports by electronic means to the Eudravigilance database.

Within 90 days after receipt of the reports referred to in paragraph 1, they shall send electronically notifications about non-serious suspected adverse reactions to the Eudravigilance database.

The marketing authorisation holder has access to these alerts via the Eudravigilance database.

5. Member States shall ensure that reports of suspected adverse reactions as a result of medication errors, as they gain knowledge of, be made available to the Eudravigilance database and for the authorities, agencies, organisations and/or institutions responsible for patient safety in Member States. They shall also ensure that all competent authorities for medicinal products in the Member States shall be informed of all suspected adverse reactions, like any other authority of the Member States knowledge of. These alerts are identified in an appropriate way in the in article 25 of Regulation (EC) No 1782/2003. 726/2004 referred to forms.

6. Each of the Member States do not subject the marketing authorisation holder additional obligations with regard to the reporting of suspected adverse reactions, unless these be justified on the basis of results of pharmacovigilance activities.

Section 2

Periodic safety update reports

Article 107b

1. Marketing Authorisation holders shall submit periodic safety update reports for the Agency, containing: a) summaries of information relevant to the assessment of the benefits and risks of the medicinal product, including the results of all surveys containing an analysis of the potential implications for the marketing authorisation



(b)) a scientific evaluation of the relationship between the benefits and risks of the medicinal product



c) all information on the volume of sales of the medicinal product and all the information about the prescription volume, as the holder of the marketing authorisation held by including an estimate of how large a population that is exposed to the drug.

The evaluation referred to in subparagraph (b)) shall be based on all available information, including information from clinical trials do not approved indications and populations.

The periodic safety update reports are submitted electronically.

2. The Agency shall provide the safety update reports referred to in paragraph 1 available to the competent national authorities, members of the Committee for risk assessment in the field of pharmacovigilance, the Committee for medicinal products for Human use and the coordination group using it in article 25a of Regulation (EC) No 1782/2003. 726/2004 referred to archive.

3. by way of derogation from paragraph 1, the holder of a marketing authorisation for a medicinal product referred to in article 6. Article 10, paragraph 1, or Article 10a, and the holder of the records for a medicinal product referred to in article 6. Article 14 or 16a, submit periodic safety update reports for such a medicinal product in the following cases: (a)) if such an obligation is laid down as a condition of the marketing authorisation in accordance with article 21a or article 22, or



(b)) when requested to do so by a competent authority on the basis of concerns relating to pharmacovigilance data or as a result of lack of periodic safety update reports concerning an active substance after the granting of a marketing authorisation. Evaluation reports concerning the desired periodic safety update reports shall be sent to the Committee for risk assessment in the field of pharmacovigilance, which decides 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, inform the coordination group or the Committee for medicinal products for Human use, with a view to the application of the procedures set out in article 107 c, paragraph 4, and article member.

Article 107 c

1. Frequency of submission of the periodic safety update reports specified in the marketing authorisation.

Dates of submission, in accordance with the prescribed frequency is calculated from the date of the marketing authorisation.

2. Holders of marketing authorisations granted before the 21st century. July 2012, and for which the frequency and dates of the periodic safety update reports not laid down as a condition of the marketing authorisation, shall submit the periodic safety update reports in accordance with the second subparagraph, until another frequency or other dates laid down in the marketing authorization or shall be decided on in accordance with paragraphs 4, 5 or 6.

Periodic safety update reports shall be submitted to the competent authorities, as soon as requested, or in accordance with the following: (a)) where a medicinal product is not yet on the market, at least six months after the marketing authorisation, and until the medicinal product placed on the market



(b)) If a drug is marketed, at least every six months for the first two years following the initial placing on, once a year the following two years, and every third year thereafter.

3. paragraph 2 shall also apply to medicinal products authorised in one Member State only, and to which paragraph 4 does not apply.

4. If the medicinal products for which marketing authorisations have been issued various, contains the same active substance or combination of active substances, the frequency and dates of the periodic safety update reports, resulting from the application of paragraphs 1 and 2, shall be amended and shall be coordinated, so that can be made in a single assessment in the context of a procedure for Division of labour around periodic periodic safety update reports, and establish a Community reference date from which delivery dates are calculated.

This harmonised frequency of alerts and the EU-reference date may, after consulting the Committee for risk assessment in the field of pharmacovigilance shall be determined: (a)) either by the Committee for medicinal products for Human use, if at least one of the marketing authorisations for medicinal products containing the active substance concerned has been issued under the centralised procedure set out in Chapter 1 of title II of Regulation (EC) No 1782/2003. 726/2004



(b)) or by the coordination group, in cases other than those referred to in subparagraph (a)).

The Agency publishes the harmonised frequency for safety update reports provided for under the first and second subparagraphs. The holder of a marketing authorisation must accordingly submit an application for amendment of the marketing authorisation.

5. For the purposes of paragraph 4, the EU-reference date for medicinal products containing the same active substance or combination of active substances, one of the following: a) the date of the first marketing authorisation in the Union of a medicinal product containing that active substance or combination of active substances



(b) if the date referred to in subparagraph (a))) cannot be established, the earliest of the known dates for marketing authorisations for medicinal products containing that active substance or combination of active substances.

6. Marketing Authorisation holders for one of the following reasons may ask the Committee for medicinal products for Human use or the coordination group to lay down Community reference date or change the frequency of the periodic safety update reports: (a)), in order to protect public health



(b)) in order to avoid overlapping reviews



(c)) in order to achieve international harmonisation.


Such requests must be submitted in writing and duly justified. After consultation of the Committee for risk assessment in the field of pharmacovigilance responds to or rejects the Committee for medicinal products for Human use or the coordination group such requests. In the event of a change in the reference dates or frequency of submission periodic safety update reports, the Agency shall publish a communication to this effect. Marketing authorisation holders must accordingly submit an application for amendment of the marketing authorisation.

7. The Agency shall publish a list of Community reference dates and frequency of the periodic safety update reports via the European Web portal on medicinal products.

Any change in the dates and the frequency of the periodic safety update reports specified in the marketing authorisation as a result of the application of paragraphs 4, 5 and 6, shall enter into force six months after their publication.

Article 107d

The national competent authorities shall assess the periodic safety update reports to determine whether there are new or changed risks or whether there are changes in the relationship between the benefits and risks of medicines.

Article Member

1. Made a single assessment of periodic safety update reports for medicinal products authorised in more than one Member State, and in the cases referred to in article 107 c, paragraphs 4, 5 and 6, for all medicinal products containing the same active substance or combination of active substances for which there is a Community reference date and frequency of the periodic periodic safety reports.

This assessment shall be carried out by one of the following: a) a Member State, as designated by the coordination group, if none of the concerned marketing authorisation issued in accordance with the centralised procedure set out in Chapter 1 of title II of Regulation (EC) No 1782/2003. 726/2004



(b)) a Rapporteur of the Committee for risk assessment in the field of pharmacovigilance have appointed, if at least one of those marketing authorisations issued in accordance with the centralised procedure set out in Chapter 1 of title II of Regulation (EC) No 1782/2003. 726/2004.

In the selection of a Member State in accordance with the second subparagraph, point (a)), takes the coordination group as to whether a Member State acts as reference Member State in accordance with article 28, paragraph 1.

2. Member State or Rapporteur shall draw up an assessment report within 60 days after receipt of the periodic safety update report and send it to the Agency and the Member State concerned. The Agency shall forward the report to the holder of the marketing authorisation.

Within 30 days of receipt of the assessment report, the Member State and the marketing authorisation holder shall submit comments to the Agency and to the rapporteur or the Member State concerned.

3. within 15 days after the receipt of the comments referred to in paragraph 2, the Member State or Rapporteur shall update the assessment report, having regard to the observations and transmit it to the Committee for risk assessment in the field of pharmacovigilance. The Committee for risk assessment in the field of pharmacovigilance shall adopt the assessment report with or without further changes at its subsequent meeting and issue a recommendation. The recommendation sets out the dissent and the reasons therefor. The Agency stores the adopted recommendation in the assessment report and in accordance with article 25a of Regulation (EC) No 1782/2003. 726/2004 created the archive and transmit them both to the holder of the marketing authorisation.

Article 107f

After the assessment of periodic safety update reports considering the national competent authorities, whether measures are needed as regards the marketing authorisation for the medicinal product concerned.

They maintain, change, shall suspend or revoke the marketing authorisation.

Article 107 g

1. In the case of a single assessment of periodic safety update reports, which recommend measures concerning more than one marketing authorisation referred to in article 6. Article Member, paragraph 1, and which does not include a marketing authorisation issued in accordance with the centralised procedure set out in Chapter 1 of title II of Regulation (EC) No 1782/2003. 726/2004, the coordination group shall, within 30 days after it has received the report of the Committee for risk assessment in the field of pharmacovigilance, report and take a position regarding the conservation, modification, suspension or revocation of the marketing authorisations concerned, including a time limit for the implementation of the established attitude.

2. When the Member States, which are represented in the coordination group, to agree on the measures to be taken, the Chairman, that there is a consensus, and sends the established position to the marketing authorisation holder and the Member States. Member States shall adopt the measures necessary for the conservation, modification, suspension or revocation of the marketing authorisations concerned in accordance with the implementation timetable laid down in the attitude.

In the event of a change in the holder of the marketing authorisation within the framework of the prescribed implementation timetable a proper request for change to the national competent authority. The request must contain an up-to-date summary of product characteristics and a leaflet.

There can be no agreement is reached, it will send the position taken by the majority of the Member States, which are represented in the coordination group, has agreed to the Commission, using the procedure set out in article 33 and 34.

Differ by the position taken by the Member States, which are represented in the coordination group, agreed, or the attitude of the majority of Member States from the recommendation of the Committee for risk assessment in the field of pharmacovigilance, the coordination group shall attach to its opinion or majority a detailed explanation of the scientific basis for the differences, along with the recommendation.

3. In the case of a single assessment of periodic safety update reports, which recommend measures concerning more than one marketing authorisation referred to in article 6. Article Member, paragraph 1, and which includes at least one marketing authorisation issued in accordance with the centralised procedure set out in Chapter 1 of title II of Regulation (EC) No 1782/2003. 726/2004, the Committee for medicinal products for Human use report no later than 30 days after it has received it from the Committee for risk assessment in the field of pharmacovigilance, and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the opinion.

Depart the opinion of the Committee for medicinal products for Human use from the recommendation of the Committee for risk assessment in the field of pharmacovigilance, shall attach to the Committee for medicinal products for Human use, its opinion a detailed explanation of the scientific basis for the differences, along with the recommendation.

4. on the basis of the opinion of the Committee for medicinal products for Human use referred to in article 6. (3) the Commission shall adopt: (a)) a decision addressed to the Member States on measures to be taken with regard to marketing authorisations granted by the Member States and concerned by the procedure provided for in this section, and



b) if the opinion determined that the legislative measures with regard to the marketing authorisation is required, a decision on the modification, suspension or revocation of the marketing authorisations granted in accordance with the centralised procedure set out in Chapter 1 of title II of Regulation (EC) No 1782/2003. 726/2004 and concerned by the procedure provided for in this section.

Article 33 and 34 of this Directive shall apply to the adoption of the decision in the first subparagraph, point (a)), and on its implementation in the Member States.

Article 10 of Regulation (EC) No 1782/2003. 726/2004 apply to in the first subparagraph, point (b)), decision referred to. If the Commission adopts 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

1. With regard to medicinal products authorised pursuant to this Directive shall take the national competent authorities in cooperation with the Agency, adopt the following measures: (a) monitor the outcome of the) risk minimisation measures included in the flood risk management plans, and the conditions referred to in articles 21a, 22 or 22a;



(b) assess updates to the risk management system)



c) monitors data 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 Committee for risk assessment in the field of pharmacovigilance shall carry out the initial analysis and prioritisation of signals of new or changed risks or changes in the relationship between benefits and risks. If the Committee is of the opinion that a follow-up action may be necessary, the assessment of these signals is carried out and consensus on a possible follow-up action as regards marketing authorisation within a time frame that is proportionate to the extent and gravity of the infringement.

3. The Agency and national competent authorities and the marketing authorisation holder should inform each other if detected new or changed risks or changes in the relationship between benefits and risks.


Member States shall ensure that marketing authorisation holders shall inform the Agency and national competent authorities if found new or changed risks or changes in the relationship between benefits and risks.

Section 4

EU emergency procedure

Article 107i

1. A Member State or, where appropriate, the Commission is initiating the procedure within the meaning of this section, know when an emergency procedure deemed necessary as a result of the assessment of data from pharmacovigilance activities, to inform the other Member States, the Agency and the Commission of one or more of the following cases: (a)) if it is considering to suspend or revoke a marketing authorisation



(b)) if it is considering banning the extradition of a drug



(c)) if it is considering to refuse renewal of a marketing authorisation



(d)) if the holder of the marketing authorisation of informed that this due to concerns about safety have stopped the marketing of a medicinal product, has taken steps to revocation of a marketing authorisation or proposes to do so



e) if it considers that it is necessary to have a new contraindication, a reduction in the recommended dose or a limitation of the indications.

The Agency is investigating whether the concern regarding safety concerns other than medicinal products covered by the information, or whether it is common to all medicinal products belonging to the same range or therapeutic group.

If the medicinal product concerned is authorised in more than one Member State, the Agency shall notify without undue delay the who initiated the procedure, on the outcome of this study, and the procedures referred to in article 107 shall apply 107j. If this is not the case, the Member State concerned takes itself of concern regarding safety. The agency or, where applicable, the Member State shall inform the holder of the marketing authorisation to initiate the procedure.

2. without prejudice to the provisions of paragraph 1 of this article and article 107j and 107 k, a Member State may, if it is in the interests of the protection of public health is required to act quickly, suspend or prohibit the use of the marketing authorisation for the medicinal product concerned on its territory, pending a final decision. It shall inform the Commission, no later than the following working day, the Agency and the other Member States about the reasons for doing so.

3. the Commission may, at any time during the procedure referred to in article 107j and 107 k request those Member States in which the medicinal product is authorised to take temporary measures immediately.

If the scope of a procedure, as determined in accordance with paragraph 1, relate to medicinal products authorised in accordance with Regulation (EC) No 1782/2003. 726/2004, the Commission may, at any time in the course of the procedure initiated pursuant to this section shall immediately take provisional measures in connection with these marketing authorisations.

4. the Information referred to in this article may relate to individual drugs or a range of medicinal products or a therapeutic group.

If the agency finds that concerns in relation to security concerns more drugs than those covered by the contents, or that it is common for all medicinal products belonging to the same range or therapeutic group, expands the scope of the procedure accordingly.

If the scope of a proceeding initiated pursuant to this article concerns a range of medicinal products or a therapeutic group, also be subject to medicinal products authorised in accordance with Regulation (EC) No 1782/2003. 726/2004, which belong to this Committee or group, of the procedure.

5. At the time of the information referred to in article 6. paragraph 1, the Member State all relevant scientific information it has available, as well as its assessments available to the Agency.

Article 107j

1. After receipt of the information referred to in article 6. Article 107i, paragraph 1, the Agency shall make publicly available via the European portal on medicinal products, a message that a procedure has been initiated. In parallel, Member States may, on their national Web portals for medical safety publish a notification that a procedure has been initiated.

This communication describes the issues submitted to the Agency in accordance with article 107i, and those medicinal products and, if necessary, the relevant active substances. It contains information on the right of the holder of a marketing authorisation, health-care professionals and the general public have to submit to the Agency the information that is relevant to the proceeding, and explains how such information may be provided.

2. The Committee for risk assessment in the field of pharmacovigilance assesses the issues which were presented to the Agency in accordance with article 107i. The rapporteur is working closely with the rapporteur appointed by the Committee for medicinal products for Human use or reference Member State for the medicinal product concerned.

For the purposes of this assessment, the marketing authorisation holder may submit written comments.

If the urgency of the work permits, the Committee for risk assessment in the field of pharmacovigilance hold public hearings when the Committee deems it appropriate, on justified grounds with regard to the scope and seriousness of the security of our worries. Hearings shall be held in accordance with the modalities as established by the Agency and communicated via the European Web portal on medicinal products. The notification shall contain the provisions for the participation in the consultations.

In connection with public hearings shall take due account of the drug's therapeutic effect.

The Agency shall develop, in consultation with the parties concerned rules of procedure concerning the organisation and conduct of public hearings in accordance with article 78 of Regulation (EC) No 1782/2003. 726/2004.

If a marketing authorisation holder or another person who would like to submit information, confidential information relevant to the relationship, they can request to be allowed to submit this information on behalf of the Committee for risk assessment in the field of pharmacovigilance in a non-public hearing.

3. Not later than 60 days after the submission of the information makes the Committee for risk assessment in the field of pharmacovigilance a reasoned recommendation taking due account of the drug's therapeutic effect. The recommendation sets out the dissent and the reasons therefor. The Committee for risk assessment in the field of pharmacovigilance may, in urgent cases, and acting on a proposal from its Chairman, lay down a shorter period. The 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 authorisation holder should undertake further assessment of the information and follow up on the results of this assessment



(c)) the marketing authorisation holder should sponsor a post-authorisation safety study marketing and follow up on the results of this study



(d) Member States) or the marketing authorisation holder should implement risk minimisation measures



e) marketing authorisation should be suspended, revoked or not renewed



f) marketing authorisation should be changed.

For the purposes of applying the first subparagraph, point (d)), the recommendation to clarify the risk minimisation measures recommended and any conditions or limitations applicable to the marketing authorisation.

If it referred to in the first subparagraph, subparagraph (f)), it is recommended to change or add information to the summary of product characteristics or leaflet, the recommendation include proposals for how the text for such an amendment or addition shall be formulated, and where in the summary of product characteristics, labelling or the package leaflet text should be placed.

Article 107 k

1. Include the scope of the procedure as laid down in accordance with article 107i (4), no marketing authorisation issued in accordance with the centralised procedure set out in Chapter 1 of title II of Regulation (EC) No 1782/2003. 726/2004, the coordination group, no later than 30 days after receipt of the recommendation of the Committee for risk assessment in the field of pharmacovigilance, recommendation and establishes a position on conservation, modification, suspension, revocation or refusal of renewal of the marketing authorisations concerned, including a timetable for the implementation of the established attitude. The coordination group may, if it is necessary to establish a position immediately and on a proposal from its Chairman, lay down a shorter period.

2. When the Member States represented in the coordination group, to agree on the measures to be taken, the Chairman, that there is a consensus, and sends the established position to the marketing authorisation holder and the Member States. Member States shall adopt the measures necessary for the conservation, modification, suspension, revocation or refusal of the concerned marketing authorisation in accordance with the implementation timetable laid down in the attitude.

In the event that agreement is reached on a change, the holder of a marketing authorisation within the framework of the prescribed implementation timetable a proper request for change to the national competent authority. The request must contain an up-to-date summary of product characteristics and a leaflet.


There can be no agreement is reached, it will send the position taken by the majority of the Member States represented in the coordination group is agreed on, to the Commission, using the procedure set out in article 33 and 34. Notwithstanding the provisions of article 34, paragraph 1, the procedure laid down in article 121, paragraph 2, shall apply.

Differ by the position, as the Member States represented in the coordination group, or the attitude of the majority of Member States that are represented in the coordination group, from the recommendation of the Committee for risk assessment in the field of pharmacovigilance, the coordination group shall attach to its opinion or majority a detailed explanation of the scientific basis for the differences, along with the recommendation.

3. Include the scope of the procedure as laid down in accordance with article 107i (4) at least one marketing authorisation issued in accordance with the centralised procedure set out in Chapter 1 of title II of Regulation (EC) No 1782/2003. 726/2004, the Committee for medicinal products for Human use, no later than 30 days after receipt of the recommendation of the Committee for risk assessment in the field of pharmacovigilance, the recommendation and adopt an opinion on the maintenance, variation, suspension, revocation or refusal of renewal of the marketing authorisations concerned. Committee for medicinal products for Human use may, if it is necessary immediately to adopt the opinion and acting on a proposal from its Chairman, agree to a shorter period.

Depart the opinion of the Committee for medicinal products for Human use from the recommendation of the Committee for risk assessment in the field of pharmacovigilance, shall attach to the Committee for medicinal products for Human use, its opinion a detailed explanation of the scientific basis for the differences, along with the recommendation.

4. on the basis of the opinion of the Committee for medicinal products for Human use referred to in article 6. (3) the Commission shall adopt: (a)) a decision addressed to the Member States on measures to be taken with regard to marketing authorisations granted by the Member States and concerned by the procedure provided for in this section, and



b) where the opinion states that regulatory measures are required, a decision on the modification, suspension, revocation or refusal of renewal of marketing authorisation issued in accordance with Regulation (EC) No 1782/2003. 726/2004 and concerned by the procedure provided for in this section.

Article 33 and 34 of this Directive shall apply to the adoption of the decision in the first subparagraph, point (a)), and on its implementation in the Member States. Notwithstanding the provisions of article 34, paragraph 1, of this directive the procedure laid down in article 121, paragraph 2, shall apply.

Article 10 of Regulation (EC) No 1782/2003. 726/2004 apply to in the first subparagraph, point (b)), decision referred to. Notwithstanding the provisions of article 10, paragraph 2, of the said regulation, the procedure referred to in article 87, paragraph 2, shall apply. If the Commission adopts 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 assessments

Article 107l

The Agency shall publish the definitive conclusions of judgements, opinions, recommendations and decisions referred to in article 107b-107 k, via the European portal on medicinal products.

CHAPTER 4

Monitoring of safety investigations in accordance with the marketing authorisation

Article 107 m

1. This chapter shall apply to non-Interventional post-authorisation safety studies marketing initiated, conducted or financed by the holder of the marketing authorisation either voluntarily or as a result of obligations in accordance with article 21a or 22a, and which involves the collection of security information from patients or healthcare professionals.

2. This chapter is without prejudice to national requirements and EU requirements concerning protection of the well-being and rights of participants in non-Interventional post-authorisation safety studies for marketing.

3. Investigations will fail if the application of a drug thereby promoted.

4. The remuneration of health-care professionals who participated in the non-Interventional post-authorisation safety studies after a marketing authorisation should be limited to compensation for the time spent and expenses.

5. The national competent authority may require the marketing authorisation holder to submit the Protocol and progress reports, to the competent authorities of the Member State in which the investigation is conducted.

6. Not later than 12 months after the collection of the data is completed, the marketing authorisation holder shall forward the final report to the competent authorities of the Member State in which the investigation is conducted.

7. During the implementation of a study monitors the marketing authorization holder obtained data and examines their consequences for ratio between the benefits and risks of the medicinal product concerned.

Any new information which might influence the evaluation of the relationship between the benefits and risks of the medicinal product, shall be communicated to the competent authorities of the Member State where the medicinal product is authorised in accordance with article 23.

The obligation referred to in the second subparagraph shall be without prejudice to the information about the survey results, which the marketing authorization holder shall make available by means of the periodic safety update reports, as laid down in article 107b.

8. Article 107n-107q shall apply only to the examinations referred to in paragraph 1, carried out under an obligation, in accordance with article 21a or 22a.

Article 107n

1. Prior to the implementation of a study on the marketing authorisation holder shall submit a draft of a Protocol on behalf of the Committee for risk assessment in the field of pharmacovigilance, except if the surveys only implemented in one Member State which requires the investigation carried out in accordance with Article 22a. In the case of such studies the marketing authorisation holder shall submit a draft Protocol for the national competent authority of the Member State in which the investigation is conducted.

2. within 60 days of the date of submission of the draft Protocol transmits the national competent authority or Committee: a) a written approval of the draft Protocol



(b)) a reasoned written objection, stating in detail the reasons for the objection, be accounted for if the competent national authority or Committee of the pharmacovigilance risk assessment finds that



i. implementation of the study promotes the use of a medicinal product



II. the survey has been designed in such a way that the objectives of the study cannot be achieved, or



(c)) a notice in writing to the holder of the marketing authorisation that the study is a clinical trial that is within the scope of Directive 2001/20/EC.

3. The inquiry can only begin when the national competent authority or the Committee for risk assessment in the field of pharmacovigilance, has given its written approval.

If an authorisation has been issued without prejudice. paragraph 2 (a)), the marketing authorisation holder shall send the minutes to the competent authorities of the Member States, where the investigation is conducted, after which the investigation can be initiated in accordance with the approved Protocol.

Article 107o

After the commencement of an investigation, all material changes prior to their implementation of the Protocol be submitted to the national competent authority or on behalf of the Committee for risk assessment in the field of pharmacovigilance. The national competent authority or Committee of the pharmacovigilance risk assessment evaluates the change and shall inform the holder of the marketing authorisation for its approval or objection. The marketing authorisation holder shall inform the Member States, where appropriate, about where the investigation is conducted.

Article 107p

1. After the study's completion, the final investigation report shall be submitted to the national competent authority or on behalf of the Committee for risk assessment in the field of pharmacovigilance within 12 months after the collection of the data is completed, unless the national competent authority or the Committee for risk assessment in the field of pharmacovigilance in writing has given dispensation for this.

2. the marketing authorisation holder shall assess whether the study results have implications for marketing authorisation and, if necessary, submit an application for the amendment of the marketing authorisation for the national competent authorities.

3. Together with the final investigation report, the marketing authorisation holder shall submit a summary of survey results electronically to the national competent authority or to the Committee for risk assessment in the field of pharmacovigilance.

Article 107q

1. On the basis of the results of the study and after hearing the holder of the marketing authorisation, the Committee for risk assessment in the field of pharmacovigilance put forward reasoned recommendations for marketing authorisation. In the recommendations be followed dissent and the reasons therefor.

2. If put forward recommendations on the modification, suspension or revocation of the marketing authorisation of a medicinal product which is authorized by the Member States pursuant to this directive, lay down the Member States represented in the coordination group, a position on the issue, taking account of the recommendation referred to in paragraph 1 and shall attach to a timetable for the implementation of the established attitude.


When the Member States represented in the coordination group, to agree on the measures to be taken, the Chairman, that there is a consensus, and sends the established position to the marketing authorisation holder and the Member States. Member States shall adopt the necessary measures to amend, suspend or revoke the marketing authorisation concerned in accordance with the implementation timetable laid down in the attitude.

In the event of agreement on an amendment to the holder of the marketing authorisation within the framework of the prescribed implementation timetable a proper request for change to the national competent authority. The request must contain an up-to-date summary of product characteristics and a leaflet.

The opinion will be published on the European medicines Web-portal established in accordance with article 26 of Regulation (EC) No 1782/2003. 726/2004.

There can be no agreement is reached, it will send the position taken by the majority of the Member States represented in the coordination group, has agreed to the Commission, using the procedure set out in article 33 and 34.

Differ by the position, as the Member States represented in the coordination group, agreed, or the attitude of the majority of the Member States represented in the coordination group, from the recommendation of the Committee for risk assessment in the field of pharmacovigilance, the coordination group shall attach to its opinion or majority a detailed explanation of the scientific basis for the differences, along with the recommendation.

CHAPTER 5

Implementation, delegation and guidelines

Article 108

In order to harmonise the conduct of pharmacovigilance activities in this directive, the Commission shall adopt implementing measures for the following areas, on which the pharmacovigilance activities laid down in article 8, paragraph 3, and article 101, 104, 104a, 107, 107a, 107b, 107h, 107n and 107p.



a) content of the master file of the pharmacovigilance system and the marketing authorisation holder's maintenance of this file



(b)) minimum requirements for quality management system for the national competent authorities and the holder of the marketing authorization implementation of pharmacovigilance activities



(c)) the application of internationally recognized terminologies, formats and standards that are recognized at the international level, for the performance of pharmacovigilance activities



d) minimum requirements for monitoring of data in the Eudravigilance database to determine whether there are new or changed risks



(e)) the format and content of electronic reporting of suspected adverse reactions from Member States and the marketing authorisation holder



f) the format and content of electronic periodic safety update reports and flood risk management plans



g) format for protocols, summary and final study reports for surveys after marketing authorization, These measures shall take account of international harmonisation work carried out in the field of pharmacovigilance, and reviewed, if necessary, to take account of technical and scientific progress. These measures shall be adopted in accordance with the regulatory procedure referred to in article 121, paragraph 2.

Article 108a

In order to facilitate the conduct of pharmacovigilance activities in the Union, the Agency shall, in cooperation with the competent authorities and other stakeholders: a) guidelines on good pharmacovigilance practice for both the competent authorities and the holders of marketing authorisations



b) scientific guidelines for impact studies in accordance with the marketing authorisation.

Article 108b

The Commission shall publish a report on the conduct of pharmacovigilance tasks the Member States no later than the 21. July 2015, and then every three years.

TITLE X

SPECIAL PROVISIONS FOR MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD OR PLASMA

Article 109

For the collection and testing of human blood and plasma, see European Parliament and Council Directive 2002/98/EC of 27. January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EF30) application.

Article 110

Member States shall take the necessary measures in order to achieve self-sufficiency in the community with blood and plasma from humans. To this end, encourages the voluntary and unpaid donation of blood and plasma and shall take the necessary measures to promote the production and use of products which are manufactured on the basis of such derived from human blood or human plasma derived from voluntary and unpaid donation of blood or plasma. They shall inform the Commission of the measures taken.

SECTION XI

SUPERVISION AND SANCTIONS

Article 111

1. the Agency shall ensure, in cooperation with the competent authority of the Member State concerned by an inspection, if necessary, unannounced, and, where appropriate, by asking an official medicines control laboratory or a laboratory designated for that purpose to carry out spot checks that the requirements governing medicinal products are complied with. Such cooperation consists in exchanging information with the Agency on both planned and carried out an inspection. Member States and the Agency shall cooperate with the coordination of inspections in third countries. Inspection visits includes but is not limited to those referred to in paragraph 1a-1f.

1a. Manufacturers in the European Union or in third countries and wholesale distributors of medicinal products are the subject of repeated inspection visits.

1B. The competent authority of the Member State concerned must have a monitoring system that includes an inspection at suitable intervals based on risk, with manufacturers, importers, or distributors of active substances which are resident on their territory, and an effective follow-up.

The competent authority may, where it considers that there are grounds for suspecting non-compliance with the legal requirements laid down in this directive, including the principles and guidelines of good manufacturing practice and good distribution practice, see. Article 46, point f), and article 47, inspect the premises of: a) the manufacturers or distributors of active substances which are domiciled in third countries



b) phonogram producers or importers of excipients.

1 c. in paragraph 1a and 1b referred to inspections may also be carried out in the Union and in third countries, at the request of a Member State, the Commission or the Agency.

1 d. may also undertake inspections of holders of marketing authorisations and with intermediaries of medicinal products.

1E. in order to verify whether the data submitted in order to obtain a conformity certificate comply with the monographs of the European Pharmacopoeia, the standardisation body of the nomenclatures and standards for quality as referred to in the Convention on the elaboration of a European Pharmacopoeia (The European Directorate for quality of medicines) turn to the Commission or the Agency to request such an inspection visit, if the starting material concerned is the subject of a monograph of the European Pharmacopoeia.

1F. The competent authority of the Member State concerned may carry out inspections in a company that produces source materials, after specific request from the company.

1 g. Inspection visits carried out by the representatives of the competent authority who shall be empowered to: a) inspect the manufacturing or commercial departments of companies manufacturing medicines, active substances or excipients, as well as in any laboratories employed by the holder of the manufacturing authorization has been delegated control tasks in accordance with article 20



b) take samples, among other things. with a view to an independent analysis in an official medicines control laboratory or a laboratory that a Member State has designated for that purpose



(c) examine any documents relating to) the inspection, subject, without prejudice to the Member States in the 21st century. May 1975 applicable provisions that restrict access to it with regard to descriptions of the method of preparation



d) inspect the premises, records, documents and master file for pharmacovigilance with holders of marketing authorisations and in any undertakings by the holder of the marketing authorisation has been given a mandate to carry out the activities referred to in section IX.

28. An inspection shall be carried out in accordance with the guidelines referred to in article 111a.

2. Member States shall take all appropriate provisions to ensure that the manufacturing processes used in the manufacture of immunological products are properly validated and batch-to-batch consistency.

3. The competent authority shall draw up after each of the inspections referred to in paragraph 1 shall provide a report on whether the inspected entity is in compliance with the principles referred to in article 47 and 84 and guidelines of good manufacturing practice and good distribution practice to the extent that they are relevant in individual cases, or whether the marketing authorisation holder complies with the requirements laid down in Title IX.

The competent authority which carried out the inspection, shall notify the inspected unit about the content of the reports.

Before the report is adopted, it shall inform the competent authority of the concerned inspected unit the opportunity to submit comments.


4. subject to any agreements between the Union and third countries, a Member State, the Commission or the Agency may require a manufacturer established in a third country undergo an inspection as referred to in this article.

5. Within 90 days of an inspection as referred to in paragraph 1 shall be issued a certificate of good manufacturing practice or good distribution practice, depending on the specific case, for the inspected unit, if the conclusion of the visit is that the person concerned is in compliance with the EU legislation laid down the principles and guidelines of good manufacturing practice or good distribution practice.

If the inspection is carried out in the context of the procedure for certification of conformity with the monographs of the European Pharmacopoeia, shall be issued a certificate.

6. Member States shall enter the certificates they issue of good manufacturing practice and good distribution practice, introduce in an EU database, which the agency manages on behalf of the Union. In accordance with article 52a, paragraph 7, Member States shall also introduce information in this database relating to registration of importers, manufacturers and distributors of active substances. The database must be publicly available.

7. Is the conclusion of an inspection as referred to in paragraph 1, point (a)), (b)), and (c)), or the conclusion of an inspection visit to a distributor of medicinal products or active substances or with a manufacture of excipients that the inspected device does not comply with the requirements and/or those in EU law laid down the principles and guidelines of good manufacturing practice and good distribution practice, introduction of this information in the provided for in paragraph 6, the EU database.

8. where the conclusion of an inspection as referred to in paragraph 1, point (d)), is that the marketing authorisation holder does not follow the pharmacovigilance system as described in the master file of pharmacovigilance and of title IX, the competent authority of the Member State concerned, the marketing authorisation holder aware of these shortcomings and shall give him an opportunity to submit comments.

The Member State concerned shall inform the other Member States in such cases, the Agency and the Commission.

The Member State concerned shall, where appropriate, the necessary measures to ensure that a marketing authorisation holder penalties that are effective, stand in reasonable proportion to tionate and dissuasive.

Article 111a

The Commission shall adopt the detailed guidelines on the principles governing an inspection as referred to in article 111.

Member States shall, in cooperation with the Agency, the form and content of the authorisation referred to in article 40, paragraph 1, and article 77, paragraph 1, of the reports referred to in article 111, paragraph 3, of the certificates of good manufacturing practice and good distribution practice certificates, as referred to in article 111, paragraph 5.

Article 111b

1. At the request of a third country, the Commission shall assess whether the third country existing legislative framework relating to active substances which are exported to the European Union, and the respective control and enforcement activities ensures a level of protection of public health equivalent to the Union. If this is the case, the Commission shall take a decision to construct the third country on a list assessment shall consist of a review of relevant documentation, and — unless there exist arrangements, as referred to in article 51, paragraph 2 of the directive, which covers this area of activity — the assessment must also include a review of the third country's legislative system on site and, if necessary, an observed inspection by one or more of the third country's factories where the active substance is manufactured. In this assessment, particular account shall be taken of: (a)) the country's rules on good manufacturing practice



(b) inspections to be carried out on a regular basis) where the control of compliance with good manufacturing practice



(c)) where the effective enforcement of good manufacturing practice are



(d)) where regularly and quickly the country to provide information on the producers of active substances which do not comply with the requirements.

2. The Commission shall adopt the implementing measures necessary for the application of the provisions of paragraph 1 of this article,) (a)-(d)). These implementing acts adopted in accordance with the procedure referred to in article 121, paragraph 2.

3. the Commission shall verify regularly that the conditions set out in paragraph 1 are fulfilled. The first inspection will take place no later than three years after the country has been included in the list referred to in paragraph 1.

4. the Commission shall carry out the assessment and verification in accordance with paragraphs 1 and 3, in cooperation with the Agency and the competent authorities of the Member States.

Article 112

Member States shall take all appropriate provisions to ensure that the marketing authorisation holder and, where appropriate, the holder of the manufacturing authorisation can show that transferred control of the medicinal product and/or on the constituents and intermediate products of the manufacturing process, in accordance with in article 8, paragraph 3, point (h)), referred to the methods used for marketing authorisation.

Article 113

For the purposes of implementing article 112, Member States may require manufacturers of immunological medicinal products and medicinal products derived from blood or human plasma to submit to a competent authority copies of all the control reports signed by the qualified person in accordance with article 51.

Article 114

1. A Member State may, if it considers it necessary in the interests of public health, require the holder of the marketing authorisation for: – live vaccines



-immunological medicinal products used for the primary immunization of children or other groups, who are exposed to risks



-immunological medicinal products used in connection with public health immunization programs



– or immunological medicinal products that are new, or which are manufactured by means of new or changed technology or having the character of a novelty for a particular manufacturer, during a transitional period, which would normally be laid down in the marketing authorization before being placed on the market shall submit samples from each batch of the bulk and/or the medicinal product for testing by an official medicines control laboratory or a laboratory that a Member State has designated for that purpose unless the competent authority of another Member State in connection with a party that is produced in that Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that such trials are completed within 60 days after receipt of the samples.

2. the competent authorities may, where the laws of a Member State contains provisions to this effect in order to protect public health, require the holder of the marketing authorisation for medicinal products manufactured on the basis of derived from human blood or human plasma to submit samples from before placing each batch of bulk and/or finished product for testing in an official medicines control laboratory or a laboratory that a Member State has designated for that purpose unless the competent authorities of another Member State has already examined the relevant party and stated that it is in conformity with the approved specifications. Member States shall ensure that such trials are completed within 60 days from receipt of these tests.

Article 115

Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the manufacture of medicinal products derived from human blood or human plasma are properly validated, as well as that happens the continually ensures batch consistency and, as far as technology permits, the absence of specific viral contamination. The manufacturer shall notify the competent authorities, therefore the method used to limit or eliminate the disease-causing viruses that can be transmitted through medicinal products derived derived from human blood or plasma. To this end, the competent authorities may submit samples of bulk and/or drugs for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application in accordance with article 19 or after the granting of a marketing authorisation.

Article 116

The competent authorities shall suspend, withdraw or amend the marketing authorisation, if it is assessed, either that the medicinal product is harmful or that it has no therapeutic effect, or that the risk-benefit ratio is not favourable, or that it does not have the specified quantitative and qualitative composition. Therapeutic effect is considered to be missing, if it is considered that there is no therapeutic results can be obtained with the medicinal product.

The marketing authorisation may also be suspended, revoked or modified if the information pursuant to article 8, article 10 or 11 are listed in the file are incorrect or have not been amended in accordance with article 23, or where the conditions laid down pursuant to articles 21a, 22 or 22a have not been met, or if the verification 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 provided in accordance with article 8, paragraph 3, subparagraph (d)), or where there is no control is performed in accordance with the testing methods described in article 8, paragraph 3, point (h)).

Article 117

1. without prejudice to the measures provided for in article 116, Member States shall take all the appropriate provisions in order to ensure that the extradition of a medicinal product is prohibited and that this is withdrawn from the market, if it is assessed that: a) the medicinal product is harmful, or



(b)) the drug's therapeutic efficacy is lacking, or



(c)) the risk-benefit ratio is at a disadvantage, or



(d)) that the medicinal product does not have the specified qualitative and quantitative composition, or



e) the monitoring of the medicinal product and/or on the constituents and intermediate products of the manufacturing process have not been carried out, or any other requirements or any other obligation in connection with the issuance of the manufacturing authorisation has not been fulfilled.

2. The competent authority may limit the prohibition on extradition and withdrawal from the market to only apply to each separate consignment, against which objections have been raised.

3. the competent authority may, in respect of a medicinal product for which extradition has been banned, or which has been withdrawn from the market in accordance with paragraphs 1 and 2, and in particular circumstances, for a transitional period to allow the extradition of the drug to patients already treated with the medicinal product concerned.

Article 117a

1. Member States must have a system that aims to prevent pharmaceutical products that are suspected to pose a health risk, to reach the patient.

2. The system referred to in paragraph 1 shall cover the receipt and handling of notifications of suspected counterfeit medicines, as well as about suspected quality defects in medicinal products. The system is also intended to cover withdrawals of drugs at the behest of marketing authorisation holders or withdrawals of medicinal products from the market ordered by the competent national authorities from all relevant actors in the supply chain both in and outside of normal working hours. The system should also provide an opportunity to withdraw the drugs back from patients who have received such drugs, if necessary with the assistance of health personnel.

3. If the medicinal product concerned is suspected to pose a serious risk to public health, it shall send the competent authority of the Member State where the medicinal product was first identified, promptly a quick warning to all Member States and all stakeholders in the supply chain in the Member State concerned. In the event that such drugs are assumed to have reached patients, must immediately be issued public announcements within 24 hours to withdraw these medicines back from patients. These messages must contain sufficient information about the suspected quality defect or counterfeiting and the risks involved.

4. Member States shall communicate, not later than the 22nd. July 2013 the Commission communication about the details of their respective national systems referred to in this article.

Article 118

1. The competent authority shall suspend or withdraw the manufacturing authorization for a category of preparations or all preparations where any one of the conditions laid down in article 41 is no longer complied with.

2. the competent authority may, in addition to the measures provided for in article 117, either suspend manufacture or imports of medicinal products coming from third countries or suspend or withdraw the manufacturing authorization for a category of preparations or all preparations where articles 42, 46, 51 and 112 administrative provisions are not complied with.

Article 118a

1. 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 sanctions. Penalties provided for must be effective, proportionate and dissuasive tionate to.

These sanctions must not be more lenient than those applicable to infringements of national law of a similar nature and importance.

2. The rules referred to in paragraph 1 shall include the following. geared towards: (a)) the production, distribution, dissemination, import and export of counterfeit medicines as well as distance selling of counterfeit medicinal products to the public through the services of the information society



b) non-compliance with the provisions of this directive on the manufacture, distribution, import and export of active substances



c) failure to comply with the provisions of this directive on the use of excipients.

Sanctions, where appropriate, take account of the risk to public health, as the counterfeiting of medicines.

3. Member States shall, within the 2. January 2013 the Commission of the provisions adopted pursuant to this article, and shall notify immediately subsequent amendments to those provisions.

Within the 2. January 2018 the Commission shall submit to the European Parliament and the Council a report, which provides an overview of Member States ' implementing measures for the purposes of this article, together with an assessment of the effectiveness of these measures.

Article 118b

Member States shall organise meetings with the participation of patient and consumer organizations, and, where necessary, the Member States ' law-enforcement officials, in order to disseminate public information on the measures taken in the field of prevention and enforcement, in order to fight the counterfeiting of medicines.

Article 118 c

For the purposes of this directive, Member States shall take the necessary measures to ensure cooperation between the competent authorities for medicines and the Customs authorities.

Article 119

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

TITLE XII

STANDING COMMITTEE

Article 120

The Commission shall adopt the amendments necessary to adapt annex I in accordance with the scientific and technical development. These measures, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 121, paragraph 2a.

Article 121

1. the Commission shall be assisted by the Standing Committee on medicinal products for Human use, hereinafter referred to as "the Standing Committee", when adapting the directives on the removal of technical barriers to trade in the medicinal products to technical progress.

2. where reference is made to this paragraph, articles 5 and 7 of decision 1999/468/EC shall apply. its article 8.

Period referred to in article 5 (6) of decision 1999/468/EC shall be set at three months.

2A. where reference is made to this paragraph, article 5a, paragraphs 1 to 4, and article 7 of decision 1999/468/EC shall apply. its article 8.

3. where reference is made to this paragraph, articles 4 and 7 of decision 1999/468/EC shall apply. its article 8.

The period in article 4, paragraph 3, of decision 1999/468/EC shall be set at one month.

4. the Standing Committee on the rules of procedure shall be made public.

Article 121a

1. the Commission shall be empowered 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 expiry of the five-year period. The delegation of power shall be automatically extended for periods of the same duration, unless the European Parliament or the Council revokes the delegation as provided for in article 121b.

2. As soon as the Commission adopts a delegated Act, it shall inform the European Parliament and the Council at the same time accordingly.

3. The powers to adopt delegated acts are conferred on the Commission subject to the conditions set out in article 121b and 121 c.

Article 121b

1. In Article 22b, 47, 52b and 54a referred to the delegation of powers may at any time be revoked by the European Parliament or the Council.

2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, and specifies at the same time, delegated powers which could be subject to revocation, and possible reasons for this.

3. the decision on the revocation brings delegation of the powers specified in that decision, to an end. It shall take effect immediately or at a later date, to be specified in the decision. It shall not affect the validity of the delegated acts already in force. The decision shall be published in the official journal of the European Union.

Article 121 c

1. the European Parliament or the Council may object to a delegated act within a period of two months from notification.

The time limit may be extended for two months at the initiative of the European Parliament or the Council.

2. Neither the European Parliament nor the Council on the expiry of the period referred to in paragraph 1 shall objected to the delegated Act, it shall be published in the official journal of the European Union and shall enter into force on the date laid down therein.

The delegated Act may be published in the official journal and enter into force before the expiry of the term, if both the European Parliament and the Council has informed the Commission of their intention not to raise any objections.


3. If the European Parliament or the Council, within the period referred to in paragraph 1 shall object to a delegated Act, it shall not take effect. The institution, which objects to the delegated Act, shall indicate the reasons for doing so.

SECTION XIII

GENERAL PROVISIONS

Article 122

1. Member States shall take all appropriate measures to ensure that the competent authorities concerned shall exchange relevant information with a view to ensuring that the conditions for the granting of the authorisations referred to in articles 40 and 77, in article 111, paragraph 5 referred to the marketing authorisations and certificates must be observed.

2. upon reasoned request, Member States shall send electronically in article 111, paragraph 3, provided reports to the competent authorities of another Member State or to the Agency.

3. The conclusions reached in accordance with article 111, paragraph 1, applies throughout the community.

If a Member State may exceptionally and for reasons related to public health, cannot accept the conclusions of an inspection as referred to in article 111, paragraph 1, it shall forthwith inform the Commission and the Agency. The Agency shall inform the Member States concerned.

The Commission will be informed of such divergent opinion, it may, in consultation with the Member States concerned, ask the Inspector who performed the first inspection, to carry out a new inspection; This authority inspector may be accompanied by two other inspectors from Member States which are not party to the dispute.

Article 123

1. Each Member State shall take all appropriate measures to ensure that decisions about marketing, refusing or revoking a marketing authorization, cancelling a decision refusing or revoking a marketing authorization, prohibiting supply or withdrawing a product from the market, as well as the reasons therefor are promptly brought to the Agency's knowledge.

2. the marketing authorisation holder shall be obliged to immediately inform the Member States concerned on all measures he has taken to suspend the sale of or to pull the drug from the market, as well as specify the reason, if this relates to the effectiveness of the medicinal product or the protection of public health. Member States shall ensure that this information will immediately be brought to the Agency's knowledge.

3. Member States shall ensure that adequate information on measures referred to in paragraphs 1 and 2, and which may affect public health in third countries, without delay, be notified to the World Health Organization, with a copy to the Agency.

4. The Agency shall publish each year a list of the medicinal products for which marketing authorisation has been refused, revoked or suspended, for which extradition has been banned, or which has been withdrawn from the market.

Article 124

Member States shall communicate to each other the necessary information, in particular the information referred to in Articles 122 and 123, to ensure the quality and safety of homeopathic medicinal products manufactured and marketed within the community.

Article 125

Any of the decisions referred to in this directive, shall be taken by the competent authorities of the Member States, need to be carefully justified.

The decision must be notified to the applicant, with an indication of the remedies available under the laws in force and of the time limits allowed in connection therewith.

Decisions to grant or revoke a marketing authorisation shall be made available to the public.

Article 126

A marketing authorisation may only be denied, suspended or revoked except on the grounds set out in this directive.

Any decision on suspension of the manufacture or importation of medicinal products coming from third countries, prohibition of extradition and the recall of a drug from the market can only be taken with the justifications mentioned in articles 117 and 118.

Article 126a

1. in the absence of a marketing authorisation or an application not to treat for a medicinal product authorised in another Member State pursuant to this directive, a Member State may, when it is justified for reasons of public health, authorise the placing on the market of the medicinal product concerned.

2. When a Member State avails itself of this option, shall adopt the measures necessary in order to meet the requirements of this directive, in particular those referred to in titles V, VI, VIII, IX and XI. Member States may decide that article 63, paragraphs 1 and 2 shall not apply to medicinal products authorised under paragraph 1.

3. a Member State shall, before giving such a marketing authorisation: a) notify the marketing authorisation holder in the Member State in which the medicinal product concerned is authorised, of the consideration of the issue of a marketing authorisation for the medicinal product concerned in accordance with this article



b) where applicable, request the competent authority of the Member State in question to submit a copy of the evaluation report referred to in article 21, paragraph 4, and of the marketing authorisation that is valid for the medicinal product concerned; receive the competent authority in the Member State in question, such a request, it shall within 30 days after receipt of the request shall send a copy of the evaluation report and of the marketing authorisation for the medicinal product concerned.

4. The Commission shall set up a publicly accessible register of medicinal products authorised under paragraph 1. Member States shall inform the Commission of the marketing authorisation for a medicinal product which is given or is terminated pursuant to paragraph 1, including the name or business name of the authorisation-holder, as well as his residence. The Commission shall make the necessary changes in the Danish register and make this register available on their website.

5. The Commission shall, not later than 30 June 2006. April 2008 the Council and the European Parliament a report on the application of this provision in order to make the necessary amendments.

Article 126b

In order to ensure independence and transparency, the Member States shall ensure that staff of the competent approval authorities, rapporteurs and experts concerned with the authorisation and supervision of medicinal products do not have financial or other interests in the pharmaceutical industry which could affect their impartiality. These persons shall deliver an annual declaration of their financial interests.

In addition, the Member States shall ensure that the competent authority makes its own internal rules of procedure and those of its committees, agendas and minutes of meetings accompanied by the decisions taken, the results of votes and explanations of votes, including minority opinions available to the public.

Article 127

1. At the request of the manufacturer, the exporter or the authorities of the third country shall certify an importing Member States that a manufacturer of medicinal products is in possession of the manufacturing authorization. When issuing such certificates, the following conditions must be observed: a) Member States shall have regard to the prevailing administrative arrangements within World Health Organization



b) for medicinal products which are intended for export and already permitted on their territory, they must submit a summary of the product characteristics as approved in accordance with article 21.

2. If the manufacturer is not in possession of a marketing authorization he shall for the authorities responsible for issuing the certificate referred to in paragraph 1, make a statement with explanation as to why this permission is not available.

Article 127a

When a medicinal product must be approved in accordance with Regulation (EC) No 1782/2003. 726/2004, and the Committee for medicinal products for Human use in its opinion refers to recommended conditions or restrictions in accordance with article 9, paragraph 4, point (c)), ca), cb) or cc), of that regulation, the Commission shall take a decision addressed to the Member States in accordance with article 33 and 34 of this directive on the implementation of those conditions or restrictions.

Article 127b

Member States shall ensure the establishment of appropriate arrangements for the collection of drugs that have not been applied or where the deadline for final use is exceeded.

TITLE XIV

FINAL PROVISIONS

Article 128

Directive 65/65/EEC, 75/318/EEC, 75/319/EEC, 89/342/EEC, 89/343/EEC, 89/381/EEC, 92/25/EEC, 92/26/EEC, 92/27/EEC, 92/28/EEC and 92/73/EEC, as amended by the annex II, part A, in the directives listed, are hereby repealed, without prejudice to the obligations of the Member States concerning the deadlines for transposition set out in annex II part B, 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 twentieth day following that of its publication in the official journal of the European Union.

Article 130

This directive is addressed to the Member States.



Annex 2 European Parliament and Council Directive 2001/82/EC

of 6. November 2001

establishing a Community code relating to veterinary medicinal products

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

having regard to the Treaty establishing the European Community, and in particular article 95,

having regard to the proposal from the Commission,

having regard to the opinion of the Economic and Social Committee1),

in accordance with the procedure referred to in article 2512), and

on the basis of 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 veterinærlægemidler3), Council Directive 81/852/EEC of 28. September 1981 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinærlægemidler4), Council Directive 90/677/EEC of 13. December 1990 extending 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 veterinærlægemidler5) 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 laws relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinærlægemidler6) has on several occasions been subjected to extensive changes. Directives should therefore be codified and brought together in a single text, so that their provisions can clearly and rationally.

(2) All provisions regarding the production and distribution of veterinary medicinal products must have as a main purpose to protect the public health.

(3) However, this objective must be attained by means which will not inhibit the development of industry and trade in medicinal products within the community.

(4) in so far as in Member States already exist certain provisions laid down by law, regulation or administrative action relating to veterinary medicinal products, these differ from each other with regard to the essential principles. The inhibitory to the trade in medicinal products within the community and thus have a direct impact on the functioning of the internal market.

(5) It is therefore important that these obstacles are removed. For this purpose is an approximation of the relevant provisions is necessary.

(6) in the interests of public health and the free movement of veterinary medicinal products, it is necessary that the competent authorities are in possession of all relevant information on authorized veterinary medicinal products in the form of approved summaries relating to the characteristics of products.

(7) With the exception of pharmaceuticals, which come under the community's centralised authorisation procedure introduced by Council Regulation (EEC) No 2377/90. 2309/93 of 22. July 1993 laying down Community procedures for the authorisation and supervision of products for human and veterinary use and establishing a European Agency for lægemiddelvurdering7), should a marketing authorization issued by a competent authority in a Member State, in principle, recognised by the competent authorities of the other Member States unless there are serious grounds for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health or to the environment. In the event of disagreement between Member States about the quality, safety or effectiveness of the veterinary medicinal product, a scientific evaluation should be made of the issue at Community level in order to reach a single decision on the contentious issue, which should be binding for the Member States concerned. Decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States.

(8) for this purpose, a Committee for veterinary medicinal products is subject to the European Agency for the evaluation of medicinal products established by Regulation (EEC) No 2377/90. 2309/93.

(9) This directive is only one stage of the realization of the objectives relating to the free movement of veterinary medicinal products. New measures will therefore in the light of the experience gained, in particular in the Committee for medicinal products for veterinary use, prove necessary for the Elimination of still existing obstacles to free circulation.

(10) medicated feedingstuffs do not come within the scope of this directive, but it is, as well as for economic reasons, for reasons of public health, it is necessary to prohibit the use of non-approved drugs for the manufacture of medicated feedingstuffs.

(11) The harmfulness and therapeutic efficacy can only be examined in context and have only a relative significance, judging from the current state of science and taking into account the drug's intended purpose. The documents and information which should accompany the application for marketing authorization, must demonstrate that the benefits connected with efficiency, outweighs the potential risks. In the case of a negative outcome, the application shall be refused.

(12) a marketing authorisation should be denied if the drug's therapeutic efficacy is lacking or is insufficiently substantiated, and the concept of therapeutic effect must be understood as the of the manufacturer promised effect.

(13) a marketing authorisation should also be denied if the specified wait time is insufficient to eliminate the health hazard, as the residues pose.

(14) in the field may be granted authorization to market an immunological veterinary medicinal product, the manufacturer must be able to demonstrate that he will be able to ensure batch consistency.

(15) the competent authorities should have the power to prohibit the use of an immunological veterinary medicinal product if the immunological response of treated animal will interfere with the implementation of national or community programmes for diagnosis, control or eradication of animal diseases.

(16) first and foremost, should the users of homeopathic medicinal products with a very clear indication of that in the case of homeopathic medicines, like they should have adequate security for their quality and safety.

(17) the provisions on the preparation of and the control and supervision of homeopathic veterinary medicinal products must be harmonized to permit the marketing throughout the community of safe medicinal products of good quality.

(18) in the light of the homeopathic medicinal products for specific characteristics, such as their weak concentration of active ingredients, and the difficulty of applying the traditional statistical methodology for clinical trials on them, provision should be made for a special, simplified registration system for traditional homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not and poses a risk for the animal.

(19) For homeopathic veterinary medicinal products marketed with therapeutic indications or in information on a form which may present risks in connection with the expected therapeutic effect, the usual rules of authorisation for the placing on the market of veterinary medicinal products used. Member States should, however, when these medicines are intended to be applied to pet animals and exotic species, be able to apply particular rules for the evaluation of the test results to determine the safety and efficacy of these medicinal products, provided that the Commission is informed of these rules.

(20) in order to protect human and animal health, better and avoid unnecessary duplication of work in connection with the processing of applications for marketing authorisations for veterinary medicinal products, Member States should systematically prepare assessment reports in respect of each veterinary medicinal product, they approve, and upon request exchange such reports. A Member State should be able to suspend the examination of an application for marketing authorisation for treatment in another Member State, in order to recognize the latter Member State decision.

(21) in order to facilitate the movement of veterinary medicinal products and to prevent the checks carried out in a Member State measures repeated in another Member State, should be on veterinary medicinal products used minimum requirements with regard to manufacture and imports from third countries, as well as the issue of similar permits.

(22) the quality of veterinary medicinal products manufactured within the community should be guaranteed by the principles of good manufacturing practice for medicinal products required compliance, irrespective of their end-uses.

(23) measures should be taken to ensure that distributors of veterinary medicinal products are authorized by Member States and maintain the necessary records.

(24) standards and protocols for the implementation of the testing of veterinary medicinal products as an effective means of control of these and hence for the preservation of public health will be able to facilitate the free movement of veterinary medicinal products, if they lay down common rules for the time of execution and journalernes design, allows the competent authorities to give its opinion on the basis of uniform tests and by common criteria, and thus contributes to prevent divergent ratings.

(25) It should more accurately be specified, in which case it is not necessary to provide the results of pharmacological and toxicological tests or clinical trials in order to obtain authorisation for the placing on the market of a veterinary medicinal product which is essentially similar to an innovative drug, while ensuring that innovative firms are not placed at a disadvantage. In the public interest, it should be avoided that tests on animals is repeated, unless absolutely necessary.

(26) following the establishment of the internal market can only renounced, specific controls to guarantee the quality of veterinary medicinal products imported from third countries, if the community has taken appropriate measures to ensure that the necessary controls are carried out in the exporting country.

(27) in order to ensure the continued safety of veterinary medicinal products in use, it is necessary to ensure that pharmacovigilance systems in the community are continually adapted to take account of scientific and technical progress.


(28) for reasons of protection of public health, relevant data on adverse effects in humans related to the use of veterinary medicinal products are collected and evaluated.

(29) the pharmacovigilance systems should consider the available data on lack of efficacy.

(30) in addition, collection of information on adverse reactions caused by use other than, investigations of the validity of the withdrawal period and on potential environmental problems may contribute to improve regular monitoring of that veterinary medicinal products shall be used properly.

(31) it is necessary to take account of changes that have been a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance.

(32) the increased use of electronic means of communication of information on adverse reactions to veterinary medicinal products marketed in the community, aims to bring together all information on side effects at a single location, while ensuring that the information also comes out to the competent authorities of all Member States.

(33) It is in the community's interest to ensure that there is consistency between monitoring systems for medicinal products for veterinary use of centrally-authorised medicinal products and monitoring systems for medicinal products authorised by other procedures.

(34) holders of marketing authorisations should be proactively responsible for ongoing pharmacovigilance of the veterinary medicinal products they place 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 June 1999. June 1999 laying down the procedures for the exercise of implementing powers conferred on the Kommissionen8).

(36) in order to improve the protection of public health it is necessary to specify that foodstuffs must not come from animals which have been used for clinical trials of veterinary medicinal products unless a maximum level laid down for residues of the medicinal product concerned in accordance with Council Regulation (EEC) No 2377/90. 2377/90 of 26. June 1990 concerning a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in animal levnedsmidler9).

(37) the Commission should be empowered to adopt any necessary changes to the annex in order to adapt it to scientific and technical progress.

(38) this directive should not affect the obligations of the Member States concerning the deadlines for transposition of the in annex II, part B, directives set out

HAS ADOPTED THIS DIRECTIVE:

TITLE I

DEFINITIONS

Article 1

For the purposes of this directive: 1) (repealed).



2) veterinary medicinal product:



(a)) any substance or combination of substances presented as an appropriate means of properties for the treatment or prevention of animal disease, or



(b)) any substance or combination of substances which may be used on or administered to animals with a view either to restoring, or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.



3) (repealed).



4) Fabric



  any substance, regardless of its origin, since this can be:



– human, as for example:



  human blood and preparations of human blood



– animal, as for example:



  micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood substances derived preparations



– vegetable, as for example:



  micro-organisms, plants, parts of plants, vegetable secretions, substances obtained by extraction



– chemical, as for example:



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



5) pre-mix for medicated



  any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs.



6) medicated feed



  any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal referred to in (i); 2.



7) Immunological veterinary medicinal product:



  a veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the State of immunity.



8) Homeopathic veterinary medicinal product:



  Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the currently has official status in the Member States. A homeopathic veterinary medicinal product may contain several active substances.



9) withdrawal period:



  Necessary period, which under normal conditions of use and in accordance with the provisions of this Directive shall be observed from the last treatment of the animal with the veterinary medicinal product, for this animal may be used for the production of food, in order to protect public health by ensuring that such foodstuffs do not contain residues in quantities in excess of the maximum residue limits for active substances laid down pursuant to Regulation (EEC) No 2377/90. 2377/90.



10) adverse reaction:



  A harmful and unintended reaction to a veterinary medicinal product, which occurs at doses normally used in animals for the prophylaxis, diagnosis or therapy of disease or for the restoration, modification, or the influence of a physiological function.



11) side effect in humans



  a reaction which is noxious and unintended and which occurs in humans following exposure to a veterinary medicine.



12) serious adverse reaction



  an adverse reaction which results in death, is life-threatening or result in significant disability or incapacity, is a congenital anormali/birth defect, or which results in permanent or prolonged signs in the animals treated.



13) unexpected adverse reaction



  an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.



14) periodic safety update reports:



  the periodical reports containing the records referred to in article 75.



15) post-marketing surveillance studies



  pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying and investigating a safety hazard relating to an authorized veterinary medicinal product.



16) off-label 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 product.



17) wholesale distribution of veterinary medicinal products



  any activity which includes the purchase, sale, import, export, or any other commercial transaction in veterinary medicinal products, whether or not for profit, except



– a manufacturer's supply of veterinary medicinal products, he himself has produced



– retail supply of veterinary medicinal products by persons authorized for this purpose in accordance with article 66.



17A) representative of the marketing authorisation holder:



  The person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned.



18) Agency



  The European Medicines Agency established by Regulation (EC) No 1782/2003. 726/200410).



19) risks associated with the drug's use:



-any risk relating to the quality, safety and efficacy of the veterinary medicinal product to animal or human health



-any risk of undesirable effects on the environment.



20) the relationship between benefits and risks:



  An evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the risk of adverse effects as described above.



21) veterinary prescription:



  Any prescription for a veterinary medicinal product which is printed by an expert empowered for this purpose in accordance with applicable national legislation.



22) the veterinary medicinal product name:



  The name, may be either an invented name not liable to confusion with the common name a common name or scientific name with the addition of a trademark or the name of the holder of the marketing authorisation.



23) Common name:



  The name recommended by the World Health Organization International common name, or if one does not exist the usual common name.



24) strength:



  The content of active substances, expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.



25) immediate packaging:



  The container or any other form of packaging that is in direct contact with the medicinal product.



26) outer packaging:



  The packaging, which surrounds the inner packaging.



27) labelling:



  The information affixed to the inner or the outer packaging.



28) leaflet:




  The information note to the user, containing information for the user which accompanies the medicinal product.

SECTION II

The SCOPE of the

Article 2

1. This Directive shall apply to veterinary medicinal products, including pre-mixes for medicated feedingstuffs, which must be placed on the market in Member States and either prepared industrially or by means of an industrial process.

2. In the event of doubt as to whether a product on the basis of an overall assessment of its properties may be included in the definition of ' veterinary medicinal product ' and the definition of a product falling under other Community legislation, this Directive shall apply.

3. Notwithstanding paragraph 1, this Directive shall apply to active substances used as starting materials to the extent set out in articles 50, 50a, 51 and 80 and additionally to certain substances which may be used as veterinary medicinal products, and affording metabolic stimulant, anabolic, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties to the extent provided for in article 68.

Article 3

1. This Directive shall not apply to: a) medicated feedingstuffs as defined in Council Directive 90/167/EEC of 26. March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Fællesskabet11)



b) inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality



c) veterinary medicinal products manufactured on the basis of radio-isotopes



d) additives as referred to in Council Directive 70/524/EEC of 23 April 1990. November 1970 concerning additives in foderstoffer12), which is mixed with animal feed, and complementary feedingstuffs on the conditions laid down in that directive, and



e) without prejudice to article 95 medicinal products for veterinary use intended for research and development trials.

Medicated feedingstuffs as referred to in point (a)), however, must be prepared only on the basis of pre-mix for medicated feedingstuffs which have been approved in accordance with this directive.

2. without prejudice to the provisions on the possession, prescription, dispensing and submission of veterinary medicinal products, this Directive shall not apply to: (a)) any medicinal product prepared in a pharmacy in accordance with a veterinary prescription for a particular animal or a small group of animals, commonly known as the magistral formula funds



(b)) any medicinal product prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the end-user, commonly known as the Officinal.

Article 4

1. Member States may provide that this Directive shall not apply to non-inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality.

2. Member States may, on their own territory in respect of veterinary medicinal products intended solely for aquarium fish, ornamental birds, homing pigeons, terrarium animals, small rodents, ferrets, rabbits and company, derogate from the provisions of article 5-8, where those medicinal products do not contain substances the use of which requires veterinary control and that the necessary measures are taken to prevent abuse of those drugs to other animal species.

TITLE III

MARKETING

CHAPTER 1

Marketing authorisation

Article 5

1. No veterinary medicinal product may be placed on the market in a Member State, without prejudice to the competent authority of that Member State has authorised the placing on the market in accordance with this directive, or who have been granted authorisation in accordance with Regulation (EC) No 1782/2003. 726/2004.

When a medicinal product has been given an initial authorisation in accordance with the first subparagraph, any additional species, strengths, pharmaceutical forms, administration routes, presentations, as well as all changes and extensions also have a permit in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered to come under the same overall marketing authorisation, in particular for the purposes of article 13, paragraph 1.

2. the marketing authorisation holder is responsible for the placing on the market of the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility.

Article 6

1. There must not be authorised for placing on the market of a veterinary medicinal product with a view to submission to one or more food-producing species unless the pharmacologically active substances as the medicinal product contains, in annex I, II or III to Regulation (EEC) No 2377/90. 2377/90.

2. the marketing authorisation holder or, where appropriate, the competent authorities must, if it is justified as a result of an amendment to the annexes to Regulation (EEC) No 2377/90. 2377/90, take all the necessary measures to amend or revoke the marketing authorisation within 60 days following the date of the relevant amendment to the annexes to that regulation in the official journal of the European Union.

3. Notwithstanding paragraph 1, a veterinary medicinal product containing pharmacologically active substances not listed in Annex i, II or III to Regulation (EEC) No 2377/90. 2377/90 shall be accepted for the specific animals of the horse genus, which in accordance with Commission decision 93/623/EEC of 20. October 1993 on an identification document (passport) accompanying registered hovdyr13) and Commission decision 2000/68/EEC of 22. December 1999 amending Decision 93/623/EEC and on the identification of equidae for breeding and brugsdyr14) have been declared unfit for slaughter for human consumption. Such veterinary medicinal products shall not contain active substances listed in annex IV to Regulation (EEC) No 2377/90. 2377/90 nor be intended for processing modes, see. the approved summary of product characteristics, for which a veterinary medicinal product is authorised for animals of the horse genus.

Article 7

When the health situation so requires, a Member State may authorise the placing on the market of 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 provisionally allow the use of immunological veterinary medicinal products without a marketing authorisation, in the absence of a suitable medicinal product and after they have notified the Commission of the detailed conditions of use.

The Commission may make use of the option referred to in the first subparagraph when it explicitly follows from Community rules concerning certain serious epizootic diseases.

A Member State may, when an animal is subject to import from or export to a third country and is subject to specific mandatory health provisions, permit the use of an immunological veterinary medicinal product to the animals concerned, although in that Member State are not granted any permission for the marketing of this drug, but it is approved in accordance with 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 product.

Article 9

No veterinary medicinal product may be administered to animals, without marketing authorisation thereto is given, except in the case of the testing of veterinary medicinal products referred to in article 12, paragraph 3, subparagraph (j)), approved by the competent national authorities, following notification or authorization has been granted in accordance with the applicable national legislation.

Article 10

1. Member States shall take the necessary measures to ensure that where a Member State has no veterinary medicinal product that is approved for the treatment of a condition in a non-food-producing species, by way of exception, the veterinarian responsible may, under his direct personal responsibility for the treatment of the animal concerned, and in particular to avoid causing unacceptable suffering, apply: a) a veterinary medicinal product in the Member State concerned is approved by virtue of this directive, or by virtue of Regulation (EC) No. 726/2004 for another species or of the same species, but of a different mode, or



b) if the pharmaceutical product referred to in point (a)), does not exist, either



i. a medicinal product in the Member State concerned has been approved in the power of the European Parliament and Council Directive 2001/83/EC or by virtue of Regulation (EC) No 1782/2003. 726/2004, or



II. in accordance with specific national measures a veterinary medicinal product authorised in another Member State by virtue of this directive for the same species, or for another species and of the concerned State or against another State, or



(c)) if the medicinal product referred to in (b)) doesn't exist and within the limits resulting from the legislation of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorized for that purpose under national law.

The veterinarian may administer the medicinal product personally or let someone else do it under its responsibility.

2. Byway of derogation from article 11, the provisions of paragraph 1 shall also apply to the treatment by a veterinarian, an animal of the horse genus, where this animals in accordance with Commission decision 93/623/EEC and 2000/68/EC is declared unfit for slaughter for human consumption.


3. Byway of derogation from article 11, the Commission shall establish a list of substances essential for the treatment of equidae and for which the withdrawal period, the genus is at least six months pursuant to the control procedure laid down in decision 93/623/EEC and 2000/68/EC.

This measure, designed to amend non-essential elements of this directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

Article 11

1. Member States shall take the necessary measures to ensure that where a Member State has no veterinary medicinal product that is approved for the treatment of a condition in a food-producing species, by way of exception, the veterinarian responsible may, under his direct personal responsibility, in particular to avoid causing unacceptable suffering, treat the animals concerned on a particular holding with: a) a veterinary medicinal product in the Member State concerned is approved by virtue of this directive, or by virtue of Regulation (EC) No. 726/2004 for another species or to the same species, but against another State, or



b) if the pharmaceutical product referred to in point (a)) does not exist, with:



i. a medicinal product in the Member State concerned is approved by virtue of Directive 2001/83/EC or regulation (EC) No 1782/2003. 726/2004, or



II. a veterinary medicinal product authorised in another Member State by virtue of this directive for the same species, or for another food-producing species and of the concerned State or against another State, or



c) if there is no veterinary medicinal product referred to in point (b)), with a veterinary medicinal product which is prepared in accordance with a veterinary prescription by a person authorized for that purpose in accordance with national legislation and within the limits resulting from the legislation of the Member State concerned.

The veterinarian may administer the medicinal product personally or let someone else do it under its responsibility.

2. paragraph 1 shall apply provided that pharmacologically active substances of the medicinal product are listed in Annex i, II or III to Regulation (EEC) No 2377/90. 2377/90, and provided that the veterinarian establishes an appropriate withdrawal period.

If not on the applied medicine has specified any withdrawal period for the species concerned, the specified withdrawal period shall not be less than: – 7 days for eggs



– 7 days for milk



– 28 days for meat from poultry and mammals including fat and offal,



– 500 degree days for fish meat.

The Commission can, however, change these specific withdrawal periods. These measures, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

3. with regard to the waiting time, which is referred to in the second subparagraph of paragraph 2, set this to zero, when there is talk about a homeopathic veterinary medicinal product if the active substance is included in annex II to Regulation (EEC) No 2377/90. 2377/90.

4. In connection with the veterinarian's treatment in accordance with paragraphs 1 and 2 shall maintain records of all relevant information, including the date of examination of the animals, the identity of the owner, the number of animals treated, the diagnosis, the medicinal products prescribed, the doses, the duration of treatment as well as the recommended withdrawal periods. The veterinarian shall for control purposes keep these records available to the competent authorities for at least five years.

5. Member States shall, without prejudice to the other provisions of this directive, all necessary measures for the import, distribution, dispensing and information about the medicinal products which they permit used for submission for food-producing animals in accordance with paragraph 1 (b)), nr. (ii)).

Article 12

1. in order to obtain a marketing authorisation for a veterinary medicinal product does not fall within the procedure is covered by Regulation (EC) No 1782/2003. 726/2004, an application shall be submitted to the competent authority of the Member State concerned.

In the case of veterinary medicinal products intended for one or more species of animals intended for food production, if pharmacologically active substances, for the species concerned, have not yet been included in annex I, II or III to Regulation (EEC) No 2377/90. 2377/90 may be first applied for marketing authorization when submitted a valid application for the establishment of maximum residue limits in accordance with the abovementioned regulation. The application for marketing authorisation shall be filed no earlier than six months after the application for the establishment of maximum residue limits.

For those in article 6, paragraph 3, provided for veterinary medicinal products may be the subject of an application for marketing authorisation without having filed a valid application in accordance with Regulation (EEC) No 2377/90. 2377/90. Presentation of the scientific documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product, see. (3).

2. A marketing authorization may only be granted to an applicant established in the community.

3. Documentation to be attached to the application for marketing authorisation shall include all the administrative information and scientific and technical material can demonstrate the quality, safety and efficacy of the veterinary medicinal product. This documentation must be presented in accordance with Annex I and, in particular, include the following information: a) name or business name and permanent address or registered place of business of the person responsible for the placing on the market and, where appropriate, to the concerned manufacturers together with an indication of the places where the production takes place



(b) name of the veterinary medicinal product)



c) qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, including international non-proprietary name recommended by the World Health Organization, where such a common name for the medicinal product exists, or its chemical name



d) description of manufacturing method



e) therapeutic indications, contra-indications and side-effects



f) dosage for the various species of animal for which the veterinary medicinal product is intended, the pharmaceutical form, route of administration and proposed shelf life as well as method



g) indication of any precautionary and safety measures to be taken for the storage of the medicinal product, by treatment to animals and for the disposal of waste products, together with an indication of potential risks that the veterinary medicinal product may entail for the environment as well as human, animal and plant health



h) indication of the withdrawal period for medicinal products intended for food-producing animal species



in) description of the control methods employed by the manufacturer



j) results of:



– (physical chemical, biological or microbiological) pharmaceutical samples



– safety studies and examinations for residues



– preclinical and clinical trials



– studies that assess the risks posed by the medicinal product might pose to the environment. The impact should be examined and considered in particular cases to introduce specific provisions with a view to reducing the



k) a detailed description of the pharmacovigilance system and, where appropriate, the risk management system which the applicant intends to introduce



l) a summary of product characteristics in accordance with article 14, a model of the immediate packaging and outer packaging of the veterinary medicinal product as well as leaflet in accordance with article 58-61



m) a document showing that the manufacturer is authorised for the manufacture of veterinary medicinal products in its home country



n) copies 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 those Member States in which an application for authorisation submitted in accordance with this directive is under examination, copies of the summary of product characteristics 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 copies of the package leaflet proposed as well as details of any decisions on refusal of authorisation, whether in the community or in a third country and the reasons for these. All this information is updated on a regular basis



o) proof that the applicant is in possession of a qualified person responsible for pharmacovigilance and has the necessary means to report any suspected side effect in the community or in a third country



p) in the case of veterinary medicinal products intended for one or more food-producing species, and if pharmacologically active substances for the species concerned or for the species concerned have not yet been included in annex I, II or III to Regulation (EEC) No 2377/90. 2377/90, a certificate in respect of the filing of a valid application for the establishment of maximum residue limits to the Agency in accordance with the abovementioned regulation.

Documents and information concerning the results of tests, investigations and trials, as referred to in point (j)), must be accompanied by detailed and critical summaries, drawn up in accordance with article 15.

Article 13


1. Notwithstanding the provisions of article 12, paragraph 3, first subparagraph, point (j)), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant is not required to provide the results of safety tests, residue tests or of pre-clinical tests or clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product, in accordance with article 5 is or has been authorised for not less than eight years in a Member State or in the community.

A generic veterinary medicinal product which has received approval pursuant to this provision, shall not be placed on the market before, the ten-year period after the initial marketing authorisation of the reference medicinal product has expired.

Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the application for the generic medicinal product is lodged. In this case, the applicant must specify in the application form the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is lodged, the competent authority of the other Member State within one month to forward a confirmation that the reference medicinal product is or has been authorised, as well as the full composition of the reference product and if necessary other relevant documentation.

In the case of veterinary medicinal products which are intended for fish and bees or other species designated by the Commission for an extension of the ten-year period referred to in article 6. second subparagraph, however, for 13 years.

This measure, designed to amend non-essential elements of this directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

2. for the purposes of this article: — ' reference medicinal product ' shall mean a medicinal product authorised in accordance with article 5 and in accordance with article 12



– ' generic medicinal product ' shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. Is this the case, applicants shall supply any further information showing that the different salts, esters or derivatives of an authorised active substance is safe and/or effective. Various oral dosage forms with immediate release is considered one and the same pharmaceutical form. The applicant can be exempted from conducting bioavailability studies, if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.

3. If the veterinary medicinal product does not fall within the definition of a generic medicinal product in paragraph 2 (b)), paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes, seen in relation to the reference medicinal product, the active substances, the therapeutic indications, strength, pharmaceutical form or route of administration, the results of the relevant safety tests, residue tests and pre-clinical tests or clinical trials shall be presented.

4. where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions set out in the definition of generic medicinal products, in particular due to differences as raw materials or because the manufacturing processes of the biological medicinal product and the reference product are different, the results of appropriate pre-clinical tests or submission of clinical trials relating to these conditions. The additional data to be submitted, shall, with respect to the nature and quantity of the satisfy the relevant criteria in annex 1 and the appropriate detailed guidelines. The results of other tests and trials from the reference medicinal product's dossier shall not be provided.

5. In the case of veterinary medicinal products intended for one or more food-producing species and containing a new active substance which, on 30 June. April 2004 had not yet been authorised in the community, extended the period of 10 years in the second subparagraph of paragraph 1, with a year of any extension of the marketing authorisation to include another food-producing species, if it is approved within five years following the granting of the initial marketing authorisation.

This period may not exceed thirteen years in total for a marketing authorisation, which shall cover at least four food-producing animal species.

The ten-year period may only be extended to eleven, twelve or thirteen years for a veterinary medicinal product intended for food-producing species, if the marketing authorisation holder also originally applied for the establishment of maximum residue limits for the species covered by the authorisation.

6. The implementation of the necessary studies and trials with a view to the application of paragraphs 1 to 5 and the consequential practical requirements shall not be considered to be in violation with the rights relating to patents and supplementary protection certificates for medicinal products.

Article 13a

1. Notwithstanding the provisions of article 12, paragraph 3, first subparagraph, point (j)), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant is not required to provide the results of safety tests, residue tests or of pre-clinical tests or clinical trials if it can demonstrate that the active substances contained in veterinary medicinal products, has found common uses in veterinary medicine in the community for at least ten years and are recognized as effective and sufficiently secure in accordance with the requirements laid down in annex I. applicant submit in such a case, the relevant bibliographic scientific evidence.

2. The assessment report published by the Agency following the evaluation of an application for the establishment of maximum residue limits in accordance with Regulation (EEC) No 2377/90. 2377/90, can appropriately be used as scientific evidence, in particular as regards the safety investigations.

3. If an applicant makes use of scientific evidence in order to obtain a permit in respect of a food-producing animal species and in respect of the same medicinal product presenting new studies for residues in accordance with Regulation (EEC) No 2377/90. 2377/90 and new clinical trials with a view to obtaining an authorisation of another food-producing species, can a third party does not refer to such studies and experiments within the framework of article 13 for a period of three years from the date of issuance of the permit, as studies have provided the basis for.

Article 13b

In the case of veterinary medicinal products containing active substances used in veterinary medicinal products authorised composition, which has not been used in combination for therapeutic purposes, must be in accordance with the provisions of article 12, paragraph 3, first subparagraph, point (j)), if necessary, be submitted to the results of safety tests, residue tests and of new pre-clinical tests or clinical trials relating to the new combination, but it shall not be necessary to provide documentation relating to each individual active substance.

Article 13 c

The holder of a marketing authorisation may, in accordance with the issuance of this permit may authorize the use of the proprietary documentation, safety studies, the examinations for residues, pre-clinical and clinical trials, which is apparent from the documents before the Court concerning the veterinary medicinal product concerned, with a view to treatment of a later application for a veterinary medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form.

Article 13d

Notwithstanding the provisions of article 12, paragraph 3, first subparagraph, point (j)), and in special circumstances with respect to immunological veterinary medicinal products, the applicant shall not be required to present the results of certain field studies of the species of the medicinal product is intended, if these studies of well-founded reasons, cannot be implemented, in particular on account of other Community provisions.

Article 14

The summary of product characteristics shall contain the following information in this order: 1) name of the veterinary medicinal product followed by its strength and pharmaceutical form



2) the qualitative and quantitative composition in terms of the active substances and excipients must be familiar with a view on the proper use of the veterinary medicinal product, taking the general common name or chemical description shall apply



3) pharmaceutical form



4) clinical information:



4.1. target species, is intended for



4.2. indications for use, specifying the target species, is intended for



4.3. contraindications



4.4. Special warnings for each animal species, the drug is intended for



4.5. Special precautions, including special precautions, as the person who treats animals with the medicinal product, shall follow the



4.6. adverse reactions (frequency and seriousness),



4.7. use during pregnancy, milk or egg production



4.8. interaction with other medicinal products interactions and other interactions



4.9. dosage and route of administration



4.10. overdose (symptoms, emergency procedures, antidotes)




4.11. withdrawal period for the various foods, including foods with no withdrawal period.



5 pharmacological properties)



5.1. pharmacodynamic properties



5.2. pharmacokinetic properties



6) pharmaceutical information:



6.1. list of excipients



6.2. incompatibilities



6.3. shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time



6.4. Special precautions for storage



6.5. nature and composition of immediate packaging



6.6. any special precautions to be taken for the disposal of unused veterinary medicinal products or waste derived from the application of these



7) the holder of the marketing authorisation



8) marketing authorisation number/numbers



9) date of the first authorisation or renewal of the authorisation



10) date of text change.

With regard to authorisations in accordance with article 13, it is not necessary to include those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which were still covered by patent law at the time when the generic medicinal product is marketed.

Article 15

1. The applicant shall ensure that the detailed and critical summaries referred to in article 12, paragraph 3, second subparagraph, shall be drawn up and signed by persons with the necessary technical or professional qualifications, set out in a brief curriculum vitae, before they are submitted to the competent authorities.

2. the Persons referred to in paragraph 1, with the technical or professional qualifications shall justify any use of it in article 13a (1) bibliographic scientific documentation in accordance with Annex I.

3. A brief curriculum vitae of the persons referred to in paragraph 1 shall be accompanied by annexed to it or the detailed and critical summaries.

CHAPTER 2

Particular requirements for homeopathic veterinary medicinal products

Article 16

1. Member States shall ensure that homeopathic veterinary medicinal products manufactured and marketed within the community are registered or authorized in accordance with articles 17, 18 and 19, with the exception of veterinary medicinal products registered or authorised in accordance with national law by 31 December 2006. December 1993. Article 32 and article 33, paragraphs 1 to 3 shall apply in the case of homeopathic medicinal products registered in accordance with article 17.

2. Member States shall establish a special simplified registration procedure for the homeopathic veterinary medicinal products referred to in article 17.

3. Notwithstanding the provisions of article 10 may, under the responsibility of a veterinarian, homeopathic veterinary medicinal products shall be submitted to the non-food-producing animals.

4. Notwithstanding the provisions of article 11, paragraphs 1 and 2, Member States shall permit, under the responsibility of a veterinarian used homeopathic veterinary medicinal products intended for food-producing animal species and whose active substances are listed in annex II to Regulation (EEC) No 2377/90. 2377/90. Member States shall take appropriate measures to control the use of homeopathic veterinary medicinal products in another Member State is registered or approved by virtue of this directive for the same species.

Article 17

1. without prejudice to the provisions of Regulation (EEC) No 2377/90. 2377/90 on the establishment of maximum residue limits with regard to pharmacologically active substances intended for food-producing animals, only apply a special simplified registration procedure for homeopathic veterinary medicinal products which satisfy all of the following conditions: (a)) the route of Administration is as described in the European Pharmacopoeia or the pharmacopoeias currently has official status in the Member States



(b)) there is no specific therapeutic indications on the label or in the information on the veterinary medicinal product



(c)) a sufficient degree of dilution to guarantee that the medicinal product is harmless. In particular it must not contain more than one part per 10,000 of the mother tincture.

In the case of new scientific information, can the provisions of the first subparagraph, point (b)) and (c)), shall be adjusted by the Commission. These measures, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

At registration, Member States shall determine the classification for the dispensing of the medicinal product.

2. The criteria and rules of procedure are set out in Chapter 3, undtagenartikel 25, shall apply by analogy to the special, simplified registration procedure for homeopathic veterinary medicinal products referred to in paragraph 1, with the exception of the proof of therapeutic effect.

Article 18

The special, simplified application for registration may cover a series of medicinal products derived from the same homeopathic stock (s). The application be accompanied by the following documents in order in particular to demonstrate these medicines pharmaceutical quality and the manufactured batch homogeneity: – the (n) homeopathic (s) scientific name or another name of a pharmacopoeia with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered,



— documentation with description of the manufacture and control of the trunk (the tribes), justifying its homeopathic nature by means of an adequate bibliography; for homeopathic veterinary medicinal products containing biological substances, also a description of the necessary measures for the prevention of pathogens,



-manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentization,



– the authorization to manufacture the relevant medicinal products



– copy of any registrations or approvals for the same drugs in other Member States



-one or more mock-ups of the outer packaging and the immediate packaging of the medicinal products to be registered.



– information relating to the medicinal product durability.



– the recommended withdrawal period accompanied by all the necessary information.

Article 19

1. homeopathic veterinary medicinal products Other than those referred to in article 17, paragraph 1, shall be approved in accordance with articles 12, 13a, 13b, 13 c, 13d and 14.

2. A Member State may introduce or retain in its territory specific rules for the safety tests, pre-clinical and clinical trials of homeopathic veterinary medicinal products intended for pet food or non-food-producing exotic species, and which are not covered by article 17, paragraph 1, in accordance with the principles and the specific practices that applies to homeopathy in this Member State. In that case, the Member State concerned shall notify the Commission of the specific rules in force.

Article 20

This chapter does not apply to immunological veterinary medicinal products.

The provisions of titles VI and VII shall also apply to homeopathic veterinary medicinal products.

CHAPTER 3

Proceedings concerning the granting of a marketing authorisation

Article 21

1. Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation are not longer than a maximum of 210 days from the submission of a valid application.

If you require marketing authorisation issued for the same veterinary medicinal product in more than one Member State, applications shall be submitted in accordance with articles 31 to 43.

2. If a Member State notes that an application for marketing authorization for the same medicinal product already under treatment in another Member State, it shall reject the application and inform the applicant of treating that article 31-43 shall apply.

Article 22

If a Member State in accordance with article 12, paragraph 3) (n), is informed that another Member State has authorized a veterinary medicinal product which is the subject of an application for marketing authorisation in the Member State concerned, it shall reject the application if it has not been submitted in accordance with articles 31 to 43.

Article 23

When examining a pursuant to articles 12 to 13d application submitted to the competent authority of the Member State: 1) check that the submitted material is in accordance with articles 12 to 13d and ascertain whether the conditions for the granting of a marketing authorisation have been fulfilled



2) have the option of letting the veterinary medicinal product, its raw materials and if necessary intermediate products or other constituent control by an official medicines control laboratory or a laboratory that a Member State has designated for that purpose, and ensure that the testing methods employed by the manufacturer and described in the application, the material in accordance with article 12, paragraph 3, first subparagraph, point (i)), is satisfactory



3) in the same way could ensure, in particular, in consultation with the national reference laboratory or EFreference laboratory, the analytical method used for detecting residues, as is proposed by the applicant in accordance with article 12, paragraph 3, subparagraph (j)), the second indent is satisfactory



4) could, where appropriate, require the applicant to supplement the material with further information on the points mentioned in articles 12 to 13d. Where the competent authority makes use of this option, the time-limits referred to in article 21 shall be suspended until the requisite additional information is provided. These time limits shall be suspended also in that time, which in this case is given by the applicant to submit oral or written explanation.

Article 24


Member States shall take all the measures necessary in order that (a)) the competent authorities verify that manufacturers and importers of veterinary medicinal products from third countries are able to carry out manufacture in compliance with the article 12, paragraph 3, subparagraph (d)), contained entries and/or to carry out controls according to the methods described in the material in accordance with article 12; (3) paragraph (i))



(b)), the competent authorities in justified cases can provide manufacturers and importers of veterinary medicinal products from third countries, permission to let certain parts of the manufacture and/or of the checks provided for in point (a)) carried out by third parties; in such cases, the competent authorities shall be carried out also in these companies.

Article 25

1. When the marketing authorization is issued, the competent authority shall send to the holder notice of product characteristics which is approved.

2. The competent authority shall take all necessary measures to ensure that the information concerning the veterinary medicinal product, including the labelling and package leaflet, is in conformity with the information in the summary of product characteristics approved when the marketing authorization is issued or subsequently.

3. The competent authority shall without delay make the marketing authorisation together with the summary of product characteristics for each veterinary medicinal product which it has authorised, accessible to the public.

4. The competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the pharmaceutical tests, security studies, examinations for residues as well as pre-clinical and clinical trials of the veterinary medicinal product concerned.

The assessment report shall be updated as soon as new information relevant to the evaluation of the quality, safety or efficacy of the veterinary medicinal product.

The competent authority shall make the assessment report without delay, accompanied by the reasons for his opinion directly available to the public after having removed all information of commercial confidential nature.

Article 26

1. the marketing authorisation may be made subject to the marketing authorisation holder on the inner and/or outer packaging as well as on the leaflet, if required, indicate other important information for security or protection of public health, including special precautions to be observed in use, and other warnings, as follows in article 12, paragraph 3, subparagraph (j)), and articles 13 to 13d referred to studies and trials or by the experience that is achieved by the use of the veterinary medicinal product after it is marketed.

2. (repealed).

3. In exceptional circumstances and following consultation with the applicant, the issuing of the permit can be made conditional on the applicant to introduce specific mechanisms, in particular with regard to the safety of the veterinary medicinal product, the information of the competent authorities of any incident relating to the application and on measures to be taken. Such a permit shall be issued only for objective and verifiable reasons. Continue marketing depends on an annual reassessment of these conditions.

Article 27

1. Holder, following the granting of the marketing authorisation shall, in respect of the products listed in article 12, paragraph 3, subparagraph (d)) and i), referred to the manufacturing and control methods, take account of scientific and technical development and introduce the changes that are necessary to enable the veterinary medicinal product is manufactured and checked in accordance with the generally accepted scientific methods.

These changes must be approved by the competent authority of the Member State concerned.

2. The competent authority may require the applicant or the marketing authorisation holder shall provide substances in sufficient quantities to permit monitoring for the detection of residues of the veterinary medicinal products concerned.

The marketing authorisation holder shall, at the request of the competent authority to assist with its technical expertise in order to make it easier for the national reference laboratory designated under Council Directive 96/23/EC of 29 April 2004. April 1996 on the control measures to be implemented for certain substances and residues thereof in live animals and animal products heraf15), to implement analytical method used for detecting residues of veterinary medicinal products.

3. The authorisation-holder shall submit new information immediately to the competent authority, if they may involve changes to the particulars and documents referred to in article 12(3), 13, 13a, 13b and 14 or Annex I.

The consent holder is in particular obliged to immediately notify the competent authority of any prohibition or restriction imposed by the competent authorities of the country in which the veterinary medicinal product is marketed and of any other new information which might influence the evaluation of the relationship between the benefits and risks of the veterinary medicinal product concerned.

To the relationship between benefits and risks must be assessed on a continuous basis, the competent authorities may at any time ask the holder of the marketing authorisation to forward data demonstrating that the risk-benefit ratio remains favourable.

4. (repealed).

5. the marketing authorisation holder shall, in order to obtain a permit shall notify the competent authorities immediately informed of any intended change in the information referred to in articles 12 to 13d or documents.

Article 27a

After a marketing authorisation has been granted, the marketing authorisation holder shall inform the competent authority of the Member State which has granted the authorization, whether, when placing on the market of the veterinary medicinal product actually begins in that Member State, taking into account the various presentations authorised.

Furthermore, the holder shall notify the competent authority if the veterinary medicinal product is temporarily or permanently no longer marketed in the Member State. Such notification shall, unless there are exceptional circumstances, be made at least two months before the termination of the placing on the market.

At the request of the competent authority, in particular in the context of pharmacovigilance, the marketing authorisation holder shall submit to the competent authority all information on the volume of sales of the veterinary medicinal product, and any information which he is in possession of about prescription volume.

Article 27b

The Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this directive.

The Commission shall adopt these arrangements by an implementing regulation. This measure, designed to amend non-essential elements of this directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

Article 28

1. The marketing authorisation shall be valid for five years, without prejudice to article. However, paragraphs 4 and 5.

2. The authorisation may be renewed after five years on the basis of a re-evaluation of the relationship between benefits and risks.

To this end, the marketing authorisation holder shall submit a consolidated list of all documents submitted in respect of quality, safety and efficacy, including all variations introduced since the marketing authorization is issued, 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 listed documents.

3. A marketing authorization, there is renewed, for an unlimited period, unless the competent authority, on justified grounds relating to pharmacovigilance decides to proceed with one additional five-year period in accordance with paragraph 2.

4. If an authorisation does not lead to actual placing on the market of the authorised veterinary medicinal product in the Member State of issue, lapse the authorization not later than three years after its date of issue.

5. If an authorised veterinary medicinal product previously marketed in the Member State which granted the authorisation, no longer be placed on the market in that Member State for three consecutive years, the authorisation of this drug.

6. In exceptional circumstances and for reasons of human or animal health, the competent authority may derogate from paragraphs 4 and 5. Such derogations shall be duly substantiated.

Article 29

The authorisation shall be without prejudice to the liability under ordinary, which is the responsibility of the manufacturer and, where appropriate, the holder of the marketing authorisation.

Article 30

Marketing authorisation shall be refused if the documentation submitted to the competent authorities does not comply with articles 12 to 13d and 15.

Marketing authorisation shall be refused if, after verification of also in article 12 and article 13, paragraph 1, referred to documents and information is clearly (a)) that the estimate of the relationship between the benefits and risks of the veterinary medicinal product under normal conditions of use is negative, in particular taking into account the benefits with regard to animal health and welfare and consumer safety, when the application concerns veterinary medicinal products intended for zootechnical use , or



(b)) to the veterinary medicinal product has no therapeutic effect or the drug's therapeutic effect is insufficiently substantiated by the applicant for the species of animal which is to be the subject of the examination, or



(c)) the veterinary medicinal product does not have the specified qualitative and quantitative composition, or




(d)) that the withdrawal period, which is indicated by the applicant is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer, or is insufficiently substantiated;



(e)) to the labelling or the package leaflet proposed by the applicant are not in accordance with this directive, or



f) the veterinary medicinal product is offered for sale for a use prohibited under other Community provisions.

However, the competent authorities may, as long as Community legislation in this area is still under construction, refuse to grant an authorisation for the placing on the market of a veterinary medicinal product, if this is necessary to ensure the protection of public health, consumer or animal health.

The applicant or the marketing authorisation holder shall be responsible for ensuring that the submitted documents and data are correct.

CHAPTER 4

Mutual recognition procedure and decentralised procedure

Article 31

1. a coordination group shall be for the purpose of the examination of any question relating to marketing authorisation of a veterinary medicinal product in two or more Member States in accordance with the procedures laid down in this chapter. The Agency shall provide the Secretariat of the coordination group.

2. The coordination group shall be composed of one representative of each Member State, who are appointed for a period of three years, renewable. The members of the coordination group may be accompanied by experts.

3. the coordination group shall adopt its rules of procedure, which shall enter into force after the Commission has delivered a favourable opinion. The rules of procedure shall be made public.

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. Documentation to be attached to the application for marketing authorisation shall include all the administrative information and scientific and technical material, referred to in articles 12 to 14. The documentation submitted must contain a list of the Member States covered by the application.

The applicant requests one of these Member States to act as reference Member State and to prepare an assessment report on the veterinary medicinal product in accordance with paragraphs 2 or 3.

The evaluation report shall, where appropriate, contain an analysis according to article 13, paragraph 5 or article 13a (3).

2. If at the time the application is submitted, have already been granted a marketing authorisation for the veterinary medicinal product concerned, the Member States concerned shall recognise the authorisation granted by the reference Member State. To this end, the marketing authorisation holder shall request the reference Member State to prepare an evaluation report or, where appropriate, update the existing evaluation report. The reference Member State shall prepare or update the assessment report within 90 days of receipt of the valid application. The approved assessment report, the approved summary of product characteristics, the labelling and the approved approved the package leaflet shall be forwarded to the concerned Member States and the applicant.

3. If at the time the application is submitted, the absence of a marketing authorisation for the veterinary medicinal product concerned, the applicant shall request the reference Member State to prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet.

The reference Member State shall prepare these drafts within 120 days after receipt of a valid application and shall send them to the concerned Member States and the applicant.

4. Within 90 days after receipt of the documents referred to in paragraphs 2 and 3, the Member States concerned shall approve the assessment report, summary of product characteristics and the labelling and package leaflet and shall inform the reference Member State to this effect. The latter determines that there is a consensus, terminating the procedure and shall inform the applicant accordingly.

5. within 30 days after that there is established consensus, adopts all the Member States in which an application has been submitted in accordance with paragraph 1, a decision that is consistent with the assessment report, summary of product characteristics and the labelling and package leaflet/insert, as they have been approved.

Article 33

1. If a Member State on grounds of a potential serious risk to human or animal health or to the environment cannot approve the assessment report, summary of product characteristics, labelling or the package leaflet within the time limit laid down in article 32, paragraph 4, it shall send a detailed statement of the reasons therefor to the reference Member State, the other Member States concerned and the applicant. The disputed points shall be submitted immediately to the coordination group.

If a Member State in which an application has been filed, refers to the reasons in article 71, paragraph 1, that Member State with regard to this chapter will no longer be considered a Member State concerned.

2. the Commission shall adopt guidelines to define what is meant by a potential serious risk to human or animal health or to the environment.

3. Within the coordination group does all the Member States referred to in paragraph 1, their utmost to reach an agreement on the measures to be taken. They give the applicant the opportunity to submit its views orally or in writing. If the Member States reach an agreement within a period of 60 days from the date of notification of the disputed points in the coordination group, the reference Member State shall record the agreement reached, terminating the procedure and shall inform the applicant accordingly. Article 32, paragraph 5, shall apply.

4. If the Member States fail to reach agreement within the period of 60 days, the Agency shall be immediately informed with a view to the application of the procedure laid down in articles 36, 37 and 38. Transmitted a detailed description of the disputed question and of the reasons for their disagreement to the Agency. The applicant will receive a copy of such information.

5. As soon as the applicant has been informed that the matter has been submitted to the Agency, immediately send a copy of this in article 32, paragraph 1, referred to in the first subparagraph information and documents.

6. In the cases referred to in paragraph 4, the Member States that have approved the assessment report of the reference Member State and the summary of product characteristics, at the request of the applicant, the placing on the market of the veterinary medicinal product without waiting for the outcome of the procedure laid down in article 36. In such a case, the authorisation does not prejudge the outcome of this procedure.

Article 34

1. Is a veterinary medicinal product subject of multiple applications for a marketing authorisation submitted in accordance with articles 12 to 14, and the Member States have adopted divergent decisions concerning the authorization, suspension or withdrawal of this, can a Member State, the Commission or the marketing authorisation holder may refer the matter to the Committee for veterinary medicinal products, in the following referred to as the ' Committee ', in order to get it treated in accordance with the procedure referred to in article 36 , 37 and 38.

2. With a view to promoting the harmonisation of veterinary medicinal products which are authorised in the community, and to improve the impact of articles 10 and 11, Member States shall communicate no later than 30 June. April 2005 a list of medicines for which there must be harmonised product summaries to the coordination group.

The coordination group shall draw up a list of medicinal products on the basis of Member States ' proposals and shall be transmitted to the Commission.

The medicines on this list is covered by paragraph 1 in accordance with the timetable laid down in cooperation with the Agency.

The Commission shall fix the final list and timetable in consultation with the Agency and in consultation with the parties concerned.

Article 35

1. Member States or the Commission or the applicant or the marketing authorisation holder shall, in specific cases where the interests of the community are involved, refer the matter to the Committee in order to get it treated in accordance with the procedure laid down in articles 36, 37 and 38, before deciding on an application, a suspension or a revocation of a marketing authorisation or of any other change in the terms of a marketing authorisation that seems to be required, in particular taking into account the information collected in accordance with Title VII.

The Member State concerned or the Commission shall indicate clearly which issues submitted to the Committee for consideration and shall inform the applicant or the marketing authorisation holder.

Member States and the applicant or the marketing authorisation holder shall send to the Committee all available information relating to the matter under consideration.

2. Where the referral to the Committee concerns a range of medicinal products or a therapeutic group, the Agency may limit the procedure to specific parts of the authorisation.

In that case, article 39 shall apply only to those medicinal products only if they were covered by the procedure for the marketing authorisation referred to in this chapter.

Article 36

1. where reference is made to the procedure laid down in this article, the Committee shall examine the matter and shall give its reasoned opinion within 60 days after it has received the case presented.

In the cases presented to the Committee in accordance with articles 34 and 35, the Committee may, however, extend this period by a total of 90 days, taking into account the views of the concerned marketing authorisation holders had to make.

In urgent cases, the Committee may, on a proposal from its Chairman, lay down a shorter period.


2. To consider the matter, the Committee shall appoint one of its members to act as rapporteur. The Committee may also appoint independent experts to advise it on specific questions. When the Committee shall appoint such experts, define their tasks and shall fix a time limit for the execution thereof.

3. the Committee shall deliver its opinion, Before giving the applicant or the marketing authorisation holder to submit written or oral observations within a time limit, as this sets.

The Committee's opinion, be accompanied by proposals for the draft summary of product characteristics and the labelling and package leaflet.

If the Committee deems it appropriate, may invite any other person to provide information about the case, it has to treat.

The Committee may suspend the time limit referred to in paragraph 1 in order to allow the applicant or the marketing authorisation holder with an opportunity to prepare its observations.

4. the Agency shall forthwith inform the applicant or the marketing authorisation holder thereof, if in its opinion the Committee is that:-the application does not satisfy the acceptance criteria, or



-the summary of product characteristics proposed by the applicant or the marketing authorisation holder in accordance with article 14 should be amended, or



– that the authorisation should be made dependent on certain conditions, IE. conditions that are considered to be of vital importance for the safe and effective use of the veterinary medicinal product including pharmacovigilance, or



– that a marketing authorisation should be suspended, modified or revoked.

No later than 15 days after receipt of the opinion, the applicant or the marketing authorisation holder shall inform the Agency in writing that he wants the decision taken up for reconsideration. In that case, he sends the Agency a detailed justification for its request no later than 60 days after receipt of the opinion.

Within 60 days following receipt of the grounds for the request, taking the Committee reconsidered its opinion in accordance with article 62, paragraph 1, second subparagraph, of Regulation (EC) No 1782/2003. 726/2004. The Committee's conclusions concerning the request shall be annexed to the assessment report referred to in paragraph 5 of this article.

5. within 15 days after the Committee has adopted its final opinion, the Agency shall forward this to the Member States, the Commission and the applicant or the marketing authorisation holder together with a report describing the assessment of the veterinary medicinal product and stating the reasons for its conclusions.

If an opinion is favourable to the granting or extension of a marketing authorisation, the following documents shall be annexed to the opinion: (a)) a draft summary of product characteristics, as referred to in article 14; If necessary, this reflects differences in the veterinary conditions in Member States



b) any conditions for the granting of the authorisation referred to in paragraph 4



c) details of any recommended conditions or restrictions with regard to the safe and effective use of the veterinary medicinal product, and



d) draft of the labelling and package leaflet.

Article 37

No later than 15 days after receipt of the opinion, the Commission shall draw up a draft of the decision to be taken in respect of the application, taking into account Community law.

If a draft decision which envisages the granting of marketing authorization, the documents referred to in article 36, shall be attached to the paragraph 5, second subparagraph, annex.

If, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall attach to the annex a detailed explanation of the reasons for the differences.

The draft decision shall be forwarded to the Member States and the applicant or the marketing authorisation holder.

Article 38

1. the Commission shall take a final decision in accordance with, and within 15 days after the completion of the procedure laid down in article 89, paragraph 3.

2. The rules of procedure of the Standing Committee set up by article 89, paragraph 1, be adapted to take account of the tasks incumbent upon it pursuant to this chapter.

These adaptations involves the following:-except in cases referred to in the third subparagraph of article 37, the opinion of the Standing Committee shall be obtained in writing,



-each Member State shall have 22 days to forward to the Commission his written observations on the draft decision. If the decision is of urgency, the President may, however, provide for a shorter period, depending on how much the issue of urgency. Apart from exceptional circumstances should the deadline not be shorter than five days



– the individual Member State the opportunity to submit a request in writing that the draft decision be discussed in a plenary session of the Standing Committee.

When the written observations of a Member State, the Commission considers that raises important new scientific or technical questions that are not affected in the Agency's opinion, the procedure and the Chairman shall communicate the application back to the Agency for further consideration.

The Commission shall adopt the necessary detailed rules for the application of this paragraph in accordance with the procedure referred to in article 89, paragraph 2.

3. The decision referred to in paragraph 1 shall be transmitted to all Member States and communicated to the applicant or holder of the marketing authorisation for information. The concerned Member States and the reference Member State shall grant or withdraw marketing authorisation or make the changes in the marketing authorisation, which may be necessary in order to comply with the decision within 30 days after that this is communicated, and refers in this connection to the decision. They shall inform the Commission and the Agency.

Article 39

1. Any application by the marketing authorization holder to vary a marketing authorization which has been granted in accordance with the provisions of this chapter shall be submitted to all the Member States which have previously authorized the veterinary medicinal product concerned.

The Commission shall adopt these measures in the form of an implementing regulation. This measure, designed to amend non-essential elements of this directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

2. In cases of arbitration submitted to the Commission case, the procedure laid down in articles 36, 37 and 38 shall apply by analogy to variations made to marketing authorizations.

Article 40

1. Where a Member State considers it necessary to amend the terms of a marketing authorisation granted in accordance with the provisions of this section, or to suspend or revoke the order to protect human or animal health or the environment, shall refer the matter without delay to the Agency to get it treated in accordance with the procedures laid down in articles 36, 37 and 38.

2. Notwithstanding the provisions of article 35, Member States may, in exceptional cases, when the exigencies of human or animal health or to the environment is required to act quickly, until a definitive decision is adopted, may suspend the marketing and the use of the medicinal product concerned on its territory. They shall notify not later than the following working day at the Commission and the other Member States about the reasons for doing so.

Article 41

Articles 39 and 40 shall apply mutatis mutandis to veterinary medicinal products which have been authorised by Member States on the basis of an opinion from the Committee, which is made in accordance with article 4 of Directive 87/22/EEC before 1 July. January 1995.

Article 42

1. The Agency shall publish an annual report on the application of the procedures set out in this chapter and shall forward this report to the European Parliament and the Council for information.

2. At least every ten years the Commission shall publish a report on the experience gained in the application of the procedures that are described in this chapter and shall propose any changes 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, paragraphs 4, 5 and 6, and article 34 to 38 shall not apply to the homeopathic veterinary medicinal products referred to in article 17.

Articles 32 to 38 shall not apply to the homeopathic veterinary medicinal products referred to in article 19, paragraph 2.

TITLE IV

MANUFACTURE AND IMPORT

Article 44

1. Member States shall take the necessary measures to ensure that the manufacture of veterinary medicinal products within their territory conditional upon authorisation. This authorisation to manufacture is required, although the quantities of veterinary medicinal products intended for export.

2. The authorization referred to in paragraph 1 shall be required for both the full and the partial manufacture, as well as for processes of dividing up, packaging and presentation.

This permission is not required for processing, splits and changes by wrapping or presentation, in so far as such operations are carried out solely for the purpose of retail supply by pharmacists in dispensing pharmacies or by other persons under the law of the Member States are authorized to perform these processes.

3. The authorization referred to in paragraph 1 shall also be required for imports from third countries into a Member State, and to this end, this section and article 83 shall apply to such imports in the same way as they apply to the manufacture.

Member States shall take the necessary measures to ensure that veterinary medicinal products imported from third countries, in their territory and intended for another Member State, be accompanied by a copy of the authorization referred to in paragraph 1.


4. Member States shall send a copy of the manufacturing authorization referred to in paragraph 1 to the Agency. The Agency establishes that information in the Community database referred to in article 80, paragraph 6.

Article 45

In order to obtain the manufacturing authorization, the applicant must prove that he meets the following requirements at least: (a)) specify the veterinary medicinal products and pharmaceutical forms which are to be manufactured and/or imported and also the place for their manufacture and/or control



(b)) for the manufacture or importation of them dispose of premises, technical equipment and control options that are suitable and sufficient, and complying with the legal requirements which the Member State concerned shall make, both as regards manufacture and controls with regard to the storage of medicinal products, taking into account article 24 all



c) have at least one person who is qualified in accordance with article 52, available.

The applicant must provide the application with evidence that he satisfies these requirements.

Article 46

1. The competent authority of the Member State shall notify the manufacturing authorisation only after verifying by means of an inquiry carried out by its representatives, pursuant to article 45 information given is correct.

2. In order to ensure compliance with the conditions laid down in article 45 may be attached to the permit certain obligations imposed either by its issue or at a later time.

3. The authorization shall apply only to the premises specified in the application and for the same application in veterinary medicinal products and pharmaceutical forms specified.

Article 47

Member States shall take all appropriate measures to ensure that the proceedings concerning 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 modification of one of the products listed in article 45, paragraph 1, point (a)) and (b)), the information provided, taken for the procedure relating to this request shall not exceed 30 days. In special cases, this period may be extended to 90 days.

Article 49

The competent authority of the Member State of the applicant may require further information with regard to the information obtained pursuant to article 45, as well as in respect of the qualified person referred to in article 52; where the competent authority makes use of this possibility shall be suspended in articles 47 and 48 deadlines until the required additional information has been provided.

Article 50

The holder of the manufacturing authorization is required at least: a) to have at its disposal personnel who, in the Member State concerned complies with the applicable regulatory requirements, both in terms of the manufacture and control



(b)) only to disclose the authorized veterinary medicinal products in accordance with the laws of the Member States concerned



c) in advance to inform the competent authorities of any changes he may wish to make to any of the particulars supplied pursuant to article 45; However, the competent authorities shall be informed immediately in the event of unforeseen replacement of the qualified person referred to in article 52



(d)) at any time to allow representatives of the competent authorities of the Member State concerned access to his premises;



(e)) to enable the qualified person referred to in article 52 to carry out its task, in particular by providing all necessary resources at his disposal



f) to respect the principles and guidelines of good manufacturing practice for medicinal products and use as starting materials only active substances, which are manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials



g) to keep detailed records of all veterinary medicinal products, to whom he has supplied, including samples, in accordance with the laws of the country of destination. At least the following information shall be recorded for each transaction, whether it is done in return for payment or not:



– date



– name of the veterinary medicinal product



– delivered quantity



– the name and address of the recipient



— the lot number.

These records must be kept for inspection purposes at the disposal of the competent authorities for at least three years.

Article 50a

1. For the purposes of this directive, manufacture of active substances used as starting materials, complete or partial manufacture or import of an active substance used as a starting material as defined in Annex i, 2. part, section (C), as well as the various processes of dividing up, packaging or presentation related to prior to its use in a veterinary medicinal product, including repackaging and re-packaging or re-labelling as made, inter alia, by a trader of raw materials.

2. the Commission shall adopt any amendments which may be necessary to adapt the provisions of paragraph 1 of this article to scientific and technical progress.

These measures, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

Article 51

The principles and guidelines of good manufacturing practice for veterinary medicinal products, as referred to in article 50, subparagraph (f)), adopted by the Commission in the form of a directive addressed to the Member States. These measures, designed to amend non-essential elements of this directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

Detailed guidelines in line with those principles shall be published by the Commission and revised as appropriate to take account of scientific and technical progress.

In article 50, subparagraph (f)), referred to the principles of good manufacturing practice for active substances used as starting materials, shall be adopted in the form of detailed guidelines.

In addition, the Commission will publish guidelines on the form and content of the authorisation referred to in article 44, paragraph 1, of the reports referred to in article 80, paragraph 3, and of the certificate of good manufacturing practice referred to in article 80, paragraph 5.

Article 52

1. Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization has permanently and continuously at least one qualified person who fulfils the conditions laid down in article 53, and which, in particular, is responsible for the performance of the tasks defined in article 55.

2. If the authorisation-holder personally fulfils the conditions laid down in article 53, he may himself assume the responsibility referred to in paragraph 1.

Article 53

1. Member States shall ensure that the qualified person referred to in article 52, paragraph 1, referred to in paragraphs 2 and 3 of this article provided requirements for qualifications.

2. The qualified person shall be in possession of a diploma, certificate or other evidence of a university course of study, or a course, as recognised by the Member State concerned as being equivalent thereto in a period of at least four years of theoretical and practical study in one of the following scientific disciplines: Pharmacy, medicine, veterinary science, chemistry, pharmaceutical chemistry and technology, biology.

However, the minimum duration of the University course may be three and a half years, if it is followed by a theoretical and practical training, culminating in an examination at university level of a duration of at least one year and including a praktikanttid of at least six months in a pharmacy open to the public.

If in a Member State at the same time are two university educations or two studies, as of that State recognised as covering each other, one of which extends over four years and the other over three years, is considered the diploma, certificate or other evidence of the three-year university degree or training recognized as equivalent thereto, to meet the requirements referred to in the first subparagraph on the duration , in so far as the diplomas, certificates or other evidence of formal qualifications in the two studies of that State recognised as having the same value.

The study includes theoretical and practical instruction, covering at least the following basic subjects: – experimental physics



-General and inorganic chemistry



– organic chemistry



-analytical chemistry



-pharmaceutical chemistry, including analysis of medicinal product



-General and applied Biochemistry (medical)



– Physiology



– Microbiology



— Pharmacology



-pharmaceutical technology



– Toxicology



-pharmacognosy (study of the composition and effects of the active substances of natural substances of plant and animal origin).

The teaching of these subjects must be given in such a way that the person concerned will be able to meet the obligations specified in article 55.

In so far as certain diplomas, certificates or other evidence of formal qualifications referred to in the first subparagraph, do not meet the criteria referred to in this paragraph, the competent authorities of the Member State shall ensure that the person concerned in these subjects shall submit proof of adequate language skills in respect of the manufacture and control of veterinary medicinal products.

3. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products.

The duration of the practical experience may be reduced by one year, if the University extends over at least five years, and with a year and a half, if the Studio stretches over at least six years.

Article 54


1. A person in a Member State shall, in article 52, paragraph 1, referred to in the person's undertaking at the time of the implementation of Directive 81/851/EEC without complying with the requirements referred to in article 53 to qualifications is eligible to continue to engage in those activities in the community.

2. the holder of a diploma, certificate or other evidence of completed university course of study, or a course of study, that of the Member State concerned is recognised as being equivalent thereto, within a scientific discipline that qualifies the person to carry on the activities of the person referred to in article 52, in accordance with the legislation of that State, may-when he has begun his training before the 9. October 1981-deemed qualified in that Member State to assume the duties of the person referred to in article 52, provided that he previously, before the 9. October 1991, for at least two years directly under the leadership of the person referred to in article 52 has exercised supervisory company for the manufacture and/or carried out qualitative and quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of veterinary medicinal products, in one or more companies which have obtained the manufacturing licence.

When the person concerned has acquired the practical experience referred to in the first subparagraph, before the 9. October 1971, required that an additional years of practical experience corresponding to the conditions referred to in the first subparagraph; This additional practical experience must be obtained immediately prior to the exercise of these activities.

Article 55

1. Member States shall take all appropriate measures to ensure that the qualified person referred to in article 52, without prejudice to his relationship with the holder of the manufacturing authorization, within the framework of the procedures referred to in article 56 are responsible for securing: (a)) to any party of veterinary medicinal products manufactured within the Member State concerned, are produced and controlled in accordance with the legislation in force in that Member State and in accordance with the requirements of the marketing authorization at the time of notification of



(b)) to each batch of veterinary medicinal products imported from third countries, irrespective of whether they are manufactured in the community in a Member State have been subjected to a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of veterinary medicinal products in accordance with the requirements of the marketing authorisation at the time of notification of the conditions laid down.

Batches of veterinary medicinal products, which therefore is controlled in a Member State, shall be exempt from the above controls when they are placed on the market in another Member State, accompanied by the control reports signed by the qualified person.

2. In cases where the veterinary medicinal products imported from a third country, and the community has taken the appropriate measures with the exporting country to ensure that the manufacturer of the veterinary medicinal product applies standards of good manufacturing practice at least equivalent to the standards laid down by the community, and to ensure that the under paragraph 1, first subparagraph, point (b)), referred to the control is carried out in the exporting country, the qualified person may be relieved of responsibility in order to exercise this control.

3. In all cases, and particularly where the veterinary medicinal products are released for sale, the qualified person in a register or equivalent document certifying that each production batch satisfies the provisions of this article; This register or equivalent document must be updated as the work processes are terminated, and made available to the competent authorities ' representatives in a period that is in accordance with the provisions of the Member State concerned, however, at least five years.

Article 56

Member States shall ensure, through appropriate administrative measures or by rules of professional conduct, to the qualified person in accordance with article 52 of its commitments.

Member States may provide for the temporary suspension of such a person, if the commencement of administrative or disciplinary proceedings against him for dereliction of duty.

Article 57

The provisions of this title shall apply to homeopathic veterinary medicinal products.

TITLE V

LABELLING AND PACKAGE LEAFLET

Article 58

1. Veterinary lægemidlernes inner and outer packaging shall, unless they are covered by article 17, paragraph 1, be approved by the competent authorities. The packaging must bear the following information in perfectly legible characters, which shall conform with the particulars and documents submitted in accordance with articles 12 to 13d and the summary of product characteristics: a) the name of the medicinal product followed by its strength and pharmaceutical form. The common name shall be included, if the product contains only one active substance and if its name is an invented name



(b)) the qualitative and quantitative composition in active substances specified per unit or according to the form of submission for a particular volume or weight, using the common names



(c) manufacturer's batch number)



(d) marketing authorisation number)



e) name or corporate name and permanent address or registered place of business of the marketing authorization holder and of the representative, that may be designated by the marketing authorisation holder



f) the animal species for which the medicinal product is intended, as well as the method and, if necessary, the route of administration. Allocated space on packaging to indicate the prescribed dosage



g) the withdrawal period for veterinary medicinal products intended for use in food-producing species, for all the species concerned and for the various foodstuffs concerned (meat and offal, eggs, milk and honey), including those for food without a withdrawal period



h) expiry date, in clear language



in) any special storage precautions



j) specific precautions relating to the disposal of unused medicinal products or waste derived from veterinary medicinal products, as well as a reference to existing suitable collection systems



k) where applicable in accordance with article 26, paragraph 1, the information required



l) the words ' for veterinary use ', or in the case of the medicinal products referred to in article 67 the inscription ' for veterinary use-extradition requires veterinary prescription ' 2. The pharmaceutical form and the contents by weight, by volume or by number of dose-units need only be shown on the outer packaging.

3. In so far as they concern the qualitative and quantitative composition in terms of active substances in veterinary medicinal products, the provisions in Annex i, 1. part, section (A), apply to those under paragraph 1 (b)), the information provided.

4. In accordance with paragraph 1 (f)) to (l)), prescribed information must be on the outer package and on the container be drawn up in the language or languages used in the country in which the medicinal product is placed on the market.

5. Member States may provide, as regards medicinal products for which a marketing authorisation has been issued in accordance with Regulation (EC) No 1782/2003. 726/2004, permit or require that the outer packaging bear additional information with regard to the negotiation, possession, sale or any security measures, provided that such information is not contrary to Community law or the marketing authorization and do not have the character of advertising.

These supplementary information should appear in a blue frame, so that they are clearly separated from the information referred to in paragraph 1.

Article 59

1. As regards ampoules to the information referred to in article 58, paragraph 1, is applied to the outer packaging. The internal packaging on the other hand, only need to be provided with the following information: the container on the other hand, need only to be provided with the following information: – name of the veterinary medicinal product



– the amount of active substances



– the route of the road



– the manufacturer's batch number



– last date of application



– the words ' for veterinary use '.

2. With regard to other small immediate packaging units than ampoules, containing only a single dose, and on which it is impossible to give the information referred to in paragraph 1, apply article 58, paragraphs 1, 2 and 3 shall apply only to the outer package.

3. Pursuant to paragraph 1, the third and the sixth indent of the prescribed information to be on the outer packaging and the immediate packaging, be drawn up in the language or languages used in the country in which the medicinal product is marketed.

Article 60

If there is no outer packaging, the particulars required for the outer package, see. Article 58 and 59, appear on the immediate packaging.

Article 61

1. A veterinary medicinal product package must contain a leaflet, unless all the information required is specified in this article on the inner and the outer packaging. Member States shall take the necessary measures to ensure that the package leaflet relates only to the veterinary medicinal product to which it is attached.

The package leaflet shall be drawn up in one easy-to-understand language in the official language or languages of the Member State where the medicinal product is placed on the market.

The first subparagraph shall not prevent the package leaflet can be written in several different languages, provided that the same information must be given in all languages.


The competent authorities may waive the requirement that certain information must be shown on the label and package leaflet of certain veterinary medicinal products, and that the leaflet must be in the official language or languages of the Member State in which the veterinary medicinal product on the market, when the veterinary medicinal product concerned is only intended to be filed by a veterinarian.

2. the competent authorities shall approve package leaflets. It must at least, in this order, include the following information, which shall conform with the particulars and documents submitted in accordance with articles 12 to 13d and the approved summary of product characteristics: with a) name or corporate name and permanent address or registered place of business of the marketing authorisation holder and, where appropriate, of the manufacturer and, where appropriate, of the representative of the marketing authorisation holder



(b)) the veterinary medicinal product followed by its strength and pharmaceutical form name. The common name shall be included, if the product contains only one active substance and if its name is an invented name. The drug 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 approved names for each Member State.



c) therapeutic indications



d) contra-indications and adverse reactions, in so far as such information is necessary for the use of the veterinary medicinal product



(e)) the animal species for which the medicinal product is intended, the dosage in relation to these species, the scope, including the method of administration and, where appropriate, indications for proper use



f) the withdrawal period, even if this is nil, in the case of veterinary medicinal products administered to food-producing animals;



(g)), where appropriate, special storage precautions



h) where applicable, pursuant to article 26, paragraph 1, the information required



in), where appropriate, special precautions for disposal of unused medicinal products or waste derived from medicinal products.

Article 62

Compliance with the provisions of this section do not, the competent authorities of the Member States, if a call to the person concerned has been ineffectual, suspend or revoke the marketing authorisation.

Article 63

Member States ' legislation on the conditions for extradition to the audience, on the indication of the prices of veterinary medicinal products and on industrial property rights shall not be affected by the provisions of this section.

Article 64

1. Without prejudice to paragraph 2, homeopathic veterinary medicinal products shall be labelled in accordance with the provisions of this section and on the label with clear and legible written bear the words ' homeopathic medicinal product for veterinary use ".

2. The labelling and package leaflet to the any medicinal products referred to in article 17, paragraph 1, on the very visible way bear the words ' homeopathic veterinary medicinal product without approved therapeutic indications ', and, in addition, contain only the following information: – the tribe's/scientific name of the stock or stocks followed by the degree of dilution through the use of the symbols of the pharmacopoeia used as referred to in article 1, no. 8); If the homeopathic veterinary medicinal product is composed of several tribes, in addition to the scientific names of the stocks indicate a brand name on the labelling



– name and address of the marketing authorisation holder and, where appropriate, of the manufacturer



– the method and, if necessary, route of administration



– the expiry date, in clear terms (month/year)



– pharmaceutical form



– the content of sales packaging



-any special precautions to be taken by storage



– target



– a special warning, if the drug requires it



– the manufacturer's batch number



-the registration number.

TITLE VI

POSSESSION, DISTRIBUTION AND DISPENSING OF VETERINARY MEDICINAL PRODUCTS

Article 65

1. Member States shall take the necessary measures to ensure that wholesale distribution of veterinary medicinal products shall be subject to a permit, and to ensure that the time taken for processing an application for the authorization does not exceed 90 days from the day on which the competent authority receives the application.

Member States may exempt the supply of small quantities of veterinary medicinal products from one retailer to another from the definition of wholesale distribution.

2. in order to obtain the authorization for distribution, the applicant shall have at its disposal personnel with technical skills, suitable and sufficient premises and suitable and sufficient equipment that meets the requirements of the Member State concerned shall be made for the storage and handling of veterinary medicinal products.

3. the holder of the authorization for distribution shall maintain and keep detailed records of all incoming and outgoing transactions shall include at least the following information: a) date



b) precise indication of the veterinary medicinal product



c) manufacturer's batch number, expiry date;



d) received or delivered quantities



e) name and address of the supplier or recipient.

At least once a year to be made an accurate review, where the list of entry and discontinued drugs must be read in conjunction with inventory and a report drawn up on any discrepancies.

This statement must be kept for inspection purposes at the disposal of the competent authorities for at least three years.

3A. the holder of a distribution authorisation must be in possession of an emergency plan which ensures effective implementation of any measure to withdraw a medicinal product from the market, undertaken by order of the competent authorities or in cooperation with the manufacturer of the medicinal product in question or the holder of the marketing authorisation.

4. Member States shall take the necessary measures to ensure that wholesalers supply veterinary medicinal products only to persons who have retail authorisation in accordance with article 66, or to other persons who have proper authorization to receive veterinary medicinal products from wholesalers.

5. Any Distributor, not being the marketing authorisation holder, who imports a medicinal product from another Member State shall notify the marketing authorisation holder and the competent authority in the importing Member State that he intends to perform this import. With regard to products for which a permit has been issued in accordance with Regulation (EC) No 1782/2003. 726/2004, it shall inform the competent authority without prejudice to additional procedures which may be laid down in the legislation of that Member State.

Article 66

1. Member States shall take the necessary measures to ensure that the retail supply of veterinary medicinal products shall only be carried out by persons who, according to the legislation of the Member State concerned are authorised to carry out such sales.

2. Any person permitted under paragraph 1 to sell veterinary medicinal products, shall, in respect of all prescription-only veterinary medicines to keep detailed records, and for all incoming and outgoing transactions, the following information shall be recorded: (a)) date



b) precise indication of the veterinary medicinal product



(c) manufacturer's batch number)



d) received or delivered quantities



e) name and address of the supplier or recipient



f) the name and address of the prescribing veterinarian, if any, and a copy of the prescription.

At least once a year to be made an accurate review, where entry and discontinued drugs will be reconciled with inventory and a report drawn up on any discrepancies.

These records shall be kept for inspection purposes at the disposal of the competent authorities for a period of five years.

3. Member States may allow, in their territory, are provided veterinary medicinal products intended for food-producing animals, and which require a veterinary prescription, either by or under the supervision of a registered person in accordance with the national legislation have appropriate qualifications in terms of being able to maintain records and issue an alert. Member States shall inform the Commission of relevant provisions in national legislation. This provision shall not apply to the extradition of veterinary medicinal products intended for oral or parenteral treatment of bacterial infections.

4. (repealed).

Article 67

Without prejudice to stricter community or national rules relating to dispensing veterinary medicinal products and to protect human and animal health veterinary prescription shall be required for the following veterinary medicinal products can be released to the public: a) medicinal products, which shall be subject to official restrictions on supply or use, such as.



– limitations due to the implementation of the relevant UN conventions on illicit trafficking in narcotic drugs and psychotropic substances



– limitations due to EC-regulations



AA) veterinary medicinal products intended for food-producing animals.



  However, Member States may provide for exceptions to this requirement in accordance with criteria to be set by the Commission. This measure, designed to amend non-essential elements of this directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.



  Member States may continue to apply national provisions until either:



– the date of application of a decision adopted in accordance with the first subparagraph, or



– the 1. January 2007, if no such decision has been adopted by 31 December. December 2006





b) medicinal products in respect of which special precautions must be taken by the veterinarian in order to avoid any unnecessary risk to:



-the target species, is intended for



– the person who lodges the animal drug



– environment



c) drugs, that are intended for treatment of disease course, which require a precise prior diagnosis or the use of which may cause effects which impede or interfere with later diagnoses or treatments



d) officinel preparation, as described in article 3, paragraph 2 (b)), which is intended for food-producing animals.

Member States shall take all the measures necessary to ensure that, as regards the drugs be supplied only on prescription, the quantity prescribed and supplied shall be limited to what is necessary for that treatment, or treatment.

In addition, the required prescription for new veterinary medicinal products containing an active substance whose use in veterinary medicinal products have been approved in less than five years.

Article 68

1. Member States shall take the necessary measures to ensure that only persons empowered under their national legislation, is in possession of or in possession of veterinary medicinal products or substances which may be used as veterinary medicinal products, and affording metabolic stimulant, anabolic, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties.

2. Member States shall set up a register of producers and distributors, who are allowed to sleep inside with active substances that can be used in the manufacture of veterinary medicinal products with the characteristics referred to in paragraph 1.

Such persons must keep detailed records of all transactions involving substances that can be used in the manufacture of veterinary medicinal products, and for control purposes keep these records available to the competent authorities for at least three years.

3. the Commission shall adopt any amendments to the list of the substances referred to in paragraph 1.

These measures, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

Article 69

Member States shall ensure that a person who owns or is responsible for food-producing animals can provide proof of having bought and stored veterinary medicinal products or to have treated such animals with this, for a period of five years after treatment, including cases where the animal is slaughtered during the five-year period.

They can, among other things. require that records 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) statement of the treated animals.

Article 70

Byway of derogation from article 9 and without prejudice to article 67, Member States shall ensure that veterinarians providing services in another Member State, may carry small quantities not exceeding the daily requirement of veterinary medicinal products other than immunological veterinary medicinal products when these drugs are not approved in the Member State where the service is provided (hereinafter referred to as the ' host Member State '), and treating animals with them, provided that: (a)) the competent authorities of the Member State in which the veterinarian is established, has given in articles 5, 7 and 8 shall be granted a marketing authorisation



(b)) the veterinary medicinal products are transported by the veterinarian in the original packaging



c) veterinary medicinal products for Administration to food-producing animals have the same qualitative and quantitative composition in terms of active substances as the medicinal products authorized in the host Member State in accordance with articles 5, 7 and 8



d) a veterinarian providing services in a host Member State acquaints himself with good veterinary practice in the Member State concerned and shall ensure that the latency that is indicated on the labelling of the veterinary medicinal product concerned is complied with, unless he could reasonably be expected to be aware of the fact that, according to good veterinary practice in the host Member State must be made for a longer waiting time



e) the veterinarian does not supply veterinary medicinal products intended for persons who own or are responsible for the animals, which are treated in the host Member State, unless it is allowed in accordance with the requirements of this State; in that case provide the veterinarian only a veterinary medicinal product to the animals, he has the task to process, and then only small amounts of the drug, which is necessary to complete the treatment of those animals



f) veterinarian keep accurate records of the animals treated, the diagnosis, the veterinary medicinal products administered, the dosage, the duration of treatment and the withdrawal period practiced. These records shall be available for inspection purposes for the competent authorities of the host Member State for at least three years



g) Committee and quantity of veterinary medicinal products, which the vet brings along, does not exceed that which by good veterinary practice in General required to meet the daily needs.

Article 71

1. If there are no specific Community provisions regarding the use of immunological veterinary medicinal products to control or eradicate animal disease, a Member State in accordance with national legislation prohibiting the manufacture, importation, possession, sale, supply and/or use of immunological veterinary medicinal products on all or part of its territory if it is satisfied (a)) that the animals are treated with the drug interferes with the implementation of a national programme for the diagnosis , control or eradicate animal disease or making it difficult to confirm that the live animals or foodstuffs or other products obtained from treated animals are not contaminated



(b)) that the disease, which the medicinal product is intended to induce immunity against, pretty much does not occur in that area.

The Member State may also, having regard to the first subparagraph shall refuse to issue a marketing authorisation in accordance with a decentralised procedure as provided for in article 31-43.

2. the competent authorities of the Member States shall inform the Commission each time the provisions referred to in paragraph 1 are applied.

TITLE VII

PHARMACOVIGILANCE

Article 72

1. Member States shall take all appropriate measures to encourage the suspected adverse reactions to veterinary medicinal products shall be reported to the competent authority.

2. Member States may lay down specific requirements for veterinarians and other health-care professionals in respect of the reporting of suspected serious or unexpected adverse reactions and side effects in humans.

Article 73

In order to ensure the adoption of appropriate and harmonised regulatory decisions concerning the veterinary medicinal products authorised within the community, having regard to information obtained about suspected adverse reactions to veterinary medicinal products under normal conditions of use, Member States shall set up a veterinary pharmacovigilance. This system must collect information useful in the surveillance of veterinary medicinal products, in particular about adverse reactions in animals and in humans, and to carry out a scientific assessment of such information.

The information is compared with the information available on sale and prescription of veterinary medicinal products.

Member States shall ensure that the relevant information collected by means of this system, shall be forwarded to the other Member States and to the Agency. The information shall be entered in the database referred to in article 57, paragraph 1, second subparagraph, point (k)) of Regulation (EC) No 1782/2003. 726/2004 referred to data base and can constantly be consulted by all Member States and shall immediately be made available to the public.

The system shall also take into account information available about the lack of expected efficacy, not label use, examination of whether the withdrawal period is sufficiently long, and on potential environmental problems in connection with the use of the product, interpreted in accordance with the Commission's instructions as set out in article 77, paragraph 1, which could have an impact on the assessment of the pros and cons of medicinal products.

Article 73a

The management of funds earmarked for activities connected with pharmacovigilance, functioning of communication networks and market surveillance shall be checked by the competent authorities in order to ensure their independence.

Article 74

The marketing authorization holder shall maintain an appropriately qualified person responsible for pharmacovigilance, at his disposal.

This qualified person must be a resident in the community and shall be responsible for: (a)) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company, including sales staff and consultants, gather and recorded so that they are accessible at least at one point within the community;



b) compilation of the records referred to in article 75 for the competent authorities in the form in which these might determine, in accordance with article 77, paragraph 1, referred to guidance



c) ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the risks and benefits of a veterinary medicinal product is answered fully and promptly, including the provision of information about how much sales are, or how many prescriptions were issued for the veterinary medicinal product concerned




(d)) the provision to the competent authorities, of any other information relevant to the evaluation of the benefits and risks afforded by a veterinary medicinal product, including appropriate information on post-marketing surveillance studies.

Article 75

1. the marketing authorisation holder shall maintain detailed records of all suspected adverse reactions which is apparent in the community or a third country.

Unless there are exceptional circumstances, be notified that information about side effects electronically in the form of a report in accordance with the instructions referred to in article 77, paragraph 1.

2. the marketing authorisation holder shall record all suspected serious adverse reactions and side effects in humans related to the use of veterinary medicinal products, which shall be communicated to him, and immediately and in any case not later than 15 days following the receipt of this information, report them to the competent authority of the Member State in whose territory they have been shown.

The marketing authorisation holder shall also record all suspected serious adverse reactions and side effects in humans related to the use of veterinary medicinal products, of which he may reasonably be presumed to have knowledge of, and immediately and no later than 15 days following the receipt of this information, report them to the competent authority of the Member State in whose territory they have been shown.

3. the marketing authorisation holder shall ensure that all suspected serious unexpected adverse reactions, human adverse reactions and any presumption of transfers via veterinary medicinal products of infections that have been found in the territory of a third country without delay and no later than 15 days following receipt of the information reported in accordance with article 77, paragraph 1, the said instructions, so they are available to the Agency and the competent authorities of the Member States where the veterinary medicinal product is authorised.

4. Notwithstanding paragraphs 2 and 3, the holder of the marketing authorisation in respect of veterinary medicinal products which are covered by Directive 87/22/EEC, or which have been subjected to the procedures for marketing authorisation in articles 31 and 32 of this directive, or medicinal products which have been subject to the procedures laid down in articles 36, 37 and 38 of this directive, additionally ensure that all suspected serious adverse reactions and suspected adverse reactions in humans that is apparent in the community are to be transmitted, so that this information is accessible to the reference Member State or a competent authority designated as reference Member State. The reference Member State shall assume responsibility for the investigation and follow-up of any such adverse reactions.

5. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation, or subsequently as indicated in the guidance referred to in article 77, paragraph 1, records of all adverse reactions shall be submitted to the competent authorities in the form of periodic safety update reports, as soon as requested, or at least every six months after authorisation and until the placing on the market. Periodic safety update reports shall be submitted, as soon as requested, or at least every six months during the first two years following the initial placing on the market and once a year in the following two years. The reports shall be submitted every three years thereafter, or as soon as requested.

The periodic safety update reports shall include a scientific evaluation of the relationship between the benefits and risks of the veterinary medicinal product.

6. The Commission may amend paragraph 5 in the light of experience of the application.

These measures, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

7. following the granting of a marketing authorisation, the holder of this request the amendment of the periods referred to in paragraph 5 of this article, in accordance with the procedure laid down in Commission Regulation (EC) No 1782/2003. 1084/200316).

8. the marketing authorisation holder shall not without the prior or at the same time informing the competent authority shall publish information on matters relating to veterinary medicinal product surveillance in connection with the authorised veterinary medicinal product.

In any case, the marketing authorisation holder shall ensure that such information is presented in an objective and not misleading way.

Member States shall take the necessary measures to ensure that a marketing authorisation holder who does not comply with these conditions, penalties that are effective, proportionate and dissuasive.

Article 76

1. The Agency, in collaboration with the Member States and the Commission a data-processing network to facilitate the exchange of pharmacovigilance information regarding medicinal products marketed in the community, so that the competent authorities to share the information at the same time.

2. for the purposes of the network referred to in paragraph 1, Member States shall ensure that reports in accordance with article 77, paragraph 1, referred to guidance about suspected serious adverse reactions and side effects in humans, that have taken place on their territory, immediately and in any case not later than 15 days after the notice is made available to the Agency and the other Member States.

3. Member States shall ensure that reports of suspected serious adverse reactions and side effects in humans, that have taken place on their territory, immediately and in any case within 15 days of their notification, shall be made available to the marketing authorisation holder.

Article 77

1. In order to facilitate the exchange of information about pharmacovigilance within the community, the Commission shall draw up, in consultation with the Agency, Member States and stakeholders, a detailed guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of veterinary pharmacovigilance information in accordance with internationally agreed terminology.

The marketing authorisation holder shall apply in accordance with the instructions the veterinary medical terminology approved at international level for the transmission of adverse reaction.

The Commission shall publish this guidance, taking account of international harmonisation work carried out in the field of pharmacovigilance.

2. for the interpretation of the definitions in article 1, no. 10 to 16, and the principles set out in this section reference is the holder of the marketing authorisation and the competent authorities to the guidance referred to in paragraph 1.

Article 78

1. If a Member State as a result of monitoring data for veterinary medicinal products, are considering to suspend, revoke or amend an authorisation in order to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary rule, it shall forthwith inform the Agency, the other Member States and the marketing authorisation holder.

2. If it is in order to protect human or animal health is required to act quickly, the Member State concerned may suspend the marketing authorisation for a veterinary medicinal product, provided the Agency, the Commission and the other Member States are informed no later than the following working day.

3. When the Agency is informed in accordance with paragraph 1 or 2, it shall deliver an opinion as soon as possible, taking into account how much the matter is urgent.

The Commission may, on the basis of this opinion may request those Member States in which the veterinary medicinal product is marketed, to take temporary measures immediately.

Final measures shall be adopted in accordance with the procedure referred to in article 89, paragraph 3.

Article 79

The Commission shall adopt any amendments which may be necessary to update provisions of articles 72 to 78 to take account of scientific and technical progress.

These measures, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

TITLE VIII

MONITORING AND SANCTIONS

Article 80

1. The competent authority of the Member State concerned shall ensure by repeated, if necessary, unannounced inspections, and, where appropriate, by asking an official medicines control laboratory or a laboratory designated for that purpose to carry out spot checks that the requirements relating to veterinary medicinal products are complied with.

The competent authority may also carry out unannounced inspections of manufacturers of active substances used as starting materials for veterinary medicinal products, or with the holder of the marketing authorization, if it has a good faith belief that the requirements referred to in article 51 has not been complied with. These inspections may also take place at the request of another Member State, the Commission or the Agency.

In order to verify whether the information submitted in order to obtain a certificate of conformity with regard to the monographs of the European Pharmacopoeia, the standardisation body for standardisation of classifications and standards for quality as referred to in the Convention on the elaboration of a European farmakopé17) (The European Directorate for quality of medicines) turn to the Commission or the Agency to request such an inspection visit, if the raw material is the subject of a monograph of the European Pharmacopoeia.

The competent authority of the Member State concerned may carry out inspections of a manufacturer producing raw materials, at the request of the manufacturer itself.


These inspections shall be carried out by representatives of the competent authority who shall be empowered to: a) inspect manufacturing or commercial establishments and any laboratories employed by the holder of the manufacturing authorization has been delegated control tasks in accordance with article 24



b) take samples, among other things. with a view to an independent analysis in an official medicines control laboratory or a laboratory that a Member State has designated for that purpose



c) familiarize themselves with all documents relating to the inspection, subject to the Member States on the 9. October 1981 in force provisions that restrict access to it with regard to the description of the manufacturing method



d) inspect the premises, records and documents of marketing authorisation holders and with manufacturers, who by the holder of the marketing authorisation has been given the task to perform in Title VII, and in particular articles 74 and 75, referred to activities.

2. Member States shall take all necessary steps to ensure that the processes used in the manufacture of immunological veterinary medicinal products, fully validated and ensures batch consistency.

3. The representatives of the competent authorities shall draw up after each of the inspections referred to in paragraph 1 shall report on whether the principles and guidelines of good manufacturing practice referred to in article 51 or, where appropriate, the requirements laid down in section VII, has been complied with. The content of such reports shall be communicated to the of the inspection concerned manufactures or holder of a marketing authorisation.

4. subject to any agreements between the community and a third country, a Member State, the Commission or the Agency may require a manufacturer in a third country undergo an inspection as referred to in paragraph 1.

5. Within 90 days of an inspection as referred to in paragraph 1 shall be issued a certificate of good manufacturing practice for the manufacturer, if the conclusion of the visit is that the person concerned is in compliance with the Community legislation laid down the principles and guidelines of good manufacturing practice.

If the inspection is carried out at the request of the European Pharmacopoeia, shall be issued, where applicable, a certificate of compliance with the monograph.

6. Member States shall enter the certificates of good manufacturing practices they adopt, they issue in a Community database, which the agency manages on behalf of the community.

7. where the conclusion of an inspection as referred to in paragraph 1 is that the manufacturer does not comply with the Community legislation laid down the principles and guidelines of good manufacturing practice, introduced this piece of information in the Community database referred to in paragraph 6.

Article 81

1. Member States shall take all appropriate measures to ensure that the marketing authorisation holder and, where appropriate, the holder of the manufacturing authorisation can show that transferred control of the veterinary medicinal product and/or on the constituents and intermediate products of the manufacturing process, in accordance with the methods used for marketing authorisation.

2. for the purposes of implementing paragraph 1, Member States may require the holder of the marketing authorisation for immunological veterinary medicinal products, shall submit to the competent authorities copies of all the control reports signed by the qualified person in accordance with article 55.

The marketing authorization holder for immunological veterinary medicinal products must ensure that there are representative samples of each batch of veterinary medicinal products in stock in sufficient quantity, at least until the last date of application, and, on request, promptly furnish them to the competent authorities.

Article 82

1. When a Member State in order to protect human or animal health deems it necessary, it may require the marketing authorisation holder for an immunological veterinary medicinal product before it is put into circulation, submit samples of batches of the product in bulk and/or the medicinal product for control by an official medicines control laboratory at.

2. the marketing authorisation holder shall, at the request of the competent authorities as soon as possible deliver the samples referred to in paragraph 1, together with those in article 81, paragraph 2, referred to control evidence.

The competent authority shall inform all the other Member States in which the veterinary medicinal product is authorised, and The European Directorate for quality of medicines (EDQM) of its intention to control batches or the batch in question.

The competent authorities of another Member State shall not apply the provisions of paragraph 1.

3. The laboratory responsible for the control, having examined the in article 81, paragraph 2, referred to evidence control repeat all the analyses carried out by the manufacturer on the finished product, on the votes of samples in accordance with the relevant provisions set out in the documentation provided with the application for marketing authorisation.

The list of tests to be repeated by the laboratory responsible for the control, may be limited to the most necessary to the extent that this agreement between all the Member States concerned and, where appropriate, in consultation with The European Directorate for quality of medicines (EDQM).

For immunological veterinary medicinal products which are the subject of a marketing authorisation in accordance with Regulation (EC) No 1782/2003. 726/2004, the list of tests to be repeated by the laboratory responsible for the control, only be shorter after a favourable opinion from the Agency.

4. the results of the analysis must be approved by all the Member States concerned.

5. Except in cases where the Commission is informed that it is necessary to provide for a longer period of time in order to carry out the analyses, Member States shall ensure that the investigation be concluded within 60 days of the date of receipt of the samples.

The competent authority shall transmit within the same time limit the results of these analyses to the other Member States concerned, The European Directorate for quality of medicines, the marketing authorisation holder and, where appropriate, the manufacturer.

If a competent authority ascertains that a party of an immunological veterinary medicinal product is not in conformity with the manufacturer's inspection certificates or the specifications laid down for the marketing authorisation, it shall take all appropriate measures at the level of the marketing authorisation holder and, where appropriate, the manufacturer and inform the other Member States in which the veterinary medicinal product concerned is authorised.

Article 83

1. Member States ' competent authorities shall suspend, revoke, withdraw or amend the marketing authorisation, if it is assessed: a) the estimate of the relationship between the benefits and risks of the veterinary medicinal product under normal conditions of use is negative, in particular taking into account the benefits with regard to the health and well-being of the animals, as well as the benefits and safety of the consumer, when the authorisation concerns veterinary medicinal products intended for zootechnical use



(b)) the veterinary medicinal product has no therapeutic effect on the species of animal which is the subject of the treatment



(c)) the medicinal product does not have the specified quantitative and qualitative composition



(d)) the specified withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard for the consumer's health



e) the veterinary medicinal product is offered for sale for a use prohibited under other Community provisions.



f) the information contained in the documentation pursuant to articles 12 to 13d and 27 is incorrect;



g) in article 81, paragraph 1, referred to control is not carried out, the competent authorities may, as long as Community legislation in this area is under construction, refuse a marketing authorisation for a veterinary medicinal product, if this step is necessary in order to ensure the protection of public health, consumer or animal health.

2. The marketing authorisation may be suspended, revoked, withdrawn or varied, if it is assessed: (a)) the information pursuant to articles 12 to 13d, have not been changed in the documentation is available in accordance with article 27, paragraphs 1 and 5



(b)) the competent authorities have not been sent any new data as referred to in article 27, paragraph 3.

Article 84

1. Without prejudice to article 83, Member States shall take all appropriate measures to the extradition of the veterinary medicinal product is prohibited and that this drug is withdrawn from the market, if it turns out that a) assessing the relationship between benefits and risks of the veterinary medicinal product under normal conditions of use is negative, in particular taking into account the benefits with regard to the health and well-being of the animals as well as for the benefits with regard to consumers ' safety and health When the authorisation concerns veterinary medicinal products intended for zootechnical use



(b)) the veterinary medicinal product has no therapeutic effect on the species of animal which is the subject of the treatment



(c)) the veterinary medicinal product does not have the specified qualitative and quantitative composition



(d)) the specified waiting time is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard for the consumer's health



e) in article 81, paragraph 1, referred to control is not carried out, or to other requirements and obligations in connection with the issuance of the manufacturing authorisation has not been met.


2. The competent authority may limit on supply and withdrawal from the market to include only the production batches, against which objections have been raised.

Article 85

1. The competent authority of a Member State shall suspend or withdraw the manufacturing authorization for a category of products or for all of them, when one of the conditions laid down in article 45 no longer a respected.

2. The competent authority of a Member State may, in addition to the measures provided for in article 84, either suspend manufacture or imports of veterinary medicinal products from third countries or suspend or withdraw the manufacturing authorization for a category of preparations or all preparations where provisions regarding manufacture or imports from third countries of non-compliance.

3. Member States shall prohibit the advertising to the general public of veterinary medicinal products in accordance with article 67 a) can only be dispensed on prescription, or



b) contain psychotropic or narcotic 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 professionals concerned to inform the competent authorities about any side effect of a veterinary medicinal product.

TITLE IX

STANDING COMMITTEE

Article 88

The Commission shall adopt any changes which are necessary for the adaptation of annex I to technical progress.

These measures, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 89, paragraph 2a.

Article 89

1. the Commission shall be assisted by a Standing Committee on veterinary medicinal products for the adaptation to technical progress of the directives on the removal of technical barriers to trade in the veterinary medicinal products, hereinafter referred to as "the Standing Committee".

2. where reference is made to this paragraph, articles 5 and 7 of decision 1999/468/EC shall apply. its article 8.

Period referred to in article 5 (6) of decision 1999/468/EC shall be set at three months.

2A. where reference is made to this paragraph, article 5a, paragraphs 1 to 4, and article 7 of decision 1999/468/EC shall apply. its article 8.

3. where reference is made to this paragraph, articles 4 and 7 of decision 1999/468/EC without prejudice. its article 8.

The period in article 4, paragraph 3, of decision 1999/468/EC shall be set at one month.

4. the Standing Committee rules of procedure should be made public.

TITLE X

GENERAL PROVISIONS

Article 90

Member States shall take all appropriate measures to ensure that the competent authorities concerned shall exchange relevant information, in particular to ensure that the requirements laid down in article 44, the permissions referred to in article 80, paragraph 5 referred to certificates or for marketing authorisation are adhered to.

Upon reasoned request, Member States shall communicate immediately the in article 80, paragraph 3, provided reports to the competent authorities of another Member State.

The conclusions referred to in article 80, paragraph 1, referred to inspections carried out by inspectors from the Member State concerned, valid throughout the community.

However, if a Member State because of serious human or animal health, exceptionally, do not agree with the conclusions of an inspection carried out pursuant to article 80, paragraph 1, that Member State shall immediately inform the Commission and the Agency. The Agency shall inform the Member States concerned.

Whenever the Commission is informed of such serious reasons, it may, after consulting the Member States concerned, request that the inspector from the competent supervisory authority shall carry out a new inspection. This Inspector may be accompanied by two inspectors from Member States which are not party to the dispute.

Article 91

1. each Member State shall take all appropriate measures to ensure that decisions on the marketing authorisation, and any decision concerning the refusal or withdrawal of such authorization, cancelling a decision refusing or withdrawing marketing authorization, prohibiting supply or withdrawing from the market, together with the reasons therefor, shall immediately be brought to the Agency's knowledge.

2. The marketing authorization holder shall be obliged to immediately inform the Member States concerned of any measures he takes with regard to suspension of the placing on the market or the recall of the veterinary medicinal product from the market, together with the reasons for it, if this relates to this drug effectiveness or protection of public health. Member States shall ensure that such information is brought to the Agency's knowledge.

3. Member States shall ensure that adequate information on measures taken pursuant to paragraphs 1 and 2, and which may affect the health protection in third countries, shall immediately be notified to the relevant international organizations, and that a copy of the notification shall be sent to the Agency.

Article 92

Member States shall communicate to each other the necessary information, in particular the information referred to in articles 90 and 91, in order to ensure the quality and safety of homeopathic veterinary medicinal products manufactured and marketed within the community.

Article 93

1. At the request of the manufacturer or exporter of veterinary medicinal products, or the authorities of an importing third country, Member States shall certify that the manufacturer is in possession of the manufacturing authorization. When issuing such certificates, the following conditions must be observed: a) Member States shall have regard to the prevailing administrative arrangements of the World Health Organization



b) in the case of veterinary medicinal products intended for export which are already authorized on their territory, Member States shall present the summary of the product characteristics as approved in accordance with article 25 or, if one does not exist, an equivalent document.

2. If the manufacturer is not in possession of a marketing authorisation, he shall, for the purpose of issuing the certificate referred to in paragraph 1 shall provide the competent authorities with a statement about why, in the absence of a marketing authorisation.

Article 94

The decisions referred to in this directive, taken of Member States ' competent authorities should not be taken with other than the reasons listed in this directive, and needs to be carefully justified.

Decisions shall be notified to the person concerned, with an indication of the right provided for in existing access to the complaints and the time limit 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 do not allow the foods derived from animals which have been used for clinical trials, unless the competent authorities have established an appropriate withdrawal period. Such a withdrawal period shall either (a)) at least equal to that provided for in article 11, paragraph 2, possibly in combination with a safety factor that takes into account the nature of the substance to be tested, or



b) if laid down maximum limits for residues in accordance with Regulation (EEC) No 2377/90. 2377/90, ensure that this maximum limit will not be exceeded in those foods.

Article 95a

Member States shall ensure the establishment of appropriate arrangements for the collection of veterinary medicinal products which have not been applied or where the deadline for final use is exceeded.

Article 95b

When a veterinary medicinal product shall be approved in accordance with Regulation (EC) 726/2004 and the Scientific Committee in its opinion refers to recommended conditions or restrictions with regard to the safe and effective use of the veterinary medicinal product in accordance with article 34, paragraph 4, subparagraph (d)), of the said regulation, shall be adopted a decision addressed to the Member States in accordance with the procedure laid down in articles 37 and 38 of this directive on the implementation of those conditions or restrictions.

SECTION XI

FINAL PROVISIONS

Article 96

Directive 81/851/EEC and 81/852/EEC, 90/677/EEC and 92/74/EEC, as amended by the annex II, part A, in the directives listed, are hereby repealed, without prejudice to the obligations of the Member States with regard to the implementation dates in annex II, part B, 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 97

This Directive shall enter into force on the twentieth day following that of its publication in the official journal of the European Union. (Entered into force 18/12 2001, Schultz, eds.).

Article 98

This directive is addressed to the Member States.
Official notes 1) Ordinance contains provisions implementing parts of a European Parliament and Council Directive 2001/83/EC of 6 May 2003. November 2001 establishing a Community code relating to medicinal products for human use, the official journal of the European Communities 2001, nr. L 311, p. 67, as last amended by European Parliament and Council directive 2010/84/EU of 15. December 2010, the official journal of the European Union 2010, nr. L 348, p. 74, and European Parliament and Council directive 2011/62/EU of 8. June 2011, official journal 2011, nr. L 174, p. 74, and parts of the European Parliament and Council Directive 2001/82/EC of 6 May 2003. November 2001 establishing a Community code relating to veterinary medicinal products, the official journal of the European Communities 2001, nr. L 311, p. 1, as last amended by European Parliament and Council Regulation (EC) No 1782/2003. 596/2009 of 18. June 2009, the official journal of the European Union 2009, nr. L 188, p. 14.

1 OJ C 368 of 20.12.1999), p. 3.

2) opinion of the European Parliament 3. July 2001 (not yet published in the official journal) and Council decision of 27 November. September 2001.


3) OJ 22 9.2.1965, p. 369/of 65. As last amended by Directive 93/39/EEC (OJ L 214 of 24.8.1993, p. 22).

4) OJ L 147 of 9.6.1975, p. 1. Directive as last amended by Commission Directive 1999/83/EC (OJ L 243 of 15.9.1999, p. 9).

5 OJ L 147 of 9.6.1975), p. 13. Directive as last amended by Commission Directive 2000/38/EC (OJ L 139 of 10.6.2000, p. 28).

OJ L 142 of 25.5.1989) 6, s. 14.

OJ L 142 of 25.5.1989) 7, s. 16.

OJ L 181 of 28.6.1989) 8, s. 44.

9 OJ L 113 of 30.4.1992), p. 1.

OJ L 113 of 30.4.1992) 10, p. 5.

11 OJ L 113 of 30.4.1992), p. 8.

12 OJ L 113 of 30.4.1992), p. 13.

13) OJ L 297 of 13 October, p. 8.

14 OJ L 214 of 24.8.1993), p. 1. Regulation as amended by Commission Regulation (EC) No 1782/2003. 649/98 (OJ L 88 of 24.3.1998, p. 7).

15) OJ L 265, 5.10.1984 of s. 1. Directive repealed with effect from 13. 5.2000 by Directive 97/43/Euratom (OJ L 180 of 9.7.1997, p. 22).

16) OJ L 246 of Justice, p. 1. Directive as last amended by Directive 84/467/EEC (OJ L 265 of 5.10.1984, p. 4), repealed with effect from the end of 13.5.2000 by Directive 96/29/EC (OJ L 314 of 4.12.1996, p. 20).

17) OJ L 250 of 19.9.1984, p. 17. Directive amended by Directive 97/55/EC (OJ L 290 of 23 October 1997, p. 18).

18) OJ L 298 of 17.10.1989, p. 23. Directive amended by Directive 97/36/EC (OJ L 202 of 30.7.1997, p. 60).

OJ L 184 of 17.7.1999) 19, p. 23.

20) OJ L 324 of 10.12.2007, p. 121.

21) OJ L 136, 30.4.2004, p. 1.

22) OJ L 121 of 1.5.2001, p. 34.

23) OJ L 136, 30.4.2004, p. 1. As amended by Regulation (EC) No 1782/2003. 1901/2006 (OJ L 378 of 27.12.2006, p. 1).

24) OJ L 207 of 30.7.1986, p. 1.

OJ L 210 of 7.8.1985) 25, p. 29. As last amended by European Parliament and Council Directive 1999/34/EC (OJ L 141 of 4.6.1999, p. 20).

26 OJ L 18 of 22.1.2000), p. 1.

27 OJ L 262 of 14.10.2003), p. 22.

OJ L 204 of 21.7.1998) 28, p. 37.

29 OJ L 178, 17.7.2000), p. 1.

30) OJ L 33 of 8.2.2003, p. 30.

1) OJ C 75 of 15 March 2000, p. 11.

2 3.7.2001) opinion of the European Parliament of (not yet published in the official journal) and Council decision of 27 November. September 2001.

3) OJ L 317 of 6.11.1981, p. 1. Directive as last amended by Commission Directive 2000/37/EC (OJ L 139 of 10.6.2000, p. 25).

4) OJ L 317 of 6.11.1981, p. 16. Directive as last amended by Commission Directive 1999/104/EC (OJ L 3, 6.1.2000, p. 18 of).

5) OJ L 373 of 31.12.1990, p. 26.

6) OJ L 297 of 13 October, p. 12.

7 OJ L 214 of 24.8.1993), p. 1. Regulation as amended by Commission Regulation (EC) No 1782/2003. 649/98 (OJ L 88 of 24.3.1998, p. 7).

OJ L 184 of 17.7.1999) 8, p. 23.

OJ L 224 of 18.8.1990) 9, p. 1. Regulation as last amended by Commission Regulation (EC) No 1782/2003. 1274/2001 (OJ L175 of 28. 6.2001, p. 14).

10) OJ L 136, 30.4.2004, p. 1.

11) OJ L 92 of 7.4.1990, p. 42.

12) OJ L 270 of 14.12.1970, p. 1. As last amended by Regulation (EC) No 1782/2003. 1756/2002 (OJ L 265 of 3 October 2002, p. 1).

13) OJ L 298 of 3.12.1993, p. 45. Amended by Commission decision 2000/68/EC (OJ L 23, 28.1.2000, p. 72 of).

14 OJ L 23 of 28.1.2000), p. 72.

15) OJ L 125 of 23.5.1996, p. 10. As amended by Regulation (EC) No 1782/2003. 806/2003 (OJ L 122 of 16.5.2003:, p. 1). '

OJ L 159 of 27.6.2003) 16, p. 1.

17) OJ L 158 of 25.6.1994, p. 19.

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