Law Revision Of Pharmaceutical Legislation (1)

Original Language Title: Loi portant révision de la législation pharmaceutique (1)

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Posted the: 2006-05-16 Numac: 2006022353 PUBLIC SERVICE FEDERAL public health, food chain safety and environment 1 May 2006. -Law concerning revision of pharmaceutical legislation (1) ALBERT II, King of the Belgians, to all, present and to come, hi.
The Chambers have adopted and we endorse the following: Chapter I - general provision Article 1. This Act regulates a matter referred to in article 78 of the Constitution.
CHAPTER II. -Amendments to the law of 25 March 1964 on medicines article 2. in article 1 of the law of 25 March 1964 on medicines, replaced by the law of October 20, 1998, is replaced as follows: Article 1. -§ 1. For the purposes of this Act, means: 1) "drug, being either a medicinal product for human use or a veterinary drug": has) medicines for human use:-any substance or composition presented as having curative or preventive properties against human diseases; or -any substance or composition that can be used in humans or administered in order to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

(b) medicines for veterinary use, including pre-mixes for medicated feedingstuffs:-any substance or composition presented as having curative or preventive properties against animal diseases; or - any substance or composition which may be used in the animal or administered with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;
(2) ' substance': any matter irrespective of origin, which may be between other:-human, such as: blood, cells and human tissues and products;
-animal, such as: micro-organisms, animals, parts of organs, animal secretions, toxins, substances obtained by extraction, products derived from blood;
-vegetable, such as: micro-organisms, plants, parts of plants, vegetable secretions, substances obtained by extraction;
-chemical, such as: the elements, naturally occurring chemical materials and chemical products processing and synthesis;
(3) "premix for medicated feedingstuffs": any medicinal product for veterinary use prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs;
(((4) "medicated": any mixture of drug (s) veterinary and food (s) prepared prior to putting it on the market and intended to be administered to animals without further processing, because of curative or preventive or other properties of the medicinal product for veterinary use referred to in point 1), b);
(5) "homeopathic remedy": any drug obtained from substances called homeopathic stocks according to a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain several active substances;
(6) ' medicinal product for human use herbal': medicines for human use whose active substances are exclusively one or more herbal substances or preparations made from plants or a combination of one or more herbal substances or preparations made from plants;
(7) ' plant substances': all plants, plant parts, algae, fungi, lichens, mainly whole, fragmented or cut, used in the State, often dried, but sometimes fresh. Some exudates not having undergone specific treatments are also considered as plant substances. Herbal substances are precisely defined by the part of the plant used and the botanical name according to the system in two words (genus, species, variety and author);
(8) ' herbal preparations': preparations obtained by treatment of herbal substances, such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. They include crushed or powdered herbal substances, tinctures, extracts, essential oils, the juice obtained by pressure and exudates treated;
(9) "traditional medicine herbal for human use": any medicinal product herbal for human use which meets the criteria laid down by the King in accordance with Community law;
(10) "adverse reaction": a noxious and unintended drug reaction which occurs at doses normally used in man or animals for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
(11) "serious adverse effect of a medicinal product for human use": an adverse reaction which results in death, endangers life, requires hospitalisation or prolongation of existing hospitalization, results disability or significant incapacity or is a congenital anomaly/birth in the patient.
(12) "serious adverse effect of a medicinal product for veterinary use": an adverse reaction which results in death, endangers life, causes disability or major disability, translates into an anomaly / congenital malformation or causes permanent symptoms or prolonged in the animals treated;
(13) "unexpected adverse reaction": an adverse reaction, which the nature, severity or outcome is not consistent with the summary of the characteristics of the drug.
(14) "abuse of medicinal products for human use": excessive use intentional, persistent or sporadic, medicinal products for human use is accompanied by physical or psychological Effets.
(15) ' adverse effect on humans': a harmful and unintended reaction which occurs in a human being following exposure to a veterinary drug;
(16) ' using non-summary of the characteristics of a medicinal product for veterinary use": the use of a veterinary drug in a manner that is not consistent with the summary of the product characteristics ("RCP"), including the misuse or serious abuse of medicines for veterinary use;
(17) "wholesale distribution of medicinal products for human use": any activity which consists to procure, possess, deliver or export of medicines for human use, excluding the issue of medicinal products for human use to the public. These activities are carried out with manufacturers or their depositories, importers, other distributors wholesale or with pharmacists and other persons authorized to supply medicinal products for human use to the public in accordance with article 4 of the royal decree No 78 of 10 November 1967 on the practice of the professions of health care;
(18) "wholesale distribution of medicinal products for veterinary use': any activity which includes the purchase, sale, import and export of veterinary drugs or any other commercial transaction involving these drugs, for profit or not, excluding:-delivery by a manufacturer of veterinary drugs manufactured by itself;
-the sale at retail of veterinary drugs by pharmacists and veterinarians to heads of animals, in accordance with article 4 of the Decree royal No. 78 of 10 November 1967 on the practice of the professions of health care;
(19) ' public service obligation': the obligation for wholesale distributors to guarantee permanently an assortment of medicinal products to meet the requirements of a specific geographical area and to deliver the requested commands in very short time over the whole of territory;
(20) ' wholesale - dispatcher ": distributor wholesale to public service obligations in relation to medicinal products for human use or for veterinary use;
(21) "representative of the holder of the marketing authorisation / registration»: the person, commonly known as the"local representative", designated by the holder of the authorisation for placing on the market or registration to represent in Belgium;
(22) ' prescription': any document by which the prescriber prescribed one or more drugs for a particular patient or one or more animals;
(23) "prescriber": practitioners referred to in articles 2 and 3 of the order royal No. 78 of 10 November 1967 on the practice of the professions of health care and veterinary doctors referred to in article 1 (1) of the Act of 28 August 1991 on the practice of veterinary medicine;
(24) «person entitled to supply medicinal products to the public»: pharmacists referred to in article 4, § 1, of royal decree No 78 of 10 November 1967 on the exercise of the professions of health care, including pharmacists in a pharmaceutical pharmacy not open to the public, as well as persons referred to in article 4, § 2, of the royal decree No 78 of 10 November 1967 above exclusion of persons referred to in items 4 ° and 5 °;
(25) "person entitled to provide medicines to animals officials": veterinary medical referred to in article 4 of the Act of 28 August 1991 on the practice of veterinary medicine;
(26) ' name': name, which may be either an invented name not liable to confusion with

the common name, or a common or scientific name accompanied by a trademark or the name of the holder of the marketing authorisation / registration;
(27) ' common name': the International Nonproprietary name recommended by the world Organization of health, or, failing that, the usual common name;
(28) ' determination of the drug': the content of active substances, expressed quantitatively per dosage unit, per unit of volume or weight according to the presentation;
(29) ' primary wrapping': the container or other form of packaging that is in direct contact with the drug.
(30) "outer packaging": the packaging into which is placed the immediate packaging.
(31) ' labelling': the statements made on the outer packaging or primary packaging;
(32) ' notice': the leaflet containing information for the user which accompanies the medicinal product.
(33) ' European Agency': the European Agency of medicinal products established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision with regard to medicinal products for human use and veterinary and establishing a European Medicines Agency;
(34) "risks related to the use of the medicinal product for human use":-any risk to the health of the patient or public health related to quality, safety or efficacy of the medicinal product for human use;
-any risk of undesirable effects on the environment;
(35) "risks relating to the use of the veterinary drug":-any risk to animal or human health linked to the quality, safety or effectiveness of medicines for veterinary use;
-any risk of undesirable effects on the environment;
((36) report risk-benefit balance of a medicinal product for human use: evaluation of the positive therapeutic effects of the medicinal product for human use with regard to the risks as defined in point 34), first indent;
((37) ' report risk-benefit balance of a medicinal product for veterinary use": evaluation of the positive therapeutic effects of the medicinal product for veterinary use with regard to the risk of adverse effects defined in point 35);
(38) "waiting time": the period necessary between the last administration of the veterinary drug to animals under normal conditions of use and according to the provisions of this Act and its implementing orders, and production of foodstuffs from such animals, in order to protect public health, by ensuring that such foodstuffs contain no residues in quantities exceeding the limits of residues of active substances such as fixed pursuant to Regulation (EEC) No 2377/90 of 26 June 1990 Council laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin;
(39) "Pharmacopoeia": a set of normative texts dealing with substances for pharmaceutical use used as active substances or excipients used in the preparation of medicinal products for human or veterinary use, same as on their pharmaceutical forms and methods of analysis y;
(40) "the Minister: the Minister having health in its attributions;
(41) ' Member State': a Member State of the European Union or a State which is a party to the European economic area agreement.
§
2. In case of doubt, where, taking into account all its characteristics, a may fall within the definition of a drug and the definition of a product covered by other legislation, the provisions of this Act shall apply.
The King created, by Decree deliberated in the Council of Ministers, a joint Commission which is responsible for an opinion to determine under what legislation falls a product. It also fixes the composition and functioning.
The Minister or her delegate renders a decision on the basis of this opinion. The Minister or his delegate makes these decisions available to the public.
Those responsible for the placing on the market of these products are informed that the Joint Commission has been seized. They can be heard, either at the initiative of the Joint Commission or at their request.
If the decision of the Minister or her delegate relating to the product States that this product falls under the application of other legislation that under which the person responsible for putting it on the market has or wants to put the product on the market, the Minister may decide for reasons of public health, that product, due to its characteristics or its presentation must be withdrawn from the market if it is already placed on the market and/or that the product cannot be (re) placed on the market only from where it will be consistent with the legislation as stated in the decision of the Minister or his delegate. If the Minister's decision implies that the product is otherwise due to its presentation, this Act and its implementing orders, the decision may imply that the product can remain on the market provided that its presentation is adapted. In both cases, the Minister shall set a date where its decision is to be executed.
The King determines the conditions, time limits and arrangements for the procedure whereby decisions pursuant to this paragraph are taken and lays down more detailed rules for the application of the provisions of this paragraph.
The Minister may establish guidelines specifying the applicable law relating to the implementation of this provision on the advice of the Joint Commission.
» Art. 3. at article 1bis of the Act, inserted by the law of June 21, 1983 and amended by the Act of 20 October 1998, § 4 is completed as follows: «, except for the provisions which are necessary for the implementation of the treaties and the international acts taken pursuant to them.»
S. (4. article 2 of the Act, as amended by the law of August 12, 2000, is amended as follows: 1 °) paragraph 2 is replaced by the following subparagraph: "the European Pharmacopoeia is application. The King may approve other pharmacopoeias, on the advice of the Pharmacopoeia Commission. In the cases and under the conditions it lays down, the King may, on the advice of the Pharmacopoeia Commission, with regard to compendial and masterful preparations, impose the reference to the European Pharmacopoeia, the Belgian Pharmacopoeia, to form therapeutic Magistral or, Alternatively, in an official pharmacopoeia, corresponding to the current state of knowledge or a monograph. »;
2 °) is added a paragraph 4 worded as follows: «The King creates the Pharmacopoeia Commission and determines its composition, its functioning and its missions.»
S. (5A article 3 of the same Act, amended by law of October 20, 1998 and January 2, 2001, which the current text will form the § 1, the following changes are made: 1 °) to the § 1, the words "and reactive" and the words "when they are destined to human medicine, and by the Minister of Agriculture when they are destined for veterinary medicine" shall be deleted;
2 °) the § 1 is complete as follows: "The King may also establish rules concerning administrative tasks to be completed by these people and administrative record keeping by them."
3 °) § 2, § 3 and § 4 are added, worded as follows: ' ' § § 2 2 The King establishes the requirements and procedures for conservation, preparation, receipt and delivery of drugs by persons authorised to supply medicinal products to the public. These people cannot procure drugs for human use only to holders of a wholesale distribution authorisation or the distributors. They can get drugs for veterinary use only from the distributors.
§
3. The King establishes the requirements and procedures for conservation, receipt and provision of drugs by veterinarians authorised to provide to makers of animal drugs intended for use in animals. Veterinarians cannot get drugs that either from the distributors or pharmacists in a pharmaceutical pharmacy open to the public and in accordance with the terms and conditions laid down by the King.
§
4. Any medication is delivered or supplied to the patient or in charge of animals or their representative, except in the cases determined by the King. It establishes the terms and conditions.
However, the offer on sale at distance to patients or those responsible for animals by any means of prescription medicines is prohibited. » Art. (6 A article 4 of the Act, as amended by the Act of 16 June 1970, the following changes are made: 1 °) to 1 paragraph, the words "and rate" shall be replaced by the words ", the issuance and the provision";
2 °) paragraph 2 is repealed.
S. (7A article 5 of the same Act, replaced by the law of 29 April 1996 and amended by law of October 20, 1998 and December 30, 2001, the following changes are made: 1 °) in the § 1, "the Ministry of Social Affairs, public health and the environment" shall be replaced by the words "Service federal public health. ', Food chain security and environment ' and 'providers referred to order royal No. 78 on the exercise of the art of healing, nursing, paramedical and medical committees' shall be replaced by the words 'practitioners referred to in order No. royal, 78.

of 10 November 1967 on the practice of the professions of health care. "
2 °) the § 1 is supplemented by the words 'or to the public. "
3 °) to § 2, the first sentence shall be supplemented as follows: "intended for practitioners referred to the § 1 as well as the public."
S. (8A section 6 of the Act, as amended by the royal decree of 8 August 1997 and by the laws of the October 20, 1998, August 12, 2000, December 30, 2001 and December 22, 2003, the following changes are made: 1 °) the § 1 is replaced by the following provision: «§ 1.» No medicinal product may be placed on the market without a marketing authorisation was granted, either by the Minister or his delegate in accordance with the provisions of this Act and its orders of execution, either by the Commission European in accordance with Community law.
To this end, except in the case of authorizations on the market granted by the European Commission, a request must be addressed to the Minister or his delegate who takes a decision in respect of the application on the basis of the opinion of the Committee concerned referred to in paragraph 11. The applicant or the holder of an authorisation for the placing on the market must be established in a Member State.
The King determines the conditions, time and the details of the procedure for review of applications for an authorisation for the placing on the market, as well as the requirements for an authorization for placing on the market. This review aims to verify if a medicinal product for which a marketing authorisation has been requested complies with the General requirements of quality, safety and effectiveness laid down by him, on the basis inter alia of the results of the pharmaceutical and pre-clinical tests and clinical. To this end, it sets the contents of the request which shall include at least the draft package leaflet, the draft summary of the characteristics of the product, the project of the immediate packaging and the outer packaging of the drug bill and which are approved for the granting of the authorisation on the market. It can also determine the form in which the request should be introduced. To hear applications submitted under this section, article 6bis and their execution orders, the Minister or his delegate verifies that the dossier submitted conforms to the provisions of these articles and their orders of execution and examine whether the conditions for granting an authorisation for the placing on the market are fulfilled. This review may also include additional information to be provided by the applicant. In addition the Minister or his delegate may submit the medicinal product, raw materials, and if necessary intermediate products or other substances of the drug to control of a laboratory recognized by him or by the competent authority of another State member with equivalent legislation or by an official laboratory for the control of drugs in order to ensure that control methods described in the application are satisfactory.
In addition to the General requirements for the granting of a marketing authorisation for medicinal products, as referred to in paragraph 3, the King may, for certain specific categories of drugs which it designates, impose additional conditions due to their nature.
The King may also for homeopathic medicines and traditional medicines for human use herbal derogate from the General requirements referred to in paragraph 3 for the granting of authorisations for medicinal products by providing an authorisation procedure simplified application of Community law. It lays down the conditions, deadlines and modalities of the review process for applications for authorisation of placing on the market for these drug categories, hereinafter referred to as the recording, as well as the requirements for obtaining a registration. Similarly, it determines the provisions of this Act and its implementing orders that apply to each of these classes of drugs and it may, if necessary, adapt the rules of this Act to the nature of these medications in application of Community law.
An application for authorisation for placing on the market or registration is admissible only if it is complete and introduced in accordance with the provisions laid down by the King. The application is submitted to the opinion of the Committee concerned referred to in paragraph 11 as if it has been previously declared admissible the terms, time limits and conditions fixed by him.
The authorisation for placing on the market or the registration is denied if the drug for which an application is made does not meet the conditions laid down by this law or its implementing orders.
The King fixed also the conditions, deadlines and modalities of the review process for applications for authorisation of placing on the market or registration, where for one same drug, an authorization for placing on the market or a record is granted or pending in another Member State, referred to as mutual recognition procedure. It also lays down the conditions for obtaining an authorization for placing on the market or registration in these cases. It sets also the terms and conditions that the Minister or his delegate is collaborating with the competent authorities of other Member States in the assessment of applications for authorisation of placing on the market or for the registration of medicines that are introduced at the same time in Belgium and one or more other Member States, referred to as the decentralised procedure. It sets the conditions, time and the modalities of the review process for applications for authorisation of placing on the market or of registration in such cases, as well as the conditions for an authorization for placing on the market or registration in these cases. This collaboration may consist of the delivery of all data relevant to the assessment of this medicine. If the Minister or his delegate finds that the granting of an authorisation for the placing on the market or a record for the medicinal product concerned generates a potential serious risk to public health in the case of a medicinal product for human use or creates a potential serious risk to human or animal health, or the environment in the case of a medicinal product for veterinary use It communicates to the application of the procedure referred to in the following subparagraph.
If one or more other Member States rely on applying either the mutual recognition procedure or the decentralised procedure the above risks, the Minister or his delegate may, at the request of the applicant, authorize the placing on the market or the registration of the medicinal product without waiting for the outcome of the procedure in the following paragraph. In this case, the authorisation for placing on the market or the registration shall be granted without prejudice to the outcome of the procedure in the following paragraph.
When a medicinal product is the subject of several applications for authorisation of placing on the market or recording and States members have adopted the diverging decisions regarding the granting, suspension or withdrawal of the authorisation of placing on the market or the registration, the Minister or his delegate or the applicant or the holder of the authorisation for placing on the market or the registration may refer to the concerned Committee created within the Agency European. In special cases with a community interest, the Minister or his delegate or the applicant or the holder of the authorisation on the market or registration seize the Committee concerned, before that a decision be taken on the application, suspension, withdrawal or any other modification of the authorisation of placing on the market or the registration. The Minister or his delegate shall notify to the applicant or to the holder of the authorisation for placing on the market or recording the fact that he seized the Committee concerned.
On basis of the decision adopted by the Commission European, be assisted by the Standing Committee set up by article 121 of directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, or article 89 of directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products the Minister or his delegate grant or withdraw an authorization for placing on the market or the registration or authorization or registration brings the necessary changes for compliance with this decision. The Minister or his delegate shall communicate the modalities of application of this decision to the European Commission and the European Agency.
The King sets the conditions, time and the necessary arrangements for the implementation of the provisions of the preceding paragraph.
The King establishes a Committee for medicinal products for human use and a Committee for medicinal products for veterinary use intended to provide advice on requests for authorisation of placing on the market, the availability of drugs to patients or animals in cases referred to in article 6quater and determined by the King, as well as scientific issues in connection with drugs. It may also establish other committees to provide advice on applications for registration. It determines missions, the functioning and the composition of these Commissions. For the coordination of their work, the Commissions can foresee the creation of a Bureau, which the King fixed tasks, the functioning and the composition.
The

holder of the authorisation for placing on the market or the registration of a drug is responsible for the placing on the market of this medicine. The appointment of a representative in Belgium does not exempt the holder of the authorisation for placing on the market or the registration of civil liability.

The placing on the market or the registration authority shall not affect joint liability of the manufacturer and, where appropriate, the holder of the authorization or registration.
The applicant or the holder of the authorisation for placing on the market or the registration is responsible for the accuracy of documents and data provided.
In the absence of authorisation on the market or pending application for a medicinal product for human use authorised in another Member State, the Minister or his delegate may, for justified public health reasons grant authorisation for the placing on the market for this drug. The Minister or delegate watch in this case comply with this Act and its implementing decrees, and especially of prescribed of § 1bis and § 1erquinquies and the prescribed articles 7, 8, 8A, 9, 10, 12, 12quinquies, 12sexies, 14 and 14A. The King fixed conditions, deadlines and modalities of the review process for applications for authorisation of placing on the market or of registration in such cases, as well as the conditions for an authorization for placing on the market or registration in these cases';
2 °) there is inserted a § 1bis as follows: "§ 1bis.»
When the granting of the authorisation for placing on the market or the registration of a drug, the Minister or his delegate shall specify the classification of the medicinal product into: - drug prescription - drug not subject to prescription.
The Minister or his delegate also determines the classification of the medicinal products for which an authorization for placing on the market or a registration has been issued by the European Commission, taking into account applicable sub-categories for medicinal products for human use as defined in the following paragraph.
Medicinal products for human use which cannot be supplied only on prescription, may be subject to the following subcategories:-drug prescription that the issue cannot be extended;
-drug prescription including the issue may be extended;
-subject to special prescription drugs;
-drug prescription known as 'restricted', reserved for certain groups of specialists including the issue is reserved for hospital pharmacists.
On the basis of the provisions of the law of 28 August 1991 on the practice of veterinary medicine, veterinary medicinal products which are subject to prescription may be subject to additional conditions as regards prescription, supply and administration.
The King determines the criteria on the basis of which, when granting the authorisation of placing on the market or the registration the drug is classified in these categories and, where appropriate, in these subcategories.
The Minister or her delegate establishes the list of drugs whose issuance is subject to the obligation of prescription, specifying, if necessary, the subcategory. This list is updated annually and communicated to the European Commission and the other Member States.
The Minister or his delegate may change the classification after the granting of an authorisation for placing on the market or a recording, either on its own initiative or at the request of the holder of the authorization or registration.
The King sets the terms and conditions under which this amendment is granted.
In addition, the authorisation for a medicinal product may, in exceptional circumstances and for reasons of public health, being subject to the application of a management program risk, either on a proposal from the applicant for authorisation for placing on the market of the medicinal product at the behest of the Minister or his delegate, at the time of the granting of the authorisation or subsequently. The risk management program can lay down restrictive conditions in relation to the prescription, the mode of delivery or supply, and use or the administration of the drug for its safe use. This risk management program accompanies the authorisation on the market. The holder of the authorisation for placing on the market is responsible for its implementation. The Minister or his delegate may, after consultation with the holder of the authorisation for placing on the market, take additional measures to ensure the application of the risk management program, if imposed by the European Commission and to inform business users, patients or those responsible for animals of specific measures which object the placing on the market of this medicine.
If the authorisation for a specific medicinal product is linked to the implementation of a program management risks, the Minister or his delegate may decide that all medicines that contain the same (s) substance (s) active (s) are also subject to a programme of risk according to similar rules management. To this end, the Minister or his delegate may also impose that permissions for placing on the market medicinal products which have already been granted should be amended in this sense.
The King lays down the conditions, deadlines and modalities of the review process for applications for authorisation of placing on the market or registration in these cases or their modification, as well as the requirements for an authorization for placing on the market or registration or alteration in these cases.
In exceptional circumstances and after consultation with the applicant, the authorisation on the market may be granted subject to the obligation of the applicant to meet certain conditions regarding the safety of the drug, the notification to the Minister or his delegate of any incident relating to its use and measures to be taken. The King sets out the reasons and objective and verifiable conditions and the terms and conditions under which an authorization for placing on the market subject to fulfilling certain conditions may be granted. The maintenance of such an authorization for placing on the market is linked to the annual reassessment of these conditions. The list of these conditions as well as the time limits and dates of fulfilment of these conditions are made available to the public. »;
3 °) there is inserted a § 1B, as follows: "§ 1B.»
The authorisation for placing on the market or the registration is valid for five years.
The Minister or her delegate may, at the end of five years, extend the validity of the authorisation to place on the market or of the registration, at the holder's request and on the basis of an evaluation of the risk-benefit ratio.
The King sets conditions, deadlines and modalities for this purpose.
Once renewed, the marketing authorisation on the market or the registration is valid for an unlimited period, unless the Minister or his delegate decides, on justified grounds relating to pharmacovigilance, to proceed with a new five-year renewal of authorising the placing on the market or registration. The King sets the terms and conditions for this purpose.
Any authorisation for placing on the market or any registration which, in the three years that followed its granting is not followed by a placing on the actual market of the medicinal product concerned is void.
When a medicinal product authorized or registered, previously placed on the market, is not or is more effectively on the market for three consecutive years, the authorisation of placing on the market or the registration granted for this drug lapses.
Pursuant to the two preceding paragraphs, the authorisation for placing on the market or the registration is cancelled. Before it could proceed to the cancellation of the authorization for placing on the market or the registration as provided for in the two preceding paragraphs, the holder of the authorization or registration is advised by the Minister or his delegate of this intention and it can be heard, either on its own initiative or at the initiative of the Minister or his delegate.
The Minister or his delegate may, in exceptional circumstances and for reasons of public health or for the protection of human or animal health grounds, grant exemptions from paragraphs 4 and 5. »;
4 °) there is inserted a § 1erquater, as follows: "§ 1erquater.» The holder of the authorisation for placing on the market or registration shall, after the granting of this permission on the market or this record with regard to the methods of manufacture and control, take account of scientific and technical progress and introduce any necessary changes so the drug is manufactured and checked by means of generally accepted scientific methods.
These changes are subject to an amendment of the authorisation for placing on the market or registration and must be approved beforehand either by the Minister or his delegate or by the European Commission.
The holder of the authorization or registration shall immediately communicate to the Minister or his delegate any new information that could lead to a modification of the introduced during file the request for authorisation of placing on the market or for registration, or of the information or documents accompanying the placing on the market or the registration authority.
The holder of the authorisation for placing on the market

or registration shall immediately communicate to the Minister or his delegate any prohibition or restriction imposed by the competent authority of any country where the drug is placed on the market and any other new information which might influence the evaluation of the benefits and risks of the medicinal product concerned.
So that the risk-benefit ratio may be assessed continuously, the Minister or his delegate may at any time ask the holder of the authorisation for placing on the market or registration transmit data demonstrating that the risk-benefit balance remains favourable.
The holder of the authorisation for placing on the market or informed registration either the Minister or his delegate or the European Commission for information or for approval of any amendments it proposes to make to the folder introduced with the application or the documents that accompany the authorization for placing on the market or the registration. Each amendment must be submitted to the competent authorities that granted the authorisation for placing on the market or the registration, where appropriate in accordance with the procedure laid down in the § 1, paragraph 8. The King fixed deadlines, the terms and conditions under which these changes may be granted.
The King shall lay down the conditions and arrangements whereby, in exceptional circumstances and for reasons of public health, restrictive emergency measures can be taken against the drug until a final decision is taken by the Minister or his delegate on the issuing of the modification, the suspension or withdrawal of the authorisation on the market or registration. These measures are implemented within a period defined in agreement with the Minister.
Without prejudice to the possible immediate application of these measures, the holder of the authorisation for placing on the market or registration must submit an application for amendment in accordance with the terms and conditions laid down in the preceding paragraph. »;
5 °) there is inserted a § 1erquinquies, as follows: "§ 1erquinquies.» Authorization for placing on the market and, where appropriate the registration, of a medicinal product is accompanied by instructions and a summary of the characteristics of the product approved by the Minister or his delegate or the European Commission.
The King fixed the content and the conditions to which these documents must comply.
These documents are approved by the Minister or his delegate at the granting of the authorisation for placing on the market or of the registration and shall be made immediately available to the public. During the evaluation of the application for authorisation on the market or registration, the Minister or his delegate prepares an assessment report and comments on the dossier as regards the results of testing pharmaceutical, pre-clinical and clinical trials of the medicinal product concerned and, when it concerns a medicinal product for veterinary use, also with respect to the results of the tests for safety and residue studies. This evaluation report is updated as soon as new information that are important for the assessment of quality, safety and efficacy of the medicinal product concerned becomes available. The Minister or his delegate shall immediately available to the public, after the granting of the authorisation for placing on the market or the registration, the evaluation report with reasons for its decision, after deletion of any information with a character of commercial confidentiality, although this report is available only in the language used in the procedure of examination of the application.
The reasons are listed separately for each requested indication for a drug.
The record must be designed and drafted in terms legible, clear and understandable, enabling users and makers of animals using the drug in an appropriate manner, if necessary with the help of health professionals. To this end, the applicant or the holder of an authorisation for the placing on the market or registration of a medicinal product for human use takes into account the results of consultations with target patient groups to ensure readability, clarity and ease of use of the manual. These results are submitted to the Minister or his delegate or the European Commission.
The King fixed the content and the conditions on which the outer packaging, the immediate packaging and the labelling of medicines must satisfy. The markings shall be registered so as to be easily legible, clearly comprehensible and indelible.
Due to their nature, it may impose additional terms for specific medications. »;
6 °) is inserted a § 1ersexies, as follows: "§ 1ersexies."
After the granting of an authorisation for the placing on the market or registration the holder informs the Minister or his delegate to the date of the effective market the drug, taking into account the various presentations authorised or registered.
The holder of the authorisation for placing on the market or the registration also prevents the Minister or his delegate if the medication is again put on the market, either temporary or permanently. This notification must take place, except in exceptional circumstances, at the latest two months before the termination of the placing on the market of the medicinal product.
At the request of the Minister or his delegate, in particular in the context of pharmacovigilance, the holder of the authorisation for placing on the market or registration of a medicinal product shall provide all information relating to the volume of sales and any information it holds in relation to the volume of prescriptions.
The King may establish more specific detailed rules for the application of the provisions of this paragraph. » Art. 9. article 6bis of the Act repealed by the Act of 7 May 2004, was re-established in the following wording: «art.» 6bis. - § 1. By way of derogation from article 6, § 1, paragraph 3, and without prejudice to the legislation on the protection of industrial and commercial property, the applicant for a marketing authorisation for a medicinal product for human use is not required to provide the results of pre-clinical and clinical trials if he can demonstrate that the medicinal product for human use is a generic of a reference medicinal product for human use that is or has been authorized within the meaning of article 6 , § 1, for at least eight years in Belgium or in another Member State.
A generic medicinal product for human use authorised under this provision cannot be released before the end of the period of ten years following the authorisation on the initial market of the drug for human use.
Paragraph 1 is also applicable when the drug for human use is not allowed in Belgium.
In such a case, the applicant mentioned in the application form the Member State where the medicinal product of reference for human use is or has been authorized on the basis of the data referred to in article 6, § 1, paragraph 3. In these cases, the Minister or his delegate request to the competent authorities of the Member State which is reference in the application to send a confirmation that drug for human use is or has been authorized in that Member State, as well as the full composition of the medicinal product of reference to human use and If necessary, any other relevant documentation. At the request of the competent authorities of another Member State where an application for authorisation for placing on the market is introduced to a generic medicinal product for human use which refers to a reference medicinal product for human use for which an authorization for placing on the market is or was issued in Belgium, the Minister or his delegate sent to these authorities , within a period of one month, confirmation that drug for human use is or has been authorised, accompanied by its composition full and, if necessary, by any other relevant documentation.
The period of 10 years referred to in paragraph 2 shall be maximum of eleven years if the holder of the marketing authorisation for a medicinal product for human use Gets an authorization for placing on the market for one or more new therapeutic indications which are considered during the scientific assessment carried out with a view to their authorization during the first eight years of the period of ten years on the market bring a clinical significant advantage over existing therapies.
For the purposes of this paragraph, means:-"drug reference for human use": a medicinal product for human use authorised in accordance with article 6 § 1;
-generic drug for human use": a medicinal product for human use which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference for human use drug and whose bioequivalence with the reference for human use drug has been demonstrated by appropriate bioavailability studies.
The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered with the same active substance, unless they have significantly different properties with regard to safety and/or efficacy. In this case, additional information providing proof of the safety and/or efficacy of the different salts, esters or derivatives of an authorised active substance should

be given by the applicant. Various immediate-release oral dosage forms are considered to be pharmaceutical form. The applicant may be exempted from bioavailability studies if it can demonstrate that the generic medicinal product meets the relevant criteria contained in the detailed guidelines applicable and fixed by the King.
When the medicinal product for human use which does not meet the definition of the generic drug for human use listed in the preceding paragraph, second indent, or where the bioequivalence cannot be demonstrated through bioavailability or studies in case of changes of the active substances, the therapeutic indications, dosage, pharmaceutical form or route of administration compared with those of the drug for human use the results of pre-clinical tests or clinical trials appropriate must be provided.
Where a biological medicinal product for human use which is similar to a biological medicinal product of reference for human use does not fulfil the conditions contained in the definition of generic drugs for human use, because such differences relating to raw materials or differences in manufacturing processes of the biological for human drug and biological drug for human use the results of pre-clinical or appropriate clinical trials relating to these conditions must be provided. The type and quantity of additional to provide data must meet the relevant criteria as established by the King on the basis of article 6, § 1, paragraph 3. The results of other tests in the folder of the drug for human use should not be provided.
In addition to the provisions laid down in paragraphs 1 to 4, when an application for a new indication for a substance well established within the meaning of the provisions of § 2, is made a non-cumulative one-year data exclusivity period is granted provided that significant clinical or pre-clinical studies have been made in what concerns the new indication.
The King may, with regard to the application of the preceding provisions of this paragraph, lay down terms and conditions more accurate.
For authorisations for the placing on the market of medicinal products for human use granted under the preceding provisions, the indications or dosage forms which were still protected by the patent law at the time where the medicinal product for human use has been on the market should not be mentioned on the documents that accompany the drug for human use at the time of placing on the market. The King may determine the conditions and modalities for this purpose.
The realization of studies, tests and the tests necessary to meet the terms and conditions laid down in paragraphs 1 to 7 and the practical requirements resulting from it, are not considered to be contrary to the patent and the supplementary protection certificates for medicinal products for human use.
§ 2. By way of derogation from article 6, § 1, paragraph 3, and without prejudice to the legislation on the protection of industrial and commercial property, the applicant is not required to provide the results of the preclinical and clinical trials if he can demonstrate that the active substances of the medicinal product for human use are a well established medicinal use for at least ten years in the community and recognized efficacy and an acceptable level of security under the conditions laid down by the King. In this case, the results of these tests shall be replaced by an appropriate scientific literature.
§ 3. With regard to a medicinal product for human use containing active substances used in the composition of medicinal products for human use authorised but which have not yet been linked for therapeutic purposes, the results of new pre-clinical and clinical trials relating to that combination of these substances are provided in accordance with article 6, § 1, paragraph 3, without it being necessary to provide scientific references relating to each individual active substance.
§
4. After the granting of the authorisation for placing on the market for a medicinal product for human use, the holder of this authorization on the market may consent to that being used in the documentation on the pharmaceutical, pre-clinical and clinical tests contained in the file of the medicinal product for human for the review of an application use subsequent relative to any other drugs for human use having the same qualitative and quantitative active substance composition and the same shape pharmaceutical.
§
5. When a change of classification of a medicinal product for human use referred to in article 6, § 1bis, was authorized on the basis of pre-clinical or clinical significant, it is not referred to the results of these trials when examining an application by another applicant or holder of a marketing authorisation on the market or to amend the classification of a medicinal product for human use on the basis of the same substance for a period of one year after registration authorization of the first amendment.
§ 6. By way of derogation from article 6, § 1, paragraph 3, and without prejudice to the legislation on the protection of industrial and commercial property, the applicant for a marketing authorisation for a medicinal product for veterinary use is not required to provide the results of tests for safety and studies of residues or preclinical and clinical trials if he can demonstrate that the veterinary drug is a generic of a reference veterinary medicinal product which is or has been authorized within the meaning of article 6 § 1, for at least eight years in Belgium or in another Member State.
A generic drug for veterinary use authorised under this provision cannot be released before the end of the period of ten years following the authorisation on the initial market of reference veterinary drug.
Paragraph 1 is also applicable where the reference veterinary medicinal product is not authorised in Belgium. In such a case, the applicant must mention in the application form the Member State where the reference veterinary medicinal product is or has been authorised. In these cases, the Minister or his delegate request to the competent authorities of the Member State which is reference in the application to send a confirmation that the reference veterinary medicinal product is or has been authorized in that Member State, as well as the full composition of the reference veterinary medicinal product and If necessary, any other relevant documentation. At the request of the competent authorities of another Member State where an application for authorisation for placing on the market is introduced for a generic drug for veterinary use which refers to a reference medicinal product for veterinary use for which an authorization for placing on the market is or was issued in Belgium, the Minister or his delegate sent to these authorities , within a period of one month, confirmation that the reference veterinary medicinal product is or has been authorised, accompanied by its composition full and, if necessary, by any other relevant documentation.
For medicinal products for veterinary use intended for species targets determined by the King, the period referred to in paragraph 2 is however increased to thirteen.
For the purposes of this paragraph, means:-"reference veterinary medicinal product": a drug for veterinary use authorised in accordance with article 6, § 1;
-generic drug for veterinary use': a veterinary drug which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference veterinary medicinal product, and whose bioequivalence with the reference veterinary 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 are considered with the same active substance, unless they have significantly different properties with regard to safety and/or efficacy. In this case, additional information to provide proof of the safety and/or efficacy of the different salts, esters or derivatives of an authorised active substance must be given by the applicant. Various immediate-release oral dosage forms are considered to be pharmaceutical form. The applicant may be exempted from bioavailability studies if it can demonstrate that the generic medicinal product meets the relevant criteria contained in the detailed guidelines applicable and fixed by the King.
When the veterinary drug does not meet the definition of generic medicines for veterinary use, which is contained in the previous paragraph, second indent, or where the bioequivalence cannot be demonstrated through bioavailability or studies in case of changes of the active substances, the therapeutic indications, dosage, pharmaceutical form or route of administration compared to the reference veterinary medicinal product the results of appropriate tests safety, residue and pre-clinical or clinical analyses should be provided.
When a biological medicinal product for veterinary use which is similar to a reference veterinary biologic drug

does not satisfy the conditions in the definition of generic medicines for veterinary use, in particular because of differences relating to raw materials or differences in manufacturing processes of the biological medicinal product for veterinary use and reference veterinary biologic medicines, the results of pre-clinical tests or clinical appropriate relating to these conditions must be provided. The type and quantity of additional to provide data must meet the relevant criteria as established by the King on the basis of article 6, § 1, paragraph 3. The results of other tests in the folder of the reference veterinary medicinal product should not be provided.
For veterinary medicines intended for one or more species producing foodstuffs and containing a new active substance which, at April 30, 2004, was not authorised in the community, the ten year period laid down in paragraph 2 is extended by one year for each extension of the authorization for placing on the market in an another food-producing animal species If it is allowed in the five years following the granting of the initial marketing authorisation.
This period can however exceed thirteen years in total, for an authorization for placing on the market on four food-producing species or more.
The extension of the period of ten to eleven, twelve or thirteen years for a drug for veterinary use intended for a food-producing species shall be granted only on condition that the holder of the authorisation for placing on the market has also been originally apply for the establishment of maximum residue limits for the species covered by the authorization to place on the market.
The King may, with regard to the application of the preceding provisions of this paragraph, attach conditions and more specific terms.
For authorisations for placing on the market of medicinal products for veterinary use granted under the preceding provisions, the indications, pharmaceutical forms or the target species that were still protected by the patent law at the time where the veterinary drug has been on the market should not be mentioned on the documents that accompany the veterinary drug at the time of placing on the market. The King may determine the terms and conditions for this purpose.
Implementing studies, tests and trials, necessary to comply with the conditions and procedures laid down in paragraphs 1 to 10 of this paragraph and the practical requirements resulting are not considered as contrary to the patent and the supplementary protection certificates for medicinal products for veterinary use.
§ 7. By way of derogation from article 6, § 1, paragraph 3, and without prejudice to the legislation on the protection of industrial and commercial property, the applicant is not required to provide the results of safety and residue analysis test or tests, pre-clinical and clinical trials if he can demonstrate that the active substances of the medicinal product for veterinary use have a well established use for at least ten years in the community in veterinary medicine and recognised efficacy an acceptable level of safety in accordance with the conditions laid down by the King.
In this case, the results of these tests are replaced by references to appropriate scientific literature.
The assessment report published by the Agency European following the evaluation of an application for establishment of maximum limits of residues under Regulation (EEC) No 2377/90 referred to above can be used appropriately as scientific bibliography, including instead of the results of the safety tests.
If an applicant uses a scientific literature in order to obtain an authorization for placing on the market for a-producing species of food and this, for the same medicinal product for veterinary use, to obtain an authorization for placing on the market for another producer of foodstuffs, new studies of residues in accordance with Regulation (EEC) No 2377/90 as well as of new clinical trials a third party may resort to these studies and trials under § 6 for a period of three years after the granting of the marketing authorisation for which they have been achieved.
§ 8. In the case of veterinary drugs containing active substances used in the composition of authorised veterinary drugs, but have not yet been involved in therapeutic purposes, the results of the safety tests and residue analyses and, if necessary, new pre-clinical and clinical trials related to this composition must be provided in accordance with article 6 , § 1, paragraph 3, without it being necessary to provide scientific references relating to each individual active substance.
§ 9. After the granting of the marketing authorisation, the holder of this authorization may consent to that being used in the documentation on the pharmaceutical, safety tests, residues, pre-clinical and clinical analysis contained in the file on the veterinary drug for the review of an application for a veterinary drug with the same composition qualitative and quantitative active substances and the same pharmaceutical form.
§ 10. By way of derogation from article 6, § 1, paragraph 3, and in exceptional circumstances to immunological medicinal products for veterinary use, the applicant is not required to provide the results of certain tests of ground for the target species if they cannot be carried out for duly substantiated reasons, including the fact of Community provisions.

§ 11. In addition, in accordance with article 3.3 of the Regulation No 726/2004 referred to above, an authorization for placing on the market may be granted for a generic of a reference medicinal product authorised by the European Commission, under the same conditions as those laid down in §§ 1 and 6, if:-the summary of product characteristics is consistent on all relevant points, to that of the medicinal product authorized by the Commission European except in the case of application of the provisions laid down in the § 1, paragraph 10 and § 6, paragraph 12;
-the generic medicinal product is authorised under the same name in all Member States where the application is submitted. For the purposes of this provision, all the language versions of the name common international ("DCI") are considered as the same name. ».
S.
10A article 6ter of the Act, inserted by the law of June 21, 1983, the words "wholesale distributors, distributors, exporters" are inserted in the § 1, introductory sentence, between the word "manufacturers' and the words 'and importers '.
S. 11. article 6quater of the Act repealed by the law of August 10, 2001, is restored in the following wording: «art.» 6quater. - § 1. By way of derogation from the provisions of article 6 § 1, the human medicinal products for which no authorisations for placing on the market or no record is granted or those who are yet to be put on the market in Belgium, can be made available to patients in the following cases: 1 °) to meet special needs and when the patient cannot be treated adequately with drugs licensed and available in Belgium the King may exclude one or several provisions of this Act the drugs provided to respond to an order made in good faith by a prescriber. These medicines are prepared according to its specifications on the basis of a written request for a group of patients or on basis of a prescription for a particular patient. They are intended for the use of patients who fall under his direct personal responsibility. The King sets the terms and conditions for this purpose.
2 °) the King may also establish rules to make available medicines for human use for compassionate use within the meaning of article 83 of Regulation (EC) No 726/2004.
3 °) the King may also determine the terms and conditions whereby medicinal products for human use may be made available in the event of execution of emergency medical programmes.
'Emergency medical programme' means the provision of a medicinal product for human use in order to meet the medical needs for the benefit of patients suffering from a chronic illness, a disease that weakens serious health or disease constituting a threat to the life, and that can be treated satisfactorily with a drug that is in commerce and which is approved for the treatment of this condition. The medicinal product for human use concerned must have been the subject of an authorization for placing on the market but the indication for the treatment of this condition, however, is not permitted or medicines for human use is not yet on the market with this approved indication.
An emergency medical programme may also be applied for the medicinal product for human use for the treatment of the relevant condition that:-If an application for authorisation for placing on the market is under consideration for this indication, or - the placing on the market for this indication is granted but that the medicinal product for human use is not yet put on the market with this indication or – if clinical trials

y related are still current or if clinical trials has been made showing the relevance of the use of the drug for human use for the treatment of the relevant condition.
At the written request of a doctor who starts under his personal responsibility the treatment of a patient, the holder of an authorisation for the placing on the market of the medicinal product for human use can make this drug available in accordance with a medical emergency program established by him.
4 °) in order to run a prescription, a person authorised to supply medicinal products to the public, may, when there is no authorisation for placing on the market or registration in Belgium for a drug the same qualitative and quantitative composition in active substances and pharmaceutical form and the prescriber declares that the patient may not be treated adequately with drugs authorized at that time in Belgium import a medicinal product for human use that is allowed in the country of origin. The King sets the terms and conditions for this purpose.
5 °) in order to combat the spread of suspected or confirmed of pathogenic agents, toxins, chemical agents or nuclear radiation, which are likely to cause damage, the Minister or his delegate may temporarily authorise the distribution of unauthorized drugs. The King sets the terms and conditions, in particular as regards the respective responsibility of the parties concerned.
(The availability of medicinal products for human use by the holder/applicant of the authorization for placing on the market in accordance with the terms and conditions referred to in points 2 °) and 3 °) does not fall under the scope of application of articles 10 and 12.
§
2. By way of derogation from the provisions of article 6, § 1, medicinal products for veterinary use authorized or not registered in Belgium can be used for the treatment of animals in the following cases: 1 °) immunological not inactivated veterinary medicinal products 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. The King fixed the terms and the conditions therefor.
2 °) the veterinary drugs exclusively for animals that the King designates, provided that these medicines do not contain substances whose use requires veterinary control and that all measures are taken to prevent unauthorized use of these drugs for other animals.
The King fixed the terms and the conditions therefor.
3 °) where the health situation so requires, the Minister or his delegate may authorise the placing on the market or the administration to animals of veterinary drugs authorized in another Member State. The King fixed the terms and the conditions therefor.
4 °) in the event of serious epizootic diseases, the Minister or his delegate may provisionally allow the use of drugs immunological veterinary use without authorisation of placing on the market, in the absence of a suitable medicinal product authorized. The King fixed the terms and the conditions therefor.
5 °) where an animal is under import or export from or to a third country, and it is thus subjected to specific mandatory sanitary provisions, the Minister or his delegate may allow the use, for this animal, an immunological medicinal product for veterinary use with no authorisation for the placing on the market in Belgium but authorized under the legislation of the third country concerned. The King lays down the conditions and procedures for the control of the importation and the use of such immunological veterinary.
6 °) if there is no authorized medicinal product for veterinary use for a condition causing unacceptable suffering among the animals concerned, the veterinarian may, exceptionally, under his direct personal responsibility, treat these animals with drugs for which an authorization for placing on the market or a record was not granted. The King fixed the terms and the conditions therefor.
7 °) veterinary doctors of another State member service providers in Belgium, can carry drugs for veterinary use in small amounts, not exceeding the daily and needs other than immunological veterinary drugs for which there is no authorisation for placing on the market or registration in Belgium and administer to animals. The King sets the terms and conditions for this purpose.
§ 3.
Authorisation for placing on the market or a registration is not required to: 1 °) medicinal products prepared in a pharmacy according to a prescription to a patient or to a / animal/animals determined (s), commonly known as compounding.
2 °) medicinal products prepared in a pharmacy in accordance with the directions of a Pharmacopoeia or form therapeutic Magistral and intended to be supplied directly to patients or to end users supplied by this pharmacy, commonly known as mustard preparation;
3 °) investigational medicinal products for human use covered by the Act of 7 May 2004 experiments on the human person and investigational medicinal products for veterinary use;
4 °) intermediate products intended for further processing by authorized manufacturers;
5 °) radionuclides used in sealed form, as well as the veterinary drugs based on radioactive isotopes;
6 °) whole blood, plasma, cells or tissues of human or animal origin, with the exception of plasma, cells and tissues in the production or processing of which involving an industrial process;
7 °) inactivated immunological veterinary medicinal products manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or of that holding in the same locality;
8 °) radiopharmaceuticals prepared at the time of the use by a person or institution that is authorized to use these drugs, in accordance with the manufacturer's instructions, in an approved health centre and exclusively from authorized radionuclide, of kits of radionuclide or radionuclide precursors generators;
9 °) medicated feedingstuffs covered by the Act of 21 June 1983 the medicated feedingstuffs;
10 °) additives in the diet of animals such as referred to in the royal decree of 8 February 1999 on trade and the use of products for feeding animals;
The authorisation provided for in article 12A and 12B is not required for goods provided for in points 1 °), 2 °), 5 °), 6 °), 7 °), 8 °), 9 °) and 10 °).
The King may take specific measures with respect to the products referred to in this paragraph. » Art. 12. article 6quinquies of the Act, inserted by the law of October 20, 1998, is replaced as follows: «art.» 6quinquies. - the King may, by Decree deliberated in the Council of Ministers, establish the terms and conditions under which clinical trials can be conducted with drugs for veterinary use.
These terms and conditions specifically concern the protection of consumers, the goal of clinical trials, the persons responsible for performing these tests, the communication of data and reports on clinical trials and adverse effects found during clinical trials, as well as the quality of the investigational drug.
If it finds that these conditions and these conditions are not met, the Minister or his delegate may prohibit or suspend further execution of clinical trials. » Art.
13. in the Act, it is inserted an article 6sexies as follows: «art.» 6sexies.-the King may, by Decree deliberated in the Council of Ministers, establish the conditions and the modalities according to which the Directorate General medicines with the federal public Service health, food chain safety and environment, gives a scientific opinion or technical research and the development of a drug for the possible introduction of an application for authorisation of placing on the market or registration of a drug or a request for amendment of these.
It determines the conditions, time limits and arrangements for the procedure of processing of these notices, as well as the conditions for obtaining these notices. » Art. 14. in the same Act, it is inserted an article 6septies, worded as follows: «art.» 6septies. - the data provided for in article 6, § 1erquinquies, which are mentioned in the manual, on the outer packaging or primary packaging if the outer packaging is lacking, and labelling each drug which is placed on the market, shall be drafted in the three national languages.
This shall not preclude to what these data are also written in other languages, provided that the same information is contained in all the languages used.
These data must conform to approved data for the granting of the authorization for placing on the market or the registration, or subsequently. With regard to the particulars mentioned in the summary of product characteristics and in the package leaflet, a derogation is possible in case of application of the provisions laid down in article 6bis, § 1, paragraph 10, and § 6, paragraph 12.
Holder

authorising the placing on the market or registration of a medicinal product for human use makes the notice available upon request of patient organizations, in formats appropriate for the blind and the visually impaired. The King may determine the implementing rules.
The inclusion of a leaflet in the packaging of any drug that is on the market is mandatory, unless all of the required information is directly on the outer packaging or on the immediate packaging.
If the packaging or the presentation of a drug is amended or divided, hereinafter referred to as fractionation, by persons entitled under article 12bis, § 1, paragraphs 3 and 4, they must ensure that, in the event of issuance or direct provision to the patient or in charge of animals, a copy of the notice be issued or provided with the medication.
The name of the medicinal product for human use must also be included in braille on the outer packaging or, if no outer packaging, on the immediate packaging. The King may determine the cases in which the strength and the pharmaceutical form of the medicinal product for human use must also be included in braille on the outer packaging or, if no outer packaging, on the immediate packaging.
When the drug is not intended to be delivered directly to the patient or in charge of animals but only to be administered by health care professionals, the Minister or his delegate may exempt from the requirement to include certain particulars on the labelling and package leaflet and the leaflet of the medicinal product concerned in the three official languages.
In the case of certain orphan medicinal products for human use, this information can be written in one of the official languages of the European Community, on the basis of a decision of the European Commission. » Art.
15. article 7 of the Act, as amended by the law of October 20, 1998, is replaced by the following provision: «art.» 7 - § 1. The King may prohibit the dispensing of drugs and remove the drug from the market where it finds, on the advice of the relevant Committee referred to in article 6, § 1, paragraph 11, that:-the medicinal product is harmful in the normal conditions of use or;
-the therapeutic effect of the drug is lacking or;
-the risk-benefit balance is not favourable under the authorised conditions of use or;
-the medicinal product does not have the qualitative and quantitative composition declared or;
-controls on the drug itself or on substances and intermediates manufacturing have not been made or any other requirement or obligation relating to the grant of the manufacturing authorization has not complied or;
-in relation to a veterinary drug, the specified waiting time is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues constitute a hazard to the health of the consumer.
It also determines the period in which the drug should be withdrawn from the market.
It can limit the prohibition to only batch subject to controversy.
If the ban is for a particular substance, the prohibition may extend to all drugs with this particular substance or its derivatives.
§ 2.
With regard to the use of immunological veterinary medicinal products for the control or eradication of animal disease, the Minister or his delegate may prohibit the manufacture, import, possession, sale, delivery, delivery, issuance and/or use of immunological medicinal products for veterinary use on all or part of its territory, if it is established that:-the administration of the drug to animals interferes with a program for the diagnosis , the control or eradication of an animal disease or cause difficulties in certifying the absence of contamination in live animals or food or other products obtained from animals treated;
-disease against which the drug is supposed to confer immunity is largely absent from the territory in question. » Art. 16 A article 7bis, § 1, of the Act, inserted by the law of 10 July 1997, 'it stopped royal No. 78 of 10 November 1967 on the exercise of the art of healing, nursing, paramedical and medical committees' shall be replaced by the words "it stopped royal No. 78 of 10 November 1967 on the practice of the professions of health care" and social "Affairs". public health and the environment"shall be replaced by the words"federal public Service public health, food chain safety and environment.
S. 17. article 8 of the Act, as amended by the law of October 20, 1998, is replaced by the following provision: «art.» 8. - in case of emergency, the Minister or his delegate may suspend the issuance or provision of a drug if it considers that:-the medicinal product is harmful in the normal conditions of use or;
-the therapeutic effect of the drug is lacking - the risk/benefit ratio is not favourable under the authorised conditions of use - the drug has no qualitative or quantitative composition declared or - controls on the drug itself or on substances and intermediates manufacturing have not been made or when any other requirement or obligation relating to the grant of the manufacturing authorization has not complied or - with regard to a veterinary drug the specified waiting time is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues constitute a hazard to the health of the consumer.
The Minister or his delegate also determines the period in which the drug should be withdrawn from the market.
It can limit the suspension to only batch subject to controversy.
If the suspension is for a particular substance, the suspension may extend to all drugs with this particular substance or its derivatives. » Art. 18. in the same Act, there shall be inserted an article 8bis, as follows: «art.» 8bis. - the Minister or his delegate suspend, withdraw or amend the authorisation for placing on the market or the registration of a drug if it considers that:-this product is harmful in the normal conditions of use - therapeutic effect of this medicine is lacking - the risk/benefit ratio is not favourable under the normal conditions of use or - this medicine has no qualitative or quantitative composition declared or - controls on the drug itself or on substances and intermediates manufacturing has not been performed or when any other requirement or obligation relating to the grant of the manufacturing authorization has not been respected or - the information contained in the record to obtain an authorization for placing on the market or registration are incorrect or have not been transmitted or modified so that requires it the application of article 6 , § 1erquater, or - in what concerns a medicinal product for veterinary use, the waiting time is inadequate to ensure that foodstuffs obtained from the treated animal contain residues which might constitute a hazard to the health of the consumer, or - the veterinary drug is presented for a use prohibited under Community law other areas.
Before these measures, the holder of the authorisation for placing on the market or the registration is advised by the Minister or his delegate of this intention and it may, either at the initiative of the Minister or his delegate, or on its own initiative, be heard by the Committee referred to in article 6, § 1, paragraph 11.
The King may establish implementing rules with regard to this provision. » Art. (19A article 9 of the same Act, replaced by the law of June 21, 1983, the following changes are made: 1 °) in the § 1, paragraph 1, the words ', for which a marketing authorisation has not granted' shall be inserted between the words "which is not registered" and the words "or is the subject", and the words «» ", 7A and 8A" shall be inserted after the words "of the articles 7 and 8.
2 °) the § 1, paragraph 2, is hereby amended as follows: "any advertising to the public for medicinal products containing psychotropic or narcotic substances within the meaning of international conventions, is also prohibited.";
3 °) the § 1 shall be supplemented by the following paragraphs: "However, the prohibition of advertising referred to in the preceding paragraph does not apply to vaccination campaigns carried out by holders of authorization referred to in articles 12A and 12B and approved by the Minister or his delegate, nor approved beforehand by the Minister or his delegate public interest campaigns.
Is also prohibited direct distribution by industry of medicinal products to the public for promotional purposes.
"Advertising for drugs" means any form of solicitation of information, prospecting or incentives which aims to promote the prescription, the issue, the supply, sale or consumption of drugs. The King may determine more precise rules relating to acts that are regarded as advertising.
Are not covered by the term "advertising for medicines":-package leaflet and labelling referred to in article 6septies.
-correspondence, accompanied by

If applicable of any document advertising, needed to answer a specific question on a particular drug;
-practical information and reference documents, for example, packaging changes, upgrades warnings on adverse events post-marketing, and sale catalogues and price lists provided that is there any information on the medicinal product;
-the information relating to health or human or animal diseases provided that there is no reference, even indirect, to a drug.
All elements of the advertising of a medicinal product must comply with the information contained in the summary of the product characteristics.
Any advertising of a medicinal product must encourage the rational use of this medicine, by presenting it objectively and without exaggerating the properties, and may not be misleading. »;
4 °) § 2 is supplemented by the following paragraphs: 'with regard to radio and television advertising for medicinal products for human use, these measures may be based on a system of prior checking. The King introduces a Monitoring Committee of the advertising of medicinal products for human use, to provide advice to the Minister or her delegate relating to the granting of a visa.
It establishes the tasks, composition and operation. The King also establishes the conditions, time and the modalities of the consideration of requests for a visa, as well as the conditions for obtaining a visa.
Any person having a legitimate interest may make a complaint to the Minister or his delegate against an advertising contrary to the provisions of this Act or its implementing orders.
The Minister or his delegate may, if it considers it necessary for the protection of the general interest: - order the cessation of advertising contrary to the provisions of this Act or its implementing orders, - prohibit the advertisement referred to in the preceding indent if it has not yet brought to the knowledge of the public but that its publication is imminent, even in the absence of proof of a loss or actual harm, intention or negligence on the part of the advertiser.
In addition, the Minister or his delegate may, with a view to eliminating the continuing effects of publicity which the termination has been ordered by a final decision: - require the publication of this decision in whole or in part in the form it deems appropriate, - require the publication of a corrigendum release.
If the measures referred to in paragraphs 4 and 5 relate to radio and television advertising for medicinal products for human use, the Minister takes these measures on the advice of the Commission on control of the advertising of medicinal products for human use.
Before proceeding with the measures referred to in paragraphs 4 and 5, the advertiser is informed by the Minister or his delegate of this intention and it may, either at the initiative of the Minister or his delegate, or on its own initiative, be heard by the Minister or his delegate and, in the cases referred to in the preceding paragraph, by the Control Board of the advertising of medicinal products for human use. » Art.
20. in the same Act, it is inserted a section 12bis as follows: «art.» 12bis. - § 1. The manufacture of medicinal products or intermediates on Belgian territory is subject to authorization. This permission is also required if the medicinal product is manufactured for export. The Minister or his delegate grants permission, possibly on the advice of the Advisory Commission. The King fixed cases, the terms and conditions under which this Commission must be consulted. The King also establishes the composition and functioning of the Advisory Commission.
Permission is required for the total or partial manufacture for the operations division, packaging or presentation.
However, this permission is not required for preparations and splitting insofar as these operations are executed only for the issuing retail, by persons authorized to supply medicinal products to the public. These people can delegate these operations either to other persons authorised to supply medicinal products to the public, or to a holder of authorization referred to in this article. The King determines the conditions and modalities for this purpose.
Permission is not required for splitting insofar as such operations are executed only for retail supply by authorized persons to provide medicines to the heads of animals. The King determines the conditions and modalities for this purpose.
Authorization is required for imports from third countries. For the importation of consignments of drugs from countries with which the Community European has concluded appropriate agreements guaranteeing that the drug manufacturer applies rules of good manufacturing practice at least equivalent to those laid down by Community law, the King may lay down the conditions and manner in which monitoring reports concerning these lots are recognized. The King also lays down the conditions and the arrangements if lots of drugs are coming from another Member State.
For certain specific categories of drugs designated by him, the King may impose additional requirements because of the nature of these medicines.
A copy of the authorizations is transmitted to the Agency.
The certificates of good manufacturing practices are also transmitted to the Agency. If an inspection results lead to the conclusion that the principles and guidelines of good practice which must be respected in the manufacture of drugs, are not, this information is also transmitted to the Agency.
The King sets conditions, deadlines and modalities of the procedure for review of applications for an authorisation, as well as the conditions for obtaining an authorization referred to in this article. It also takes steps to protect public health about the manufacture, import and export of drugs. It sets the content of the application and may prescribe the form in which this request should be introduced. The King may also establish rules relating to the admissibility of an application.
The Minister or his delegate grants permission only after ascertaining by a survey that the information provided is accurate. The authorization is valid only for the premises indicated in the authorisation as well as medicinal products and pharmaceutical forms for which permission was sought and granted. The permission can be matched, to ensure compliance with all conditions, of certain obligations imposed either when authorization or subsequent to its approval.
The King lays down the principles and guidelines for good manufacturing practices. These principles and guidelines also apply to the manufacture of raw materials which are used as active substances and can also be declared applicable in excipients to be set by the King.
The King also sets the terms and conditions which the manufacture or import of medicines authorisation holders are required in the exercise of their licensed activities.
In the event of non-compliance with the requirements of this Act or its execution orders, the Minister or his delegate may, fully or partially, suspend or withdraw the authorisation.
Before these measures, the holder of the authorization shall be informed by the Minister or his delegate of this intention and it may, either at the initiative of the Minister or his delegate or on its own initiative, be heard by the Advisory Panel.
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2. Drugs intended solely for export to third countries which are not members of the European Union or are not part of the EEA European and which are not placed on the Belgian market, are not subject to the market authorisation or registration. The King sets the terms and conditions under which these drugs can be exported.
If a drug has obtained an authorization for placing on the market or a registration, and this drug is exclusively intended for export to third countries, it is deviated from the provisions of article 6, § 1B, paragraphs 4 and 5, at the request of the holder of the authorization or registration. ».
S. 21. in the Act, it is inserted an article 12ter, worded as follows: «art.» 12B. - authorization is required for the wholesale distribution of medicinal products.
The Minister or his delegate grants permission, possibly on the advice of the Advisory Committee referred to in article 12bis. The King determines the conditions, cases and the manner in which this Committee must be consulted.
Wholesale distribution activities can take place only if the drug is covered by an authorization for placing on the market or a registration granted either by the Minister or his delegate or by the European Commission. The King may grant exceptions for cases in which according to Community law for medicinal products for veterinary use unauthorized can be used for the treatment of animals.
Any wholesale distributor, other than the holder of the authorisation for placing on the market or the record, which is important at the same time a

medicinal product from another Member State shall notify its intention to import this drug for its placing on the market in Belgium to the holder of the authorisation for placing on the market or of the registration and the Minister or his delegate. The King sets the terms and conditions to satisfy this parallel importation.
The King sets conditions, deadlines and modalities of the procedure for review of applications for an authorisation, as well as the conditions for obtaining an authorization referred to in this article. It also takes the necessary measures about these activities, in order to protect public health. It sets the content of the application and may prescribe the form in which the request should be introduced. The King may also lay down the rules relating to the admissibility of an application.
The Minister or his delegate grants permission only after ascertaining by a survey that the information provided is accurate. The authorization is valid only for the premises indicated in the authorisation as well as medicinal products and pharmaceutical forms for which permission was sought and granted. The permission can be matched, to ensure compliance with all conditions, of certain obligations imposed either when authorization or subsequent to its approval.
The possession of an authorization to manufacture of medicinal products for human use shall include authorization to distribute wholesale the medicinal products for human use covered by this authorization.
The authorization for distribution wholesale is not required for the trade carried out by persons qualified to supply medicinal products to the public or to provide medicines to the heads of animals. Quality wholesale distributor and wholesaler - distributor of drugs is incompatible with that of person entitled to issue medicines to the public or person entitled to provide medicines to heads of animals.
The obligation to hold a clearance wholesale distribution of medicinal products is not required for the delivery of small quantities of drugs by a person authorised to supply medicinal products to the public to a person authorised to provide medicines to the heads of animals.
The holders of an authorisation of wholesale distribution of medicines can deliver drugs to other holders of authorization or to persons who are authorised to supply medicinal products to the public or to provide medicines to heads of animals, in accordance with the terms and conditions laid down by the King.
The King determines the terms and conditions under which certain public service obligations may be imposed on the holders of an authorisation of wholesale distribution of drugs.
The King also sets the terms and conditions required the holders of an authorisation of wholesale distribution of medicines in the exercise of their licensed activities.
The King may set the principles and guidelines on good practice of wholesale distribution of medicinal products.
The holder of the authorization of wholesale distribution of medicinal products should be established in a Member State.
In the event of failure to comply with the requirements of this Act or its execution orders, the Minister or his delegate may, fully or partially, suspend or withdraw the authorisation. Data relating to the suspension and withdrawal are communicated to the European Commission and the Member States concerned.
Before these measures, the holder of the authorization shall be informed by the Minister or his delegate of this intention and it may, either at the initiative of the Minister or his delegate, or on its own initiative, be heard by the Advisory Committee referred to in article 12bis. » Art. 22. in the same Act, it is inserted an article 12quater, worded as follows: «art.» 12quater. - articles 12A and 12B do not apply to consumers and end users who provide or are another Member State to send a small amount of drugs for their personal therapeutic use. The King fixed the terms and the conditions therefor. » Art. 23. in the same Act, it is inserted an article 12quinquies, worded as follows: «art.» 12quinquies.-licensees of the authorisation for the placing on the market of a medicinal product and, once this drug is placed on the market, distributors of this medicine, ensure in an effective way, within the limits of their respective responsibility, an appropriate and continuous supply of this drug for the persons empowered to issue or to provide medicines, so as to cover the needs of patients or animals.
For reasons of protection of public health, the King may, for the implementation of this provision, determine more specific terms. » Art. 24. in the same Act, it is inserted an article 12sexies, worded as follows: «art.» 12sexies. - in order to ensure the adoption of regulatory decisions appropriate and harmonised in the European Community concerning the medicinal products authorised or registered in the light of the information collected on adverse effects of medicinal products under normal conditions of use, a pharmacovigilance system is implemented. This system is used to collect information useful in the surveillance of drugs, including with respect to their adverse effects on human and animal, and to evaluate such information scientifically. The King lays down the procedures according to which this information shall be communicated by the holders of an authorisation for the placing on the market or a registration. It may also lay down rules on the exchange of information about pharmacovigilance within the community.
Relevant information collected using this system are transmitted by the Minister or his delegate to the other Member States and the European Agency and, where applicable, to the holders of an authorisation for the placing on the market or a registration.
In relation to medicinal products for human use, this system takes into account also any available information on the cases of misuse and abuse of medicinal products for human use which may have an impact on the assessment of their risks and benefits. This information is linked to the potentially available data relating to the sale, the use and prescription of drugs for human use.
Regarding medicinal products for veterinary use, these information is made in relation to available data on the sale, use and prescribing of medicines for veterinary use. This system also takes into account all available information on the efficacy of medicinal products for veterinary use effectiveness laid down on their use "off-RCP" and studies to determine the validity of the waiting time and the possible risks for the environment, because of the use of the veterinary drug, insofar as they may have an impact on the assessment of their risks and benefits.
The King takes the necessary steps to organize the system of pharmacovigilance within the competent authority and to ensure that its operation is under the permanent control of the competent authorities.
It can also impose specific requirements to professional care health and veterinary medicine, in relation to the notification of suspected unexpected or serious adverse events.
The holder of a marketing authorisation on the market or registration cannot communicate to the public or to health care professionals, on its drug authorized or registered, information relating to pharmacovigilance without notifying beforehand or simultaneously the Minister or his delegate.
In any event the holder of the authorisation for placing on the market or registration presents this information in an objective manner and not misleading. » Art. 25. in the Act, it is inserted an article 12septies as follows: «art.» 12septies.-the King may, in the interest of public health, take all other necessary measures relating to import, export, manufacture, preparation, packaging, presentation, name, capacity, labelling of packaging, detention, conservation, transport, distribution, offer for sale, sale, assignment for payment or free of charge, the issuance, the requirement, the provision , delivery and administration of medicinal products and pharmacovigilance.
» Art. (26A article 13bis of the Act, inserted by the Act of 29 December 1990 and amended by the royal decree of 22 February 2001 and by the law of 27 December 2004, the following changes are made: 1 °) in the § 1, the word "registration" is replaced by the words "authorisation to place on the market and the record", the word "may" shall be replaced by the word "may" and the words "and bail" are deleted;
2 °) in § 2, first sentence, the word "royalty" is replaced by the words «remuneration and a provision ", and in the second sentence the words"and a provision"shall be inserted after the word"compensation ".
3 °) § 2 is supplemented by the following subparagraph: "the provision referred to in paragraph 1 constitutes an advance on the due payments.";
4 °) there is inserted a § 2B, as follows: "§ 2B.» For certain specific categories of drugs designated by him, the King may determine the cases in which and the terms and conditions

that it may be granted exemptions, reductions or reports of payment in regard to fees fixed pursuant to the provisions of §§ 1 and 2. The King may also determine that in these cases, administrative assistance is provided. »;
5 °) in § 3, the words "§§ 1, 2 and 2A" are replaced by the words "§§ 1, 2, 2A and 2B" and "missions" shall be replaced by the words "missions referred to in those paragraphs.
S. (27A article 14, § 2, of the Act, replaced by the law of December 22, 2003, the following changes are made: 1 °) in the point 1 °, paragraph 1, the word ", transferred" is inserted between the words "issued" and "remuneration";
(2 °) in the Dutch text of the point 2 °, b), the word «verklaring» is replaced by «verhoor ';
(3 °) in the Dutch text of the point 2 ° c), 'die gegevens kunnen bevatten' is inserted between the words "informatiedragers" and "die ingevolge wetgeving";
4 °) in the text Dutch of the same provision, the word "die" is inserted between the words «of zich» and «kosteloos ';
5 °) in the same provision, the words "as well as all other books, records, documents, records, tapes or no matter what other media of information as they deem necessary for the exercise of supervision," shall be inserted between the words "monitoring" and the words "and taking extracts."
(6 °) in the Dutch text of the point 2 °, d), the word "die" is inserted between the words «of zich» and «kosteloos ';
7 °) in the french text of the provision the words 'others' are inserted between the words 'all' and 'books '.
S. (28A article 14bis, § 3, paragraph 1, of the Act, inserted by the Act of 22 December 2003, the following changes are made: 1 °) «to take» shall be replaced by the words "get";
2 °) 'public institutions that depend on it, as well as all public institutions that depend on' shall be replaced by the words "and public institutions that depend on it."
3 °) the words "that they have" shall be inserted between the words "all information" and the words ", as well as";
4 °) the words "acts, parts and ' and are inserted between the words 'all' and 'books '.
S. 29. in the same Act inserted an article 14ter as follows: «art.» 14B. - the King fixed the cases in which and the terms according to which the findings of the inspections carried out by the competent authorities of other Member States can be recognized. » Art.
30. in article 15, § 2, of the Act, amended by Act of 22 December 2003, the word ", obsolete" is inserted between the words "corrupted, altered" and the words "or non-compliant with the provisions of this Act".
S. 31. article 16 §§ 1, 2, 3 and 4 of the same Act, amended by the laws of the 29 December 1990, July 10, 1997, October 20, 1998, 2 August 2002 and December 22, 2003, is replaced as follows: "§ 1.» Shall be punished by a fine of 1.25 EUR 12,50 EUR: 1 °) who contravenes the provisions of article 2, paragraph 2, article 6, §§ 1erquinquies and 1ersexies articles 6septies and 12septies with regard to the packaging, labelling and denomination of drugs, and of article 6ter, § 1, paragraph 3, or of their arrested performance;
2 °) one who buys, possesses, sells, offers for sale, issue, book, distributes, provides, imports or exports medicines spoiled, altered, outdated, forged or imitated as well as drugs not conforming to the provisions of this Act or its implementing orders.
§ 2. Is punished by imprisonment from eight days to one month and a fine of 2.50 EUR 25.00 EUR, or one of those penalties only, one who violates the provisions of article 3, § 1, article 4, Article 6quinquies of article 6ter, § 2 of article 11, article 12, article 13 article 13bis or their execution orders.
§ 3. Shall be punished by a prison term of one month to one year and a fine of 375,00 EUR EUR 5.00 or one of those penalties only: 1 °) who contravenes the provisions of article 3, §§ 2, 3 or 4, article 6, §§ 1, 1bis, 1B, 1erquater, 1ersexies or 2, Article 6a, article 6ter, § 1, paragraph 1, article 6quater, article 7 Article 7bis, article 8, article 8bis, article 9, article 10, article 12bis, article 12ter, article 12quater, article 12quinquies or article 12sexies or their orders of execution as well as articles 6, § 1erquinquies, 6septies and 12septies or their execution orders for as much as these activities are not covered by the § 1 of this section;
2 °) those who reject as well as opposed to the visits, inspections, investigations, inspections, hearings, consultations of documents, samples, gatherings of evidence or the seizure or other by members of the staff or contract, as provided for in article 14 or in its orders of execution;
3 °) one who has spoofed or imitated or has been falsified or imitate medicines which are intended to be sold, offered for sale, issued, delivered, distributed, provided, imported, or exported;
4 °) one who found drugs that are intended to be sold, offered for sale, issued, delivered, distributed, supplied, imported or exported, and who sells, offers for sale, issue, delivers, distributes, provides, imports or exports knowing that they are damaged, altered, obsolete, falsified, imitated or not comply with the provisions of this Act or its implementing decrees;
5 °) that which, in breach of article 3, paragraph 1, of Regulation (EC) No 726/2004 referred to above, puts on the market a medicinal product referred to in the annex to this regulation unless an authorization for placing on the market referred to in this regulation has been issued therefor.
§ 4. Is punished by imprisonment from three months to five years and a fine from 25,00 2.500,00 EUR or one of those penalties only, who contravenes the provisions of orders made pursuant to this Act for medicinal products that contain soporific, narcotic or psychotropic substances, or substances that can be used in the illicit manufacture of narcotic substances or drugs may cause dependence and whose list is arrested by the King. » Art. (32A article 17 of the same Act, replaced by the law of October 20, 1998 and amended by the royal decree of 22 February 2001 and by the law of December 22, 2003, the following changes are made: 1 °) the § 1, paragraph 4 is replaced by the following: "in the event of competition of several offences, amounts whose payment off public action are cumulative. without however they can exceed double the maximum of a fine punishing the offence for which the highest fine is foreseen. »;
2 °) between paragraphs 6 and 7, the following paragraphs shall be inserted: 'when the infringement of the provisions of this Act or its implementing orders gave rise to charges of analysis or expertise, the sum may be increased amount or part of the amount of such fees; the portion of the amount paid for these costs will be allocated to the agency or the person who exposed.
The person to whom the payment of a fine is proposed, may upon request from the employee - lawyer referred to in paragraph 1 take knowledge of the dossier for the offence dependants.
The payment proposal referred to in paragraph 1 is sent to the author of the offence within three months of the date of the report.
The employer is liable for the payment of the fine proposed to his servant ";
3 °) inserted a § 3 and § 4, worded as follows: ' § § 3 3» The scheduled faculty by the § 1 cannot be exercised when the tribunal is already seized of the fact or the investigating judge is required to instruct.
§ 4. The damage possibly caused to another must be fully repaired until the contemplation in the § 1 can be applied. However, payment of the sum may still be proposed if the author acknowledged in writing his civil liability for the operative event for the damage, and produced evidence of compensation for uncontested fraction of the damage and the method of payment thereof. In any case, the victim may assert his rights before the competent court. In this case, the acceptance of the transaction by the author is an irrebuttable presumption of fault. » Art. 33. in article 19A, paragraph 2 of the same Act, inserted by the law of June 21, 1983, as amended by the Act of 22 December 2003, the words 'fifty francs' and 'fifteen thousand francs' are replaced by the words '1.25 EUR' and "375,00 EUR" respectively.
S. 34. in the same Act, it is inserted an article 19ter, worded as follows: «art.» 19ter. - § 1. Each of the Minister or his delegate decision taken pursuant to this Act or its orders of execution shall be duly substantiated.
Without prejudice to the application of the advertising administration Act of 11 April 1994, decisions of the Minister or his delegate shall be notified to those concerned with the indication of the means to claim or possible remedies provided for in this Act or its orders of execution, and the time in which the appeal may be presented.
Decisions to grant or withdraw an authorisation for placing on the market or a record is made available to the public.
§ 2.
The decisions granting, refusal or withdrawal of an authorisation for the placing on the market or registration,

as well as the decisions of annulment of the refusal or withdrawal of an authorisation of placing on the market or a registration, and decisions of prohibition of delivery and withdrawal from the market, as well as their motives, are brought to the attention of the European Agency.
If these measures are likely to affect public health protection in third countries, they are also transmitted to the competent international bodies with copy to the Agency. » Art.
35. in the Act, it is inserted an article 19quater, worded as follows: 'Art. 19quater. - § 1. All bodies or committees established or recognized under this Act or its implementing orders accountable publicly available their internal rules, as well as the agenda of their meetings, the minutes of their meetings, together with the decisions taken, details of votes and explanations of vote, including minority opinions.
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2. The staff of the Directorate General drugs with the federal public Service public health, safety of the food chain and environment as well as external experts and members of commissions and bodies referred in the § 1, shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. These people make annually a declaration of their financial interests or other. These statements are made available to the public. » Art. 36. in the same Act, it is inserted an article 19quinquies, worded as follows: «art.» 19quinquies. - articles 6, 6 bis, 6septies, 8A and 12sexies are not applicable to drugs:-who are not prepared industrially or - which are manufactured by a method involving no industrial process. » Art. 37. in the same Act, it is inserted an article 19sexies, worded as follows: «art.» 19sexies - the King may coordinate the provisions of this Act with the provisions which, explicitly or implicitly, have made changes until the time coordinate.
To this end, it can:-change order, the numbering and the presentation of the provisions to coordinate;
-amend the references that are contained in the provisions to coordinate to put them in line with the new numbering;
-change the wording of the provisions to coordinate to ensure consistency and to unify the terminology, without that it cannot however be infringed the principles embodied in these provisions.
The consolidated version will be entitled: "Act on drugs, coordinated the...» ». » CHAPTER III. -Amendments to the law of June 21, 1983 on medicated feedingstuffs s. 38. at article 1 of the law of June 21, 1983 on the medicated feedingstuffs, replaced by the royal decree of 7 March 1995, the point 2 ° is repealed.
S. 39. in section 2 of the Act, the words "Medicated pre-mixes and" are deleted.
S. 40. in article 3, 1 °, of the Act, the words "Medicated pre-mixes and" are deleted.
S. 41. article 5, paragraph 1, of the Act, is repealed.
S. 42. article 6 of the Act is repealed.
S. 43. in article 8, paragraph 1, of the Act the words "Medicated pre-mixes or ' are deleted.
S. 44 A section 9 of the Act, the following changes are made: 1 ° in the paragraph 1, the words ' to medicated premixes and ' shall be deleted;
2 ° in paragraph 3, the words ' the Medicated pre-mixes and ' shall be deleted;
3 ° in paragraph 4, the words ' premixes and "are deleted.
S. 45. A article 11, § 1, of the Act, the following changes are made: 1 ° in the point 4, has), the words "Medicated pre-mixes or ' shall be deleted;
2 ° the point 4, b), is repealed.
S.
46 A section 12 of the Act, as amended by the royal decree of February 22, 2001, the following changes are made: 1 ° in the § 1, the words ' premixes and ' shall be deleted;
2 ° in § 2, first and third sentences, the words ' premixes and ' shall be deleted;
3 ° in § 3, paragraph 1, the words ' premixes and ' shall be deleted;
4 ° in § 3, paragraph 2, the words ' premixes and ' shall be deleted;
5 ° in § 4, the words ' premixes and "are deleted.
S. 47. in section 13 of the Act, the words "Medicated pre-mixes and" are deleted.
S. 48. in article 14, paragraph 1, of the Act, the words "Medicated pre-mixes or ' are deleted.
CHAPTER IV. -Amendments to the law of 28 August 1991 on the exercise of the veterinary art. 49. in chapter VI of the law of 28 August 1991 on the practice of veterinary medicine, it is inserted an article 27A, as follows: «art.» 27bis: § 1. In the event of infringement of the provisions of this Act, or by-laws made in pursuance thereof, the official lawyer, designated for this purpose by the King within the federal public Service health, food chain safety and environment, may set a sum whose payment voluntary by the author of the offence discharges public action. In the event of non-payment, as well as in the case where the official jurist makes no payment proposal, the file will be transmitted to the Prosecutor of the King.
An annual report describing the result of the activities referred to in the preceding paragraph is written.
The amount by which the payment off public action cannot be lower the minimum fine provided for the breach of the legal provision concerned, nor greater than set.
In the case of competition of several offences, amounts whose payment off public action are cumulative, unless they can however exceed twice the maximum of a fine punishing the offence for which the highest fine is foreseen.
In case of recidivism endeans a period of three years after payment of the sum which turn off the public, established action for violation of this Act or its orders of execution, the sum can be doubled.
The amount of these sums is increased by additional decimated that apply to the fines provided for in the penal Code and increased, where appropriate, charges of expertise.
When the breach of the provisions of this Act or its implementing orders gave rise to charges of analysis or expertise, the sum may be increased the amount or a portion of these costs; the portion of the amount paid for these costs will be allocated to the agency or the person who exposed.
The person to whom the payment of a fine is proposed, may upon request from the employee - lawyer referred to in paragraph 1 take knowledge of the dossier for the offence dependants.
The payment proposal referred to in paragraph 1 is sent to the author of the offence within three months of the date of the report.
The terms of payment are determined by the King as well as the other rules necessary for the implementation of this article.
The employer is liable for the payment of the fine proposed to his servant.
§ 2. The scheduled faculty by the § 1 cannot be exercised when the tribunal is already seized of the fact or the investigating judge is required to instruct.
§ 3. The damage possibly caused to another must be fully repaired until the contemplation in the § 1 can be applied. However, the payment of the sum may still be proposed if the author acknowledged in writing his civil liability for the fact generator damage and produced evidence of compensation of the uncontested portion of the injury and the terms of regulation one - ci. In any case, the victim may assert his rights before the competent court. In this case, the acceptance of the transaction by the author is an irrebuttable presumption of fault.
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4. This section does not apply to infringements pursuant to the royal decree of 22 February 2001 organizing the checks carried out by the Federal Agency for the safety of the food chain and amending various legal provisions. » Chapter V. - measures transitional art. 50. the King may, for medicinal products which are placed on the market or for which an application for authorisation for placing on the market or registration is being processed the day of the entry into force of this Act, provide for transitional measures as regards the application of the provisions of this Act.
Promulgate this Act, order that it self under the seal of the State and published by le Moniteur.
Given to Brussels, may 1, 2006.
ALBERT by the King: the Minister of Social Affairs and public health, R. DEMOTTE sealed with the seal of the State: the Minister of Justice, Ms. L. ONKELINX _ Notes Documents of the House of representatives: 51 - 2189 - 2005/2006 N ° 1: Bill No. 2: report No. 3: text corrected by the commission No. 4: amendments N ° 5: text adopted in plenary meeting and forwarded to the full Senate : 8-March 9, 2006 the Senate Documents: 3 - 1615 - 2005/2006 N ° 1: project mentioned by the No. 2 Senate: report No. 3: Decision not to amend annals of the Senate: March 30, 2006