1^er MAI 2006. - Revision of Pharmaceutical Legislation Act (1)

ALBERT II, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
CHAPTER I^er - General provision
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
CHAPTER II. - Amendments to the Act of 25 March 1964 on Drugs
Art. 2. Article 1^er of the Act of 25 March 1964 on Drugs, replaced by the Act of 20 October 1998, is replaced as follows:
“Article 1^er . - § 1^er. For the purposes of this Act:
1) "Medicine, being either a human drug or a veterinary drug":
(a) human drug:
- any substance or composition presented as having curative or preventive properties in respect of human diseases; or
- any substance or composition that may be used in or may be administered to humans in order to either restore, correct or modify physiological functions by carrying out pharmacological, immunological or metabolic action, or to establish a medical diagnosis;
(b) veterinary medicine, including premixes for drug products:
- any substance or composition presented as having curative or preventive properties in respect of animal diseases; or
- any substance or composition that may be used in or may be administered to the animal in order to either restore, correct or modify physiological functions by carrying out pharmacological, immunological or metabolic action, or to establish a medical diagnosis;
2) “substance”:
any material of any origin, such material may be, inter alia:
- human, such as blood, cells and human tissue and derivatives;
- animal, such as: micro-organisms, whole animals, organ parts, animal secretions, toxins, extracted substances, blood products;
- plant, such as: micro-organisms, plants, plant parts, plant secretions, substances obtained by extraction;
- chemical, such as: elements, natural chemicals and chemicals of transformation and synthesis;
3) "premix for medicinal foods":
any pre-prepared veterinary drug for further manufacturing of drug products;
4) "Drug foods":
any mixture of veterinary drug(s) and food(s) prepared prior to placing it on the market and intended to be administered to animals without processing, due to the curative or preventive properties or other properties of the veterinary drug referred to in paragraph (1), (b);
5) "homeopathic medicine":
any drug obtained from substances called homeopathic strains according to a homeopathic manufacturing process described by the European pharmacopoeia or, if not, by the pharmacopoeia currently used officially in the Member States. A homeopathic drug may contain several active substances;
6) "human-use drug":
human-use drug whose active substances are exclusively one or more plant-based substances or plant-based preparations or an association of one or more plant-based substances or plant-based preparations;
7) "plant substances":
all plants, plant parts, algae, mushrooms, lichens, mainly whole, fragmented or cut, used in the state, most often dried, but sometimes fresh. Some exudates that have not undergone specific treatments are also considered vegetable substances. Plant substances are precisely defined by the part of the plant used and the botanical name according to the two-word system (genre, species, variety and author);
8) "plant-based preparations":
preparations obtained by treatment of plant substances, such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. They include crushed or sprayed vegetable substances, dyes, extracts, essential oils, juice obtained by pressure and treated exudates;
9) "Traditional drug based on human plants":
any human-use drug that meets the criteria established by the King under community law;
10) "desirable effect":
a nocive and unintended reaction to a drug, occurring in the dosages normally used in man or animal for the prophylaxis, diagnosis or treatment of a disease or for the restoration, correction or modification of a physiological function;
11) "Serious adverse effect of a human drug":
an adverse effect that causes death, endangers life, requires hospitalization or extension of hospitalization, results in significant or long-term disability or disability or results in a congenital abnormality/malformation in the patient;
12) "Serious adverse effect of a veterinary drug":
an adverse effect that leads to death, endangers life, causes a significant disability or disability, results in a congenital abnormality / malformation or causes permanent or prolonged symptoms in the treated animal;
13) "an unexpected adverse effect":
an adverse effect whose nature, severity or evolution do not correspond to the summary of the drug characteristics;
14) "abuse of human drugs":
intentional, persistent or sporadic excessive use of medications for human use accompanied by harmful physical or psychological reactions;
15) "desirable human effect":
a harmful and unintended reaction, occurring in a human being following exposure to a veterinary drug;
16) "excluding use of the characteristics of a veterinary drug":
the use of a veterinary drug in a manner that is not consistent with the summary of the characteristics of the product ("CPR"), including the serious misuse or abuse of the veterinary drug;
17) "big distribution of drugs for human use":
any activity that involves obtaining, holding, delivering or exporting human-use drugs, excluding the issuance of human-use drugs to the public; these activities are carried out with manufacturers or their depositaries, importers, other wholesale distributors or with pharmacists and other persons authorized to deliver human-use drugs to the public in accordance with article 4 of Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions;
18) "big distribution of veterinary drugs":
any activity that includes the purchase, sale, import and export of veterinary medicines or any other commercial operation relating to such drugs, for profit or non-profit purposes, excluding:
- delivery by a manufacturer of veterinary medicines made by himself;
- the retail sale of veterinary medicines by pharmacists and veterinary physicians to animal officials in accordance with article 4 of Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions;
19) “public service obligation”:
the obligation of wholesale distributors to continuously guarantee an assortment of drugs capable of meeting the requirements of a geographically determined territory and to ensure the delivery of orders requested in a timely manner throughout that territory;
20) "grosser - spreader":
the wholesale distributor responsible for public service obligations with respect to drugs for human use and/or veterinary use;
21) "representing the licensee of the marketing/registration authorization":
the person, commonly referred to as "local representative", designated by the holder of the marketing authorization or registration to represent him in Belgium;
22) "prescription":
any document by which the prescriber prescribes one or more medications for a specified patient or one or more animals;
23) "prescriptor":
practitioners referred to in articles 2 and 3 of Royal Decree No. 78 of 10 November 1967 relating to the exercise of health care professions and veterinary physicians referred to in section 1^er1° of the Act of 28 August 1991 on the Exercise of Veterinary Medicine;
24) "any person authorized to deliver drugs to the public":
pharmacists referred to in Article 4, § 1^er, of Royal Decree No. 78 of 10 November 1967 relating to the exercise of the professions of health care, including pharmacists in a non-open pharmaceutical informal to the public, as well as persons referred to in Article 4, § 2, of Royal Decree No. 78 of 10 November 1967, excluding persons referred to in paragraphs 4 and 5;
25) "any person authorized to provide medication to animal officials":
veterinary physicians referred to in section 4 of the Act of 28 August 1991 on the exercise of veterinary medicine;
26) "name of the drug":
the name, which may be either a fantasy name, which may not be confused with the common name, or a common or scientific name with a mark or name of the holder of the marketing/registration authorization;
27) “common name”:
the international common name recommended by the World Health Organization, or, failing that, the common common common name used;
28) "Measurement of the drug":
the active substance content, expressed in quantity per unit of catch, per unit of volume or weight depending on the presentation;
29) "primary conditioning":
the receptacle or any other form of packaging that is in direct contact with the drug;
30) "Outdoor packaging":
the packaging in which the primary packaging is placed;
31) "labelling":
references on the outer packaging or primary packaging;
32) “Notice”:
the user information notice, which accompanies the drug;
33) "European Agency":
the European Medicines Agency, established by the Regulation (EC) No. 726/2004 of the European Parliament and the Council of 31 March 2004 establishing community procedures for authorisation and monitoring with regard to drugs for human use and veterinary use and establishing a European Medicines Agency;
34) "risks associated with the use of the drug for human use":
- any risk to the patient's health or public health related to the quality, safety or efficacy of the human drug;
- any risk of adverse environmental effects;
35) "risks related to the use of the veterinary drug":
- any risk to animal or human health related to the quality, safety or efficacy of the veterinary drug;
- any risk of adverse environmental effects;
36) "benefit/risk relationship of a human drug":
assessment of the positive therapeutic effects of the drug for human use against the risk as defined in paragraph 34), first dash;
37) "benefit/risk ratio of a veterinary drug":
the assessment of the positive therapeutic effects of the veterinary drug with respect to the risk of adverse effects defined in section 35);
38) "due time":
the period necessary between the last administration of the veterinary drug to the animal under normal conditions of employment and under the provisions of this Act and its enforcement orders, and the obtaining of foodstuffs from that animal, in order to protect public health, by ensuring that such foodstuffs do not contain residues in quantities greater than the maximum residue limits of active substances, as established under the Regulations (EEC) Council No. 2377/90 of 26 June 1990 establishing a community procedure for establishing maximum limits for residues of veterinary drugs in foods of animal origin;
39) “Pharmace”:
a set of normative texts on substances for pharmaceutical use used as active or excipient substances for the preparation of drugs for human use or for veterinary use, as well as their pharmaceutical forms and related analytical methods;
40) "the Minister":
the Minister who has public health in his or her duties;
41) “Member State”:
a Member State of the European Union or a State that is a party to the European Economic Area Agreement.
§ 2. In the event of doubt, where a product, having regard to all its characteristics, is likely to meet both the definition of a drug and the definition of a product governed by another legislation, the provisions of this Act apply.
The King creates, by deliberate decree in the Council of Ministers, a joint commission which is responsible for rendering a notice in order to determine under which legislation a product falls. It also sets its composition and operation.
The Minister or his or her delegate makes a decision on the basis of that notice. The Minister or his or her delegate makes these decisions accessible to the public.
The marketers of these products are informed that the Joint Commission has been seized. They may be heard, either at the initiative of the Joint Commission or at their request.
If the Minister's decision on the product states that the product falls under the application of any other legislation than that under which the person in charge of the product has put or wants to put the product on the market, the Minister may decide on public health grounds that the product, because of its characteristics or its presentation, must be removed from the market if it is already put on the market, and/or that the product may not be ( If the Minister's decision implies that the product is contrary, because of its presentation, to this Act and its enforcement orders, the decision may imply that the product may remain on the market provided that its presentation is appropriate. In both cases, the Minister sets out the time limit for its decision to be executed.
The King shall determine the conditions, deadlines and procedure in which decisions pursuant to this paragraph are made and establish more precise rules for the application of the provisions of this paragraph.
The Minister may set guidelines specifying the applicable legislation relating to the performance of this provision on the advice of the Joint Commission. »
Art. 3. Article 1^erbis of the same law, inserted by the law of 21 June 1983 and amended by the law of 20 October 1998, § 4 is supplemented as follows:
", except for the provisions that are necessary for the execution of treaties and international acts taken under them. »
Art. 4. Section 2 of the Act, as amended by the Act of 12 August 2000, is amended as follows:
1°) paragraph 2 is replaced by the following paragraph:
"European Pharmacopoeia is applied. The King may approve other pharmacopoeia, on the advice of the Pharmacopoeia Commission. In the cases and under the conditions that He sets, the King may, on the advice of the Pharmacopoeia Commission, with respect to informal and magisterial preparations, impose the reference to the European Pharmacopoeia, the Belgian Pharmacopoeia, the Magistral Therapeutic Form or, if not, an official pharmacopoeia corresponding to the current state of knowledge or monograph. »;
2°) it is added a paragraph 4, which reads as follows:
"The King creates the Pharmacopoeia Commission and determines its composition, operation and missions. »
Art. 5. Article 3 of the Act, amended by the Acts of 20 October 1998 and 2 January 2001, the current text of which will form § 1^erthe following modifications are made:
1°) to § 1^erthe words "and reactive" and the words "when they are intended for human medicine, and the Minister of Agriculture when they are intended for veterinary medicine" are deleted;
2°) § 1^er is completed as follows:
"The King may also set rules on administrative tasks to be performed by these individuals and determine the administrative data to be retained by them. »;
3°) a § 2, a § 3 and a § 4 are added, as follows:
Ҥ2. The King sets out the conditions and conditions for the conservation, preparation, receipt and delivery of medicines by the persons authorized to deliver drugs to the public. These people can only obtain human-use medicines from holders of a wholesale distribution authorization or wholesalers-retributors. They can only obtain veterinary medicines from wholesalers-retributors.
§ 3. The King sets out the conditions and conditions for the conservation, receipt and supply of medicines by veterinary physicians authorized to provide animal officials with drugs intended for use in the animal. Veterinary doctors may not obtain medicines either from wholesalers or from pharmacists in an open-ended pharmaceutical field to the public in accordance with the terms and conditions established by the King.
§ 4. Any medication is delivered or provided personally to the patient or animal manager or their agent, except in cases determined by the King. It sets out the conditions and modalities.
However, the provision for remote sale to patients or animal officials by any prescribed medicine is prohibited. »
Art. 6. In section 4 of the Act, as amended by the Act of 16 June 1970, the following amendments are made:
1°) to paragraph 1^er, the words "and flow" are replaced by the words ", deliverance and supply";
(2) Paragraph 2 is repealed.
Art. 7. In section 5 of the Act, replaced by the Act of 29 April 1996 and amended by the Acts of 20 October 1998 and 30 December 2001, the following amendments are made:
1°) to § 1^er, the words "the Ministry of Social Affairs, Public Health and the Environment" are replaced by the words "Federal Public Service Public Health, Safety of the Food Chain and Environment" and the words "providers referred to in Royal Decree No. 78 relating to the exercise of the art of healing, nursing, paramedical professions and medical commissions" are replaced by the words "Royal Practitioners of 1967"
2°) § 1^er is supplemented by the words "or to the public";
3°) in § 2, the first sentence is supplemented as follows:
“for practitioners referred to in § 1^er and the public. »
Art. 8. Section 6 of the Act, amended by the Royal Decree of 8 August 1997 and by the Acts of 20 October 1998, 12 August 2000, 30 December 2001 and 22 December 2003, are amended as follows:
1°) § 1^er is replaced by the following provision:
« § 1^er. No medication may be placed on the market without a marketing authorization, either by the Minister or his delegate in accordance with the provisions of this Act and its enforcement orders, or by the European Commission in accordance with Community law.
For this purpose, except in the case of market authorizations granted by the European Commission, an application must be directed to the Minister or his delegate who makes a decision on the application on the basis of the opinion of the Commission concerned referred to in paragraph 11. The applicant or holder of a marketing authorization must be established in a Member State.
The King determines the conditions, deadlines and terms of the procedure for reviewing applications for a marketing authorization, as well as the conditions for obtaining a marketing authorization. The purpose of this review is to verify whether a drug for which a marketing authorization has been sought meets the general quality, safety and efficacy requirements set by him, on the basis of, inter alia, the results of pharmaceutical, preclinical and clinical trials. To this end, it sets out the content of the application that must include at least the draft of the notice, the draft summary of the product characteristics, the project of the primary packaging and the project of the outer packaging of the drug and which are approved when granting the marketing authorization. It may also determine the form in which the application must be introduced. In order to instruct applications filed under this section, section 6bis and their enforcement orders, the Minister or his delegate shall verify that the file submitted is in accordance with the provisions of these sections and their enforcement orders and shall examine whether the conditions for granting a marketing authorization are met. This review may also include additional information to be provided by the applicant. In addition, the Minister or his delegate may submit the drug, raw materials, and if necessary, intermediate products or other substances of the drug to the control of a laboratory recognized by him or by the competent authority of another Member State with equivalent legislation or by an official laboratory for the control of drugs to ensure that the control methods described in the application are satisfactory.
In addition to the general requirements for the granting of an authorization to market drugs, as referred to in paragraph 3, the King may impose additional conditions for certain specific categories of medicines that he designates because of their nature.
The King may also for homeopathic medicines and traditional medicines based on human-use plants derogate from the general requirements referred to in paragraph 3 for the granting of drug marketing authorizations by providing a simplified authorization procedure under community law. It sets out the conditions, deadlines and terms of the procedure for reviewing applications for a marketing authorization for these categories of medicines, below referred to as registration, as well as the conditions for obtaining a registration. Similarly, it determines the provisions of this Act and its enforcement orders that apply to each of these categories of medicines and may, if necessary, adapt the rules of this Act to the nature of these drugs under Community law.
An application for authorization to market or register is admissible only if it is complete and filed in accordance with the provisions laid down by the King. The application shall be subject to the notice of the Commission concerned referred to in paragraph 11 only if it has been previously declared admissible under the conditions, deadlines and terms established by him.
Permission to market or registration is denied if the drug for which an application has been filed does not meet the conditions set by this Act or its enforcement orders.
The King also sets out the conditions, deadlines and terms of the procedure for reviewing applications for a marketing or registration authorization, in the event that, for the same drug, a marketing authorization or registration is granted or pending in another Member State, referred to as a mutual recognition procedure. It also sets out the conditions to be met for obtaining a marketing authorization or registration in these cases. It also sets out the modalities under which the Minister or his delegate collaborates with the competent authorities of other Member States in appreciating applications for marketing authorization or registration of drugs that are introduced at the same time in Belgium and in one or more other Member States, called decentralized procedure. It sets out the conditions, deadlines and terms of the procedure for reviewing applications for marketing authorization or registration in such cases, as well as the conditions to be met for obtaining a marketing authorization or registration in such cases. This collaboration may consist in the delivery of all useful data for the evaluation of this drug. If the Minister or his or her delegate considers that the granting of a marketing authorization or registration for the drug concerned generates a serious potential risk to public health in the case of a human-use drug or generates a serious potential risk to human or animal health, or to the environment in the case of a veterinary drug, the Minister shall communicate it with a view to applying the procedure referred to in the procedure. If one or more other Member States invoke the application either of the mutual recognition procedure or of the decentralized procedure the above-mentioned risks, the Minister or his delegate may, at the request of the applicant, authorize the marketing or registration of the drug without waiting for the outcome of the procedure referred to in the following paragraph. In this case, the marketing or registration authorization is granted without prejudice to the outcome of the procedure referred to in the following paragraph.
Where a single drug is subject to a number of applications for marketing or registration authorization and Member States have adopted diverging decisions regarding the granting, suspension or withdrawal of the marketing or registration authorization, the Minister or delegate or the applicant or licensee of the marketing or registration authorization may refer to the Committee established within the European Agency. In particular cases of community interest, the Minister or his or her delegate or the applicant or licensee of the marketing or registration authorization shall enter the Committee concerned, before a decision is made on the application, suspension, withdrawal or any other change in the marketing or registration authorization. The Minister or his or her delegate shall communicate to the applicant or the holder of the marketing or registration authorization the fact that he or she has seized the Committee concerned. On the basis of the decision adopted by the European Commission, assisted by the Standing Committee established by either section 121 of Directive 2001/83/EC of 6 November 2001 establishing a Community Code for Human-Use Medicines, or section 89 of Directive 2001/82/EC of 6 November 2001 establishing a Community Code for Veterinary Drugs, the Minister or his delegate shall grant or withdraw the authorization to make the necessary amendments to the market or registration or to The Minister or his delegate shall communicate the terms and conditions for the implementation of this decision to the European Commission and the European Agency.
The King shall establish the conditions, deadlines and terms and conditions necessary for the application of the provisions of the preceding paragraph.
The King shall establish a Commission for Human Drugs and a Commission for Veterinary Drugs to provide advice on applications for marketing authorization, the provision of medicines to patients or animals in the cases referred to in Article 6quater and determined by the King, as well as scientific questions related to drugs. It may also establish other Commissions to provide advice on applications for registration. It determines the missions, functioning and composition of these Commissions. For the coordination of their tasks, the Commissions may provide for the creation of a Bureau, whose task, function and composition is fixed by the King.
The licensee of the marketing authorization or registration of a drug is responsible for placing the drug on the market. The designation of a representative in Belgium does not exempt the licensee from the marketing authorization or registration of its civil liability.
The authorization to market or registration does not affect the common law responsibility of the manufacturer and, where applicable, the holder of the authorization or registration.
The applicant or licensee of the marketing or registration authorization is responsible for the accuracy of the documents and data provided.
In the absence of market authorization or pending application for an authorized human-use drug in another Member State, the Minister or his delegate may, for justified public health reasons, grant a marketing authorization for this drug. In this case, the Minister or his or her delegate shall ensure compliance with this Act and its enforcement orders, including the requirements of § 1^erbis and § 1^erquinquies and prescribed articles 7, 8, 8bis, 9, 10, 12, 12quinquies, 12sexies, 14 and 14bis. The King sets out the conditions, deadlines and terms of the procedure for reviewing applications for marketing authorization or registration in such cases, as well as the conditions to be met for obtaining a marketing authorization or registration in such cases."
2°) it is inserted a § 1^erbis, as follows:
« § 1^erbis. When granting marketing authorization or registration of a drug, the Minister or his delegate specifies the classification of the drug by:
- prescription drug
- medication not subject to prescription.
The Minister or his delegate also determines the classification of drugs for which a marketing authorization or registration was issued by the European Commission, taking into account, where appropriate, subcategories for human-use drugs defined in the following paragraph.
Human-use drugs that can only be issued on prescription may be subject to the following subcategories:
- prescription drugs that cannot be extended;
- prescription drugs that may be extended;
- drugs subject to special prescription;
- prescription drugs "restricted", reserved for certain groups of specialists and/or whose delivery is reserved for hospital pharmacists.
Veterinary medicines that are subject to prescription may, on the basis of the provisions of the Act of 28 August 1991 on the exercise of veterinary medicine, be subject to additional conditions with respect to prescription, supply and administration.
The King sets out the criteria on which, when granting market authorization or registration, the drug is classified in these categories and, where applicable, in these subcategories.
The Minister or his or her delegate shall establish a list of drugs that are subject to the prescription requirement, specifying, if necessary, the subcategory. This list is updated annually and communicated to the European Commission and other member States.
The Minister or his or her delegate may amend the classification after the granting of a marketing authorization or registration, either on his or her own initiative or upon request from the licensee of the authorization or registration.
The King sets out the conditions and conditions under which this amendment is granted.
In addition, the marketing authorization of a drug may, in exceptional circumstances and for public health reasons, be subject to the application of a risk management program, either on the applicant's proposal for the marketing authorization of the drug, or on the Minister's or his delegate's injunction, at the time of granting the authorization or at a later date. The risk management program may set restrictive conditions with respect to the prescription, method of delivery or supply, and the use or administration of the drug for its safe use. This risk management program supports market authorization. The licensee of the marketing authorization is responsible for its application. The Minister or his or her delegate may, after consultation with the licensee of the marketing authorization, take additional measures to ensure the implementation of the risk management program, if applicable imposed by the European Commission and to inform professional users, patients or animal officials of the specific measures to be put on the market of this drug.
If the market authorization for a specific drug is related to the application of a risk management program, the Minister or his or her delegate may decide that all drugs that contain the same active substance(s) are also subject to a risk management program under similar rules. To this end, the Minister or his or her delegate may also require that authorizations to market drugs that have already been granted be amended to that effect.
The King sets out the conditions, deadlines and terms of the procedure for reviewing applications for marketing authorization or registration in these cases or their modification, as well as the conditions to be met for obtaining a marketing authorization or registration or modification in these cases.
In exceptional circumstances and after consultation with the applicant, the marketing authorization may be granted subject to the applicant's obligation to meet certain conditions, including the safety of the drug, the notification to the Minister or his or her delegate of any incident related to the use of the drug and the measures to be taken. The King sets out objective and verifiable reasons and conditions as well as the terms under which a marketing authorization may be granted subject to certain conditions. The maintenance of such a marketing authorization is linked to the annual reassessment of these conditions. The list of these conditions as well as the deadlines and dates for the execution of these conditions are made available to the public. »;
3°) it is inserted a § 1^erter, as follows:
« § 1^erter. The marketing or registration authorization is valid for five years.
The Minister or his or her delegate may, at the end of five years, extend the validity of the marketing or registration authorization, upon request of the holder and on the basis of an assessment of the profit/risk report. The King sets the conditions, deadlines and terms for this purpose.
Once renewed, the marketing or registration authorization is valid for an unlimited period of time, unless the Minister or his or her delegate decides, for justified reasons related to pharmacovigilance, to renew a five-year renewal of the marketing or registration authorization. The King sets the terms and conditions for this purpose.
Any marketing authorization or registration that, within three years of its grant, is not followed by an effective marketing of the drug concerned, becomes null and void.
When an authorized or registered drug, previously placed on the market, is not or is no longer in the market for three consecutive years, the marketing authorization or registration granted for this drug becomes obsolete.
Pursuant to the preceding two paragraphs, the marketing or registration authorization is terminated. Prior to the cancellation of the marketing authorization or registration as provided for in the preceding two paragraphs, the licensee of the authorization or registration shall be informed by the Minister or his or her delegate of that intention and may be heard, either on its own initiative or on the initiative of the Minister or his or her delegate.
The Minister or his or her delegate may, in exceptional circumstances and for public health reasons or on grounds of protection of human or animal health, grant exemptions to paragraphs 4 and 5. »;
4°) it is inserted a § 1^erquater, as follows:
« § 1^erquater. The holder of the marketing or registration authorization shall, after the granting of this marketing authorization or registration, take into account scientific and technical progress, and introduce all necessary modifications to ensure that the drug is manufactured and controlled according to generally accepted scientific methods.
These amendments are subject to an amendment to the marketing or registration authorization 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 or her delegate any new information that may result in an amendment to the file introduced at the request for a marketing or registration authorization, or information or documents that accompany the marketing or registration authorization.
The holder of the marketing or registration authorization shall forthwith communicate to the Minister or his delegate any prohibition or restriction imposed by the competent authority of any country in which the drug is placed on the market and any other new information that may influence the assessment of the benefits and risks of the drug concerned.
In order for the benefit/risk report to be assessed on an ongoing basis, the Minister or his or her delegate may at any time request the licensee to submit data demonstrating that the benefit/risk relationship remains favourable.
The holder of the marketing or registration authorization shall inform either the Minister or his or her delegate or the European Commission, for information or for approval, of any changes that he or she proposes to make to the file introduced with the application or documents that accompany the marketing or registration authorization. Each amendment must be submitted to the competent authorities who have granted the marketing authorization or registration, if applicable in accordance with the procedure provided for in § 1^erParagraph 8. The King sets the deadlines, terms and conditions for such amendments to be granted.
The King sets out the conditions and terms and conditions under which, in exceptional circumstances and for public health reasons, restrictive emergency measures may be taken against the drug until a final decision is made by the Minister or his delegate regarding the granting, modification, suspension or withdrawal of the marketing or registration authorization. These measures are implemented within a specified time frame in agreement with the Minister. Without prejudice to the possible immediate application of these measures, the licensee of the marketing or registration authorization must apply for an amendment in accordance with the conditions and conditions set out in the preceding paragraph. »;
5°) it is inserted a § 1^erquinquies, as follows:
« § 1^erQuiet. The marketing authorization, and if applicable the registration, of a drug is accompanied by a notice and a summary of the characteristics of the product approved by the Minister or his delegate or the European Commission. The King sets out the content and conditions to which these documents must satisfy.
These documents are approved by the Minister or his or her delegate during the granting of the marketing or registration authorization and are made immediately available to the public. When assessing the application for market or registration authorization, the Minister or his or her delegate prepares an assessment report and comments on the file on the results of the pharmaceutical, preclinical and clinical trials of the drug in question and, when it concerns a veterinary drug, also on the results of safety tests and residue studies. This evaluation report is updated as soon as new information is available to assess the quality, safety and effectiveness of the drug in question. The Minister or his or her delegate shall immediately make the assessment report available to the public, after the issuance of the marketing or registration authorization, with the reasons for the decision, after the removal of any information of a commercial confidentiality character, even if the report is only available in the language used in the application review procedure.
The reasons are indicated separately for each indication of a drug.
The notice must be designed and written in easily readable, clear and understandable terms, allowing users and animal officials to use the medication appropriately, if necessary with the help of health professionals. To this end, the applicant or holder of a marketing authorization or registration of a human-use drug shall take into account the results of the consultation of patient target groups in order to ensure the readability, clarity and ease of use of the notice. These results are submitted to the Minister or his delegate or the European Commission.
The King sets out the content and conditions to which the outer packaging, primary packaging and labelling of medicines must satisfy. Mention must be entered in such a way as to be easily readable, clearly understandable and indelible.
Because of their nature, it may impose additional mentions for certain specific drugs. »;
6°) it is inserted a § 1^ersexies, as follows:
« § 1^erSexies. After the issuance of a marketing authorization or registration, the licensee shall inform the Minister or his or her delegate of the date of the effective marketing of the drug, taking into account the various authorized or registered submissions.
The holder of the marketing or registration authorization shall also notify the Minister or his or her delegate if the drug is no longer being marketed on a temporary or final basis. This notification must take place, except in exceptional circumstances, no later than two months before the interruption of the drug market.
At the request of the Minister or his delegate, in particular in the context of pharmacovigilance, the holder of the marketing authorization or registration of a drug shall communicate to him all the information relating to the volume of sales carried out and any information held in relation to the volume of the requirements.
The King may establish more precise terms for the application of the provisions of this paragraph. »
Art. 9. Section 6bis of the Act, repealed by the Act of 7 May 2004, is reinstated in the following wording:
"Art. 6bis. § 1^er. By derogation from Article 6, § 1^er, paragraph 3, and without prejudice to the legislation relating to the protection of industrial and commercial property, the applicant for an authorization to market a human-use drug is not required to provide the results of preclinical and clinical trials if the applicant can demonstrate that the human-use drug is a generic of a reference drug for human use that is or has been authorized within the meaning of Article 6, § 1^erfor at least eight years in Belgium or another Member State.
A generic human-use drug authorized under this provision may not be marketed before the end of the ten-year period following the initial marketing authorization of the reference drug for human use.
Paragraph 1^er is also applicable when the reference drug for human use is not allowed in Belgium. In such a case, the applicant mentions in the application form the Member State where the reference drug for human use is or has been authorized on the basis of the data referred to in Article 6, § 1^erParagraph 3. In such cases, the Minister or his delegate requests the competent authorities of the Member State to whom reference is made in the application form to send him a confirmation that the reference drug for human use is or has been authorized in that Member State, as well as the complete composition of the reference drug for human use and, if necessary, any other relevant documentation. At the request of the competent authorities of another Member State where an application for market authorization is filed for a generic human-use drug that refers to a reference drug for human use for which a marketing authorization is or has been issued in Belgium, the Minister or his delegate sends to these authorities, within one month, a confirmation that the reference drug for human use is or has been authorized, together with its full composition, if necessary and
The 10-year period referred to in paragraph 2 shall be extended to a maximum of eleven years if the holder of the marketing authorization of a human-use drug obtains, during the first eight years of that ten-year period, a marketing authorization for one or more new therapeutic indications that are deemed, during the scientific assessment conducted for their marketing authorization, to provide a significant clinical advantage with respect to existing therapies.
For the purposes of this paragraph:
- "human reference drug": a human-use drug authorized in accordance with Article 6, § 1^er;
- "genic medicine for human use": a human drug that has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference drug for human use and whose bioequivalence with the reference drug for human use has been demonstrated by appropriate bioavailability studies.
The different salts, esters, ethers, isomers, mixtures of issomers, complex or derived from an active substance are considered to be the same active substance, unless they have substantially different properties in terms of safety and/or efficiency. In this case, additional information providing evidence of the safety and/or effectiveness of the various salts, esters or derivatives of an authorized active substance must be given by the applicant. Oral pharmaceutical forms with immediate release are considered to be the same pharmaceutical form. The applicant may be exempted from bioavailability studies if it can prove that the generic drug meets the relevant criteria set out in the applicable detailed guidelines and set by the King.
When the human-use drug does not meet the definition of the generic human-use drug contained in the previous paragraph, second dash, or where bioequivalence cannot be demonstrated through bioavailability studies or in the event of changes in the active substance(s), therapeutic indications, dosage, pharmaceutical form or route of administration in relation to those of the reference drug for human use, the results of the appropriate clinical tests
When a human-use biological drug that is similar to a reference biological drug for human use does not meet the conditions in the definition of generic human-use drugs, in particular due to differences in the raw material or differences in the manufacturing processes of the human-use biological drug and the reference biological drug for human use, the results of appropriate pre-clinical or clinical trials related to these conditions must be provided. The type and quantity of the additional data to be provided must meet the relevant criteria as set by the King on the basis of Article 6, § 1^erParagraph 3. The results of other tests in the human reference drug folder should not be provided.
In addition to the provisions of subparagraphs 1^er at 4, where a request for a new indication for a well-established substance within the meaning of the provisions provided for in § 2, a non-cumulative period of exclusive data of one year is granted provided that significant preclinical or clinical studies have been conducted with respect to the new indication.
The King may, with respect to the application of the preceding provisions of this paragraph, establish more precise terms and conditions.
For authorizations to market human-use drugs granted under the preceding provisions, indications or pharmaceutical forms that were still protected by patent law at the time the human-use drug was put on the market should not be mentioned on the documents that accompany the human-use drug at the time of the market. The King may determine the terms and conditions for this purpose.
The conduct of the necessary studies, tests and tests to meet the conditions and conditions specified in paragraphs 1^er 7 and the resulting practical requirements are not considered to be contrary to patents and complementary protection certificates for human-use drugs.
§ 2. By derogation from Article 6, § 1^er, paragraph 3, and without prejudice to the legislation relating to the protection of industrial and commercial property, the applicant is not required to provide the results of preclinical and clinical trials if it can demonstrate that the active substances of the drug for human use have been of well-established medical use for at least ten years in the Community and have recognized effectiveness and an acceptable level of safety under the conditions established by the King. In this case, the results of these tests are replaced by appropriate bibliographical scientific documentation.
§ 3. With respect to a human-use drug containing active substances in the composition of authorized human-use drugs but which have not yet been associated for a therapeutic purpose, the results of new preclinical and clinical trials related to the association of these substances are provided in accordance with Article 6, § 1^er, paragraph 3, without the need to provide scientific documentation for each individual active substance.
§ 4. After the granting of the marketing authorization for a human-use drug, the holder of this marketing authorization may consent to the use of documentation on pharmaceutical, preclinical and clinical trials on the human-use drug record for the review of a subsequent application for another human-use drug with the same qualitative and quantitative composition in active and quantitative substances.
§ 5. When an amendment to the classification of a human-use drug referred to in Article 6, § 1^erbis, was authorized on the basis of significant preclinical or clinical trials, it is not referred to the results of these tests when examining an application from another applicant or holder of a marketing authorization or registration to amend the classification of a drug for human use on the basis of the same substance for a period of one year after the authorization of that first modification.
§ 6. By derogation from Article 6, § 1^er, paragraph 3, and without prejudice to the legislation relating to the protection of industrial and commercial property, the applicant for an authorization to market a veterinary drug is not required to provide the results of the safety tests and studies of residues or pre-clinical and clinical tests if the applicant can demonstrate that the veterinary drug is a generic of a reference drug for veterinary use that is or has been^erfor at least eight years in Belgium or another Member State.
A generic veterinary drug authorized under this provision may not be marketed before the end of the ten-year period following the authorization to market the reference drug for veterinary use.
Paragraph 1^er is also applicable where the reference drug for veterinary use is not permitted in Belgium. In such a case, the applicant must mention in the application form the Member State where the reference drug for veterinary use is or has been authorized. In such cases, the Minister or his delegate requests the competent authorities of the Member State to whom reference is made in the application form to send him a confirmation that the reference drug for veterinary use is or has been authorized in that Member State, as well as the complete composition of the reference drug for veterinary use and, if necessary, any other relevant documentation. At the request of the competent authorities of another Member State where an application for market authorization is filed for a generic veterinary drug that refers to a reference drug for veterinary use for which a marketing authorization is or has been issued in Belgium, the Minister or his or her delegate sends to these authorities, within one month, a confirmation that the reference drug for veterinary use is or has been authorized, accompanied by its complete composition and
For veterinary drugs that are intended for target species determined by the King, the period referred to in paragraph 2 is, however, extended to 13 years.
For the purposes of this paragraph:
- "Veterinary reference drug": a veterinary drug authorized in accordance with Article 6, § 1^er;
- "general medicine for veterinary use": a veterinary drug that has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference drug for veterinary use and whose bioequivalence with the reference drug for veterinary use has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of issomers, complex or derived from an active substance are considered to be the same active substance, unless they have substantially different properties in terms of safety and/or efficiency. In this case, additional information intended to demonstrate the safety and/or effectiveness of the various salts, esters or derivatives of an authorized active substance must be provided by the applicant. Oral pharmaceutical forms with immediate release are considered to be the same pharmaceutical form. The applicant may be exempted from bioavailability studies if it can prove that the generic drug meets the relevant criteria set out in the applicable detailed guidelines and set by the King.
When the drug for veterinary use does not meet the definition of the generic drug for veterinary use contained in the previous paragraph, second dash, or where bioequivalence cannot be demonstrated through bioavailability studies or in the event of changes in the clinical or active substances, therapeutic indications, dosage, pharmaceutical form or route of administration in relation to those of the reference drug for veterinary use, the results of the tests
Where a veterinary biologic drug that is similar to a veterinary reference biological drug does not meet the conditions in the definition of a veterinary generic drug, in particular due to differences in the raw material or differences in the manufacturing processes of the veterinary biological drug and the reference biological drug for veterinary use, the results of appropriate pre-clinical or clinical trials related to these conditions must be provided. The type and quantity of the additional data to be provided must meet the relevant criteria as set by the King on the basis of Article 6, § 1^erParagraph 3. The results of other tests in the veterinary reference drug folder should not be provided.
For veterinary medicines intended for one or more food-producing species and containing a new active substance that, as of 30 April 2004, has not yet been authorized in the Community, the ten-year period provided for in paragraph 2 is extended by one year for each extension of the marketing authorization to another food-producing animal species, if authorized within five years of the original market authorization.
However, this period may not exceed 13 years in total, for a marketing authorization for four or more food-producing species.
The extension of the ten-year period to eleven, twelve or thirteen years for a veterinary drug intended for a food-producing species is granted only provided that the holder of the marketing authorization has also been at the origin of a request for maximum residue limits for the species covered by the marketing authorization.
The King may, with respect to the application of the preceding provisions of this paragraph, establish more precise conditions and terms.
For veterinary drug marketing authorizations granted under the preceding provisions, indications, pharmaceutical forms or target species that were still protected by patent law at the time the veterinary drug was put 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.
The conduct of the studies, tests and tests required to meet the conditions and conditions set out in paragraphs 1 to 10 of this paragraph and the practical requirements resulting therefrom are not considered to be contrary to the patents and complementary certificates of protection for veterinary medicines.
§ 7. By derogation from Article 6, § 1^er, paragraph 3, and without prejudice to the legislation relating to the protection of industrial and commercial property, the applicant is not required to provide the results of safety tests and residue analyses, or pre-clinical and clinical tests if the applicant can demonstrate that the active substances of the veterinary drug are of a well-established use for at least ten years in the Community in veterinary medicine in accordance with a recognized level of safety as well
In this case, the results of these tests are replaced by an appropriate scientific bibliography.
The assessment report published by the European Agency following the assessment of a request for maximum residue limit fixing under the Regulations (EEC) No. 2377/90 above can be used appropriately as a scientific bibliography, especially in place of safety test results.
If an applicant uses bibliographic scientific documentation to obtain a marketing authorization for a food-producing species and submits, for the same veterinary drug, for the purpose of obtaining a marketing authorization for another food-producing species, new residue studies in accordance with the regulations (EEC) No. 2377/90 as well as new clinical trials, a third party may not use these studies and tests under § 6 for a period of three years after the granting of the marketing authorization for which they were carried out.
§ 8. In the case of veterinary medicines containing active substances entering the composition of authorized veterinary medicines, but which have not yet been associated for a therapeutic purpose, the results of safety tests and residue analyses and, if necessary, new preclinical and clinical tests related to this composition must be provided in accordance with Article 6, § 1^er, paragraph 3, without the need to provide scientific documentation for each individual active substance.
§ 9. After the granting of the marketing authorization, the licensee of this authorization may consent to the use of documentation on pharmaceutical, safety, residue analysis, preclinical and clinical trials on the record of the veterinary drug for the purpose of examining a subsequent application for a veterinary drug that has the same qualitative and quantitative composition in active substances.
§ 10. By derogation from Article 6, § 1^er, paragraph 3, and in exceptional circumstances involving immunological drugs for veterinary use, the applicant is not required to provide the results of certain field tests for the species of destination if they cannot be carried out for duly justified reasons, particularly as a result of community provisions.
§ 11. In addition, pursuant to Article 3.3 of Regulation No. 726/2004 referred to above, a marketing authorization may be granted for a generic drug of a reference drug authorized by the European Commission under the same conditions as those provided for in §§ 1^er and 6, if:
- the summary of the characteristics of the product conforms, on all relevant points, to that of the drug authorized by the European Commission, except in case of application of the provisions provided for in § 1^erparagraphs 10 and 6, paragraph 12;
- the generic drug is authorized under the same name in all Member States where the application is submitted. For the purposes of this provision, all language versions of the international common name ("CI") are considered to be the same name. "
Art. 10. In article 6ter of the same law, inserted by the law of June 21, 1983, the words "big distributors, wholesalers-retributors, exporters" are inserted in § 1^er, introductory sentence, between the words "builders" and the words "and importers".
Art. 11. Section 6quater of the Act, repealed by the Act of 10 August 2001, is reinstated in the following wording:
"Art. 6quater. § 1^er. By derogation from the provisions of Article 6, § 1^er, drugs for human use for which no marketing authorization or registration has been granted or those not yet marketed in Belgium, may be made available to patients in the following cases:
1°) In order to meet special needs and where the patient cannot be adequately treated with the medicines authorized and available in Belgium, the King may exclude from one or more provisions of this Act the medications provided to respond to an order made in good faith by a prescriber. These drugs are prepared according to its specifications on the basis of a written request for a group of patients or on the basis of a prescription for a specified patient. They are intended for the use of patients who fall under their direct personal responsibility. The King sets the conditions and modalities for this purpose.
2°) The King may also set rules to make available medicines for human use for compassionate use within the meaning of Rule 83 (EC) No. 726/2004 above.
3°) The King may also determine the conditions and conditions under which medications for human use can be made available in the event of emergency medical programs.
"Emergency medical programs" means the provision of a human-use drug to meet medical needs for patients with chronic disease, a disease that severely weakens health or a disease that poses a threat to life, and cannot be treated satisfactorily by means of a drug that is in commerce and is authorized to treat this condition. The drug for human use concerned must have been licensed to market but the indication for the treatment of this condition is not permitted, however, or the drug for human use is not yet on the market with this permitted indication.
In addition, an emergency medical program can only be applied for the human-use drug for the treatment of the affected condition:
- if an application for marketing authorization is being examined for this indication, or
- if the marketing authorization for this indication is granted but the drug for human use is not yet marketed with this indication, or
- if clinical trials are still underway or clinical trials have been conducted demonstrating the relevance of the use of the human-use drug for the treatment of the affected condition.
At the written request of a physician who begins the treatment of a patient under his or her personal responsibility, the holder of an authorization to market the drug for human use may make this medication available in accordance with an emergency medical program established by him or her.
4°) In order to enforce a prescription, a person authorized to issue medications to the public, may, where there is no marketing authorization or registration in Belgium for a drug of the same qualitative and quantitative composition in active substances and the same pharmaceutical form and when the prescriber declares that the patient cannot be adequately treated with drugs authorized at that time in Belgium, import a drug for human use that is authorized in the country. The King sets the conditions and modalities for this purpose.
5°) In order to combat the suspected or confirmed spread of pathogens, toxins, chemical agents or nuclear radiation, which may cause damage, the Minister or his delegate may temporarily authorize the distribution of unauthorized drugs. The King sets the terms and conditions, particularly with regard to the respective responsibility of the parties concerned.
The provision of drugs for human use by the holder/applicant of the marketing authorization in accordance with the conditions and terms referred to in paragraphs 2°) and 3°) does not fall under the scope of sections 10 and 12.
§ 2. By derogation from the provisions of Article 6, § 1^er, unauthorised or unregistered veterinary drugs in Belgium may be used for the treatment of animals in the following cases:
1°) immunological drugs for non-inactivated veterinary use made from pathogenic organisms and antigens obtained from an animal or animals of the same livestock and used for the treatment of that animal or animals of that animal in the same locality. The King sets out the conditions and modalities for this purpose.
2°) Veterinary drugs exclusively for animals that the King designates, provided that these drugs do not contain substances whose use requires veterinary control and that all measures are taken to avoid unauthorized use of these drugs for other animals. The King sets out the conditions and modalities for this purpose.
3°) where the health situation requires, the Minister or his delegate may authorize the marketing or administration of drugs for veterinary use authorized in another Member State. The King sets the conditions and terms for this purpose.
4°) in the event of serious epizootic diseases, the Minister or his delegate may temporarily permit the use of immunological drugs for veterinary use without market authorization, in the absence of suitable permitted drugs. The King sets the conditions and terms for this purpose.
5°) in the event that an animal is imported or exported from or to a third country, and thus subject to specific mandatory sanitary provisions, the Minister or his delegate may permit the use, for that animal, of an immunological drug for veterinary use that does not have an authorization to market in Belgium but authorized under the legislation of the third country concerned. The King sets out the conditions and conditions for the control of the importation and use of such an immunological drug for veterinary use.
6°) if there are no licensed veterinary medicines for a condition that in the animals concerned cause unacceptable suffering, the veterinary doctor may, on an exceptional basis, treat these animals with drugs for which a marketing authorization or registration has not been granted. The King sets out the conditions and modalities for this purpose.
7°) veterinary physicians from another Member State service providers in Belgium, may carry veterinary medicines in small quantities, not exceeding daily and other needs than veterinary immunological drugs for which there is no authorization to market or register in Belgium and administer them to animals. The King sets the conditions and modalities for this purpose.
§ 3. A marketing authorization or registration is not required to:
1°) the medicines prepared in pharmacy according to a prescription intended for a patient or a specified animal/animal(s), commonly referred to as magistrale preparation;
2°) drugs prepared in pharmacy according to the indications of a pharmacopoeia or the Magistral Therapeutic Form and intended to be delivered directly to patients or end-users supplied by this pharmacy, commonly referred to as an official preparation;
3°) the human-use experimental drugs referred to in the Act of 7 May 2004 relating to human person experiments and experimental veterinary medicines;
(4) intermediate products for further processing by an authorized manufacturer;
5°) radionuclides used in sealed form, as well as veterinary medicines based on radioactive isotopes;
6°) total blood, plasma, cells or tissues of human or animal origin, except for plasma, cells and tissues in the production or treatment of which an industrial process occurs;
7°) Inactivated veterinary immunological drugs made from pathogenic organisms and antigens obtained from an animal or animal of the same livestock and used for the treatment of that animal or animal in the same locality;
(8) Radiopharmaceutical drugs prepared at the time of employment by a person or institution authorized to use these drugs, in accordance with the manufacturer's instructions, in a registered health centre and exclusively from radionuclides generators, radionuclides kits or authorized radionuclides precursors;
9°) the drug foods referred to in the Act of June 21, 1983 relating to animal medicines;
10°) additives to feed animals as referred to in the Royal Decree of 8 February 1999 concerning the trade and use of products intended for the feeding of animals;
The authorization provided for in article 12bis and 12ter is not required for the products provided for in points 1°), 2°), 5°), 6°, 7°), 8°), 9° and 10°).
The King may take specific measures regarding the products mentioned in this paragraph. »
Art. 12. Section 6quinquies of the Act, inserted by the Act of 20 October 1998, is replaced as follows:
"Art. 6quinquies. - The King may, by order deliberately in the Council of Ministers, establish the conditions and conditions under which clinical trials may be conducted with veterinary drugs.
These conditions and conditions are more specific to consumer protection, the objective of clinical trials, the persons responsible for conducting these trials, the communication of data and reports on clinical trials, and the adverse effects observed during clinical trials, as well as the quality of the experimental drug.
If it is found that these conditions and terms are not met, the Minister or his or her delegate may prohibit or suspend the continuation of clinical trials. »
Art. 13. In the same law, an article 6sexies is inserted as follows:
"Art. 6sexies. - The King may, by order deliberately in the Council of Ministers, set out the conditions and terms under which the Directorate General Medicines to the Federal Public Service Public Health, Food Chain Safety and Environment, shall give scientific or technical advice on the research and development of a drug for the possible introduction of an application for marketing authorization or the registration of a drug or application for modification of a drug. It determines the conditions, deadlines and terms of the procedure for the processing of requests for such notices and the conditions for obtaining such notices. »
Art. 14. In the same law, an article 6septic is inserted, which reads as follows:
"Art. 6s. - Data provided in Article 6, § 1^erquinquies, which are mentioned in the notice, on the outer packaging or primary packaging if the outer packaging fails, and on the labelling of each drug that is placed on the market, must be written in the three national languages. This does not preclude such data being also written in other languages, provided that the same information is included in all the languages used.
This data shall be in accordance with the data approved when the marketing or registration authorization is granted, or subsequently. With respect to the data mentioned in the summary of the characteristics of the product and in the notice, an exemption is possible in the case of application of the provisions provided for in Article 6bis, § 1^erParagraph 10, paragraph 6, paragraph 12.
The holder of the marketing authorization or registration of a drug for human use makes the notice available, upon request from patient organizations, in appropriate formats for blind and visually impaired persons. The King may determine the execution modalities.
The inclusion of a notice in the packaging of any medication that is on the market is mandatory unless all required information is directly on the outside packaging or on the primary packaging.
If the packaging or presentation of a drug is modified or divided, below referred to as fractionation, by persons authorized under section 12bis, § 1^er, paragraphs 3 and 4, they shall ensure that, in the case of direct delivery or supply to the patient or animal manager, a copy of the notice is issued or provided with the medication.
The name of the medication for human use must also be in Braille on the outer packaging or, if not external packaging, on the primary packaging. The King may determine the cases in which the dosage and pharmaceutical form of the drug for human use must also appear in braille on the outer packaging or, if not external packaging, on the primary packaging.
Where the drug is not intended to be provided directly to the patient or animal care provider but only to be administered by health care professionals, the Minister or his or her delegate may exempt from the requirement to include certain labelling and notices and to prepare the relevant medication record in the three official languages.
In the case of certain orphan drugs for human use, this information may be written in one of the official languages of the European Community, on the basis of a decision of the European Commission. »
Art. 15. Section 7 of the Act, as amended by the Act of 20 October 1998, is replaced by the following provision:
“Art. 7. § 1^er. The King may prohibit the issuance of medication and remove the drug from the market when he considers, on the advice of the Commission concerned under Article 6, § 1^erParagraph 11:
- the drug is harmful under normal conditions of use or;
- the therapeutic effect of the drug is lacking or;
- the profit/risk ratio is not favourable under the permitted conditions of employment or
- the drug does not have the declared qualitative or quantitative composition or
- controls on the drug itself and/or on the intermediate substances and products of the manufacture have not been carried out or where another requirement or obligation relating to the granting of the manufacturing authorization has not been met or;
- with respect to a veterinary drug, the waiting time indicated is insufficient to ensure that foodstuffs from the treated animal do not contain residues that may pose a danger to the health of the consumer.
It also determines the time limit for the drug to be removed from the market.
It may limit the prohibition to the only batches of manufacture being contested.
If the prohibition concerns a particular substance, the prohibition may extend to all drugs with this particular substance and/or its derivatives.
§ 2. With respect to the use of immunological drugs for veterinary use for the control or eradication of an animal disease, the Minister or his delegate may prohibit the manufacture, importation, detention, sale, delivery, supply, delivery and/or use of immunological drugs for veterinary use in all or part of his territory, if it is determined that:
- the administration of the drug to animals interferes with a program for the diagnosis, control or eradication of an animal disease or would cause difficulties in certifying the absence of contamination of living animals or foods or other products obtained from treated animals;
- the disease against which the drug is supposed to confer immunity, is largely absent from the territory in question. »
Art. 16. Article 7bis, § 1^er, of the same law, inserted by the law of 10 July 1997, the words "Royal Decree No. 78 of 10 November 1967 concerning the exercise of the art of healing, of the nursing art, of the paramedical professions and of the medical commissions" are replaced by the words "Royal Decree No. 78 of 10 November 1967 on the exercise of the professions of health care" and the words "Department of Public Affairs"
Art. 17. Section 8 of the Act, as amended by the Act of 20 October 1998, is replaced by the following provision:
“Art. 8. - In the event of an emergency, the Minister or his or her delegate may suspend the delivery or supply of a drug if he or she considers that:
- the drug is harmful under normal conditions of use or;
- the therapeutic effect of the medication is missing or
- the profit/risk ratio is not favourable under the permitted conditions of employment or
- the drug does not have the declared qualitative or quantitative composition or
- controls on the drug itself and/or on the intermediate substances and products of the manufacture have not been carried out or where another requirement or obligation relating to the granting of the manufacturing authorization has not been met or
- with respect to a veterinary drug, the waiting time indicated is insufficient to ensure that foodstuffs from the treated animal do not contain residues that may pose a danger to the health of the consumer.
The Minister or his or her delegate also determines the time limit for the drug to be removed from the market.
It may limit the suspension to the only batches of manufacture being contested.
If the suspension concerns a particular substance, the suspension may extend to all medications with this particular substance and/or its derivatives. »
Art. 18. In the same law, an article 8bis is inserted:
"Art. 8bis. - The Minister or his delegate suspends, removes or amends the marketing authorization or registration of a drug if he considers that:
- this medication is harmful under normal conditions of use or
- the therapeutic effect of this medication is missing or
- the profit/risk ratio is not favourable under normal conditions of employment or
- this medication does not have the declared qualitative or quantitative composition or
- controls on the drug itself and/or on the intermediate substances and products of the manufacture have not been carried out or where another requirement or obligation relating to the granting of the manufacturing authorization has not been met or
- the information in the file for obtaining a marketing authorization or registration is incorrect or has not been communicated or modified as required by the application of Article 6, § 1^erquater, or
- in the case of a veterinary drug, the waiting time is insufficient to ensure that foodstuffs from the treated animal do not contain residues that may pose a danger to the health of the consumer or
- the veterinary drug is submitted for prohibited use in other areas under community law.
Before proceeding with these measures, the holder of the marketing or registration authorization shall be informed by the Minister or his or her delegate of this intention and may, either on the initiative of the Minister or his or her delegate, or on his or her own initiative, be heard by the relevant Commission referred to in Article 6, § 1^erParagraph 11.
The King may determine the terms and conditions of application for this provision. »
Art. 19. In section 9 of the Act, replaced by the Act of 21 June 1983, the following amendments are made:
1°) In § 1^erParagraph 1^er, the words ", for which a marketing authorization has not been granted" are inserted between the words "who is not registered" and the words "or who has been the subject" and the words ", 7bis and 8bis" are inserted after the words "articles 7 and 8";
2°) § 1^er, paragraph 2, is supplemented as follows:
"Any public advertisement for drugs that contain psychotropic or narcotic substances within the meaning of international conventions is also prohibited. »;
§ 1^er is supplemented by the following paragraphs:
"However, the advertising prohibition referred to in the preceding paragraph does not apply to vaccination campaigns conducted by the licensees referred to in sections 12bis and 12ter and previously approved by the Minister or his or her delegate, or to public interest campaigns approved by the Minister or his or her delegate.
Direct distribution by the drug industry to the public for promotional purposes is also prohibited.
"Advertisement for medications" means any form of information, prospecting or incentive that aims to promote prescription, issuance, supply, sale or consumption of drugs. The King may determine more specific rules relating to acts that are considered to be advertising.
Not covered by the term "advertising for drugs":
- the notice and labelling referred to in Article 6septics;
- correspondence, if any, with any non-advertising document, necessary to answer a specific question about a particular drug;
- the specific information and reference documents relating, for example, to changes in packagings, warnings of adverse effects in the context of pharmacovigilance, as well as to sales catalogues and price lists, provided that there is no information on the drug;
- information on health or human or animal diseases, provided there is no reference, even indirect, to a drug.
All elements of advertising made in respect of a drug must comply with the information in the summary of product characteristics.
Any advertisement made in respect of a drug must promote the rational use of this drug, by presenting it objectively and without exaggerating its properties, and cannot be misleading. »;
§ 2 is supplemented by the following paragraphs:
"With respect to radio and television advertising for drugs for human use, these measures can be based on a screening system. The King shall establish an Advertising Control Board for Human Medicines, which is responsible for providing advice to the Minister or his or her delegate on the granting of a visa. It sets out missions, composition and operation. The King also sets out the conditions, deadlines and terms of the procedure for reviewing visa applications, as well as the conditions for obtaining a visa.
Any person with a legitimate interest may file a complaint with the Minister or his or her delegate against an advertisement contrary to the provisions of this Act or its enforcement orders.
The Minister or his or her delegate may, if he or she considers it necessary to protect the general interest:
- order the termination of an advertisement contrary to the provisions of this Act or its enforcement orders,
- prohibit the advertisement under the previous dash if it has not yet been made known to the public but its publication is imminent,
even in the absence of evidence of a real loss or injury, or of the intention or negligence on the part of the advertiser.
In addition, the Minister or his or her delegate may, with a view to eliminating the persistent effects of an advertisement whose 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.
If the measures referred to in paragraphs 4 and 5 relate to radio and television advertising for human-use drugs, the Minister shall take these measures on the advice of the Advertising Control Board for Human-Use Drugs.
Before proceeding with the measures referred to in paragraphs 4 and 5, the advertiser shall be informed by the Minister or his or her delegate of that intention and may, either on the initiative of the Minister or his or her delegate, be heard by the Minister or his or her delegate and, in the cases referred to in the preceding paragraph, by the Advertising Control Board for Human Drugs. »
Art. 20. In the same law, an article 12bis is inserted as follows:
"Art. 12bis. § 1^er. The manufacture of medicines or intermediate products in Belgian territory is subject to authorization. This authorization is also required if the drug is manufactured for export. The Minister or his or her delegate shall grant authorization, possibly on the advice of the Consultative Commission. The King sets out the cases, conditions and modalities under which the Commission must be consulted. The King also sets out the composition and functioning of the Consultative Commission.
Authorization is required for both total or partial manufacturing and for division, conditioning or presentation operations.
However, this authorization is not required for preparations and splitting to the extent that these operations are carried out, solely for the purpose of providing in detail, by persons authorized to issue drugs to the public. Such persons may delegate these transactions either to other persons authorized to issue medications to the public or to a licensee referred to in this section. The King shall determine the terms and conditions for this purpose.
The authorization is also not required for splitting to the extent that these operations are carried out solely for the purpose of providing in detail by persons authorized to provide drugs to animal officials. The King shall determine the terms and conditions for this purpose.
Authorization is required for imports from third countries. For the importation of batches of medicines from third countries with which the European Community has entered into appropriate agreements to ensure that the manufacturer of the drug applies rules of good manufacturing practices at least equivalent to those prescribed by Community law, the King may set the conditions and conditions under which control reports concerning these lots are recognized. The King also sets the applicable conditions and terms if the batches of medicines are from another Member State.
For certain specific categories of medicines it designates, the King may impose additional conditions due to the nature of these drugs.
A copy of the permits issued is transmitted to the European Agency.
Certificates of good manufacturing practices are also transmitted to the European Agency. If the results of an inspection result in the conclusion that the principles and guidelines of good practices that must be respected in the manufacture of drugs are not, this information is also transmitted to the European Agency.
The King sets out the conditions, deadlines and terms of the procedure for reviewing applications for authorization, as well as the conditions for obtaining an authorization referred to in this section. It also takes the necessary measures to protect public health regarding the manufacture, import and export of drugs. It sets the content of the application and may determine the form in which the application must be filed. The King may also set rules on the admissibility of an application.
The Minister or his or her delegate only authorizes an investigation that the information provided is accurate. The authorization is valid only for premises indicated in the authorization, as well as for medicines and pharmaceutical forms for which the authorization was requested and granted. Authorization may be accompanied, in order to ensure compliance with all conditions, with certain obligations imposed either on the occasion of granting or after granting.
The King sets out the principles and guidelines for good drug manufacturing practices. These principles and guidelines also apply to the manufacture of raw materials that are used as active substances and may also be declared applicable to excipients to be determined by the King.
The King also sets out the conditions and conditions to which holders of an authorization to manufacture or import drugs are required in the exercise of their authorized activities.
In the event of non-compliance with the requirements of this Act or its enforcement orders, the Minister or his or her delegate may, in whole or in part, suspend or withdraw the authorization.
Before proceeding with these measures, the licensee shall be informed by the Minister or his or her delegate of this intention and may, either at the initiative of the Minister or his or her delegate on his or her own initiative, be heard by the Advisory Board.
§ 2. Drugs intended solely for export to third countries that are not members of the European Union or are not part of the European Economic Area and are not placed on the Belgian market, are not subject to market authorization or registration. The King sets out the conditions and conditions under which these drugs can be exported.
If a drug has obtained a marketing authorization or registration and this drug is intended exclusively for export to third countries, it is derogated from the provisions of Article 6, § 1^erter, paragraphs 4 and 5, upon request of the licensee of the authorization or registration. "
Art. 21. In the same Act, an article 12ter is inserted, as follows:
"Art. 12ter. - For the wholesale distribution of medications an authorization is required. The Minister or his or her delegate shall grant authorization, possibly on the advice of the Advisory Board referred to in section 12bis. The King shall determine the conditions, cases and modalities in which the Commission shall be consulted.
Wholesale distribution activities can only take place if the drug is covered by a marketing authorization or a registration granted either by the Minister or his delegate or by the European Commission. The King may provide for exceptions for cases in which, according to Community law of unauthorized veterinary drugs may be used for the treatment of animals.
Any wholesale distributor, other than the licensee of the marketing or registration authorization, which simultaneously imports a drug from another Member State notifies its intention to import this drug for the purpose of placing it on the market in Belgium to the licensee of the marketing or registration authorization and to the Minister or its delegate. The King sets out the conditions and modalities to which this parallel import must satisfy.
The King sets out the conditions, deadlines and terms of the procedure for reviewing applications for authorization, as well as the conditions for obtaining an authorization referred to in this section. It also takes the necessary measures to protect public health. It sets the content of the application and may determine the form in which the application must be filed. The King may also set the rules on the admissibility of an application.
The Minister or his or her delegate only authorizes after an investigation has ascertained that the information provided is accurate. The authorization is valid only for premises indicated in the authorization, as well as for medicines and pharmaceutical forms for which the authorization was requested and granted. Authorization may be accompanied, in order to ensure compliance with all conditions, with certain obligations imposed either on the occasion of granting or after granting.
The possession of an authorization for the manufacture of drugs for human use carries the same as the wholesale distribution of the human-use medications involved in this authorization.
Wholesale distribution authorization is not required for trade by persons authorized to issue drugs to the public or to provide drugs to animal officials. The quality of wholesale distributor and wholesaler - drug dispatcher is incompatible with that of a person authorized to deliver drugs to the public or of a person authorized to provide drugs to animal officials.
The obligation to hold a wholesale drug distribution authorization is not required for the delivery of small amounts of medicines by a person authorized to deliver drugs to the public to a person authorized to provide drugs to animal officials.
Licensees for the wholesale distribution of medicines may only deliver drugs to other licensees or to persons who are authorized to deliver drugs to the public or to provide drugs to animal officials, in accordance with the conditions and conditions established by the King.
The King determines the conditions and conditions under which certain public service obligations may be imposed on holders of a wholesale distribution of drugs.
The King also sets out the conditions and modalities for which holders of a wholesale distribution of drugs are required in the exercise of their authorized activities.
The King may set the principles and guidelines for good drug distribution practices.
The licensee of the wholesale distribution of drugs must be established in a Member State.
In the event of non-compliance with the requirements of this Act or its enforcement orders, the Minister or his or her delegate may, in whole or in part, suspend or withdraw the authorization. Suspension and withdrawal data are provided to the European Commission and the member States concerned.
Before proceeding with these measures, the licensee shall be informed by the Minister or his or her delegate of this intention and may, either at the initiative of the Minister or his or her delegate, on his or her own initiative, be heard by the Consultative Commission referred to in section 12bis. »
Art. 22. In the same Act, an article 12quater is inserted, as follows:
"Art. 12quater. - Articles 12bis and 12ter do not apply to individuals and end-users who bring or send from another Member State a small amount of medicine for their personal therapeutic use. The King sets the conditions and terms for this purpose. »
Art. 23. In the same law, an article 12quinquies is inserted, as follows:
"Art. 12quinquies. - The holders of the marketing authorization of a drug and, once the drug is put on the market, the wholesale distributors of the drug, effectively provide, within their respective responsibility, an appropriate and ongoing supply of the drug to persons authorized to deliver or provide drugs, in order to cover the needs of patients or animals.
For reasons of public health protection, the King may, for the purposes of this provision, determine more precise terms and conditions. »
Art. 24. In the same law, an article 12sexies is inserted, as follows:
"Art. 12sexies. - To ensure the adoption of appropriate and harmonized regulatory decisions in the European Community concerning authorized or registered drugs, given the information gathered on the adverse effects of drugs under normal conditions of use, a pharmacovigilance system is implemented. This system is used to collect useful information for the monitoring of drugs, including their adverse effects on humans and animals, and to scientifically evaluate this information. The King sets out the terms and conditions under which this information must be communicated by the holders of a marketing authorization or registration. It may also set out the terms for the exchange of information relating to pharmacovigilance in the Community.
The relevant information collected using this system is transmitted by the Minister or his delegate to the other Member States and to the European Agency and, where applicable, to the holders of a marketing authorization or registration.
With respect to human-use drugs, this system also takes into account any information available on cases of misuse and abuse of human-use drugs that may affect the assessment of their risks and benefits. This information is linked to any available data regarding the sale, use and prescription of human-use drugs.
For veterinary medicines, this information is linked to the available data on the sale, use and prescription of veterinary drugs. This system also takes into account all available information on the lower effectiveness of veterinary drugs compared to the expected effectiveness, their use "out-of-CP" and the studies conducted to determine the validity of the waiting time and the potential risks to the environment, as a result of the use of the veterinary drug, to the extent that they may have an impact on the assessment of their risks and benefits.
The King takes the necessary steps to organize the pharmacovigilance system within the competent authority and to ensure that its operation is under the permanent control of the competent authorities. It may also impose specific requirements on health care professionals and veterinary medicine, with regard to the notification of alleged serious or unexpected adverse effects.
The holder of a marketing authorization or registration may not communicate to the general public or health care professionals, on his or her authorized or registered drug, information relating to pharmacovigilance without prior or simultaneous notification to the Minister or his or her delegate.
In any event, the licensee of the marketing or registration authorization shall present this information objectively and not misleadingly. »
Art. 25. In the same law, an article 12septic is inserted as follows:
"Art. 12s. - The King may, in the interest of public health, take all other necessary measures relating to the import, export, manufacture, preparation, packaging, presentation, denomination, contenance, labelling of packagings, detention, conservation, transport, distribution, offer for sale, sale, sale, assignment in an expensive or free capacity, delivery, prescription, administration of medicines and delivery, »
Art. 26. Section 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 Act of 27 December 2004, are amended as follows:
1°) in § 1^er, the word "registration" is replaced by the words "market and registration authorization", the word "can" is replaced by the word "may" and the words "and a surety" are deleted;
2°) in § 2, first sentence, the word "taxation" is replaced by the words "retribution and a provision", and in the second sentence the words "and a provision" are added after the word "retribution";
§ 2 is supplemented by the following paragraph:
"The provision referred to in paragraph 1^er is an advance on contributions due. »;
4°) a § 2ter is inserted, as follows:
§ 2ter. For certain specific categories of medicines that He designates, the King may determine the cases in which and the conditions and conditions under which it may be granted exemptions, reductions or deferrals of payment with respect to the retributions established under the provisions of §§ 1^er and 2. The King may also determine that in such cases administrative assistance is provided. »;
5°) in § 3, the words “§§ 1^er, 2 and 2bis are replaced by the words “§§ 1^er, 2, 2bis and 2ter and the words "missions" are replaced by the words "missions referred to in these paragraphs".
Art. 27. In Article 14, § 2, of the Act, replaced by the Act of 22 December 2003, the following amendments are made:
1°) In point 1°, paragraph 1^er, the word ", assigned" is inserted between the words "delivered" and "unless";
2°) in the Dutch text of point 2°, b), the word " verklaring" is replaced by the word " verhoor";
3°) in the Dutch text of point 2°, c), the words " die gegevens kunnen bevatten" are inserted between the words "informationatiedragers" and " die ingevolge de wetgeving";
4°) in the Dutch text 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, records, tapes or any other information material that they consider necessary for the exercise of surveillance," are inserted between the words "monitoring" and the words "and taking extracts thereof";
6°) in the Dutch text of point 2°, d), the word " die" is inserted between the words "of zich" and "kosteloos";
7°) in the French text of the same provision the words "others" are inserted between the words "all" and "books".
Art. 28. Article 14bis, § 3, paragraph 1^er, the same Act, inserted by the Act of 22 December 2003, is amended as follows:
1°) the words "to let take" are replaced by the words "to obtain";
2°) the words "of public institutions that depend on it, as well as of all public institutions that depend on it" are replaced by the words "and the public institutions that depend on it";
3°) the words "of which they have" are inserted between the words "all information" and the words ", as well as";
4°) the words "acts, coins and" are inserted between the words "all" and "books".
Art. 29. In the same law, an article 14ter is inserted as follows:
"Art. 14ter. - The King sets out the cases in which and how the conclusions of the inspections carried out by the competent authorities of other Member States can be recognized. »
Art. 30. In Article 15, § 2, of the same Law, as amended by the Act of 22 December 2003, the word "perished" is inserted between the words "corrupted, altered" and the words "or not in conformity with the provisions of this Law".
Art. 31. Article 16 §§ 1^er2, 3 and 4 of the Act, as amended by the Acts of 29 December 1990, 10 July 1997, 20 October 1998, 2 August 2002 and 22 December 2003, is replaced as follows:
« § 1^er. Is punished with a fine of EUR 1.25 to EUR 12.50:
(1) whoever contravenes the provisions of Article 2, paragraph 2, of Article 6, §§ 1^erquinquies and 1^ersexies, articles 6septies and 12septies with regard to the packaging, labelling and denomination of drugs, and article 6ter, § 1^erparagraph 3, or their enforcement orders;
2°) the person who buys, owns, sells, offers for sale, delivers, delivers, distributes, supplies, imports or exports of damaged, altered, perished, falsified or imitation drugs as well as drugs not in accordance with the provisions of this Act or its enforcement orders.
§ 2. shall be punished by imprisonment from eight days to one month and a fine of EUR 2.50 to EUR 25.00, or only one of these penalties, which contravenes the provisions of Article 3, § 1^erArticle 4, Article 6quinquies, Article 6ter, § 2, Article 11, Article 12, Article 13 or Article 13bis or their Implementing Orders.
§ 3. Is punished by imprisonment for a month to a year and a fine of EUR 5.00 to EUR 375.00 or only one of these penalties:
(1) whoever contravenes the provisions of Article 3, §§ 2, 3 or 4, of Article 6, §§ 1, 1^erbis, 1^erter, 1^erquater, 1^ersexies or 2, article 6bis, article 6ter, § 1^erParagraph 1^erarticle 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 decrees of execution, article 12quater, article 12quinquies or article 12sexies, or article 6^erquinquies, 6septies and 12septies or their enforcement orders as long as these activities are not covered by § 1^er of this article;
2°) the person who refuses, as well as the person who opposes visits, inspections, investigations, examinations, hearings, examinations of documents, taking samples, gatherings of evidence or seizures or others by members of the statutory or contractual personnel, as provided for in article 14 or in his or her enforcement orders;
3°) the person who has falsified or impersonated or has made falsify or imitate drugs that are intended to be sold, offered for sale, delivered, delivered, delivered, distributed, supplied, supplied, imported or exported;
4°) the person in whom are found drugs that are intended to be sold, offered for sale, delivered, delivered, delivered, distributed, supplied, supplied, imported or exported, and that sells them, offers for sale, delivers, delivers, distributes, supplies, imports or exports knowing that they are altered, altered, perished, falsified, imitated or not in conformity with the provisions of this Law
(5) the person who contravenes section 3, paragraph 1^erRegulation (EC) No. 726/2004 referred to above, puts on the market a drug referred to in the Schedule to this Regulation without an authorization to market under this Regulation.
§ 4. A penalty of three months to five years ' imprisonment and a fine of EUR 25.00 to EUR 2.500.00 or one of these penalties only, which contravenes the provisions of the Orders made pursuant to this Act concerning drugs that contain soporific, narcotic or psychotropic substances or substances that may be used for the illicit manufacture of narcotic or psychotropic substances that may engender dependency and a King ' s arrest. »
Art. 32. In section 17 of the Act, replaced by the Act of 20 October 1998 and amended by the Royal Decree of 22 February 2001 and by the Act of 22 December 2003, the following amendments are made:
1°) § 1^erParagraph 4 is replaced as follows:
"In the event of competitions of several offences, the amounts whose payment extinguishes the public action are accumulated, but they may not exceed the maximum of the fine punishing the offence for which the strongest fine is expected. »;
2°) between paragraphs 6 and 7, the following paragraphs shall be inserted:
"Where the offence of the provisions of this Act or its enforcement orders has resulted in analysis or expertise, the amount may be increased from the amount or part of the amount of such costs; the portion of the amount paid to cover these costs will be allocated to the organization or to the person who exposed them.
The person to whom the fine is proposed may, upon request, be a lawyer referred to in paragraph 1^er be aware of the file concerning the charge offence.
The proposed payment referred to in paragraph 1^er is sent to the offender within three months of the date of the report.
The employer is civilly responsible for the payment of the proposed fine to its employee."
3°) it is inserted a § 3 and § 4, written as follows:
“§3. The faculty provided by § 1^er cannot be exercised when the court is already seized of the fact or when the investigating judge is required to instruct.
§ 4. Any damage caused to others must be completely repaired before the possibility provided in § 1^er can be applied. However, the payment of the sum may still be proposed if the author has acknowledged in writing his civil liability for the fact that the damage is generated, and produces proof of compensation for the uncontested fraction of the damage and the terms and conditions of settlement of the damage. In any event, the victim may assert his rights before the competent court. In this case, the acceptance of the transaction by the author constitutes an irrefragable presumption of his fault. »
Art. 33. In article 19bis, § 2 of the same law, inserted by the law of 21 June 1983, and amended by the law of 22 December 2003, the words "50 francs" and the words "15 thousand francs" are replaced respectively by the words "1.25 EUR" and "375,00 EUR".
Art. 34. In the same law, an article 19ter is inserted, as follows:
"Art. 19ter. § 1^er. Each decision of the Minister or his or her delegate made under this Act or its enforcement orders shall be duly substantiated.
Without prejudice to the application of the Act of 11 April 1994 relating to the advertising of the administration, the decisions of the Minister or his delegate shall be notified to the interested parties with the indication of the possible means of claim or remedy provided for in this Act or its enforcement orders, and the time limit within which the appeal may be filed.
Decisions to issue or withdraw a marketing authorization or registration are made available to the public.
§ 2. Decisions for the granting, refusal or withdrawal of a marketing authorization or registration, as well as decisions for the cancellation of decisions for refusal or withdrawal of a marketing authorization or registration, and decisions for the prohibition of delivery and withdrawal of the market, as well as their reasons, 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 communicated to relevant international bodies with a copy addressed to the European Agency. »
Art. 35. In the same Act, an article 19quater is inserted, which reads as follows:
"Art. 19quater. § 1^er. All bodies or commissions established or recognized under this Act or its enforcement orders shall make available to the public their internal regulations, as well as the agenda of their meetings, the records of their meetings, including decisions taken, details of votes and explanations of vote, including minority opinions.
§ 2. Members of the Directorate General of Medicines with the Federal Public Service Public Health, Food and Environment Safety and external experts and members of the bodies and commissions referred to in § 1^er, may not have any financial or other interests in the pharmaceutical industry that may adversely affect their impartiality. These individuals make an annual statement of their financial or other interests. These statements are made available to the public. »
Art. 36. In the same law, an article 19quinquies is inserted, as follows:
"Art. 19quinquies. - Articles 6, 6bis, 6septies, 8bis and 12sexies are not applicable to drugs:
- not prepared industrially or
- that are manufactured using a method where no industrial process occurs. »
Art. 37. In the same law, an article 19sexies is inserted, as follows:
"Art. 19sexies. - The King may coordinate the provisions of this Act with the provisions which, explicitly or implicitly, have made amendments to it until the time of coordination.
To this end, He may:
- amend the order, numbering and presentation of the provisions to be coordinated;
- amend the references contained in the provisions to be coordinated to align them with the new numbering;
- to amend the drafting of the provisions to be coordinated with a view to ensuring their consistency and to unify the terminology, but without prejudice to the principles set out in these provisions.
The coordinated version will bear the following title:
"The Drugs Act, coordinated the...". »
CHAPTER III. - Amendments to the Act of June 21, 1983 relating to animal medicines
Art. 38. Article 1^er of the Act of 21 June 1983 on animal medicinal foods, replaced by the Royal Decree of 7 March 1995, point 2° is repealed.
Art. 39. In section 2 of the Act, the words "medicinal premixes and" are deleted.
Art. 40. In section 3, 1°, of the same law, the words "medicinal premixes and" are deleted.
Art. 41. Article 5, paragraph 1^er, of the same law, is repealed.
Art. 42. Section 6 of the Act is repealed.
Art. 43. In Article 8, paragraph 1^er, from the same law the words "drug premixes or" are deleted.
Art. 44. The following amendments are made to section 9 of the Act:
1° in paragraph 1^er, the words "medicinal premixes and" are deleted;
2° in paragraph 3, the words "Medicinal Premixes and" are deleted;
3° in paragraph 4, the words "medicinal premixes and" are deleted.
Art. 45. Article 11, § 1^erthe following amendments are made:
1° in point 4, (a), the words "a medicinal premix or" are deleted;
2° point 4, (b), is repealed.
Art. 46. In section 12 of the Act, as amended by the Royal Decree of 22 February 2001, the following amendments are made:
1° in § 1^er, the words "medication premixes and" are deleted;
2° in § 2, first and third sentences, the words "drug premixes and" are deleted;
3° in § 3, paragraph 1^er, the words "medication premixes and" are deleted;
4° in § 3, paragraph 2, the words "medicinal premixes and" are deleted;
5° in § 4, the words "medicinal premixes and" are deleted.
Art. 47. In section 13 of the Act, the words "medicinal premixes and" are deleted.
Art. 48. In article 14, paragraph 1^er, from the same law, the words "medicinal premixes or" are deleted.
CHAPTER IV. - Amendments to the Act of 28 August 1991 on the Exercise of Veterinary Medicine
Art. 49. In Chapter VI of the Act of 28 August 1991 on the Exercise of Veterinary Medicine, an article 27bis is inserted, as follows:
"Art. 27bis. § 1^er. In the event of a breach of the provisions of this Act, or of any order made pursuant to this Act, the public servant-law, designated by the King in the Federal Public Service Public Health, Safety of the Food Chain and Environment, may set an amount whose voluntary payment by the offender extinguishes public action. In the event of non-payment, as well as in the case where the grievor-law does not make any proposal for payment, the file will be forwarded to the King's Prosecutor.
An annual report outlining the outcome of the activities referred to in the previous paragraph is prepared.
The amount whose payment extinguishes the public action cannot be less than the minimum of the fine provided for the offence under the legal provision concerned, nor more than the maximum fixed.
In the event of a competition of several offences, the amounts whose payment extinguishes the public action are accumulated, although they may not exceed the maximum of the fine punishing the offence for which the strongest fine is expected.
In the event of recidivism within three years after payment of the sum that extinguishes the public action, established for violation of this Act and its enforcement orders, the sum may be doubled.
The amount of these sums is increased by additional decimals that are applicable to fines provided for in the Penal Code and increased, if applicable, by expertise.
Where the offence of the provisions of this Act or its enforcement orders has resulted in analysis or expertise, the amount may be increased from the amount or part of the amount of such costs; the portion of the amount paid to cover these costs will be allocated to the organization or to the person who exposed them.
The person to whom the fine is proposed may, upon request, be a lawyer referred to in paragraph 1^er be aware of the file concerning the charge offence.
The proposed payment referred to in paragraph 1^er is sent to the offender within three months of the date of the report.
The terms and conditions of payment shall be determined by the King and the other terms and conditions necessary for the execution of this article.
The employer is civilly responsible for the payment of the proposed fine to its employee.
§ 2. The faculty provided by § 1^er cannot be exercised when the court is already seized of the fact or when the investigating judge is required to instruct.
§ 3. Any damage caused to others must be completely repaired before the possibility provided in § 1^er can be applied. However, the payment of the sum may still be proposed if the author has acknowledged in writing his civil liability for the fact that the damage is generated, and produces proof of compensation for the uncontested fraction of the damage and the terms and conditions of settlement of the damage. In any event, the victim may assert his rights before the competent court. In this case, the acceptance of the transaction by the author constitutes an irrefragable presumption of his fault.
§ 4. This section does not apply to offences found pursuant to the Royal Decree of February 22, 2001, which organizes the controls carried out by the Federal Agency for the Safety of the Food Chain and amends various legal provisions. »
CHAPTER V. - Transitional measures
Art. 50. The King may, for drugs that are put on the market or for which a request for market authorization or registration is being processed on the day of the coming into force of this Act, provide for transitional measures with respect to the application of the provisions of this Act.
Promulgation of this law, let us order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given in Brussels, 1^er May 2006.
ALBERT
By the King:
Minister of Social Affairs and Public Health,
R. DEMOTTE
Seal of the state seal:
The Minister of Justice,
Ms. L. ONKELINX
____
Notes
Documents of the House of Representatives:
51-2189 - 2005/2006
No. 1: Bill
Number 2: Report
Number 3: Text corrected by commission
No. 4: Amendments
No. 5: Text adopted in plenary and transmitted to the Senate
Full report: 8 and 9 March 2006
Documents of the Senate:
3-1615 - 2005/2006
No. 1: Project referred to by the Senate
Number 2: Report
No. 3: Decision not to amend
Annales du Sénat : 30 mars 2006