belgiquelex.be - Carrefour Bank of Legislation

3 AOUT 2012. - An Act to amend the Drugs Act of March 25, 1964

ALBERT II, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
CHAPTER 1^er. - General provision
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
This Act transposes Directive 2010/84/EU of the European Parliament and the Council of 15 December 2010 amending the Directive 2001/83/EC establishing a Community Code on Human-Use Medicines and amending the Act of 25 March 1964 on Drugs.
CHAPTER 2. - Amendments to the Act of 25 March 1964
on drugs
Art. 2. Article 1^er§ 1^erof the Act of 25 March 1964 on Drugs, replaced by the Act of 1^er May 2006, the following amendments are made:
(a) to 10) the following modifications are made:
- the words "of a veterinary drug" are added after the words "adverse effect";
- the words " veterinary use" are inserted between the words "drug" and ", occurring";
- the words "human or" are repealed;
(b) a 10bis is inserted as follows:
"10bis "an adverse effect of a human drug":
a harmful and unintended reaction to a human drug; »;
(c) a 25bis is inserted as follows:
"25bis) "health care professionals":
persons subject to Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions; »;
(d) in the 33), the words "European Agency" are replaced by the word "EMA" in the title, and the words "European Medicines Agency" are inserted between the words "drugs" and the word ", instituted";
(e) the paragraph shall be supplemented by 42) to 52, as follows:
"42) "risk management system":
a set of pharmacovigilance activities and interventions designed to identify, describe, prevent or minimize the risks associated with a drug, including the assessment of the effectiveness of these activities and interventions;
43) "risk management plan":
a detailed description of the risk management system;
44) "Pharmavigilance System":
the system used by the licensee of the marketing or registration authorization and by the Member States in order to perform their duties and responsibilities in relation to pharmacovigilance, and which aims to monitor the safety of authorized or registered drugs and to identify any changes in their profit/risk relationship;
45) "permanent file of the pharmacovigilance system":
a detailed description of the pharmacovigilance system used by the holder of the marketing authorization or registration for one or more authorized or registered drugs, commonly referred to as "Pharmcovigilance system masterfile";
46) “European web portal”:
the European web portal on drugs, established under Article 26 of Regulation No. 726/2004;
47) "AFMPS":
the Federal Agency for Drugs and Health Products as established by the Act of 20 July 2006 on the establishment and operation of the Federal Agency for Drugs and Health Products;
48) Regulation No. 726/2004:
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 establishing community procedures for authorization and monitoring with regard to drugs for human use and veterinary use and establishing a European Medicines Agency and all subsequent amendments;
49) Regulation No. 1901/2006:
Regulation (EC) No. 1901/2006 of the European Parliament and Council of 12 December 2006 on pediatric drugs, amending Regulation (EEC) No. 1768/92, Directives 2001/20/EC and 2001/83/EC and Regulation (EC) No. 726/2004, and all subsequent amendments;
50) "Guideline 2001/20":
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the legislative, regulatory and administrative provisions of the Member States relating to the application of good clinical practices in the conduct of clinical trials of drugs for human use, and all subsequent amendments;
51) "Guideline 2001/82":
Directive 2001/82/EC of the European Parliament and the Council of 6 November 2001 establishing a Community Code on Veterinary Drugs and all its subsequent amendments;
52) “Guideline 2001/83”:
Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 establishing a Community Code on Human Drugs and all its subsequent amendments. "
Art. 3. § 1^er. Section 6 of the Act, amended by the Royal Decree of 8 August 1997 and the Acts of 12 August 2000, 30 December 2001, 22 December 2003, 1^er May 2006 and 24 July 2008, the following amendments are made:
1° in § 1^erParagraph 1^er, the words ", hereafter referred to as "AMM"," are inserted between the word "market" and the words "was not".
2° to § 1^erParagraph 9, the following amendments are made:
(a) in the first sentence, the word "may" is replaced by the word "may";
(b) the phrase "In special cases of community interest, the Minister or his or her delegate or the applicant or the 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 modification of the marketing or registration authorization. » is replaced by the sentence:
"In special cases of interest to the European Union, the Minister or his or her delegate or the applicant or holder of the MMA or of the registration shall refer to the Committee concerned in accordance with section 31 of Directive 2001/83 or section 35 of Directive 2001/82, so that the procedures referred to in sections 31 to 34 of Directive 2001/83 or sections 35 to 38 of Directive 2001/82 apply, »;
(c) in the fourth sentence, the words "assisted by the Standing Committee established by either Article 121 of Directive 2001/83/EC of 6 November 2001 establishing a Community Code for Human Use Medicines, or Article 89 of Directive 2001/82/EC of 6 November 2001 establishing a Community Code for Veterinary Drugs" are replaced by the words "in accordance with Article 34 of Directive 2001/82 words or Article 38
3° in § 1^erbis, paragraphs 9-12 are repealed;
4° in § 1^erter, paragraph 3, first sentence, the words "whose exposure of an insufficient number of patients to the human drug concerned" are inserted between the words "to pharmacovigilance," and the words "to proceed";
5° to § 1^erquater, the following modifications are made:
(a) in paragraph 1^er, the word "generally" is replaced by the word "commonly";
(b) paragraph 4 is supplemented by the following sentence:
"In the case of human-use drugs, the information in question includes both positive and negative results of clinical trials or other studies for all indications and populations, whether or not they are in the MMA or registration, as well as data on any use of the drug in a manner not consistent with the MMA or the registration. »;
(c) a paragraph as follows is inserted between paragraph 4 and paragraph 5:
"With respect to human-use drugs, the MMA holder or registration ensures that information on the drug is updated based on current scientific knowledge, including the findings of the evaluations and recommendations made public via the European web portal where applicable. »;
(d) to the current paragraph 5, as paragraph 6, the following amendments are made:
- the words "in permanence" are replaced by the words "in continuous";
- the paragraph is supplemented by the following sentence:
"The holder of the MMA or registration provides a complete and timely response to such requests. »;
(e) a paragraph, as follows, is inserted between current paragraph 5 and paragraph 6, becoming paragraphs 6 and 8:
"In the case of human-use drugs, the Minister or his or her delegate may, at any time, request the MMA holder or the registration to produce an updated copy of his/her ongoing pharmacovigilance system record. The holder of the MMA or registration shall submit such a copy within seven days of receipt of the application. »;
6° to § 1^erthe following amendments are made:
(a) paragraph 1^er is replaced by the following:
"MMA or the registration of a drug is accompanied by a summary of the characteristics of the product (hereinafter referred to as "RCP") and the notice as approved by the European Commission or by the Minister or his delegate during the granting of the MMA or the registration or later. The King sets out the content and conditions to which the RCP and the notice must satisfy. »;
(b) a paragraph written as follows is inserted between paragraph 1^er and paragraph 2:
"The Minister or his or her delegate shall make available to the public, for each drug authorized or registered by him or her, the MMA or the registration, the RCP and the notice, and any condition established under section 6, § 1^ersepties, § 1^erocties, § 1^ernonies or § 1^erdecies, and, where appropriate, the deadlines for the fulfilment of these conditions. »;
(c) current paragraph 2, becoming paragraph 3, is replaced by the following:
"The Minister or his or her delegate shall prepare an assessment report and make comments on the file concerning the results of the pharmaceutical, preclinical and clinical trials, the pharmacovigilance system and, where applicable, the risk management system for the drug concerned and, when it is a veterinary drug, the results of safety tests and residue studies. The evaluation report is updated as soon as new information is available to assess the quality, safety and effectiveness of the drug. »;
(d) the current paragraph 3, becoming paragraph 4, is replaced by the following:
"The Minister or his or her delegate shall make the assessment report available to the public with the reasons for his or her decision, after deletion of any information of a commercial confidentiality character, even if it is only available in the language used in the application review procedure. The reasons are indicated separately for each indication of a drug. With respect to human-use drugs, the public evaluation report contains a summary that must be understandable by the public, including a section on the conditions of use of the drug. "
§ 2. In section 6 of the Act, amended by the Royal Decree of 8 August 1997 and the Acts of 12 August 2000, 30 December 2001, 22 December 2003, 1^er May 2006 and 24 July 2008, are inserted in § 1^er7ies to § 1^erdecies as follows:
« § 1^erSevenies. In exceptional circumstances and after consultation with the applicant, the MMA may be granted subject to certain conditions, including the safety of the drug, the notification to the Minister or his or her delegate of any incident related to its use and the measures to be taken.
For human-use drugs, this MMA can only be granted if the applicant can demonstrate that it is not able, for objective and verifiable reasons, to provide complete information on the efficacy and safety of the drug under normal conditions of use.
For veterinary drugs, this MMA can only be granted for objective and verifiable reasons.
Such an AMM must be based on one of the reasons fixed by the King. The maintenance of the MMA is linked to the annual reassessment of these conditions.
With respect to human-use drugs, the Minister or his or her delegate informs the MMA of the MMAs that he or she has issued with conditions under the previous paragraph and the MMA licensee includes these conditions in its risk management system.
§ 1^erocties. With regard to medicines for human use, in addition to the provisions of Article 6, § 1^er, paragraph 3, the Minister or his delegate may attach one or more of the following conditions to the MMA:
(a) certain measures to ensure the safe use of the drug to be included in the risk management system;
(b) compliance with obligations more stringent than those set out in section 12exies in respect of the registration or notification of suspected adverse events;
(c) any other condition or restriction intended to ensure the safe and effective use of the drug;
(d) the existence of an adequate pharmacovigilance system;
(e) conducting a post-authorization security study;
(f) conducting a post-authorization efficacy study where certain aspects of drug effectiveness raise questions that can only be answered after the drug market is put in place.
The MMA specifies, where applicable, how long these conditions must be met.
The MMA licensee shall include any condition referred to in paragraph 1^er in its risk management system.
Where the conditions referred to in paragraph 1^er, (a) and (c), provide that the marketing of the drug must be accompanied by educational or informative materials, programs or services intended for health care professionals or patients, such materials, programs or services must be subject to the approval of the Minister or his delegate, in accordance with the procedure established by the King, prior to their implementation. This provision also applies to MPAs granted by the European Commission with such conditions.
The Minister or his or her delegate shall inform the MMA of the MPAs that he or she has granted them with conditions under this subsection.
The King shall establish the conditions and terms and conditions for the application of this paragraph.
§ 1^erNies. With respect to drugs for human use, after the MMA is granted, the Minister or his delegate may, according to the procedure established by the King, impose on the MMA holder:
(a) the obligation to conduct a post-authorization safety study, including where there are concerns about the safety risks posed by the authorized drug;
(b) the requirement to conduct a post-authorization effectiveness study where the understanding of the disease or clinical methodology indicates that previous efficacy assessments may need to be significantly reviewed.
The MMA licensee shall include any condition referred to in paragraph 1^er in its risk management system.
The Minister or his or her delegate shall inform the MMA of the MPAs that he or she has granted them with conditions under this subsection.
The King shall establish the conditions and terms and conditions for the application of this paragraph.
§ 1^erdecies. With respect to veterinary medicines, in addition to Article 6, § 1^er, paragraph 3, the Minister or his or her delegate may, at the time of granting the MMA or later, on his or her own initiative or at the request of the applicant or holder of a MMA, include the MMA with one or more measures ensuring the safe and effective use of the drug to be included in the risk management system.
The MMA specifies, where applicable, the terms and conditions referred to in paragraph 1^er must be filled.
The MMA licensee shall include any condition referred to in paragraph 1^er in its risk management system.
The MMA holder is responsible for the implementation of the conditions referred to in paragraph 1^er.
The King may set other conditions, terms and procedures for the application of this paragraph. »
§ 3. References to paragraphs 9 to 11 of Article 6, § 1^erbis, of the same law, as repealed by Article 3, § 1^er, 3°, of this Law, are references to § 1^erocties or § 1^erdecies of section 6 of the same Act, as entered by section 3, § 2, of this Act, as it is a human drug or a veterinary drug, respectively.
References to Article 6, paragraph 12, § 1^erbis, the same law, as repealed by Article 3, § 1^er, 3°, of this Law, are references to § 1^ersevenies of Article 6 of the same Law, as entered by Article 3, § 2, of this Law.
Art. 4. In section 6septies of the same law, inserted by the law of 1^er May 2006, paragraph 7 is replaced by the following:
"When the drug is not intended to be delivered or provided directly to the patient or animal care provider, but only to be administered by health care professionals or by a veterinarian, or where there are serious problems with the availability of a drug for human use, the Minister or his or her delegate may, subject to the measures that he or she considers necessary to protect human or animal health, exempt from the obligation to include certain labelling and labelling statements. It may also exempt completely or partially from the requirement to write the labelling and the record in the three official languages. The King may set conditions and terms for the application of this paragraph".
Art. 5. Article 7, § 1^er, of the same law, replaced by the law of 1^er May 2006, the following amendments are made:
1st paragraph 1^er is replaced by the following:
"With respect to drugs for human use, the King may prohibit the issuance of drugs and remove the drug from the market when he considers, on the advice of the relevant commission referred to in Article 6, § 1^erParagraph 11:
(a) the drug is harmful; or
(b) the therapeutic effect of the drug is lacking; or
(c) the profit/risk ratio is not favourable; or
(d) the drug does not have the qualitative or quantitative composition declared; or
(e) the controls on the drug itself or on the intermediate substances and products of the manufacture have not been performed or where another requirement or obligation relating to the granting of the manufacturing authorization has not been met. »;
2° a paragraph written as follows is inserted between paragraph 1^er and paragraph 2:
"With respect to veterinary medicines, the King may prohibit the issuance and supply of drugs and remove the drug from the market when he considers, on the advice of the relevant commission referred to in Article 6, § 1^erParagraph 11:
(a) the benefit/risk ratio of the drug under the permitted conditions of employment is not favourable, particularly taking into account the health and well-being benefits of the animals, as well as the safety and health benefits of the consumer, when the MMA or the registration concerns a zootechnical drug; or
(b) the therapeutic effect of the drug is lacking on the animal species that has been treated; or
(c) the drug does not have the qualitative and quantitative composition declared; or
(d) the indicated 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
(e) the controls on the drug itself or on the intermediate substances and products of the manufacture have not been performed or where another requirement or obligation relating to the granting of the manufacturing authorization has not been met. »;
3° current paragraph 3, becoming paragraph 4, is replaced by the following:
"It may limit the ban on the issue or supply and the withdrawal of the market to the only batches that are contested. »;
4° the article is supplemented by a paragraph, written as follows:
"With respect to human-use drugs, the King may, for a drug that has been prohibited or has been withdrawn from the market in accordance with paragraph 1^er and 4, in exceptional circumstances and for a transitional period, allow the delivery of the drug to patients who are already treated with this medication. "
Art. 6. Section 8 of the Act, replaced by the Act of 1^er May 2006, the following amendments are made:
1st paragraph 1^er is replaced by the following:
"With respect to human-use drugs, in the event of an emergency, the Minister or his or her delegate may suspend the delivery of a drug when he or she considers that:
(a) the drug is harmful; or
(b) the therapeutic effect of the drug is lacking; or
(c) the profit/risk ratio is not favourable; or
(d) the drug does not have the qualitative or quantitative composition declared; or
(e) the controls on the drug itself or on the intermediate substances and products of the manufacture have not been performed or where another requirement or obligation relating to the granting of the manufacturing authorization has not been met. »;
2° a paragraph written as follows is inserted between paragraph 1^er and paragraph 2:
"In respect of veterinary medicines, in the event of an emergency, the Minister or his or her delegate may suspend the delivery or supply of a drug when he or she considers that:
(a) the benefit/risk ratio of the drug under the permitted conditions of employment is not favourable, particularly taking into account the health and well-being benefits of the animals, as well as the safety and health benefits of the consumer, when the MMA or the registration concerns a zootechnical drug; or
(b) the therapeutic effect of the drug is lacking on the animal species that has been treated; or
(c) the drug does not have the qualitative and quantitative composition declared; or
(d) the indicated 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
(e) the controls on the drug itself or on the intermediate substances and products of the manufacture have not been performed or where another requirement or obligation relating to the granting of the manufacturing authorization has not been met. »;
3° current paragraph 3, becoming paragraph 4, is replaced as follows:
"It may limit the suspension of delivery or supply and the withdrawal of the market to the only batches of manufacture being contested. »;
4° the article is supplemented by a paragraph, written as follows:
"For human-use drugs, the King may, for a drug that has been suspended or has been withdrawn from the market in accordance with paragraph 1^er and 4, in exceptional circumstances and for a transitional period, allow the delivery of the drug to patients who are already treated with this medication. "
Art. 7. Article 8bis, paragraph 1^erof the law, inserted by the law of 1^er May 2006, the following amendments are made:
1st paragraph 1^er is replaced by the following:
"With respect to drugs for human use, the Minister or his delegate suspends, removes or amends the MMA or the registration of a drug if he considers that:
(a) the drug is harmful; or
(b) the therapeutic effect of the drug is lacking; or
(c) the profit/risk ratio is not favourable; or
(d) the drug does not have the qualitative or quantitative composition declared; or
(e) that the information in the MMA or registration file is incorrect or has not been altered, or any new information has not been communicated, in accordance with Article 6, § 1^erquater; or
(f) the conditions referred to in Article 6, § 1^ersevenies, octies or nonies were not filled; or
(g) the controls on the drug itself or on the intermediate substances and products of the manufacture have not been performed or any other requirement or obligation relating to the granting of the manufacturing authorization has not been met. »;
2° a paragraph written as follows is inserted between paragraph 1^er and paragraph 2:
"With respect to veterinary drugs, the Minister or his delegate suspends, removes or amends the MMA or the registration of a drug if he considers that:
(a) the benefit/risk ratio of the drug under the permitted conditions of use is not favourable, particularly taking into account the health and well-being benefits of the animals and the safety of the consumer, when the MMA or registration concerns a zootechnical drug; or
(b) the therapeutic effect of the drug is lacking on the animal species that is the subject of treatment; or
(c) the drug does not have the qualitative and quantitative composition declared; or
(d) the indicated 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
(e) the drug is submitted for use prohibited under other Community law provisions; or
(f) that the information in the MMA/registration file is incorrect or has not been modified, or any new information has not been communicated, in accordance with Article 6, § 1^erquater; or
(g) the conditions referred to in Article 6, § 1^ersepties or § 1^erhave not been filled; or
(h) the controls on the drug itself and/or on the intermediate substances and products of the manufacture have not been performed or where another requirement or obligation relating to the granting of the manufacturing authorization has not been met. "
Art. 8. Article 12 of the same law, inserted by the law of 1^er May 2006, is replaced by the following:
« § 1^er. With respect to human-use drugs, the PSMPS is implementing a pharmacovigilance system that is used to collect information on the risks posed by medications for patient health or public health.
In particular, this information concerns the adverse effects occurring in humans, both in the case of the use of a drug in accordance with the terms of its AMM or its registration and in the case of non-compliant use under the terms of the AMM or the registration, as well as the adverse effects associated with occupational exposure.
AFMPS also participates in the European Union's pharmacovigilance activities.
This pharmacovigilance system is used to conduct the scientific assessment of all information, to examine options for preventing or reducing risks, and, if necessary, to take regulatory action regarding MMA or registration.
The King shall take the necessary measures to ensure the implementation of the pharmacovigilance system, including those relating to:
- the establishment of a national web portal on drugs in connection with the European web portal,
- the registration, notification and monitoring of any suspected adverse effects occurring in Belgian territory and brought to its attention by health professionals or patients;
- the evaluation and monitoring of data resulting from pharmacovigilance activities;
- monitoring post-authorization security studies.
It also takes measures to:
(a) encourage patients, doctors, pharmacists and other health care professionals to report suspected adverse effects; to carry out these tasks, the associations of consumers, patients and health professionals, as well as the mutualities as referred to in the Act of 6 August 1990 on health insurance organizations and national mutuality unions, and the insurance organizations as referred to in the Act respecting compulsory health care and allowances, coordinated on 14 July 1994, may be associated, as the case may be;
(b) Facilitate the notification of adverse reactions by patients, by making other reporting modes available to them on-line;
c) to obtain accurate and verifiable information for the scientific assessment of suspected adverse reaction notifications,
(d) to ensure that the public receives important information on pharmacovigilance issues related to the use of a drug in a timely manner, by publishing them on the web portal and, if necessary, by other publicly available means of information;
(e) to clearly identify any biological medication prescribed, issued or sold on Belgian territory and subject to notification of suspected adverse reactions, indicating the name of the drug, within the meaning of Article 1^er§ 1^er, 26), and the lot number, by means of information collection methods and, if necessary, by monitoring suspicious adverse reaction notifications;
(f) to impose, where appropriate, specific obligations on physicians, pharmacists and other health care professionals for the purposes of (a) and (e).
The AFMPS conducts a periodic review of the pharmacovigilance system and communicates the results to the European Commission no later than 21 September 2013 and every two years thereafter.
The Minister or his delegate may delegate any pharmacovigilance duties to another Member State, provided that the latter consents in writing. It informs the European Commission, the EMA and all other Member States in writing, and makes this information public. It may also agree to be entrusted with pharmacovigilance tasks by another Member State, provided that it does not represent more than one Member State at a time.
Without prejudice to the application of the legal provisions concerning the protection of personal data, when the Commission for the Reimbursement of Drugs referred to in the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994, requests the data it defines, on the mention of side effects, the PSMPS authorizes their access.
§ 2. In the case of human-use drugs, the holder of an AMM or registration shall implement a pharmacovigilance system equivalent to the pharmacovigilance system referred to in § 1^er, with a view to carrying out its duties as pharmacovigilance. It uses this pharmacovigilance system to conduct the scientific assessment of all information, to examine options for preventing or minimizing risks and, if necessary, to take appropriate action.
As part of this system of pharmacovigilance, it takes the following measures:
(a) a person with appropriate qualifications who is responsible for pharmacovigilance, and, where appropriate, a contact person in the field of pharmacovigilance at the Belgian level who is attached to that qualified person, shall be permanently and continuously available to him or her; the King sets out the conditions to which the qualified person and contact person must meet in order to carry out their activities;
(b) it manages and makes available, upon request, a permanent record of the pharmacovigilance system;
(c) implement a risk management system for each drug;
(d) it monitors the results of risk reduction measures that are provided for in the risk management plan or that meet the conditions of the MMA in accordance with Article 6, § 1^ersepties, § 1^erocties or § 1^ernies;
(e) maintains the risk management system and monitors pharmacovigilance data to identify new risks, changes in existing risks or changes in the benefit/risk ratio of drugs;
(f) it records, notifies, assesses and monitors suspected adverse effects of which it is aware.
By derogation from paragraph 2, (c), the holder of an AMM or registration granted before July 21, 2012 is not required to implement a risk management system for each drug.
However, the Minister or his or her delegate may impose on the holder of an AMM the obligation to implement a risk management system in accordance with paragraph 2, (c), if he or she has concerns about the risks that may alter the benefit/risk relationship of an authorized drug.
The King sets the conditions and terms of application.
The holder of an AMM or a registration conducts a periodic audit of its pharmacovigilance system. It shall record in writing the key results of this audit in the ongoing file of the pharmacovigilance system and, based on these results, shall do the necessary to develop and implement an adequate action plan to address the problems identified. Once the corrective actions are fully implemented, the recorded statements may be deleted.
As soon as the holder of an AMM or registration intends to provide a notice to the general public on pharmacovigilance issues relating to the use of a drug and, in any event, prior to the issuance of such notice or simultaneously, the Minister or his delegate, the EMA and the European Commission are required to inform the public.
It also ensures that public information is presented objectively and not misleading.
The King may impose more specific obligations and duties on the holder of an MMA or a pharmacovigilance record.
The King shall determine the conditions and measures of application of this paragraph.
§ 3. With respect to veterinary medicines, the AFMPS is implementing a pharmacovigilance system to ensure the adoption of appropriate and harmonized regulatory decisions on drugs authorized in the European Union, given information gathered on the alleged adverse effects of drugs under normal conditions of use. This system is used to collect useful information for drug surveillance, including their adverse effects on animals and humans, and to scientifically assess this information.
The King sets out the terms and conditions under which this information must be communicated by the holder of an AMM.
The relevant information collected using this system is transmitted by the Minister or his delegate to other Member States and to the EMA and, where applicable, to the holders of an MMA.
This information is linked to the available data on the sale, use and prescription of medications.
This system also takes into account all available information on the insufficient effectiveness of medications in relation to the intended effectiveness, their use "out-of-CP" and the studies conducted to determine the validity of waiting times and the potential risks to the environment, as a result of the use of the 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 veterinarians and other health care professionals, with regard to the notification of alleged serious or unexpected adverse effects on the animal or of suspected adverse effects on the human being.
The holder of an AMM may not communicate to the public information relating to pharmacovigilance concerning his/her authorized drug, without prior notice or simultaneously to the Minister or his/her delegate.
In any event, the MMA licensee shall present this information objectively and misleadingly. »
Art. 9. § 1^er. Article 14, § 1^erParagraph 1^erin the same Act, replaced by the Act of 22 December 2003 and amended by the Act of 27 December 2006, the following amendments are made:
- the words "Federal Agency for Drugs and Health Products" are replaced by the word "AFMPS";
- the paragraph is supplemented by the words "by conducting inspections, if necessary unannounced, as well as, if necessary, by requesting an official laboratory for the control of medications or a laboratory designated for this purpose to perform tests on samples".
§ 2. In Article 14, it is inserted a § 1^erbis, as follows:
« § 1^erbis. As part of their mission under § 1^erthe members of the statutory or contractual personnel referred to in § 1^er cooperate with the EMA.
This cooperation consists of sharing information with the EMA on both planned inspections and inspections conducted.
They also cooperate with EMA in coordinating inspections in third countries.
The King shall determine by order deliberately in the Council of Ministers the scope and modalities of the inspections referred to in this paragraph, including the definition of information that may be shared. "
§ 3. Article 14, § 2, 2°, of the same law, inserted by the law of 22 December 2003 and amended by the law of 27 December 2006, is supplemented by a g, as follows:
"(g) inspect the premises, archives, documents and permanent records of the MMA holder's pharmacovigilance system or of the registration or registration of any business that the MMA holder or the registration may carry out the activities referred to in section 12exies. "
§ 4. Article 14 of the Act is supplemented by § 6 as follows:
“§ 6. If the inspection referred to in § 2, 2°, g), concludes that the holder of the MMA does not respect the pharmacovigilance system as described in the permanent file of the pharmacovigilance system, article 12sexies and its enforcement orders, the persons referred to in § 1^er signals these failures to the MMA holder by giving him the opportunity to make comments.
With regard to drugs for human use, the Minister or his delegate informs the other Member States, the EMA and the European Commission."
Art. 10. In Article 16, § 3, 1° ), of the same law, replaced by the law of 1^er May 2006, the words “, § 1^ersepties, § 1^erocties, § 1^ernonies, § 1^erdecies are inserted between the word "1^ersexies and the words ", articles".
Art. 11. In article 19quater, § 2, first sentence, of the same law, inserted by the law of 1^er May 2006, the words "Federal Health, Food Chain Safety and Environment" are replaced by the words "AFMPS".
Art. 12. In Article 6, § 1^er, paragraph 9, first and fifth sentences, article 6bis, § 7, article 12bis, § 1^er, paragraphs 7 and 8, first and second sentences, and in article 19ter, paragraph 2, paragraphs 1^er and 2, of the same law, the words "European Agency" are replaced by the word "EMA".
Art. 13. In all articles from Article 6, § 1^er, paragraph 2, of the same law, the words "market authorization" and "market authorizations" are replaced each time by the word "MMA".
CHAPTER 3. - Entry into force and transitional provision
Art. 14. This Act is effective July 21, 2012.
The King may, for medications whose MMA or registration was issued before July 21, 2012, provide for transitional measures with respect to the application 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 at Châteauneuf-de-Grasse, August 3, 2012.
ALBERT
By the King:
Minister of Social Affairs and Public Health,
Ms. L. ONKELINX
Seal of the state seal:
The Minister of Justice,
Ms. A. TURTELBOOM
____
Note
Documents of the House of Representatives:
53-2322 - 2011/2012
Number 1: Bill.
No. 2: Amendments.
Number three: Report.
No. 4: Text adopted by the commission.
No. 5: Text adopted in plenary and transmitted to the Senate.
Full report: 13 July 2012.
Documents of the Senate:
5-1715 - 2011/2012
Number 1: Project referred to by the Senate.
Number two: Report.
Annales of the Senate: July 19, 2012.