Law Amending The Law Of 25 March 1964 On Medicines

Original Language Title: Loi modifiant la loi du 25 mars 1964 sur les médicaments

Read the untranslated law here: http://www.ejustice.just.fgov.be/cgi/article_body.pl?numac=2012024282&caller=list&article_lang=F&row_id=1400&numero=1489&pub_date=2012-09-11&dt=LOI&language=fr&fr=f&choix1=ET&choix2=ET&fromtab=+moftxt&trier=publication&sql=dt+=+'LOI'&tri=pd+AS+RANK+

Posted the: 2012-09-11 Numac: 2012024282 PUBLIC SERVICE FEDERAL public health, food chain safety and environment 3 August 2012. -Law amending the law of 25 March 1964 on medicines ALBERT II, King of the Belgians, to all, present and to come, hi.
The Chambers have adopted and we endorse the following: Chapter 1. -Available general Article 1.
This Act regulates a matter referred to in article 78 of the Constitution.
This law transposes Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use and changes for this purpose the law of 25 March 1964 on medicines.
CHAPTER 2.
-Amendments to the law of 25 March 1964 on medicines article 2. in article 1, § 1, of the law of 25 March 1964 on medicines, replaced by the law of 1 May 2006, the following changes are made: has) at 10) the following changes are made:-words 'of a medicinal product for veterinary use"are added after the words"adverse effect ";
-the words "for veterinary use" are inserted between the words "drug" and ", occurring";
-the words "human or" are repealed;
(b) there shall be inserted a 10bis reading as follows: ' 10A "adverse reaction to a drug for human use": reaction noxious and unintended and a drug for human use ';
(c) there shall be inserted a 25 bis as follows: "25A)"health care professionals": persons covered by the royal decree No 78 of 10 November 1967 on the practice of the professions of health care ';
((d) in 33), 'European Agency' shall be replaced by the word "EMA" in the title, and the words '(' European Medicines Agency')' are inserted between the words "drugs" and the word ", established";
(e) subsection is supplemented by 42) 52) worded as follows: ' 42) 'risk management system': a set of activities and interventions of pharmacovigilance aimed to identify, describe, prevent or minimize the risks associated with a drug, including assessment of the effectiveness of such activities and interventions;
(43) "risk management plan": a detailed description of the risk management system;
(44) ' pharmacovigilance system': the system used by the holder of the authorisation for placing on the market or recording and by Member States in order to fulfil the tasks and responsibilities which its pharmacovigilance, and which aims to monitor the safety of drugs authorized or registered and to identify any change in their report benefit/risk;
(45) "permanent record of the pharmacovigilance system': a detailed description of the pharmacovigilance system used by the holder of the authorisation for placing on the market or registration on one or more medicinal products authorised or registered, commonly referred to as 'Pharmacovigilance system masterfile.
(46) ' European web portal': the European web portal on drugs, established under article 26 of Regulation No 726/2004;
(47) «FAMHP»: the Federal Agency for medicines and products health such as instituted by the law of 20 July 2006 relating to the creation and operation of the Federal Agency for medicines 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 laying down Community procedures for the authorisation and supervision with regard to medicinal products for human use and veterinary and establishing a European Medicines Agency, and all its subsequent amendments;
(49) Regulation No 1901/2006: the Regulation (EC) no 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use, amending Regulation (EEC) No 1768/92, Directives 2001/20/EC and 2001/83/EC and Regulation (EC) No 726/2004, and all its subsequent amendments;
(50) ' directive 2001/20 ': Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative action in the Member States provisions relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, and all its subsequent amendments;
(51) "directive 2001/82": Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, and all its subsequent amendments;
(52) ' directive 2001/83 ': Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code relating to medicinal products for human use, and all its subsequent amendments. ».
S. 3 § 1. Article 6 of the Act, as amended by the royal decree of 8 August 1997 and the laws of the August 12, 2000, December 30, 2001, 22 December 2003, 1 May 2006 and July 24, 2008, the following changes are made: 1 ° in the § 1, paragraph 1, the words ', hereinafter referred to as 'Ma',' shall be inserted between the term "contract" and the words "has been".
2 ° to the § 1, paragraph 9, the following changes are made: a) in the first sentence, the word "are" is replaced by the word "may."
b) the phrase "in particular cases with a community interest, the Minister or his delegate or the applicant or the holder of the authorisation on the market or registration seize the Committee concerned, before that a decision be taken on the request, suspension, withdrawal or on any other amendment of the authorisation of placing on the market or of the registration." is replaced by the : "In particular cases of interest to the Union European, the Minister or his delegate or the applicant or the holder of the AMM or recording captures the Committee concerned in accordance with article 31 of Directive 2001/83 or article 35 of Directive 2001/82, so that the procedures referred to in articles 31 and 34 of Directive 2001/83 or articles 35 to 38 of Directive 2001/82 shall apply. before taking a decision on the request, the suspension or the withdrawal of the AMM registration or any other modification of the AMM or registration necessary. »;
(c) in the fourth sentence, the words «assisted by the Standing Committee set up by article 121 of Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, or article 89 of Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products» are replaced by the words "in accordance with article 34 of Directive 2001/83 or article 38 of Directive 2001 / 82', and the word ", suspends" is inserted between the words "grants" and the words "or withdrawn";
3 ° in the § 1bis, paragraphs 9 to 12 are repealed;
4 ° in the § 1B, paragraph 3, first sentence, the words "including an exhibition of an insufficient number of patients to the medicinal product for human use concerned", shall be inserted between the words "pharmacovigilance", and the words ' proceed ';
5 ° to the § 1erquater, the following changes are made: a) in paragraph 1, the word "generally" is replaced by the word "commonly";
(b) paragraph 4 is supplemented by the following sentence: "In relation to medicinal products for human use, the information in question include both positive and negative clinical trials or other studies for all indications and populations, as they appear or not in the AMM or registration, as well as data regarding any use of the drug in a manner not in accordance with terms of the AMM or registration.";
(c) a paragraph worded as follows is inserted between paragraph 4 and paragraph 5: 'in regards medicinal products for human use, the holder of the AMM or registration shall ensure that information about the drug be updated according to current scientific knowledge, including the findings of the evaluations and recommendations made public through the European web portal where appropriate.
»;
(d) in the existing paragraph 5, becoming paragraph 6, the following changes are made:-"continuously" shall be replaced by the words "continuously".
-paragraph is completed with the following sentence: "the holder of the AMM or recording provides a complete and rapid response to such requests.";
(e) a paragraph worded as follows is inserted between paragraph 5 and paragraph 6 present, becoming paragraphs 6 and 8: "in relation to medicinal products for human use, the Minister or his delegate may, at any time ask the holder of the AMM or recording to produce a copy of his permanent record of the pharmacovigilance system.
The holder of the AMM or recording presents this copy within a maximum period of seven days following receipt of the request. »;
6 ° to the § 1erquinquies the following changes are made: has) 1st paragraph is replaced by the following: "the AMM or registration of a medicinal product is accompanied by the summary of the product characteristics (hereinafter referred to as the"RCP") and record such approved by the European Commission or the Minister or her delegate for the granting of the AMM or registration or later.» The King fixed the content and the conditions on which the RCP and the record must satisfy. »;
(b) a paragraph written as

following is inserted between the paragraph 1 and paragraph 2: "the Minister or his delegate shall make available to the public, for each medicinal product authorized or registered by him, the AMM or recording, the RCP and the record and any conditions laid down pursuant to article 6, § 1ersepties, § 1erocties, § 1ernonies or § 1erdecies, and, where appropriate, the time limits defined for the fulfilment of these conditions. ';
(c) the current 2 paragraph becoming paragraph 3, is replaced by the following: "the Minister or his delegate prepares an assessment report and comments on the dossier concerning the results of the pharmaceutical, pre-clinical and clinical tests the pharmacovigilance system and where appropriate the updated risk management system in place for the medicinal product concerned as well as. When it comes to a drug for veterinary use, the results of safety and residue studies test. The evaluation report is updated as soon as new information that are important for the assessment of quality, safety and efficacy of the medicinal product concerned is available. »;
(d) the current paragraph 3, becoming paragraph 4, is replaced by the following: "the Minister or his delegate puts at the disposal of the public assessment report with reasons for its decision, after deletion of any information with a character of commercial confidentiality, although this report is available only in the language used in the procedure of examination of the application. The reasons are listed separately for each requested indication for a drug. In relation to medicinal products for human use, the public assessment report contains a summary which should be understandable by the public and which includes a section dealing with the conditions of use of the drug. ».

§ 2. In article 6 of the Act, as amended by the royal decree of 8 August 1997 and the laws of the August 12, 2000, December 30, 2001, 22 December 2003, 1 May 2006 and July 24, 2008, are inserted the § 1ersepties to § 1erdecies worded as follows: ' § 1ersepties.» In exceptional circumstances and after consultation of the applicant, the WMA may be granted subject to certain conditions, including the safety of the medicinal product, notification to the Minister or his delegate any incident related to its use and measures to be taken.
In relation to medicinal products for human use, the AMM can be granted only 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 medicinal product under normal conditions of use.
In relation to medicinal products for veterinary use, this MDA may be granted only for objective and verifiable reasons.
Such marketing authorisation must be based on one of the grounds laid down by the King. The maintenance of the AMM is linked to the annual reassessment of these conditions.
In relation to medicinal products for human use, the Minister or her delegate informs the EMA to the marketing Authorisations it has issued in terms and conditions pursuant to the preceding paragraph and the holder of the AMM includes these conditions in its management system risks.
§ 1erocties. With regard to medicinal products for human use, in addition to the provisions set out in article 6, § 1, paragraph 3, the Minister or his delegate may match the AMM to one or more of the following conditions: a) certain measures to ensure the safe use of the drug to be included in the risk management system;
(b) the fulfilment of obligations more stringent than those laid down in article 12sexies registration or notification of suspected adverse;
(c) any other condition or restriction to ensure a safe and effective use of the medicinal product;
(d) the existence of an adequate system of pharmacovigilance);
(e) conduct a post-authorisation safety study).
f) the achievement of an efficient post-approval study when certain aspects of the efficiency of the drug raises questions that cannot be answered until after the placing on the market of the medicinal product.
The AMM said, where appropriate, within what timeframe these conditions must be met.
The holder of the AMM includes any condition referred to in paragraph 1 in its risk management system.
When the conditions referred to in paragraph 1, a) and (c)), provide that the placing on the market of the medicinal product must be accompanied by educational or informative services, programs or materials for health care professionals or to patients, these equipment, programs or services shall be subject to the approval of the Minister or his delegate, the procedure determined by the King , prior to their implementation. This provision also applies to marketing Authorisations granted by the European Commission which are subject to such conditions.
The Minister or her delegate informs the EMA of AMM that he has granted in terms and conditions in accordance with this paragraph.
The King sets the conditions and modalities for the application of this paragraph.
§ 1ernonies. With regard to medicinal products for human use, after the granting of the marketing authorisation, the Minister or his delegate may, according to the procedure laid down by the King, impose on the holder of the marketing authorisation: has) an obligation to conduct a post-authorisation safety study, particularly when there are concerns about the security risks posed by the medicinal product authorized.
(b)) the obligation to provide an effective post-approval study when the understanding of disease or clinical methodology indicates that previous efficacy assessments may have to be revised significantly.
The holder of the AMM includes any condition referred to in paragraph 1 in its risk management system.
The Minister or her delegate informs the EMA of AMM that he has granted in terms and conditions in accordance with this paragraph.
The King sets the conditions and modalities for the application of this paragraph.
§ 1erdecies. With regard to medicinal products for veterinary use, in addition to article 6, § 1, paragraph 3, the Minister or his delegate may, in the granting of the marketing authorisation or subsequently, on its own initiative or at the request of the applicant or the holder of a marketing authorisation, match the AMM of one or several measures to ensure the safe and effective use of the drug to be included in the risk management system.
The AMM specify, where appropriate, within what timeframe the conditions referred to in paragraph 1 must be fulfilled.
The holder of the AMM includes any condition referred to in paragraph 1 in its risk management system.
The holder of the AMM is responsible for the implementation of the conditions referred to in paragraph 1.
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, § 1bis, of the same Act, such as repealed by article 3, § 1, 3 °, of this Act, are references to the § 1erocties or to the § 1erdecies of article 6 of the Act, such as inserted by article 3, §2, of the Act, depending on whether it is a medicinal product for human use or a veterinary drug, respectively.
References to paragraph 12 of article 6, § 1bis, of the same act as that repealed by article 3, § 1, 3 °, of this Act, are references to the § 1ersepties of article 6 of the Act, as inserted by article 3, § 2 of this Act.
S. 4. in article 6septies of the Act, inserted by the law of 1 May 2006, paragraph 7 is replaced by the following: "when the drug is not intended to be issued or delivered directly to the patient or the person responsible for the animals, but only to be administered by a veterinarian or health care professionals, or where there are serious problems of availability of a medicinal product for human use the Minister or his delegate may, subject to the measures which it considers necessary to protect human or animal health waive the requirement to include certain particulars on the labelling and package leaflet. It can also provide wholly or partially from the obligation to prepare the labelling and package leaflet in the three official languages. The King may attach conditions and modalities for the application of this paragraph.
S. 5. at article 7, § 1, of the same law, replaced by the law of 1 May 2006, the following changes are made: 1 ° 1st paragraph is replaced by the following: 'in relation to medicinal products for human use, the King may prohibit the dispensing of drugs and remove the drug from the market when it considers, on the advice of the relevant Committee referred to in article 6. (, § 1, paragraph 11, that: a) the medicinal product is harmful; or (b) the drug's therapeutic effect is lacking; or (c) the risk-benefit balance is not favourable; or d) the drug is not qualitative and quantitative composition declared. or e) controls on the drug itself or on substances and intermediate products of the manufacturing has not been made or any other requirement or obligation relating to the grant of the manufacturing authorization has not complied. »;
2 ° a paragraph worded as follows is inserted between paragraph 1 and paragraph 2: ' (in relation to veterinary drugs, the King may prohibit the issuance and the provision of medicines and remove the drug from the market where it finds, on the advice of the relevant Committee referred to in article 6, § 1, paragraph 11, that: has) the risk-benefit balance of the medicinal product in the authorised conditions of use is.

not favourable, taking into account particularly the benefits on health and welfare of animals and the safety and health for the consumer benefits, when the marketing authorisation or registration concerns a medicinal product for zootechnical use; or (b) the therapeutic effect of the drug is lacking on the species of animal which is the subject of the treatment; or c) the drug is not the qualitative and quantitative composition declared. or d) the specified waiting time is inadequate to ensure that foodstuffs obtained from the treated animal contain residues which might constitute a hazard to the health of the consumer; or e) controls on the drug itself or on substances and intermediate products of the manufacturing has not been made or any other requirement or obligation relating to the grant of the manufacturing authorization has not complied. »;
3 ° the current 3 paragraph becoming paragraph 4, is replaced by the following: 'It may confine the prohibition of issuing or supply and the withdrawal from the market solely to batches of production a challenge.';
4 ° article is supplemented by a paragraph, as follows: "In relation to medicinal products for human use, the King may, for a drug whose issuance has been prohibited or which has been removed from the market pursuant to paragraphs 1 and 4, in exceptional circumstances and for a transitional period, authorize the issuance of the drug to patients who are already treated with this medicine.".
S. 6a article 8 of the same Act, replaced by the law of 1 May 2006, the following changes are made: 1 ° 1st paragraph is replaced by the following: ' (in relation to medicinal products for human use, in an emergency, the Minister or his delegate may suspend the issuance of a drug when it considers that: has) the medicinal product is harmful; or (b) the drug's therapeutic effect is lacking; or (c) the risk-benefit balance is not favourable; or d) the drug is not qualitative and quantitative composition declared. or e) controls on the drug itself or on substances and intermediate products of the manufacturing has not been made or any other requirement or obligation relating to the grant of the manufacturing authorization has not complied. »;
2 ° a paragraph worded as follows is inserted between paragraph 1 and paragraph 2: ' (regarding medicinal products for veterinary use, in an emergency, the Minister or his delegate may suspend the issuance or provision of a drug when it considers that: has) the risk-benefit balance of the medicinal product in the authorised conditions of use is not favourable, taking into account particularly the benefits on health and welfare of the animals as well as the security and. health for the consumer benefits, where the marketing authorisation or registration concerns a medicinal product for zootechnical use; or (b) the therapeutic effect of the drug is lacking on the species of animal which is the subject of the treatment; or c) the drug is not the qualitative and quantitative composition declared. or d) the specified waiting time is inadequate to ensure that foodstuffs obtained from the treated animal contain residues which might constitute a hazard to the health of the consumer; or e) controls on the drug itself or on substances and intermediate products of the manufacturing has not been made or any other requirement or obligation relating to the grant of the manufacturing authorization has not complied. »;
3 ° the current 3 paragraph becoming paragraph 4, is replaced by the following: 'It may limit the suspension of delivery or supply and the withdrawal from the market solely to batches of production a challenge.';
4 ° article is supplemented by a paragraph, as follows: "in relation to medicinal products for human use, the King may, for a drug whose issuance has been suspended or removed from the market pursuant to paragraphs 1 and 4, in exceptional circumstances and for a transitional period, authorize the issuance of the drug to patients who are already treated with this medicine.".
S.
7A article 8 bis, paragraph 1, of the Act, inserted by the Act of May 1, 2006, the following changes are made: 1 ° 1st paragraph is replaced by the following: ' (in relation to medicinal products for human use, the Minister or his delegate suspends, withdraws or modifies the AMM or the registration of a drug if it considers that: has) the medicinal product is harmful; or (b) the drug's therapeutic effect is lacking;
or (c) the risk-benefit balance is not favourable; or d) the drug is not qualitative and quantitative composition declared. or e) that the information contained in the file of marketing authorisation or registration are incorrect or have not been modified, or any new element had not been communicated in accordance with article 6, § 1erquater; or (f) the conditions referred to in article 6, § 1ersepties, g or h have not been met; or g) controls on the drug itself or on substances and intermediates manufacturing have not been made or any other requirement or obligation relating to the grant of the manufacturing authorization has not been respected. »;
2 ° a paragraph worded as follows is inserted between paragraph 1 and paragraph 2: "(in relation to veterinary drugs, the Minister or his delegate suspends, withdraws or modifies the AMM or the registration of a drug if it considers that: a) the risk-benefit balance of the medicinal product in the authorised conditions of use is not favourable, taking into account particularly the benefits on health and welfare of animals and the safety of the consumer. When the marketing authorisation or registration concerns a medicinal product for zootechnical use; or (b) the drug's therapeutic effect is lacking on the species of animal which is the subject of the treatment; or c) the drug is not the qualitative and quantitative composition declared. or d) the specified waiting time is inadequate to ensure that foodstuffs obtained from the treated animal contain residues which might constitute a hazard to the health of the consumer; or (e) the medicinal product is presented for a use prohibited under other provisions of Community law; or (f) that the information contained in the file of marketing authorisation or registration are incorrect or have not been modified, or any new element had not been communicated in accordance with article 6, § 1erquater;
or (g) the conditions referred to in article 6, § 1ersepties or § 1erdecies, have not been met; or h) controls on the drug itself or on substances and intermediate products of the manufacturing has not been made or any other requirement or obligation relating to the grant of the manufacturing authorization has not complied. ».
S. 8. article 12sexies of the Act, inserted by the Act of May 1, 2006, is replaced by the following: "§ 1.» In relation to medicinal products for human use, the FAMHP implements a pharmacovigilance system which is used to collect information about the risks of medicines for the patient's health or public health.
This information includes in particular adverse reactions occurring in humans, as well in the event of use of a drug in accordance with the terms of the AMM or its registration as you use not in accordance with the terms of the AMM or registration, as well as adverse effects related to occupational exposure.
The FAMHP also participates in the activities of the EU pharmacovigilance.
The pharmacovigilance system is used to carry out the scientific evaluation of all information, to examine options to prevent or reduce and, where necessary, to take regulatory measures concerning the marketing authorisation or registration.
The King takes the necessary measures to ensure the implementation of the system of pharmacovigilance, including: - to the establishment of a European web portal, national drugs in conjunction with the web portal, - registration, notification and monitoring of any adverse reactions suspected occurring on the territory of Belgium and brought to his attention by patients or health professionals;
-assessment and monitoring of the data resulting from the activities of pharmacovigilance;
-to the supervision of post-authorisation safety studies.
It also takes measures: has) to encourage patients, physicians, pharmacists and other professionals of health care to report adverse reactions suspected; to carry out these tasks, the associations of consumers, patients and health professionals, as well as mutual societies as referred to in the Act of 6 August 1990 to insurers to mutual societies and the national unions of mutual societies and insurers as referred to in the law on compulsory insurance health care and benefits co-ordinated on 14 July 1994, may be associated, as appropriate;
(b) to facilitate the notification of adverse reactions by patients, putting at their disposal, in addition to means of online reporting, other modes of statement;
(c) to obtain accurate and verifiable information for the realization of the scientific evaluation of the notifications of suspected adverse,

(d) to ensure that the public receives timely important information on pharmacovigilance matters related to the use of a drug, by publishing them on the web portal and, if necessary, by other means of information accessible to the public;
((e) to identify clearly any biological medicinal product prescribed, issued or sold on Belgian territory and the subject of a notification of suspected adverse, indicating the name of the drug, within the meaning of article 1, § 1, 26), and the number of the lot, and by methods of collection of information and, if necessary, through the follow-up to reports of suspected adverse;
(f) to impose specific obligations applicable to physicians, pharmacists and other health care professionals for the purposes of the application of points a) and (e)).
The FAMHP conducts a periodic review of the pharmacovigilance system and communicate the results to the European Commission September 21, 2013 at the latest, and every two years thereafter.
The Minister or his delegate may delegate any task pharmacovigilance to another Member State, provided that the latter consents in writing. He shall inform in writing the European Commission, the EMA and all other Member States, and makes this information public. It can also accept to see tasks pharmacovigilance by another Member State, insofar as it represents more than one Member State at a time.
Without prejudice to the application of the legal provisions on the protection of personal data, when the Commission's reimbursement of medicinal products referred to in the law on mandatory health care and compensation insurance, co-ordinated on 14 July 1994, requests data it sets on the mention of side effects, the FAMHP authorizes their access.
§ 2. In relation to medicinal products for human use, the holder of a marketing authorisation or a registration shall implement a pharmacovigilance system equivalent to the pharmacovigilance system referred to the § 1, intended for fulfilling pharmacovigilance tasks entrusted to it. It uses the pharmacovigilance system for the scientific evaluation of all information, to examine options to prevent or reduce to a minimum and, if necessary, to take appropriate measures.
Field this system of pharmacovigilance, it takes including the following measures: has) it permanently and continues at its disposal a person possessing the appropriate qualifications who is responsible for pharmacovigilance, as well as, if applicable, a contact person at the Belgian level which is attached to this person qualified and pharmacovigilance for each permanent of the pharmacovigilance system folder; the King lays down the conditions which the QP and the contact person must meet to carry out their activities;
(b) it manages and makes available on request a pharmacovigilance system master file;
(c) it is implementing a system of managing the risks for each drug;
(d) it monitors the results of the measures to reduce the risks that are planned in the risk management plan or that correspond to conditions attached to the AMM in accordance with article 6, § 1ersepties, § 1erocties or § 1ernonies;
(e) it maintains the system of risk management and supervises the pharmacovigilance data to identify new risks, existing risks changes or a change in the risk-benefit of drugs;
(f) it saves, notifies, assesses and monitors the suspicious side effects that he knows.
By way of derogation from paragraph 2, c), the holder of a marketing authorisation or registration granted before July 21, 2012 is not required to implement a system of management of risk for each drug.
However, the Minister or his delegate may require the holder of a marketing authorisation to implement a system of management of risk in accordance with paragraph 2, c), if he has concerns about the risks that could alter the risk-benefit of an authorised medicinal product.
The King lays down the conditions and detailed rules for the application.
The holder of a marketing authorisation or registration performs a periodic audit of his pharmacovigilance system. He logs in writing the main results of this audit in the permanent record of the system of pharmacovigilance, and based on these results, you need to develop and implement an appropriate action plan aimed at addressing the problems identified. Once the corrective measures fully implemented, the recorded entries can be deleted.
As soon as the holder of a marketing authorisation or registration intends to disseminate to the general public an opinion on matters of pharmacovigilance regarding the use of a drug and, in any case, before the mailing of such notice or at the same time, it is required to notify the Minister or his delegate, the EMA and the European Commission.
It also ensures that public information be presented objectively and is not misleading.
The King may impose obligations and more specific tasks to the holder of a marketing authorisation or registration pharmacovigilance.
The King sets the conditions and measures for the application of this paragraph.
§ 3. In regards to veterinary drugs, the FAMHP implements a pharmacovigilance system in order to ensure the adoption of regulatory decisions appropriate and harmonised regarding medicinal products authorised in the European Union, in the light of the information collected on adverse reactions suspected of medicinal products under normal conditions of use. This system is used to collect information useful in the surveillance of drugs, including with respect to their adverse effects on animals and humans, and to evaluate such information scientifically.
The King lays down the procedures according to which this information shall be communicated by the holder of a marketing authorisation.
Relevant information collected using this system are transmitted by the Minister or his delegate to the other Member States and the EMA and, where appropriate, to holders of a marketing authorisation.
These information are in relation to available data relating to the sale, the use and prescription of medicines.
This system also takes into account all available information on the insufficient effectiveness of drug effectiveness laid down on their use out RCP' and studies to determine the validity of the waiting time and the possible risks for the environment, because of the use of the medicinal product, to the extent where they can have an impact on the assessment of their risks and benefits.
The King takes the necessary steps to organize the system of pharmacovigilance within the competent authority and to ensure that its operation is under the permanent control of the competent authorities. It can also impose specific requirements for veterinarians and other health care professionals, in relation to the notification of serious adverse effects or unexpected suspected animal or suspected human adverse reactions.
The holder of a marketing authorisation may not communicate information relating to pharmacovigilance medicine authorized, without notice to previously or simultaneously the Minister or his delegate to.
In any event the holder of the AMM presents this information in an objective manner and not misleading. » Art. 9 § 1. Article 14, § 1, paragraph 1, of the Act, replaced by the Act of 22 December 2003 and amended by the Act of 27 December 2006, the following changes are made:-Federal Agency for drugs and health products"shall be replaced by the word"FAMHP ';
-article is supplemented by the words ' by performing inspections, if necessary unannounced, and, if applicable, by asking an official medicines control laboratory or a laboratory designated for that purpose to conduct analyses on samples.
§ 2. In article 14, it is inserted a § 1bis as follows: "§ 1bis.»
As part of their mission referred to the § 1, members of the staff or contract referred to the § 1 cooperate with EMA.
This cooperation is a sharing of information with the EMA both on scheduled inspections and inspections carried out.
They also cooperate with the EMA in the coordination of inspections in third countries.
The King determines by Decree deliberated in the Council of Ministers the scope and modalities of inspections referred to in this paragraph, including the definition of information that can be shared. ».
§ 3. Article 14, § 2, 2 °, of the same Act, inserted by the Act of 22 December 2003 and amended by the Act of 27 December 2006, is supplemented by a g), as follows: ' g) inspect the premises, archives, documents and the permanent record of the pharmacovigilance system of the holder of the AMM registration or any company by WMA or registration holder to carry out the activities referred to in article 12sexies. ".
».
§ 4. Article 14 of the same Act is supplemented by § 6 worded as follows: ' ' § § 6 6 If the inspection referred to in § 2, 2 °, g), determines that the holder of the AMM does not meet the pharmacovigilance system as described in the permanent record of the system

pharmacovigilance, article 12sexies and its execution orders, the persons referred to the § 1 indicates these failures to the holder of the AMM giving him the opportunity to make submissions.
In relation to medicinal products for human use, the Minister or his delegate shall inform the other Member States, the EMA and the European Commission'.
S. (10. in article 16, § 3, 1 °), of the same Act, replaced by the law of 1 May 2006, the words «, § 1ersepties, § 1erocties, § 1ernonies, § 1erdecies ' shall be inserted between the word "1ersexies" and the words ", articles.
S. 11. in article 19quater, § 2, first sentence, of the Act, inserted by the Act of May 1, 2006, the words 'the Directorate General drugs with the federal public Service health, food chain safety and environment' are replaced by the words "the FAMHP.
S. 12. in article 6, § 1, paragraph 9, first and fifth sentences, article 6 bis, § 7, article 12bis, § 1, paragraph 7, and paragraph 8, first and second sentence, and in article 19ter, § 2, paragraphs 1 and 2, of the Act, the words 'European Agency' are each time replaced by the word "EMA".
S.
13. in all sections from the article 6, § 1, paragraph 2, of the Act, the words "authorisation to place on the market" and "marketing permissions" are each time replaced by the word 'AMM.
CHAPTER 3. -Entry into force and transitional provision art.
14. this Act has effect July 21, 2012.
The King may, for drugs including the AMM or registration issued prior to July 21, 2012, provide for transitional measures as regards the application of this Act.
Promulgate this Act, order that it self under the seal of the State and published by le Moniteur.
Given at Chateauneuf-de-Grasse, August 3, 2012.
ALBERT by the King: the Minister of Social Affairs and public health, Ms. L. ONKELINX sealed with the seal of the State: the Minister of Justice, Ms. A. TURTELBOOM _ Note records of the House of representatives: 53 - 2322 - 2011/2012 No. 1: Bill.
No. 2: amendments.
No. 3: report.
No. 4: Text adopted by the commission.
No. 5: Text adopted in plenary meeting and transmitted to the Senate.
Full report: July 13, 2012.
The Senate documents: 5 - 1715 - 2011/2012 No. 1: project referred by the Senate.
No. 2: report.

Annals of the Senate: July 19, 2012.