Posted the: 2013-06-26 Numac: 2013022328 PUBLIC SERVICE FEDERAL public health, food chain safety and environment June 20, 2013. -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 Act partially transposes Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicines, and transposes article 1, 6), the EU-26-2012 Directive of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC in relation to pharmacovigilance.
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, inserted by the law of 1 May 2006 and amended by the law of August 3, 2012 and March 19, 2013, the following changes are made: 1 °) the 1A), worded as follows, is inserted between points) 1 and 2): "1A),"counterfeit drug": any medication containing a misrepresentation of. (: a) its identity, including its packaging and labelling, its name or its composition with regard to any of its components, including excipients, and dosage of these components;
b) its source, including of its manufacturer, its country of manufacture, country of origin or its marketing authorisation holder; or c) history, including records and documents related to the channels of distribution used.
This definition does not include unintentional quality defects and shall be without prejudice to the rights of intellectual property violations; »;
2 °) the 2A) and 2B), written as follows, shall be inserted between the 2) and 3): "2A) 'active substance': any substance or mixture of substances intended to be used for the manufacture of a medicament and which, when used for its production, becomes an active component said medicine exerting a pharmacological, immunological or metabolic action to restore, correct or modify physiological functions. , or to making a medical diagnosis;
2B) 'vehicle': any component of one drug, other than an active substance and packaging materials; »;
((3 °) the 17bis), worded as follows, is inserted between the 17) and 18): «17A) 'arranging of drugs': any activity related to the sale or the purchase of medicinal products, with the exception of the wholesale, distribution which includes no physical handling of drugs and which is to be negotiated, independently and on behalf of a person or entity;
(3A article 1bis of the Act, inserted by the law of June 21, 1983, and amended by law of October 20, 1998 and may 1, 2006, the following changes are made: 1 °) in the § 1, 1 °, 2 °, 3 ° and 4 °, the words 'elements, materials', shall each time be inserted between the word "to the" and the words "objects, devices";
2 °) the § 1 is completed by 5 °, as follows: '5 ° elements and materials used in the manufacture of objects, equipment, substances or compositions of items 1 °, 2 °, 3 ° and 4 ° and intended to be used for these, and which are essential to their integrity.'.
3 °) in § 2, the words "material", are inserted between the words "other" and the words "object, device";
4 °) in § 3, the words "elements, materials," shall be inserted between the words "for the regulation of" and the words "objects, devices.
4. in article 3, § 4, of the Act, inserted by the law of 1 May 2006, a paragraph worded as follows is inserted between paragraphs 1 and 2: "the King also sets the terms and conditions for the offer in distance selling of non-prescription drugs by means of services of the information society. To this end, it lays down the conditions which website providing distance selling these drugs must meet as well as the specific features of the logo that is recognizable across the Union and which allows the identification of the Member State in which the person offering for sale at distance of medicinal products to the public is established. This logo is clearly displayed on the websites offering for sale at distance of medicinal products not subject to prescription to the public. The FAMHP communicates on its website the list of persons offering for sale at distance of the non prescription drugs to the public in accordance with this paragraph through the company services information and the address of the website of these people. ».
5. in article 6, § 1erquinquies of the Act, inserted by the law of 1 May 2006 and amended by the law of August 3, 2012, paragraphs 6 and 7 are replaced by the following: 'the King fixed the content and the conditions to which the outer packaging, the immediate packaging and the labelling of medicines meet.
For this purpose, it may impose safety devices for drugs other than radiopharmaceuticals, affixed to the outer packaging or, failing that, on the immediate packaging, allowing wholesale, distributors wholesalers-dispatchers and persons authorized or entitled to supply medicinal products to the public:-to verify the authenticity of the drug, and - identify individual drug boxes , as well as a device to verify if the outer packaging has been the subject of a break-in to, inter alia, to ensure the integrity of the outer packaging.
Due to their nature, it may impose additional terms for specific medications.
The entries on the outer packaging, the immediate packaging and labelling are recorded so as to be easily legible, clearly comprehensible and indelible. » Art. 6. in article 6ter, § 2, of the Act, inserted by the law of June 21, 1983, the words "elements, materials," are inserted between the words "retail of" and the words "objects, devices.
S. 7. article 6septies of the same Act, inserted by the law of 1 May 2006 and amended by the law of August 3, 2012, including the current text will form the 1st paragraph, is supplemented by a paragraph 2, to read as follows: ' ' § § 2 2 The prescription drugs are equipped with a device of security as referred to in article 6, § 1erquinquies, except if the King to derogate from.
The non-prescription medicines must not be equipped with a device of security as referred to in article 6, § 1erquinquies, except if the King to derogate from.
In the determination of drugs or classes of drugs referred to in paragraphs 1 and 2, account shall be taken of the risk of falsification and the resulting falsification of these medicinal products or these categories of medicinal products are taken into account. To this end, in any case, the following criteria are applied: 1 °) the price and the volume of sales of the medicinal product;
2 °) the number and frequency of previous drug cases falsified notified in the Union and in third countries as well as the evolution of the number and frequency of these precedents to date;
3 °) the specific characteristics of the medicinal products concerned;
4 °) the seriousness of the diseases to treat;
5 °) of other potential risks to public health.
The King sets out the characteristics and technical specifications of the identifier unique devices of security as referred to in article 6, § 1erquinquies, to verify the authenticity of medicines and identify the individual mailboxes. When this fixation, he shall take due account of their cost-effectiveness.
Safety devices may be removed or covered partially or completely, except in the cases and under the conditions determined by the King. To this end, the King determines the criteria to the what the safety devices are to be considered equivalent, after replacement at the safety devices referred to in article 6, § 1erquinquies, paragraph 6.
The King lays down the procedures for the verification procedure of the safety devices by manufacturers, wholesale distributors, pharmacists and persons authorized to supply medicinal products to the public and by the FAMHP. This arrangement allows to verify the authenticity of each box of medicines distributed relating the safety devices and determine the scope of this audit.
The King shall determine the modalities of establishment, management and accessibility of the system of databases containing information on the safety devices to verify the authenticity of medicines and to identify. The costs of this system borne by holders of a manufacturing authorization for drugs with safety devices.
In determining the terms and conditions referred to in paragraph 7, it can determine that the establishment, management and accessibility of this system of databases is ensured by a body authorized by him under the conditions laid down by him.
The FAMHP shall notify the European Commission not subject to prescription drugs for which the FAMHP considers that there is a risk of falsification and can inform the European Commission of drugs it considers to be not affected by this risk on basis of the criteria referred to in paragraph 3.
The King may, for purposes of refund or pharmacovigilance, broaden the scope of identifier unique devices of security as referred to in article 6, § 1erquinquies, to any drug prescription or subject to a refund.
The King may, for purposes of patient safety, extend the scope of the intruder device safety as referred to in article 6, § 1erquinquies, other medicines.
The Minister or his delegate may, for purposes repayment, pharmacovigilance and Pharmacoepidemiology, use the information contained in the database system referred to in article 7, in accordance with the terms and conditions laid down by the King.
At the adoption of the measures referred to in this paragraph, the King also takes into account at least the following points: 1 °) the protection of the personal data Act of 8 December 1992 relative to the protection of privacy with regard to the processing of personal data;
2 °) the legitimate interests of protection of commercial information of a confidential nature;
3 °) the property and confidentiality of the data generated by the use of safety devices; and 4 °) the cost-effectiveness of the measures. ».
S. 8. in the same Act, it is inserted an article 7B, as follows: «art.» 7B. without prejudice to articles 7 and 7bis, the King is developing a system aimed at preventing drug believed to be falsified, not conform or which pose a potential threat to public health are not found in patients.
The system referred to in paragraph 1 covers the receipt and processing of notifications of drugs believed to be falsified or be assigned a quality defect. This system covers also recalls of drugs made by holders of marketing Authorisations or withdrawals of drugs ordered by the Minister or his delegate to all actors in the distribution chain, during and outside working hours normal. The system also allows recalls of medicines with patients who received these drugs, if necessary with the assistance of health care professionals.
If the drug is suspected to present a serious risk to public health, the Minister or his delegate shall promptly transmit rapid alert notification to all actors in the distribution chain as well as to the competent authorities of all Member States. If it appears that the medicinal products in question have been issued to patients, public releases are broadcast emergency, within twenty-four hours, so that the recall of these medicines to patients. These releases contain sufficient information on the quality defect or suspected counterfeiting and risks resulting therefrom. ».
S. (9. article 8A, paragraph 1, of the Act, inserted by the Act of May 1, 2006 and replaced by the law of August 3, 2012, is supplemented by the h), as follows: "h) or the manufacture of the medicinal product has no place in accordance with the information provided in the application for marketing authorisation relating to the manner of manufacture or if the drug controls were not conducted in accordance with the information provided in the application for marketing authorisation relating to the methods of control.
used by the manufacturer or stakeholders in the manufacturing process. ».
S. (10A article 10 of the same Act, replaced by the law of December 16, 2004 and amended by the Act of March 19, 2013, the following changes are made: 1 °) in the § 1, paragraph 1, the words "persons performing brokering activities", shall be inserted between the words "wholesalers", and the words "to persons qualified to prescribe,";
2 °) in § 3, paragraph 1, the words ", persons performing brokering activities" shall be inserted between the words ', importers' and the words 'and wholesalers '.
(11A article 12 bis of the same Act, inserted by the law of 1 May 2006 and amended by the laws of the December 23, 2009, August 3, 2012 and March 19, 2013, the following changes are made: 1 °) in the § 1, paragraphs 7 and 8 are replaced by the following: "data relating to the authorisations are introduced in the data bank of the Union which is managed by EMA on behalf of the Union. hereinafter referred to as 'European data bank.
The certificates of good manufacturing practice are inserted into the European database. Information about the registration of importers and manufacturers of active substances are also introduced in the above-mentioned database. »;
2 °) in the § 1, paragraph 11 is replaced by the following: 'the King fixed the principles and guidelines for good manufacturing practices. The King also lays down the principles and guidelines relating to the good manufacturing practices for active substances.
During the manufacturing process, only the active substances manufactured in accordance with the good manufacturing practices for active substances and distributed in accordance with good practices of distribution of active substances may be used. The King determines how this is controlled.
The holder of the manufacturing authorization ensures that the excipients are appropriate for use in medicinal products in determining what are appropriate good manufacturing practices. This determination is made on the basis of a formal risk assessment, in accordance with the guidelines laid down by the King. The risk assessment takes into account the requirements imposed by other systems of appropriate quality, as well as the source and intended use of excipients, and previous case of quality defects. The holder of the manufacturing authorization ensures that the appropriate good manufacturing practices so determined are applied. The holder of the manufacturing authorization documents actions taken under this paragraph. »;
3 °) the § 1 is supplemented by a paragraph worded as follows: "a manufacturing authorisation holders, including those carrying on business activities referred to in paragraph (2), are considered to be producers and are therefore liable for damages caused in the cases and conditions provided by the law of 25 February 1991 concerning the liability for defective products. ';
4 °) is added to article § 4, as follows: "§ § 4 4» Importers, manufacturers and distributors of active substances which are established in Belgium record their activity to the Minister or his delegate. This record is also required if the active substance is manufactured for export.
The King lays down the conditions, time limits and the procedures for registration, as well as the conditions to be met by the record holders. It sets the content of the application for registration and may prescribe the form in which this request should be introduced.
The Minister or his delegate may decide that an inspection will be conducted before the activity can be started. If this is not the case within the deadline set by the King, the activity can be started. The recording may be matching, to ensure that all the conditions for the exercise of the activities justifying the registration, of certain obligations imposed either when authorization subsequent to its approval.
The data indicated in the registration form will be included in the database referred to the § 1.
The manufacture, import and distribution of active substances, including those that are intended for export, comply with good practice manufacturing and distribution concerning the active substances.
Active substances may be imported only if they have been manufactured in accordance with standards of good manufacturing practice at least equivalent to those established pursuant to the § 1, paragraph 11.
In addition, the active substances may be imported only if they are accompanied by written confirmation from the competent authority of the exporting third country. This confirmation certify first that good manufacturing practices standards for the facility that manufactures the exported active substance is at least equivalent to those laid down by the Union. Secondly, such confirmation certifies the manufacturing establishment is the subject regular, strict and transparent controls, and effective measures of maintenance of good manufacturing practices, including repeated and unannounced inspections to ensure protection of public health at least equivalent to that provided by the Union. Thirdly, such confirmation certifies that where non-compliance would be found, information about this finding will be immediately communicated to the Union by the exporting third country.
This written confirmation shall be without prejudice to the obligations referred to in article 6, § 1, paragraphs 1, 2 and 3 and article 12bis, § 1, paragraphs 11, 12 and 13.
Paragraph 7 is not applicable if the exporting country is contained in the list established by the European Commission in accordance with article 111ter of Directive 2001/83.
Exceptionally and if necessary to ensure the availability of drugs, where an establishment for the manufacture of an active substance for export has been inspected and found to complies with the principles and guidelines of good manufacturing practices for it, the Minister or his
delegate may waive the above requirement of the written confirmation for a period not exceeding the validity of the certificate of good manufacturing practices. The Minister or his delegate shall immediately notify to the European Commission. ».
S. (12A article 12B of the Act, inserted by the law of 1 May 2006 and amended by laws of 27 December 2006, December 29, 2010, August 3, 2012 and 19 March 2013, with the current text will form the § 1, the following changes are made: 1 °) in the § 1, paragraph 2, the second sentence is replaced by the following : "In the case of a wholesale distribution of medicines to third countries, this condition so that the condition laid down in article 9 shall not apply. In addition, the King may specify what conditions do not apply when a drug is received directly from a third country without be imported. In this case, however, the Distributor wholesale ensures that drugs are obtained only from persons who are authorized or entitled to distribute drugs in accordance with the legal and administrative provisions in force in the third country concerned. When distributors wholesale provide drugs to people from third countries, they shall not provide them to individuals who are authorized or entitled to receive drugs for distribution wholesale or issuing to the public in accordance with the legal and administrative provisions in force in the third country concerned. The King may also provide exceptions for cases where in accordance with Community law on unauthorized drugs for animal use can be used for the treatment of animals. »;
2 °) in the § 1, paragraph 3, the following sentence is inserted after the first sentence: "in the case of medicinal products for which a marketing authorisation has been granted in accordance with Regulation No 726/2004, notification also addressed to the holder of the AMM of the drug as well as to the EMA.".
3 °) in the § 1, paragraph 5, the second sentence is replaced by the phrase: 'the authorization of wholesale distribution of drugs is valid only for premises located on the Belgian territory indicated in the authorisation as well as for medicines and formulations for which the permission was sought and granted.';
4 °) in the § 1, paragraph 11, the words ", including the wholesale distribution of medicinal products to third countries," shall be inserted between the words "of a wholesale distribution of medicines authorisation' and the words ' are required in";
5 °) in the § 1, clause 12 is supplemented by the following sentence: 'The King fixed the principles and guidelines for good practices for distribution of active substances';
6 °) in the § 1, clause 14 is supplemented by the following sentence: 'control of persons authorized to exercise the activity of wholesale distribution of medicinal products and the inspection of their premises, are carried out under the responsibility of the Member State which granted the authorization for premises located in its territory.';
7 °) the § 1 is supplemented by a paragraph, as follows: "information to the authorisation referred to in paragraph 1, as well as good distribution practice certificates issued, are introduced into the European database referred to in article 12bis, § 1.» At the request of the Commission or another Member State, all relevant data relating to the individual authorisation referred to in paragraph 1 are transmitted. Information about the registration of distributors of active substances are also introduced in the above-mentioned database.
8 °) article is supplemented by a paragraph 2, as follows: ' ' § § 2 2
The Minister or his delegate shall take measures to ensure that medicinal products which are brought into the Belgian territory but are not intended to be placed on the market in Belgium are not put into circulation if there is sufficient evidence for suspecting a forgery of these medicines.
The King may determine the criteria to be taken into consideration and the checks to be made in the assessment of potential falsification of drugs that are introduced into the Union but which are not intended to be placed on the market. ».
S. 13. in the same Act, it is inserted an article 12octies, worded as follows: «art.» 12octies. persons engaged in brokerage of drugs shall ensure that objects of brokerage drugs are covered by a marketing authorisation granted under this Act. Persons engaged in brokerage of drugs have a permanent address and coordinates in the Union in order to enable the competent authorities to identify and locate them accurately, communicate with them and monitor their activities.
Persons engaged in brokerage activities established in Belgium shall notify their activities to the Minister or his delegate. The King determines the data to notify for obtaining a registration. The reported data are included in a register that is made public by the FAMHP.
The King determines the conditions in which persons engaged in brokerage of drugs are required in the exercise of their activities.
Principles and guidelines of good practice referred to in article 12B, § 1, paragraph 12, include specific provisions relating to brokerage who are respected by persons performing brokering activities.
This article shall apply without prejudice to article 14. The inspections referred to in article 14 are held under the responsibility of the Member State in which the person engaged in brokerage of drugs is registered.
A removal from the register referred to in paragraph (2) takes place when it did not respond to the requirements set out in this article. The person is informed. ».
S. (14A article 13bis, inserted by the Act of 29 December 1990 and amended by the royal decree of 22 February 2001 and the laws of the 27 December 2004, may 1 2006, December 13, 2006, 27 December 2006, December 21, 2007 and August 3, 2012, the following changes are made: 1 °) in the § 1, the words 'elements, materials,' shall be inserted between the words 'substances '. ', compositions, "and the words"objects, devices ";
2 °) in § 2, the words "or one who actually brokering" shall be inserted after the words "to support someone who puts them on the market, distributes them or provides them."
S. (15 to article 14 of the same Act, replaced by the Act of 22 December 2003 and amended by the laws of the May 1 2006, December 27, 2006 and August 3, 2012, the following changes are made: 1 °) in the § 1, paragraph 3, the words 'elements, materials', shall be inserted between the words 'substances or compositions' and the words 'objects, devices,';
2 °) the § 1bis is repealed;
3 °) in § 2, 1 °:-the words "elements, materials," are inserted between the words 'substances or compositions,' and the words 'objects and devices. "
"- the words 'active substances or excipients' shall be inserted between the words"objects and devices"and the words" referred to in article 1 and 1bis of the Act ";
-the words "in the premises of a marketing authorisation holders and those engaged in activities of brokerage of drugs" are inserted between the words "prepared, kept or stored", and the words "or other places subject to their control.
S. 16 article 14 bis of the same Act, inserted by the Act of 22 December 2003 and amended by the law of 1 May 2006, is complemented by a § 5, worded as follows: ' ' § § 5 5 The King may determine the guidelines that are followed when performing inspections. ».
S. 17. article 14ter of the Act, inserted by the Act of May 1, 2006, is replaced by the following: «art.» 14B. § 1. The FAMHP, the competent authorities of other Member States and the EMA cooperate at the level of the inspections. This cooperation is a sharing of data both on scheduled inspections and inspections carried out. With regard to the inspections in third countries, cooperate for the coordination of inspections. If an inspection results lead to the conclusion that the principles and guidelines for good practices that must be respected in the manufacture of drugs are not, this information is also transmitted to the EMA.
Inspections at manufacturers, importers and distributors of medicinal products, active substances and excipients can also occur with those established in the Union and in third countries at the request of another State member of the Commission European or EMA.
King lays down the cases in which and the terms according to which the findings of the inspections carried out by the competent authorities of other Member States can be recognized.
Also by Decree deliberated in the Council of Ministers determines the scope and modalities of inspections referred to in this paragraph, including the definition of information that can be shared.
§ 2. The King may take measures to ensure cooperation between the competent authorities for medicines and the Customs authorities with regard to the application of this Act. ».
S. 18. in article 16, § 3, 1 °, of the same Act, replaced by the law of 1 May 2006, the words "of article 7bis, of article 8' are replaced by the words"of article 7bis, of article 7B article 8 of"and the words"or article 12sexies"shall be replaced by the words", article 12sexies or article 12octies.
3. - entry into force art. 19. this Act comes into force the first day of the month following the day of its publication in the Moniteur belge, with the exception of article 12bis, § 4, paragraphs 7 to 10 of the Act of 25 March 1964 on medicines, as inserted by the Act, which enters into force no earlier than July 2, 2013.
CHAPTER 4. -Provisions transitional art.
20. persons performing brokering activities of medicinal products as referred to in article 12octies of the law of 25 March 1964 on medicines, as inserted by the Act, which had begun their activities before the entry into force of this Act register no later than 2 months after its entry into force.
Importers, manufacturers and distributors of active substances referred to in article 12A, § 4, paragraph 1, of the law of 25 March 1964, as inserted by the Act, which had begun their activities prior to the entry into force of this Act register no later than two months after its entry into force. Promulgate this Act, order that it self under the seal of the State and published by le Moniteur.
Given to Brussels, June 20, 2013 ALBERT by the King: the Minister of Social Affairs and public health, Beliris and Federal Cultural Institutions, Ms. L. ONKELINX sealed with the seal of the State: the Minister of Justice, Mrs.
TURTELBOOM _ Note Documents of the Chamber of representatives: 53-2796-2012/1013: No. 1: Bill.
No. 2: report.
No. 3: Text corrected by the commission.
No. 4: Text adopted in plenary meeting and transmitted to the Senate.
Full record: 29 and 30 may 2013.