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20 JUIN 2013. - 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:
- General provision
. This Act regulates a matter referred to in Article 78 of the Constitution.
This Act partially transposes the Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC establishing a community code on human-use drugs, with regard to the prevention of the introduction into the legal supply chain of falsified drugs, and transposes Article 1er
6), Directive 2012/26/EU of the European Parliament and Council of 25 October 2012 amending Directive 2001/83/EC with regard to pharmacovigilance.
CHAPTER 2. - Amendments to the Act of 25 March 1964 on Drugs
Art. 2. Article 1er
of the Act of 25 March 1964 on Drugs, inserted by the Law of 1er
May 2006 and amended by the Acts of 3 August 2012 and 19 March 2013, the following amendments are made:
1° ) the 1bis, as follows, is inserted between points 1) and 2):
"1bis", "falsified medicine": any medication with a false presentation of:
(a) its identity, including its packaging and labelling, its name or composition with respect to any of its components, including excipients, and the dosage of these components;
(b) its source, including its manufacturer, country of manufacture, country of origin or licensee of its marketing authorization; or
(c) its history, including records and documents relating to distribution circuits used.
This definition does not include non-intentional quality defects and does not imply violations of intellectual property rights; »;
2° ) the 2bis) and 2ter, as follows, are inserted between (2) and (3):
"2bis) "active substance":
any substance or mixture of substances intended to be used for the manufacture of a drug that, when used for its production, becomes an active ingredient of the drug carrying pharmacological, immunological or metabolic action to restore, correct or modify physiological functions, or to establish a medical diagnosis;
any component of a drug, other than an active substance and packaging materials; »;
3° ) the 17bis, as follows, is inserted between 17) and 18):
« 17bis) « medicine brokerage » :
any activity related to the sale or purchase of drugs, with the exception of wholesale distribution, which does not include physical handling of drugs and that consists in negotiating, independently and on behalf of a natural or legal person; "
Art. 3. Article 1er
bis of the same law, inserted by the law of 21 June 1983 and amended by the laws of 20 October 1998 and 1er
May 2006, the following amendments are made:
1° ) in § 1er
, 1°, 2°, 3° and 4°, the words "elements, materials" are inserted each time between the word "to" and the words "objects, devices";
2° ) § 1er
is completed by the 5th, as follows:
"5° elements and materials in the manufacture of objects, apparatus, substances or compositions referred to in points 1°, 2°, 3° and 4° and intended to be used for them, and which are essential to their integrity. "
3° ) in § 2, the words "element, material" are inserted between the words "to any other" and the words "object, device";
4° ) in § 3, the words "elements, materials" are inserted between the words "for regulation of" and the words "objects, devices".
Art. 4. In Article 3, § 4, of the same law, inserted by the law of 1er
May 2006, a paragraph to read is inserted between subparagraphs 1er
"The King also sets out the terms and conditions for the remote supply of drugs not subject to prescription by means of information society services. To this end, It sets out the conditions to which the website offering for remote sale these drugs must satisfy as well as the characteristics of the logo that is recognizable through the Union and that allows the identification of the Member State in which the person offering remotely the drugs to the public is established. This logo is clearly displayed on websites offering remotely selling drugs not subject to prescription to the public. The AFMPS provides on its website a list of persons offering the remote sale of non-prescription drugs to the public in accordance with this paragraph through the services of the information society and the address of the website of these persons. "
Art. 5. In Article 6, § 1er
of the same law, inserted by the law of 1er
May 2006 and amended by the Act of 3 August 2012, paragraphs 6 and 7 are replaced by the following:
"The King sets out the content and conditions to which the outer packaging, primary packaging and labelling of drugs meet.
For this purpose, it may impose safety devices for drugs other than radiopharmaceutical drugs, to be placed on the outer packaging or, if not, on the primary packaging, allowing wholesale distributors, wholesalers, and authorized or authorized persons to deliver drugs to the public:
- verify the authenticity of the drug, and
- to identify individual drug boxes,
as well as a device to verify whether the outer packaging has been erased in order, in particular, to ensure the integrity of the outer packaging.
Because of their nature, it may impose additional mentions for certain specific drugs.
References on outer packaging, primary packaging and labelling are listed so that they are easily readable, clearly understandable and indelible. »
Art. 6. In article 6ter, § 2, of the same law, inserted by the law of June 21, 1983, the words "elements, materials" are inserted between the words "to detail" and the words "objects, devices".
Art. 7. Section 6s of the same law, inserted by the law of 1er
May 2006 and amended by the Act of 3 August 2012, the current text of which will form paragraph 1er
, is supplemented by paragraph 2, as follows:
“§2. Prescription drugs have a safety device as referred to in Article 6, § 1er
Quiet, unless the King steals it.
Drugs not subject to prescription shall not be provided with a security device as referred to in Article 6, § 1er
Quiet, unless the King steals it.
In the determination of drugs or classes of medicines referred to in paragraph 1er
and 2, consideration is given to the risk of falsification and the risk of falsification with respect to these drugs or these categories of medicines. To this end, in any event, the following criteria are applied:
1° ) the price and volume of sales of the drug;
2° ) the number and frequency of previous cases of falsified medicines notified in the Union and in third countries and the evolution of the number and frequency of these previous cases to date;
3° ) the specific characteristics of the medications concerned;
4° ) the severity of the conditions to be treated;
5° ) other potential risks to public health.
The King sets out the technical specifications and specifications of the unique identifier of security devices as referred to in Article 6, § 1er
quinquies, allowing to verify the authenticity of medications and to identify individual boxes. In this setting, due consideration shall be given to their cost-effectiveness.
Security devices may not be removed or partially or completely covered, except in the circumstances and conditions determined by the King. For this purpose, the King determines the criteria to which security devices meet in order to be considered equivalent, after replacing the security devices referred to in Article 6, § 1er
quinquies, paragraph 6.
The King sets out the procedures for the verification of safety devices by manufacturers, wholesale distributors, pharmacists and persons authorized to deliver drugs to the public and by the AFMPS. These methods allow you to verify the authenticity of each distributed drug box carrying safety devices and to determine the extent of this verification.
The King determines the modalities for the establishment, management and accessibility of the data bank system containing information on safety devices to verify the authenticity of drugs and identify them. The costs associated with this system are borne by the holders of a manufacturing authorization for drugs with safety devices.
By determining the terms and conditions referred to in paragraph 7, it may determine that the establishment, management and accessibility of this data bank system is provided by a body approved by Him under the conditions established by Him.
AFMPS shall notify the European Commission of the non-prescription drugs for which AFMPS considers that there is a risk of falsification and may inform the European Commission of the drugs that it considers to be not affected by this risk on the basis of the criteria referred to in paragraph 3.
The King may, for purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier of security devices as referred to in Article 6, § 1er
quinquies, to any medication subject to prescription or subject to reimbursement.
The King may, for patient safety purposes, extend the scope of the anti-efficiency device of safety devices as referred to in Article 6, § 1er
Quiet, other drugs.
The Minister or his delegate may, for purposes of reimbursement, pharmacovigilance or pharmacoepidemiology, use the information contained in the data banks system referred to in paragraph 7, in accordance with the terms and conditions established by the King.
When adopting the measures referred to in this paragraph, the King also takes into consideration at least the following points:
1° ) the protection of personal data under the Act of 8 December 1992 on the protection of privacy with respect to personal data processing;
(2) the legitimate interests of protection of confidential business information;
3° ) the ownership and confidentiality of data generated by the use of security devices; and
4° ) the cost/effectiveness of the measurements. "
Art. 8. In the same Act, an article 7ter is inserted, as follows:
"Art. 7ter. Without prejudice to articles 7 and 7bis, the King is developing a system that is intended to prevent drugs suspected of being falsified, non-compliant, or that have a potential public health hazard from occurring in patients.
The system referred to in paragraph 1er
covers the receipt and treatment of notifications of drugs suspected of being falsified or being affected by a quality defect. This system also covers recalls of medicines made by MMA holders or withdrawals of medications from the market ordered by the Minister or his delegate to all relevant actors in the distribution chain, during and outside normal working hours. The system also allows medication reminders to patients who have received these drugs, if necessary with the assistance of health professionals.
If the drug in question is suspected of presenting a serious risk to public health, the Minister or his or her delegate shall promptly transmit a notification of early warning to all actors in the distribution chain and to the competent authorities of all Member States. If it appears that the medications in question have been delivered to patients, public releases are issued urgently, within 24 hours, in order to recall these medications to patients. These releases contain sufficient information on the lack of quality or suspected falsification and the resulting risks. "
Art. 9. Article 8bis, paragraph 1er
of the same law, inserted by the law of 1er
May 2006 and replaced by the Act of 3 August 2012, is supplemented by (h), as follows:
"(h) or the manufacture of the drug does not take place in accordance with the information provided at the MMA's request for the method of manufacture or if the controls of the drug do not take place in accordance with the information provided at the MMA's request for control methods used by the manufacturer or stakeholders in the manufacturing process. "
Art. 10. In section 10 of the Act, replaced by the Act of 16 December 2004 and amended by the Act of 19 March 2013, the following amendments are made:
1° ) in § 1er
, the words "to persons engaged in brokering activities" are inserted between the words "to wholesalers" and the words "to persons authorized to prescribe,"
2° ) in § 3, paragraph 1er
, the words ", people carrying brokerage activities" are inserted between the words ", importers" and the words "and wholesalers".
Art. 11. Article 12bis of the same law, inserted by the law of 1er
May 2006 and amended by Acts of 23 December 2009, 3 August 2012 and 19 March 2013, the following amendments are made:
1° ) in § 1er
Paragraphs 7 and 8 are replaced by the following:
"The data on the authorizations granted are entered into the Union data bank, which is managed by the EMA on behalf of the Union, hereafter referred to as the "European data bank".
Certificates of good manufacturing practices are included in the European data bank. Information on the registration of importers and manufacturers of active substances is also included in the aforementioned data bank. »;
2° ) in § 1er
Paragraph 11 is replaced by the following:
"The King sets out the principles and guidelines for good drug manufacturing practices. The King also sets out the principles and guidelines for good manufacturing practices for active substances.
When manufacturing, only active substances manufactured in accordance with good manufacturing practices for active substances and distributed in accordance with good practices for the distribution of active substances can be used. The King determines how this is controlled.
The licensee of the manufacturing authorization ensures that excipients are appropriate for use in medicines by determining which good manufacturing practices are appropriate. This determination is made on the basis of a formalized risk assessment, in accordance with the guidelines established by the King. This risk assessment takes into account the requirements imposed by other appropriate quality systems, as well as the anticipated source and use of excipients, and previous quality defects. The licensee of the manufacturing authorization shall ensure that appropriate good manufacturing practices so determined are applied. The licensee shall document the measures taken under this paragraph. »;
3° ) § 1er
is supplemented by a paragraph that reads as follows:
"The holders of a manufacturing authorization, including those carrying out the activities referred to in paragraph 2, are considered to be producers and are therefore liable for the damage caused in the cases and conditions provided by the Act of 25 February 1991 relating to the liability of defective products. »;
4° ) the article is supplemented by a § 4, written as follows:
“§4. Importers, manufacturers and distributors of active substances established in Belgium register their activity with the Minister or his delegate. This registration is also required if the active substance is manufactured for export.
The King sets out the conditions, deadlines and terms of the registration, as well as the conditions to be met by the registration holders. It sets out the content of the application for registration and may determine the form in which the application must be filed.
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 time limit set by the King, the activity can be started. The registration may be accompanied, in order to ensure compliance with all the conditions established for the exercise of the registration activities, with certain obligations imposed either on the occasion of its grant or after its grant.
The data in the registration form will be entered into the data bank referred to in § 1er
The manufacture, import and distribution of active substances, including those intended for export, are consistent with good manufacturing and distribution practices for active substances.
Active substances may only be imported if they have been manufactured in accordance with standards of good manufacturing practices at least equivalent to those established in accordance with § 1er
In addition, active substances may only be imported if they are accompanied by a written confirmation from the competent authority of the exporting third country. This confirmation first attests that the standards of good manufacturing practices applicable to the establishment that manufactures the active ingredient exported are at least equivalent to those defined by the Union. Secondly, this confirmation attests that the manufacturing establishment concerned is subject to regular, strict and transparent controls and effective measures to maintain good manufacturing practices, including repeated and unannounced inspections, with a view to ensuring public health protection at least equivalent to that provided by the Union. Third, this confirmation attests that in the event that a non-compliance is found, the information relating to this finding will be immediately communicated to the Union by the third-country exporter.
This written confirmation is without prejudice to the obligations under Article 6, § 1er
2 and 3 and 12 bis, § 1er
paragraphs 11, 12 and 13.
Paragraph 7 is not applicable if the exporting country is listed by the European Commission in accordance with Article 111ter of Directive 2001/83.
In exceptional circumstances and in the event of a need to ensure the availability of drugs, where an establishment for the manufacture of an active substance for export has been inspected and has been in compliance with the principles and guidelines for good manufacturing practices of the latter, the Minister or his delegate may lift the above-mentioned requirement of written confirmation for a period not exceeding the validity of the certificate of good manufacturing practices. The Minister or his delegate immediately notify the European Commission. "
Art. 12. Article 12ter of the same law, inserted by the law of 1er
May 2006 and amended by the laws of 27 December 2006, 29 December 2010, 3 August 2012 and 19 March 2013, whose current text will form § 1er
the following amendments are made:
1° ) in § 1er
, paragraph 2, the second sentence is replaced by the following:
"In the case of a wholesale distribution of drugs to third countries, this condition and the condition provided for in paragraph 9 shall not apply. In addition, the King may specify which conditions do not apply when a drug is received directly from a third country without being imported. In this case, however, the wholesale distributor ensures that drugs are obtained only by persons who are authorized or authorized to distribute drugs in accordance with the legal and administrative provisions in force in the third country concerned. When wholesale distributors provide medicines to persons from third countries, they ensure that they only provide them to persons who are authorized or authorized to receive drugs for the wholesale distribution or delivery to the public in accordance with the legal and administrative provisions in force in the third country concerned. The King may also provide for exceptions in cases where in accordance with Community law non-authorized drugs for animal use may be used for the treatment of animals. »;
2° ) in § 1er
, paragraph 3, the following sentence is inserted after the first sentence:
"In the case of medications for which an AMM has been granted in accordance with Regulation No. 726/2004, the notification is also addressed to the holder of the MMA of the drug and to the MMA. »;
3° ) in § 1er
, paragraph 5, the second sentence is replaced by the sentence:
"The wholesale distribution of drugs is only valid for premises located in the Belgian territory indicated in the authorization as well as for medicines and pharmaceutical forms for which the authorization was requested and granted. »;
4° ) in § 1er
, paragraph 11, the words ", including the wholesale distribution of medicines to third countries," are inserted between the words "a wholesale distribution of drugs" and the words "are held in";
5° ) in § 1er
Paragraph 12 is supplemented by the following sentence:
"The King sets out the principles and guidelines for good practices in the distribution of active substances. »;
6° ) in § 1er
Paragraph 14 is supplemented by the following sentence:
"The control of persons authorized to exercise the bulk distribution activity of medicines, and the inspection of their premises, are carried out under the responsibility of the Member State which has granted authorization for premises located in its territory. »;
7° ) § 1er
is supplemented by a paragraph, which reads as follows:
"Information relating to the authorization referred to in paragraph 1er
, as well as certificates of good distribution practices issued, are entered into the European data bank referred to in Article 12bis, § 1er
. At the request of the European Commission or another Member State, all relevant data relating to the individual authorization referred to in paragraph 1er
are transmitted. Information on the registration of active substance distributors is also included in the aforementioned data bank. "
8° ) the article is supplemented by a § 2, written as follows:
“§2. The Minister or his delegate shall take the measures to ensure that the drugs that are introduced into Belgian territory but are not intended to be put on the market in Belgium are not put in circulation if there are sufficient evidence to suspect the falsification of these drugs.
The King may set the criteria to be considered and the verifications to be performed during the assessment of the potential falsification of drugs that are introduced into the Union but are not intended to be put on the market. "
Art. 13. In the same law, an article 12octies is inserted, as follows:
"Art. 12octies. Persons engaged in drug brokerage activities shall ensure that brokerage drugs are covered by an MMA granted under this Act. People engaged in drug brokering activities have a permanent address and contact information in the Union to enable the competent authorities to identify and locate them accurately, communicate with them and monitor their activities.
Persons engaged in brokering activities in Belgium notify the Minister or his or her delegate of their activities. The King determines the data to be notified to obtain a registration. The reported data are collected in a register that is made public by the AFMPS.
The King determines the conditions under which people engaged in drug brokering activities are held in the exercise of their activities.
The principles and guidelines of good practices referred to in Article 12ter, § 1er
Paragraph 12 includes specific brokerage provisions that are respected by persons engaged in brokering activities.
This section applies without prejudice to section 14. The inspections referred to in Article 14 shall take place under the responsibility of the Member State in which the person carrying out drug brokering activities is registered.
A delisting of the registry referred to in paragraph 2 shall take place where it is not meeting the requirements set out in this section. The person is aware of it. "
Art. 14. Article 13bis, inserted by the law of 29 December 1990 and amended by the Royal Decree of 22 February 2001 and the laws of 27 December 2004, 1er
May 2006, 13 December 2006, 27 December 2006, 21 December 2007 and 3 August 2012, the following amendments are made:
1° ) in § 1er
, the words "elements, materials" are inserted between the words "substances, compositions" and the words "objects, devices";
2° ) in § 2, the words "or the one who makes it a brokerage" are inserted after the words "in charge of the one who puts them on the market, distributes them or supplies them".
Art. 15. Section 14 of the Act, replaced by the Act of 22 December 2003 and amended by the Acts of 1er
May 2006, 27 December 2006 and 3 August 2012, the following amendments are made:
1° ) in § 1er
, paragraph 3, the words "elements, materials" are inserted between the words "substances or compositions" and the words "objects, devices,"
2° ) § 1er
bis 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" are inserted between the words "objects and devices" and the words" referred to in Article 1er
bis of this Act »;
- the words "in the premises of the holders of an AMM and those engaged in drug brokering activities" are inserted between the words "prepared, preserved or stored" and the words "or other places subject to their control".
Art. 16. Section 14bis of the Act, inserted by the Act of 22 December 2003 and amended by the Act of 1er
May 2006, is supplemented by § 5, which reads as follows:
“§ 5. The King may determine the guidelines that are followed when conducting inspections. "
Art. 17. Article 14ter of the same law, inserted by the law of 1er
May 2006, is replaced by the following:
"Art. 14ter. § 1er
. The AFMPS, the competent authorities of other member states and the EMA cooperate at the inspection level. This cooperation involves sharing data on both planned inspections and inspections. With regard to inspections in third countries, they cooperate in the coordination of inspections. If the results of an inspection result in 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 AMA.
Inspections of manufacturers, importers and wholesale distributors of medicines, active substances and excipients may also take place with those established in the Union and in third countries at the request of another Member State, the European Commission or the EMA.
The King sets out the cases in which and how the conclusions of the inspections carried out by the competent authorities of other Member States can be recognized.
It also determines by deliberate order 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.
§ 2. The King may take measures to ensure cooperation between the competent authorities for medicines and customs authorities with regard to the application of this Act. "
Art. 18. In Article 16, § 3, 1°, of the same law, replaced by the law of 1er
May 2006, the words "of Article 7bis, Article 8" are replaced by the words "of Article 7bis, Article 7ter, Article 8" and the words "or Article 12exies" are replaced by the words ", Article 12exies or Article 12octies".
CHAPTER 3. - Entry into force
Art. 19. This Act comes into force on the first day of the month following the day of its publication in the Belgian Monitor, with the exception of Article 12bis, § 4, paragraphs 7 to 10, of the Act of 25 March 1964 on medicines, as set out in this Act, which comes into force as early as 2 July 2013.
CHAPTER 4. - Transitional provisions
Art. 20. Persons engaged in drug brokering activities as referred to in section 12octies of the Medicines Act of March 25, 1964, as set out in this Act, who had commenced their activities prior to the coming into force of this Act, shall register no later than 2 months after its entry into force.
Importers, manufacturers and distributors of active substances referred to in Article 12bis, § 4, paragraph 1er
, of the Act of 25 March 1964, as set out in this Act, which had commenced their activities before the coming into force of this Act, shall register no later than two months after its entry into force.Promulsify this Act, order that it be coated with the seal of the State and published by the Belgian Monitor.
Given in Brussels, 20 June 2013
By the King:
Minister of Social Affairs and Public Health,
in charge of Beliris and Federal Cultural Institutions,
Ms. L. ONKELINX
Seal of the state seal:
The Minister of Justice,
Ms. A. TURTELBOOM
Documents of the House of Representatives:
53-2796 - 2012/1013 :
Number 1: Bill.
Number two: Report.
Number 3: Text corrected by commission.
No. 4: Text adopted in plenary and transmitted to the Senate.
Full report: 29 and 30 May 2013.