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20 JULY 2006. - Act respecting the creation and operation of the Federal Agency for Drugs and Health Products (1)

ALBERT II, King of the Belgians,
To all, present and to come, Hi.
The House of Representatives adopted and sanctioned the following:
CHAPTER I^er. - General provision - Definitions
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
Art. 2. Unless otherwise stipulated, the following provisions shall apply to this Act by:
1° "Minister": the Minister who has Public Health in his or her duties;
2° "Medicine Act": the Act of March 25, 1964 on Drugs;
3° "drugs": those covered by Article 1^er§ 1^er(1), of the Medicination Act;
4° "medical devices and accessories": those referred to in Article 10, § 7, 1° and 2°, of the Medicines Act;
5° "Raw materials": all substances as defined in Article 1^er§ 1^er, 2) of the law on medicines;
6° "blood": blood as defined in Article 1^erthe Act of 5 July 1994 on blood and blood derivatives of human origin;
7° Tissue and Cells: those referred to in the Act of June 13, 1986 on organ transplantation and transplantation;
8° "health products": products covered under 4°, 5°, 6° and 7°;
9° "European Agency": the European Medicines Agency as defined in Article 1^er§ 1^er, 33), the Medicines Act.
CHAPTER II. - Agency skills and missions
Art. 3. It is created under the name "Federal Agency for Medicines and Health Products", hereafter referred to as the "Agency", a public interest body with legal personality, classified in category A referred to in the Act of March 16, 1954 relating to the control of certain bodies of public interest.
Art. 4. The Agency's mission is to ensure, from their design to their use, the quality, safety and efficacy of human-use drugs, veterinary medicines, including herbal and homeopathic drugs, medical devices and accessories, magisterial preparations, informal preparations, raw materials for the preparation and production of drugs.
The Agency's mission is also to ensure, from their removal to their use, the quality, safety and effectiveness of all operations with blood, tissue and cells.
In particular, it is responsible for:
1° in research and development: control the risks to which the patient is subjected during the development phase of a drug or health product:
a. assessing applications for authorization for clinical trials, including the coordination of Good Clinical Practices inspections;
b. approving clinical trial applications;
c. Monitoring and monitoring of clinical trials;
d. providing scientific advice to the applicant;
2° in terms of marketing:
a. to evaluate new applications for marketing authorizations;
b. to assess records relating to amendments and requests for extensions of initial marketing authorizations;
c. granting marketing authorizations;
3° in respect of vigilance: to collect and evaluate all relevant information concerning the products referred to in paragraph 1^erfor the purpose of detecting, reducing and avoiding adverse effects for the user by:
a. centralizing and evaluating the notifications of adverse events or incidents by health care professionals and patients, as well as vigilance reports;
b. controlling the vigilance obligations of market authorization holders or manufacturers;
c. working with the European Agency, the competent authorities of other EU Member States and the holders of marketing authorizations;
d. implementing risk interventions;
e. dealing with " rapid alerts of vigilance";
4° in production and distribution: to control the manufacture, distribution and delivery of the products referred to in paragraph 1^erin order to grant authorizations, licences and certificates for the manufacture, distribution, control and delivery of these products, as well as to combat fraud in:
a. inspecting the manufacturing enterprises of the products referred to in paragraph 1^er;
b. inspecting pharmaceutical companies or other bodies that collect, import, export, store and/or distribute products referred to in paragraph 1^er;
c. inspecting companies as part of the control of raw materials for master preparations;
d. inspecting open-ended pharmaceuticals, hospital pharmacies and product deposits referred to in paragraph 1^er;
e. granting authorizations for the establishment and transfer of open pharmaceuticals to the public;
f. monitoring the trade of specially regulated products;
g. countering fraud in the manufacture, distribution, issuance and use of products referred to in paragraph 1^er;
h. granting authorizations, approvals and certificates for the collection, conservation, manufacture, distribution, control and issuance of products referred to in paragraph 1^er;
i. controlling accredited authorities to provide CE marking to medical devices and accessories;
j. dealing with rapid alerts of quality;
5° in terms of health information and communication, advertising and marketing, for the rational and safe use of the products referred to in paragraph 1^er :
a. ensure the dissemination of information on the good use of the products referred to in paragraph 1^er;
b. to broadcast alerts in respect of pharmacovigilance, materialovigilance, hemovigilance or other cases of vigilance with respect to the products referred to in paragraph 1^er;
c. ensure the monitoring and control of advertising and information on products referred to in paragraph 1^er;
6° with respect to legislation: to propose to the Minister the regulations for matters within the Agency's jurisdiction and to ensure the monitoring, enforcement, control of the following regulations related to its missions and their enforcement orders:
(a) the Act of 24 February 1921 on trafficking in poisonous, soporific, narcotic, psychotropic, disinfectant or antiseptic substances and substances that may be used for the illicit manufacture of narcotic and psychotropic substances;
(b) the Medicines Act of 25 March 1964;
(c) the Act of 15 July 1985 on the use of hormone-effect substances, anti-hormonal effect, beta-adrenergy effect or stimulator effect in animals;
(d) the Act of 13 June 1986 on organ transplantation and transplantation with respect to cells and tissues;
(e) the Act of 28 August 1991 on the Exercise of Veterinary Medicine with regard to the provision of medicines to animal officials;
(f) Royal Decree No. 78 of 10 November 1967 relating to the exercise of health care professions with regard to the issue of medicines to the public;
(g) The Blood and Blood Derivatives Act of 5 July 1994;
(h) the Human Person Experiments Act of 7 May 2004;
7° in health care: to collaborate and participate in the work of the health care unit referred to in Article 37bis, Royal Decree No. 78 of 10 November 1967 on the exercise of health care professions.
Art. 5. The King, by deliberation in the Council of Ministers, determines within the framework of the Agency's competence the tasks for which the Agency may be assisted by third parties or that the Agency may enforce by third parties and determine the conditions related thereto.
Art. 6. The King determines the conditions under which each of the senior officials of the Agency, the Federal Public Service Public Health, the Safety of the Food Chain and Environment and the Scientific Institute of Public Health sits in each of the other Executive Committees and/or Strategic Councils of which he is not a member.
Art. 7. Without prejudice to the other powers granted under this Act, the King may set out the conditions under which the Agency may work together to support the missions of the Federal Public Service Public Health, Food and Environment Safety, including its advisory, consultation and guidance bodies. The King may also determine the conditions under which the Agency can work with other State agencies, in particular the Federal Agency for Food Chain Security and INAMI, and seek advice from third parties.
CHAPTER III. - The deputy head and staff
Art. 8. § 1^er. The Agency is headed by a Director General, appointed by a term of office, for a term of six years renewable, in accordance with the terms and conditions established by Royal Decree deliberated in the Council of Ministers, after agreement of the Minister of Public Service.
The King may, by order deliberately in the Council of Ministers, after agreement of the Ministers of Budget and Public Service, establish other management functions.
§ 2. Daily management is entrusted to the deputy head. This includes management competencies for Agency staff. The King may also assign specific skills to the deputy head.
§ 3. Prior to its entry into office, any member of the Agency's statutory or contractual personnel shall declare the interests that the Agency has in any establishment or business within the jurisdiction of the Agency and undertakes to inform the Agency of any changes to the stated interests.
The King determines, by royal decree deliberated in the Council of Ministers, the conditions under which the Agency organizes the service to prevent any conflict of interest.
Art. 9. The Agency is subject to the minister's authority.
The Agency transmits to the Minister and Parliament an annual report on its activities, including the results of its missions.
It draws the annual performance account of its budget by 30 April, as well as an active and passive situation by 31 December of the year under review.
CHAPTER IV. - Advisory Committee, Scientific Committee and Transparency Committee
Art. 10. An Advisory Committee is established with the Agency to advise the Agency, both on the initiative of the Committee and at the request of the Minister or the deputy head, on all matters relating to the policy followed and to be followed by the Agency.
In any case, this Committee shall include representatives of the federal authority, sectors concerned with matters within the jurisdiction of the Agency, insurers and chairs of the Commissions established pursuant to the regulations referred to in Article 4, paragraph 2, 6°.
The King shall determine by order deliberately in the Council of Ministers the composition, the rules relating to the execution of the duties of the Committee, the terms and conditions for the designation of members, its operation and the date of its installation.
Art. 11. A Scientific Committee is established with the Agency, composed of the chairs of the Commissions established pursuant to the regulations referred to in Article 4, paragraph 2, 6°.
This Committee is the body of scientific expertise and coordination among the above-mentioned Commissions. As such, it shall provide advice, both on its own initiative and at the request of the Minister or the deputy head, on matters within the Agency's jurisdiction.
The Committee is informed of draft laws or royal decrees relating to matters within the Agency's competences.
The King determines, by order deliberately in the Council of Ministers, the rules relating to the execution of the Committee's missions, its operation and the date of its installation.
Art. 12. A Transparency Committee shall be established with the Agency, consisting of a representative of the Minister, the deputy head, representatives of the sectors contributing to the revenues referred to in Article 13, § 1^er, 2°, and a Finance Inspector designated by the Minister who has the Budget in his duties.
The Transparency Committee receives all information on how the above-mentioned revenues are used. Representatives of the above-mentioned sectors may request any information they consider relevant to the management of these revenues. The Committee is also competent to provide advice and suggestions on the management plan.
The reports of the meetings of the Transparency Committee are transmitted to the Advisory Committee.
The King shall determine by order deliberately in the Council of Ministers the composition, the rules relating to the execution of the duties of the Committee, the terms and conditions for the appointment of members, its operation and the date of its installation.
CHAPTER V. - Agency funding and resources
Art. 13. § 1^er. The Agency is funded by:
1st general budget appropriations;
2° revenues resulting from the application of the regulations referred to in section 4, paragraph 2, 6°, and sections 224 and 225 of the Act of 12 August 2000 on social, budgetary and other provisions;
3° revenues from the European Union relating to the activities of the Agency;
4° administrative fines resulting from the exercise of its control skills;
5° gifts and bequests;
6° with the agreement of the Minister who has the Finance in his powers, the proceeds of the investment of financial reserves;
7° of casual recipes;
8° any other recipe from the execution of his missions.
§ 2. The King, after the advice of the Transparency Committee, determines, by order deliberately in the Council of Ministers, in accordance with the regulations referred to in Article 4, paragraph 2, 6°, the amount of the remuneration, as well as the time and manner of their perception.
§ 3. The Agency is authorized, under the agreement of the Minister who has the Finance in his or her powers, to enter into borrowings that may benefit from the guarantee of the State and to have its financial reserves.
§ 4. Under the conditions established by the King, by a deliberate order in the Council of Ministers, the Agency may be authorized to establish a reserve fund.
Art. 14. The Agency may acquire the equipment and facilities necessary to carry out its duties.
The State may make the services, equipment and facilities belonging to the State or to a public body that are necessary for the execution of the Agency's missions, as defined in Article 4.
CHAPTER VI. - Amendments and abrogations
Art. 15. Article 1^er of the Act of 16 March 1954 on the Control of Certain Public Interest Organisms, are inserted in alphabetical order in category A, the words "Federal Agency for Drugs and Health Products".
Art. 16. Article 1^er, 3°, of the Act of 22 July 1993 on certain measures relating to public service, amended by the Acts of 24 December 2002, 7 January 2003, 27 February 2003, 3 April 2003, 27 December 2004 and 12 January 2006, is supplemented as follows: "Federal Agency for Drugs and Health Products".
Art. 17. In the table annexed to the Organic Law of 27 December 1990 creating budgetary funds, last amended by the Act of 27 December 2005, subrubricant 25-3 "Medicine Funds" is repealed.
CHAPTER VII. - Transitional, final and effective provisions
Section 1. - Transitional provisions
Art. 18. As long as the royal decree provided for in Article 8, § 1^erParagraph 1^er, has not entered into force, the selection and designation of the deputy head shall be carried out in the following manner:
In order to participate in the comparative selection for the position of deputy head, candidates must have a level A function or be able to participate in a comparative selection for a level A function in a federal public service.
Applicants to the position of deputy head must have a management experience of at least six years or have a useful professional experience of at least ten years. By management experience, there is a management experience within a public service or a private sector organization.
Applicants to the position of deputy head must have the skills and relationships, organization and management skills set out in the job description and the competency profile for the management function to be conferred.
The description of the function and the competency profile of the deputy head function are determined by the Minister.
Applications are submitted to SELOR - Federal Administration Selection Office - which examines the admissibility of these applications under the general and specific eligibility requirements.
Nominations declared admissible by SELOR - Federal Administration Selection Office - are forwarded to the selection committee.
Applicants whose application has been declared admissible present, before the selection committee, an oral examination at the beginning of a practical case relating to the management function to be filled.
The purpose of this test is to evaluate both the specific skills of the function to be exercised and the skills required to perform a management function.
At the end of the tests and the comparison of the titles and merits of the candidates, candidates for the position of deputy head are registered in the "fit" group or in the "unfit" group. This registration is motivated.
In the "fit" group, candidates are ranked.
The selection commission consists of:
1° of the SELOR Delegate Administrator - Federal Administration Selection Office - or its delegate, President;
2° of an external expert in management;
3° of an external human resources management expert;
4° of two external experts with a particular experience or knowledge of the materials specific to the function to be filled;
5° of two officers from a federal public service or a federal public service of programming, a federal department, a public social security institution, a federal scientific institution, a federal public service agency or, the services of the Governments of Region or Community or the Colleges of Community Commissions, performing at least equivalent functions to the management function to be filled;
6° of an alternate for each member under 2° to 5°. These are designated at the same time as the actual members.
Linguistic parity is ensured in each of the actual and alternate members of the selection committee referred to in paragraph 9. The effective member referred to in paragraph 9, 2°, together with the alternate member, shall be of the other linguistic affiliation than that of the effective member referred to in paragraph 9, 3°, and its alternate member. Linguistic affiliation is determined, with respect to the members referred to in paragraph 9, 2°, 3° and 4°, and their alternates, by the language of the certificate or diploma sanctioning the success of the studies taken into account for the assessment of the competence required for the mission of expertise. For members referred to in clause 9, 5°, and their alternates, linguistic membership is determined by the language role of the agent or pursuant to sections 35 to 41 of the ordinary law of August 9, 1980 of institutional reforms.
The profiles of the actual members of the selection committee referred to in paragraph 9, 2°, 3°, 4° and 5°, as well as those of their alternate members, are determined by SELOR - Federal Administration Selection Office - in consultation with the Minister.
When a management function is open to candidates of both language roles, the president of the selection commission must either have proved the knowledge of the second language in accordance with Article 43, § 3, paragraph 3, of the laws on the use of languages in administrative matters, coordinated on 18 July 1966 or be assisted by an officer who proved that knowledge.
When a management function is opened only to candidates of a single linguistic role, or when only candidates of a linguistic role remain after the examination of the admissibility of applications by SELOR - Bureau de sélection de l'Administration fédérale -, the selection committee is composed of a single representative per category of members referred to in paragraph 9, 2°, 3°, 4° and 5°. They are of the same role or of the same linguistic affiliation as candidates.
The chair of the selection board shall not be assisted by an officer referred to in paragraph 12 if it is of that role or linguistic affiliation.
The delegated administrator of the SELOR - Bureau de selection de l'Administration fédérale - communicates the composition of the selection committee, including alternates, to the Minister who has the Public Service in his or her duties. The latter shall promptly inform the members of the government who have a seven working days deadline to transmit their objections. In this case, the Minister who has the Public Service in his or her powers submits a complete file for decision to the Council of Ministers after having forwarded a copy to the member of the Government concerned.
If the Council of Ministers, on the basis of the file submitted by the Minister who has the Public Service in his or her powers, challenges a member of the selection committee, SELOR - Federal Administration Selection Office - designates another member; in that case, paragraph 1^er is applicable.
The selection board may not validly proceed to the examination of candidates and the deliberation as long as the majority of members are present, at least two of them are the candidate's linguistic role and each category of members referred to in paragraph 9, 2° to 5°, is represented.
Only the members of the commission who have conducted the hearing of all candidates may take part in the deliberation for the registration of the said candidates in "fit" and "unfit" groups. No member can abstain.
In the event of a vote-sharing, the president decides.
Applicants are informed of their registration in the "fit" or "not fit" group within fifteen working days after the selection committee's deliberation.
SELOR - Federal Administration Selection Office - communicates the result of the selection procedure to the Minister.
Complementary interviews are planned with candidates from the "fit" group to compare them with respect to their specific skills, their relational skills and their ability to lead with respect to the function description and the competency profile for the management function to be filled. This interview is conducted by the minister.
A report of each interview is written and attached to the designation file.
The chosen candidate is designated for a period of six years by the King by order deliberately in the Council of Ministers, on the proposal of the Minister.
Art. 19. § 1^er. From 1^er January 2007, the Federal Public Service Public Health, Food Chain Safety and Environment is discharged from the missions that are now assigned to the Agency.
§ 2. From 1^er January 2007, the Agency resumes the management of all cases that fall within its jurisdiction and which were introduced to the Federal Public Service Public Health, Food Chain Safety and Environment. The Agency is continuing its investigation. The deadlines for the procedures introduced to the Federal Public Service Public Health, Food Chain Safety and Environment remain unchanged.
The same applies to all files that, after 1^er January 2007 was incorrectly introduced to the Federal Public Service Public Health, Food Chain Safety and Environment for a period of 60 days on the day following 1^er January 2007. Beyond this period, the application is referred to the applicant and is considered unintroduced.
§ 3. At the time of its creation, furniture belonging to and/or made available to the Directorate General of Public Health Care, Food Chain and Environment Safety, are transferred to the Agency free of charge.
§ 4. The Agency succeeds in the rights and obligations of the Directorate General of Medicines and the Fund of Medicine, as defined in the table annexed to the Organic Law of 27 December 1990 creating budgetary funds, including its reserves as of 31 December 2006.
Art. 20. For the purpose of carrying out the duties assigned to the Agency, staff members - statutory and contractual - from the Federal Public Service Medical Branch Public Health, Safety of the Food Chain and Environment are transferred to the Agency.
For the support functions, candidates are selected following an appeal in the support functions of the Federal Public Service Public Health, Food and Environment Safety and following a selection procedure organized by the SELOR or its delegate.
Staff transferred to the Agency will continue their treatment and seniority.
Art. 21. The King may, by order deliberately in the Council of Ministers, repeal, supplement, amend, replace and coordinate the legal provisions referred to in Article 4, paragraph 2, 6°, as well as take measures and orders to carry out the transfer of competence, make the Agency operational, avoid conflicts of competence and ensure the optimal use of available means.
Royal orders issued pursuant to paragraph 1^er, are repealed in full law when they have not been confirmed by the legislator no later than eighteen months after 1^er January 2007.
Section 2. - Final provisions and entry into force
Art. 22. The King determines, by order deliberately in the Council of Ministers, the rules relating to the organization and operation of the Agency, provided that this has not been regulated in the Act of 16 March 1954 relating to the control of certain bodies of public interest or in this Act.
The Agency has its head office in Brussels. The King specifies the place of establishment.
Art. 23. This Act comes into force on 1^er January 2007.
However, articles 3, 8, 15, 18 and 20 come into force on the day of the publication of this Act to the Belgian Monitor.
Promulgate this law, order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given in Brussels on 20 July 2006.
ALBERT
By the King:
Minister of Social Affairs and Public Health,
R. DEMOTTE
Seal of the state seal:
The Minister of Justice,
Ms. L. ONKELINX
____
Note
(1) House of Representatives documents: 51-2437 - 2005/2006:
Number 1: Bill.
No. 2: Amendments.
Number three: Report.
No. 4: Text adopted by the commission.
No. 5: Amendments.
No. 6: Text adopted in plenary and transmitted to the Senate.
Full report: 24 May 2006.
Senate documents: 3-1730 - 2005/2006:
Number 1: Project referred to by the Senate.
No. 2: Amendments.
Number three: Report.
No. 4: Text corrected by the commission..
No. 5: Decision not to amend.
Annales du Sénat : 29 juin 2006.