|Federal Agency for Medicines and Health Products, FAMHP (former Directorate-General for Medicinal Products of the FPS Public Health)
Minister responsible: Maggie De Block, Minister of Social Affairs and Public Health
Chief Executive Officer: Xavier De Cuyper Public service institution with a legal personality, classified under category A Competent authority for the quality, safety and efficacy of medicines and health products Fields of competency: research and development (R&D), registration and marketing authorisation, production and distribution (inspection and control activities), vigilance, proper use of medicines and health products Personnel: 390 employees on 01.01.2012 most with scientific qualifications (doctors, pharmacists, veterinarians) Slogan : “Your medicines and health products are our concern.”
Who are we ?
The FAMHP is the competent authority responsible for the quality, safety and efficacy of medicines and health products. We work together with health professionals and other competent authorities at the national and international level to ensure the population the optimal use of the medicines and health products they need.
In the interest of public health the FAMHP ensures the quality, safety and efficacy of medicines and health products in clinical development and on the market.
The values nurtured within the FAMHP are carefully selected and form the unifying theme in our day-to-day activities:
Our mission in its legal context*
The FAMHP ensures, from development to use, the quality, safety and efficacy of medicines for human and veterinary use (including homeopathic medicines, herbal medicines, pharmacy made and officinal preparations) and also medical devices and accessories, and raw materials for the preparation and production of medicines.
From collection touse, the FAMHP ensures the quality, safety and efficacy of all the operations involving with blood, cells and tissues.
*The law of 20.07.2006 concerning the establishment and functioning FAMHP
From February 1th 2009 our activities are divided into three Directorates-General (DG), also called pillars: DG PRE authorisation , DG POST authorisation and DG INSPECTION.
Directorate-General PRE authorisation or all the activities prior to the first marketing authorisation for a medicine or health product.
Directorate-General POST authorisation or all the activities after the first marketing authorisation for a medicine or a health product.
Directorate-General Inspection or all inspection and control activities.
Our fields of competency or activities.
In terms of research and development (R&D) the FAMHP evaluates, approves, follows and controls the requests for clinical trials for medicines and health products. We also give scientific advice.
In terms of registration or marketing authorisation of medicines, the FAMHP is in charge of evaluating new requests for registration or marketing authorisation of a medicine or of requests to change existing registrations or marketing authorisations.
In terms of vigilance the FAMHP supervises the adverse effects due to the use of medicines or health products by collecting information. Information is gathered and evaluated and, if necessary, measures are taken.
In terms of production and distribution the FAMHP grants authorisations and checks that medicines and health products are conform current regulations concerning manufacture, distribution, delivery, imports and exports. It also controls pharmacists’ activities and combats illegal practices.
In terms of proper use the FAMHP sees to it that patients have relevant information so that medicines and health products are used rationally and safely. It also controls advertising for medicines and health products.
Within the FAMHP’s structure, in addition to the effective performance of the basic tasks, special attention will also be focused on a number of “centres of excellence” or spearheads.
Spearheads are fields in which the FAMHP wishes to excel.
Three spearheads (two substantive and two process-based) were chosen:
- Early phase development
Committees established within the FAMHP
Three committees provide direct advice to the Chief Executive Officer about how the FAMHP is functioning and how it can achieve its objectives.
The Transparancy Committee provides advice on management issues.
Representatives of the sectors contributing to the agency’s income are represented in the Transparency Committee, as well as an inspector
of finance, the Chief Excecutive Officer of FAMHP and a representative of the Minister for Public Health.
The Consultative Committee provides the FAMHP with advice on all matters relating to present or future policy. Representatives of patients and consumers and from all sectors involved in products falling under the agency’s competency are involved in the Consultative Committee, as well as representatives from the relevant federal public services.
The Scientific Committee provides advice regarding matters for which the agency is competent.
This Committee is a body of scientific expertise and coordinator for various commissions active within the FAMHP.
Advice commissions established within the FAMHP
Various commissions have been established within the FAMHP.
These include the following commissions (link to the page "Commissions"):
- Commission for medicines for human use
- Commission for homeopathic medicines for human and veterinary use
- Commission for herbal medicinal products for human use
- Commission for medicines for veterinary use
- Evaluation Commission for Medical Devices
- Joint Commission - Chamber for products for human use
- Joint Commission - Chamber for products intended for animal
In order to ensure transparency and in compliance with legal requirements, the FAMHP publishes information relating to these commissions set up within the Agency. This is information about the mission, the composition, the house rules, and the agenda of meetings of each committee listed above.
This information shall be supplemented regularly by the public agendas and minutes of the meetings and by the declaration of interests of its members.
Partners receiving financial support from the FAMHP
The Belgian Centre for Pharmacotherapeutic Information asbl/vzw (BCFI/CBIP) is subsidised and logistically supported by the FAMHP and issues the Commented Repertory of Medicines, the Folia Pharmacotherapeutica and the Transparency worksheets. These publications are sent for free to doctors, pharmacists and dentists.
The aim of CBIP/BCFI is to promote the rational use of medicinal products. For that reason, it is critical that health workers can rely on objective, recent and easily accessible information, prepared with due respect to the principle of evidence-based medicine.
You can find additional information on www.cbip.be.
Farmaka is subsidised by the FAMHP and follows up every day the MRS form, organises independent medical examinations, conducts literature studies and manages various projects.
Farmaka aims to contribute to the rational use of medicines and health care facilities through research and projects, in order to make this knowledge available to health care professionals, consumers and public authorities.
For additional information: www.farmaka.be.
Amcra asbl/vzw is financed by the FAMHP and provides advices in a neutral and objective manner and works to raise public awareness to reach a rational reduction of antimicrobial use in veterinary medicine in Belgium.
The aim of Amcra is to reach a sustainable policy regarding antibiotics to guarantee public and animal health and animal welfare.
More info on www.amcra.be.