FAMHP
| Federal Agency for Medicines and Health Products, FAMHP (former Directorate-General for Medicinal Products of the FPS Public Health) Created: 01.01.2007 Minister responsible: Laurette Onkelinx, Vice-Prime Minister and 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: 341 employees on 01.01.2009, 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.
Our role
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.
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
Our new organization chart
From February 1th 2009 our activities are divided into three Directorates-General (DG), also called pillars: DG PRE, DG POST and DG INSPECTION.
DG PRE or PRE-pillar or all the activities prior to the first marketing authorisation for a medicine or health product.
DG POST or POST-pillar or all the activities after the first marketing authorisation for a medicine or a health product.
DG INSPECTION or INSPECTION pillar or all inspection and control activities.
organization chart (PDF, 104.01 Kb)
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.