What does the FAMHP ?
What does FAMHP do ?
The FAMHP is the competent authority for medicines and health products in Belgium.
In the interest of public health, the FAMHP watches over the quality, safety and efficacy of medicines and health products.
• It is a public institution established on 1st January, 2007, under the trusteeship of Maggie De Block Minister of Social Affairs and Public Health
• A team of nearly 390 employees , the majority with scientific training
• Areas of expertise:
- Research and Development
- Marketing authorisation
- Inspection and control
- Good use of medicines and health products
• General Director : Xavier De Cuyper
• Slogan : "Your medicines and health products, our concern"
Who are we ?
The federal agency for medicines and health products (FAMHP) (law of 20/07/2006), a federal agency in the public interest, is the competent authority in terms of quality, safety and efficacy of medicines and health products.
The FAMHP works with health professionals and other relevant authorities at national and international levels to ensure for citizens the optimal benefit of medicines and health products that they need.
Our activities are divided into three management sectors (DG’s) also known as "pillars".
. PILLAR 1 " DG PRE authorisation " manages all activities before the first marketing authorisation of a medicine or a health product
. PILLAR 2 " DG POST authorisation " manages all activities after the first marketing of a medicine or a health product
. PILLAR 3 " DG inspection " ensures all inspection and control activities
What do we do ?
The essential mission of the FAMHP is to ensure that everyone has access to reliable medicines and health products.
The FAMHP therefore ensures the quality, safety and efficacy of medicinal products for human use (including homeopathic and herbal medicines), of medicines for veterinary use as well as medical devices and accessories designed for their use.
It also ensures the smooth running of all operations performed with blood, cells and tissues, and, their collection for their use.
Our areas of expertise are :
"Research and Development"
The FAMHP evaluates, approves, monitors and controls applications for clinical trials on medicinal and health products.
"Registration and market authorisation (AMM)"
The FAMHP evaluates AMM or medicine registration files for being awarded and for modifications.
The FAMHP prevents adverse effects related to the use of medicines or health products through the collection of information. It collects information, evaluates it and if necessary takes action.
"Production and distribution"
The FAMHP controls the manufacturing, distribution, delivery, import and export of medicines and health products, and issues authorisations under the legislation. It also controls the conduct of pharmacies and fights against illegal practices.
The FAMHP ensures that patients have relevant information so that medicines and health products are used correctly . It also controls the advertising of medicines and health products.
|Send your questions to a single e-mail address at AFMPS so that we can handle it efficiently. If you don’t know which is the appropriate department send it simply to the general e-mail address at AFMPS: email@example.com. Your question will then be passed on to the relevant department.|
Federal agency for medicines and health products - FAMHP
Place Victor Horta, 40/ 40
General phone number +32 2 528 40 00 (from 8 AM to 5 PM)
General fax number +32 2 528 40 01
EORI number BE0884579424
Secretariat of the Chief Executive Officer, Xavier De Cuyper
phone +32 2 528 40 05
fax +32 2 528 40 03
Ann Eeckhout, spokesperson of the FAMHP and responsible for the Communication Division
phone +32 2 528 40 12
mobile +32 495 23 71 69
Vigilance of medicines for human use
Call center Marketing Authorisation
Procedures for the MA (marketing authorisation) for medicines for human use
Tel. +32 2 528 40 04
Medicines for animal use
Information concerning medicines and health products
Inspection and control – Dispensing Division – Pharmacies
Inspection and control – General
Human body material
Research and Development
Scientific-technical advice/regulatory advice