- Vision and ambition
- Organisation chart
- Our core business
- The FAMHP also ensures that …
- Partners receiving financial support from the FAMHP
- FAMHP customer charter
- Social media
- Conditions for reuse (Creative Commons-0 licence)
The Federal Agency for Medicines and Health Products (FAMHP) was established by the law of 20 July 2006.
The FAMHP is a public interest organisation with legal personality, classified under category A, as referred in the law of March 16, 1954 on the control of certain public interest organisations.
The FAMHP plays an essential role in the protection of public health with the following mission:
“Ensuring, from development to use, the quality, safety and efficacy:
- of medicines for human and veterinary use, including homeopathic medicines and herbal medicines, pharmacy made and officinal preparations;
- of health products, including medical devices and accessories, and raw materials for the preparation and production of medicines.
Ensuring, from collection to use, the quality, safety and efficacy:
- of all operations involving blood, cells and tissues, which are also defined as health products”.*
The values nurtured within the FAMHP are carefully selected and form the unifying theme in our day-to-day activities.
- working in an honest and transparent manner;
- identifying intolerable situations and rectifying them;
- meeting the challenge of being exemplary.
- by involving ourselves in our work;
- seeking to perfect our skills;
- facing up to our responsibilities.
- continuing our goals, whilst taking into account the changing context;
- being attentive to developments in our fields of competence;
- being open to change and responding.
- being supportive and bound by the common interest of public health;
- listening to and advising our colleagues;
- showing mutual support and kindness.
Central to this endeavour are the six key factors which represent the FAMHP’s vision and ambition.
- Recognition at national, European and world level.
- Developing partnerships with the healthcare sector.
- Performing core tasks in a professional manner.
- Informing the public optimally.
- Developing transversality (cooperation across different divisions) within the organisation.
- Realising and establishing a learning organisation culture.
The FAMHP is the Belgian competent authority in charge of ensuring the quality, safety and efficacy of medicines and health products (medical devices and accessories, raw materials, blood and blood components of human origin, human tissue material), for human and veterinary use, in clinical development and on the market.
Since 1 February 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.
In addition to the efficient execution of the basic tasks, special attention is paid to the spearheads in which the FAMHP wishes to excel.
The spearheads which are considered as the calling card of the FAMHP at national and European level are:
- Early Phase Development.
Given the diversity of our agency's areas of competence, the various technical and scientific expertise must be present, and consolidated both internally and externally. This must be done through strictly defined, transparent and secure partnerships. This explains the absolute necessity of cooperative links between competent authorities, whether national, European or even global.
The strengthening and expansion of interaction mechanisms with our partners is one of the major achievements since the creation of the FAMHP.
The FAMHP interacts with many partners: patients, healthcare professionals, university and research centres, the industry, competent authorities and policy makers in the Member States and the EU institutions.
Given its role in protecting public health, the FAMHP believes it is necessary to maintain a genuine, open and constructive dialogue with all partners, not only within official institutions such as the Consultative Committee, but also via consultation platforms or other structures that provide an ideal framework for such a dialogue.
The FAMHP works with academia, the pharmaceutical and other relevant industries, healthcare professionals and other national, European and global bodies, as well as political leaders, to provide patients and citizens with the medicines and healthcare products they need and to help them make good use of them.
The FAMHP is the competent authority in the domains that touch upon the different phases of the life cycle of medicines and health products.
Our main activities focus on all medicines and health products for human and veterinary use and can be divided into four main domains.
Advising all our partners, starting from our expertise:
- national, European and worldwide authorities;
- policy makers such as the parliament and the minister in charge;
- the academic world;
- the industry;
- healthcare professionals;
- the press;
- patients and citizens who require further information.
Delivering official documents such as authorisations, approvals, certificates. For example:
- clinical trial approval;
- marketing authorisation (MA);
- authorisation for parallel import;
- standardisation of pharmacy made preparations and monograph approval;
- authorisation of raw material for pharmacy made preparations;
- notification number or export certificate;
- approval of advertising to the general public and visas for scientific events;
- authorisation for production an import (MIA) or for wholesale dealer (WDA);
- certificate for pharmaceutical product;
- authorisation for the establishment, transfer or registration of a retail pharmacies;
- authorisation for certain activities or for the import or export of narcotics and psychotropic substances or drug precursors;
- accreditation for human tissue material organisation.
Watching over the quality, safety and efficacy:
- ensuring follow-up of assumed adverse reaction and incident notifications with medicines and health products, evaluating these notifications and taking the necessary corrective actions;
- organising control activities and surveys;
- carrying out inspections and controls;
- ensuring follow-up of the quality problem notification system for medicines.
Imposing sanctions such as:
- imposing an administrative penalty;
- withdrawing or adapting official documents;
- taking health protecting measures;
- imposing a ban.
All patients and healthcare professionals have permanent access to objective, correct, complete and transparent information so that medicines and health products are used correctly.
- Everyone can see which medicines are authorised in Belgium and consult the current patient information leaflet and summary of product characteristics of all medicines available on the market.
- The population is made aware through information campaigns on medicines and health products with tips to protect health and to help with the proper use of medicines in general and with children in particular.
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.
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.
Brochure: FAMHP customer charter
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Unless stated otherwise, the information on this website is free of rights and may be used for private, association, scientific and commercial purposes. The FAMHP does, however, recommend stating the source and date of the information that is reused.
Where prior authorisation is required, or where specific conditions are necessary, reuse restrictions are explicitly mentioned. The reuse of multimedia content (photographs, images, sound, videos, etc.), including the content contained in downloadable documents (brochures, etc.), is always subject to prior approval.
The FAMHP makes every effort to ensure that this website is correct and up to date. Should an error be detected, it undertakes to make the necessary corrections as soon as possible.
More information on access to and reuse of government information can be found at http://data.gov.be/fr/aspects-legaux.