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Traduction de «famhp is responsible » (Néerlandais → Français) :

The R&D (research and development) department of the FAMHP is responsible for the evaluation and approval of clinical research activities, ranging from the first “use” (concept) to extensive trials with medicines that are developed and carried out by university and other research centres and by the pharmaceutical industry.

The R&D (research and development) department of the FAMHP is responsible for the evaluation and approval of clinical research activities, ranging from the first “use” (concept) to extensive trials with medicines that are developed and carried out by university and other research centres and by the pharmaceutical industry.


The Production & Distribution department of the FAMHP is responsible firstly for overseeing the conformity to current standards, guidelines and legal requirements for the manufacture, distribution and dispensing of medicines and health products and secondly for granting authorisations, recognitions and certificates, as well as for combating illegal practices and monitoring pharmacies.

The Production & Distribution department of the FAMHP is responsible firstly for overseeing the conformity to current standards, guidelines and legal requirements for the manufacture, distribution and dispensing of medicines and health products and secondly for granting authorisations, recognitions and certificates, as well as for combating illegal practices and monitoring pharmacies.


The Registration (marketing authorisation) department of the FAMHP is responsible for evaluating new applications and applications for changes to existing marketing authorisations (variations), with a view to grant the authorisation for marketing a medicine or health product.

The Registration (marketing authorisation) department of the FAMHP is responsible for evaluating new applications and applications for changes to existing marketing authorisations (variations), with a view to grant the authorisation for marketing a medicine or health product.


If a non-conforming medicine is marketed outside Belgium and the medicine manufacturer is based in Belgium, the FAMHP is responsible for alerting other medicine authorities via the RAS.

If a non-conforming medicine is marketed outside Belgium and the medicine manufacturer is based in Belgium, the FAMHP is responsible for alerting other medicine authorities via the RAS.


In 2007 the Legal service of the FAMHP was responsible for: ●● Legislation

In 2007 the Legal service of the FAMHP was responsible for: ●● Legislation


Furthermore an expert committee, the Committee for Advanced Therapies (CAT), was A transversal working group has been established within the FAMHP which is responsible for the coordination of this matter and the introduction of the new regulations in practice. This consultation process arrived at the following decisions:

Furthermore an expert committee, the Committee for Advanced Therapies (CAT), was A transversal working group has been established within the FAMHP which is responsible for the coordination of this matter and the introduction of the new regulations in practice. This consultation process arrived at the following decisions:


The proposals reflect the diversity of the activities and responsibilities of the different FAMHP commissions.

The proposals reflect the diversity of the activities and responsibilities of the different FAMHP commissions.




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Date index: 2023-09-17
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