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Vertaling van "medicines in belgium " (Nederlands → Frans) :

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.


The BUM department is legally required to provide support with putting online the list of medicines authorised in Belgium for new medicine MA and of the official information (Summary of Product Characteristics for healthcare professionals and leaflet for the general public).

The BUM department is legally required to provide support with putting online the list of medicines authorised in Belgium for new medicine MA and of the official information (Summary of Product Characteristics for healthcare professionals and leaflet for the general public).


The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.

The FAMHP intends to significantly increase its involvement in the lifecycle of immunological medicines for veterinary use by providing scientific advice, evaluating applications for clinical trials in Belgium, adopting (co-)rapporteurships for CP, MRP and DCP for MA of vaccines for veterinary use and developing pharmacovigilance and inspection activities.


The external services of Unit II inspect manufacturers of medicines (in Belgium and non-EU countries), the wholesalers, the recognised laboratories, the companies recognised on the basis of the royal decree on raw materials used by the pharmacist, the manufacturers of “Active Pharmaceutical Ingredient” (API), blood establishments and cell and tissue banks.

The external services of Unit II inspect manufacturers of medicines (in Belgium and non-EU countries), the wholesalers, the recognised laboratories, the companies recognised on the basis of the royal decree on raw materials used by the pharmacist, the manufacturers of “Active Pharmaceutical Ingredient” (API), blood establishments and cell and tissue banks.




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Date index: 2020-12-23
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