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Vertaling van "under the supervision and responsibility " (Nederlands → Frans) :

The main difference from the DG Medicinal Products is the FAMHP’s more autonomous way of working under the supervision and responsibility of the Minister of Public Health.

The main difference from the DG Medicinal Products is the FAMHP’s more autonomous way of working under the supervision and responsibility of the Minister of Public Health.


The main difference from the DG Medicinal Products is that the FAMHP can function more autonomously under the supervision and responsibility of the Minister of Public Health.

The main difference from the DG Medicinal Products is that the FAMHP can function more autonomously under the supervision and responsibility of the Minister of Public Health.


Export certificates Manufacturing sites under FAMHP supervision have to be able to provide documents quickly which demonstrate that the GMP conditions are being complied with.

Export certificates Manufacturing sites under FAMHP supervision have to be able to provide documents quickly which demonstrate that the GMP conditions are being complied with.


Since the FAMHP’s complete separation from the FPS Public Health, it has had autonomous responsibility for the coordination of international relations, under the hierarchical supervision of the Minister of Public Health.

Since the FAMHP’s complete separation from the FPS Public Health, it has had autonomous responsibility for the coordination of international relations, under the hierarchical supervision of the Minister of Public Health.


In order to regulate the quality and relevance of messages to the public, a prior licence is required for radio and TV information campaigns about human health and illness which refer directly or indirectly to medicines. This licence is normally issued by the Minister responsible following advice from the Commission for the supervision of advertising for medicines for human use.

In order to regulate the quality and relevance of messages to the public, a prior licence is required for radio and TV information campaigns about human health and illness which refer directly or indirectly to medicines. This licence is normally issued by the Minister responsible following advice from the Commission for the supervision of advertising for medicines for human use.


On the basis of these European directives, the FAMHP is thus mainly responsible for supervision of the market by following up on incidents (materiovigilance) and by inspecting manufacturers, distributors and retailers established in Belgian territory.

On the basis of these European directives, the FAMHP is thus mainly responsible for supervision of the market by following up on incidents (materiovigilance) and by inspecting manufacturers, distributors and retailers established in Belgian territory.


In the US, the FDA issued a Complete Response letter in December 2009 for this medicine (under the brand name Zortress) for prevention of organ rejection in adult kidney transplant patients.

Aux Etats-Unis, la FDA a émis, en décembre 2009, une «Complete Response letter» pour ce médicament (sous la marque Zortress) pour la prévention du rejet d'organe chez les transplantés adultes du rein.




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Date index: 2025-02-27
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