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Traduction de «safety of medicines » (Néerlandais → Français) :

The mission of the Vigilance department is to supervise the safety of medicines for users (pharmacovigilance), blood and labile blood derivatives (haemovigilance) and tissues and cells (biovigilance).

The mission of the Vigilance department is to supervise the safety of medicines for users (pharmacovigilance), blood and labile blood derivatives (haemovigilance) and tissues and cells (biovigilance).


Volgens het Britse Committee on Safety of Medicine is de risico-batenverhouding van deze associatie ongunstig: enerzijds is er geen evidentie dat de associatie doeltreffender is dan paracetamol alleen, anderzijds zijn er de belangrijke risico’s bij overdosering.

Selon le Committee on Safety of Medicine britannique, le rapport bénéfice-risque de cette association est défavorable: d’une part, il n’existe aucune preuve que cette association soit plus efficace que le paracétamol seul, d’autre part, les risques sont importants en cas de surdosage.


Meer informatie over de maatregel in het Verenigd Koninkrijk is te vinden op de website van het Committee on Safety of Medicines (www.mca.gov.uk/aboutagency/regframework/csm/csmhome.htm).

Des informations plus détaillées sur cette mesure au Royaume Uni peuvent être consultées sur le site web du Committee on Safety of Medicines (www.mca.gov.uk/aboutagency/regframework/csm/csmhome.htm).


In het Verenigd Koninkrijk heeft het Committee on Safety of Medicines de beschikbare gegevens daaromtrent opnieuw geëvalueerd; hun advies kan als volgt samengevat worden.

Au Royaume-Uni, le Committee on Safety of Medicines a récemment réévalué les données disponibles à ce sujet; son avis peut se résumer comme suit.


Veterinary medicines The Veterinary Medicines unit ensures the quality, safety and efficacy of veterinary medicines in the interests of public health and animal welfare. This involves the following set of tasks: ●● Granting MA for veterinary medicines

Veterinary medicines The Veterinary Medicines unit ensures the quality, safety and efficacy of veterinary medicines in the interests of public health and animal welfare. This involves the following set of tasks: ●● Granting MA for veterinary medicines


Er kan steeds advies gevraagd worden aan het Departement Goed Gebruik van het Geneesmiddel (BUM) van het FAGG en aan de leden van Efficacy Working Party (EWP), Safety Working Party (SWP), Biosimilar Medicinal Products Working Party (BMWP), Blood Working Party (BWP) en Quality Working Party (QWP).

On peut toujours demander un avis au Département Bon Usage du Médicament (BUM) de l’AFMPS et aux membres des groupes suivants : Efficacy Working Party (EWP), Safety Working Party (SWP), Biosimilar Medicinal Products Working Party (BMWP), Blood Working Party (BWP) et Quality Working Party (QWP).


Thanks to the introduction of a proactive vigilance policy within the FAMHP via the PROACTIVE VIGILANCE spearhead, the safety profile of medicines and health products will be better known, thereby also promoting safer use of these products.

Thanks to the introduction of a proactive vigilance policy within the FAMHP via the PROACTIVE VIGILANCE spearhead, the safety profile of medicines and health products will be better known, thereby also promoting safer use of these products.


The Scientific Committee’s mission consists of coordinating and harmonising activities carried out by the various FAMHP commissions with a view to guaranteeing the quality, safety and efficacy of medicines and health products.

The Scientific Committee’s mission consists of coordinating and harmonising activities carried out by the various FAMHP commissions with a view to guaranteeing the quality, safety and efficacy of medicines and health products.


1. Renewal of a national marketing authorisation. 2 Periodic safety reports for medicines approved according to national, MRP, DCP and centralised procedures.

1. Renewal of a national marketing authorisation. 2 Periodic safety reports for medicines approved according to national, MRP, DCP and centralised procedures.


The safety and efficacy of medicines and health products are closely associated with the correct use of these products.

The safety and efficacy of medicines and health products are closely associated with the correct use of these products.




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Date index: 2022-05-10
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