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Vertaling van "for the authorisation and supervision " (Nederlands → Frans) :

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

Règlement (CE) n o 726/2004 du Parlement européen et du Conseil du 31 mars 2004 établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments, JO L 136 du 30 avril 2004, pp.0001-0033 ( [http ...]


The FAMHP’s Marketing authorisation Department is responsible for evaluating new applications and requests for amendments to existing marketing authorisation (MA) with a view to granting authorisation for marketing a medicine or health product.

The FAMHP’s Marketing authorisation Department is responsible for evaluating new applications and requests for amendments to existing marketing authorisation (MA) with a view to granting 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.

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 for its part is required to evaluate applications for a marketing authorisation (MA), for the sake of the National Procedure (NP), the European Decentralised Procedure (DCP), the Mutual Recognition Procedure (MRP) and the Central Procedure (CP).

The Registration (marketing authorisation) department for its part is required to evaluate applications for a marketing authorisation (MA), for the sake of the National Procedure (NP), the European Decentralised Procedure (DCP), the Mutual Recognition Procedure (MRP) and the Central Procedure (CP).


In 2007, 88 licences/registrations were issued to market participants For the export of precursors, 200 export authorisations and 11 import authorisations were issued.

In 2007, 88 licences/registrations were issued to market participants For the export of precursors, 200 export authorisations and 11 import authorisations were issued.


Procedure regarding application to authorise or extend authorisation of a cell and tissue bank.

Procedure regarding application to authorise or extend authorisation of a cell and tissue bank.


Een andere bijzonderheid voor het jaar 2009, in het kader van de verwerking van de VHB-dossiers, is de effectieve opsplitsing van het oude Departement Registratie in twee afdelingen: de Afdeling Marketing Authorisation (humaan) van het DG PRE vergunning en de Afdeling Marketing Authorisation – Variaties & Hernieuwingen van het DG POST vergunning.

Une autre particularité de l’année 2009 pour le traitement des dossiers d’AMM est la scission effective de l’ancien Département Enregistrement en deux divisions : la Division Marketing Authorisation (humain) de la DG PRE autorisation et la Division Marketing Authorisation – Variations & Renouvellements de la DG POST autorisation.


En paraphant en 2008 la Charte de Tallinn sur les systèmes de santé, les États membres se sont formellement engagés à superviser et à évaluer la performance de leur système de santé.

Met het ondertekenen in 2008 van het Verdrag van Tallinn inzake gezondheidssystemen hebben de lidstaten zich er formeel toe verbonden om de performantie van het gezondheidssysteem te monitoren en te evalueren.


checked prior to publication. Radio and television advertisements are provided with a licence after advice from the Commission for the supervision of advertising of medicines for human use or after notification to the FAMHP for the other media.

checked prior to publication. Radio and television advertisements are provided with a licence after advice from the Commission for the supervision of advertising of medicines for human use or after notification to the FAMHP for the other media.


Voor de producten die niet meer onder octrooi zijn, overweegt men in het EUvoorstel data protection voor nieuwe gegevens bij kinderen over veiligheid, kwaliteit en efficaciteit, te verbinden aan een nieuw type MA, PUMA (Pediatric Use Marketing Authorisation), tegelijk met een programma van financiering voor onderzoek hierin (Medicines Investigation for the Children of Europe, MICE).

Pour les produits qui ne sont plus sous patente, la Commission envisage dans sa proposition de subordonner une protection des nouvelles données pédiatriques en matière de sécurité, de qualité et d’efficacité à un nouveau type de M.A., la PUMA (Pediatric Use Marketing Autorisation), parallèlement à un programme de financement pour la recherche dans ce domaine (Medicines Investigation for the Children of Europe, MICE).




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Date index: 2023-10-06
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