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Traduction de «medicines without a market authorisation » (Néerlandais → Français) :

Borderline products and medicines without a market authorisation The trade in traditional medicines such as TCM (Traditional Chinese Medicines, Ayurveda and others) The theft of medicines and their resale on the black market

Borderline products and medicines without a market authorisation The trade in traditional medicines such as TCM (Traditional Chinese Medicines, Ayurveda and others) The theft of medicines and their resale on the black market


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 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 latter has been designated as having expertise as an “Official Medicines Control Laboratory”, recognised by the FAMHP and the European Directorate for the Quality of Medicines (EDQM), for the monitoring of immunological products for veterinary use prior to marketing authorisation for the Belgian market.

The latter has been designated as having expertise as an “Official Medicines Control Laboratory”, recognised by the FAMHP and the European Directorate for the Quality of Medicines (EDQM), for the monitoring of immunological products for veterinary use prior to marketing authorisation for the Belgian market.


It is also essential for rational and safe use of medicines that the information in advertising agrees with the elements approved of when the marketing authorisation (MA) for the medicine was granted. Healthcare professionals when making a therapeutic choice should not be influenced by elements that are not associated with the characteristics of the medicine.

It is also essential for rational and safe use of medicines that the information in advertising agrees with the elements approved of when the marketing authorisation (MA) for the medicine was granted. Healthcare professionals when making a therapeutic choice should not be influenced by elements that are not associated with the characteristics of the medicine.


Simplified marketing authorisation (MA) for medicines for human use. Unique national registration number for medicines for human use.

Simplified marketing authorisation (MA) for medicines for human use. Unique national registration number for medicines for human use.


Veterinary medicines Unit For the fifth year in a row the number of applications closed for obtaining marketing authorisation (MA) within the Veterinary medicines Unit has exceeded the number of new applications submitted.

Veterinary medicines Unit For the fifth year in a row the number of applications closed for obtaining marketing authorisation (MA) within the Veterinary medicines Unit has exceeded the number of new applications submitted.


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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