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Traduction de «line with european legislation ●● standard » (Néerlandais → Français) :

Compliance with the European directives on electronic submissions Compliance with the European directives requires a number of objectives to be achieved: ●● Arriving at a functional vision of communication standards with EMEA and the Member States in partnership with the industry and in line with European legislation ●● Standard project management, with important steps that are sponsored/supported by the Member States: first developing an IT infrastructure and then starting on a highly secure network followed by so-called “proofs of concept” in each field ●● Success depends above all on the FAHMP’s

Compliance with the European directives on electronic submissions Compliance with the European directives requires a number of objectives to be achieved: ●● Arriving at a functional vision of communication standards with EMEA and the Member States in partnership with the industry and in line with European legislation ●● Standard project management, with important steps that are sponsored/supported by the Member States: first developing an IT infrastructure and then starting on a highly secure network followed by so-called “proofs of concept” in each field ●● Success depends above all on the FAHMP’s


formulations, production in line with the standards of the European or equivalent Pharmacopoeia

formulations, production in line with the standards of the European or equivalent Pharmacopoeia


Voor een uitgebreider inzicht in de geharmoniseerde normen bezoekt u [http ...]

Pour en savoir plus sur la liste des normes harmonisées, veuillez consulter [http ...]


Voor een uitgebreider inzicht in de geharmoniseerde normen voor centraleverwarmingsketels bezoekt u: [http ...]

Pour en savoir plus sur les normes harmonisées relatives aux chaudières à eau chaude, veuillez visiter le site suivant : [http ...]


Laboratories in countries with less stringent animal welfare legislation are audited to ensure compliance with Novartis standards.

Les laboratoires situés dans des pays où le cadre législatif n’est pas suffisamment contraignant font l’objet de contrôles afin de vérifier le respect scrupuleux de nos standards.


Safety change – Art 45 pediatrics+ Level II safety changes to bring SPC-PIL in line with revised CCDS (incl Type II update SPC and PIL according to the European Core Safety Profile following PSUR synchronization

Article 45 pediatrics + Level II safety changes to bring SPC-PIL in line with revised CCDS (incl Type II update SPC and PIL according to the European Core Safety Profile following PSUR synchronization


Article 45 pediatrics++ Level II safety changes to bring SPC-PIL in line with revised CCDS (incl Type II update SPC and PIL according to the European Core Safety Profile following PSUR synchronization -1-

Safety change – article 45 pediatrics + Level II safety changes to bring SPC-PIL in line with revised CCDS (incl Type II update SPC and PIL according to the European Core Safety Profile following PSUR synchronization /14


The key elements of this ambition are, firstly, the provision of efficient and high-quality services and, secondly, compliance with all the legal requirements imposed on the FAMHP (taking account of the revised Belgian pharmaceutical legislation and the European Directives).

The key elements of this ambition are, firstly, the provision of efficient and high-quality services and, secondly, compliance with all the legal requirements imposed on the FAMHP (taking account of the revised Belgian pharmaceutical legislation and the European Directives).




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Date index: 2022-08-17
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