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The European Medicines Agency has released a detailed list of all relevant guidelines with SmPC (Summary of Product Characteristics) recommendations as an overview and support for marketing authorisation holders.

The revised version was published on the EMA website on 27 March 2017. The guidelines listed in the five-page document cover all types of medicinal products (e.g. also radiopharmaceuticals and blood products) and concretely refer to those guidelines specific to SmPC (i.e. CHMP Position Paper, ICH Guidelines, EMA Guidelines) which have been adopted in a final version. Regarding guidelines which are currently being revised, the EMA refers to its own website. If guidelines under review are listed in the compilation, those guidelines are marked with an asterisk (*).

 

→ Scientific guidelines with SmPC recommendations

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L’Association A3P est un acteur incontournable de l’industrie pharmaceutique et biotechnologique. 
Créée en 1986, elle contribue au bon développement de la production de médicaments et de matériels propres et stériles, elle anime un réseau de 21 000 professionnels, fabricants et fournisseurs, dans le cadre de Congrès internationaux et de journées techniques.

Elle regroupe aujourd’hui plus de 1700 adhérents qui partagent leurs expériences techniques, scientifiques et réglementaires.

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