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The European Medicines Agency HAS released a detailed list of all relevant guidelines with SmPC (Summary of Product Characteristics) recommendations have an overview and media for marketing permission holders.

The revised version of Was published on the EMA website is March 27 2017. The guidelines listed in the five-page paper cover all kinds of medicinal products (eg aussi radiopharmaceuticals and blood products) and concretely Refer To Those guidelines specific to SmPC (ie CHMP Position Paper, ICH Guidelines, EMA Guidelines) qui-have-been adopté in a final release. Regarding guidelines qui ares currently being white revised, the EMA Refers to icts own website. If guidelines under review are listed in the compilation, Those guidelines are marked with an asterisk (*).


Scientific guidelines with recommendations SmPC

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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