Scientific guidelines with recommendations SmPC

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