Scientific guidelines with SmPC recommendations

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