EMA: Revised Summary of the relevant Guidelines for SmPC

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 (*).

Content-related, the national expert information corresponds to the summary of the medicinal product's characteristics (SmPC). The expert information (in Germany "Fachinformation") is a document containing data on the dosage form and strength, indications (areas of application), dosage, efficacy, adverse reactions, drug interactions and contraindications of the medicinal products. The text i.e. the SmPC must be approved by the competent authority, this means by the EMA or the respective national authorities (e.g. in Germany by the Federal Institute for Drugs and Medical Devices (BfArM), in Switzerland by the Swissmedic and in Austria by the Austrian Agency for Health and Food Safety (AGES)).

More information can be found in the document "Scientific guidelines with SmPC recommendations" on the EMA website.

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