Summary of product characteristics

A summary of product characteristics (SPC) contains the key information about a product with marketing authorisation. The SPC has to be in Finnish and in Swedish. For common European procedures (CP, MRP, DCP), the Finnish and Swedish SPC must be a translation of the English common SPC.

Fimea publishes the summaries of product characteristics for products that have been granted marketing authorisation through the national procedure, mutual recognition procedure or decentralised procedure on its website. The summaries of product characteristics for products approved through the centralised procedure are published on the website of the European Medicines Agency (EMA).

The SPC must be submitted to Fimea as a Word file. To ensure that the documents can be published, that their content is displayed correctly and that online searches function properly, marketing authorisation holders must make sure that the technical quality of their documents is sufficient and that the preparation guidelines for such files are followed. The Finnish and Swedish version of the SPC must use the headings in Fimea’s SPC templates. The headings in the document templates are based on QRD (quality review document) templates published by EMA. Because the heading styles and formats in Fimea’s SPC templates follow the technical publication guidelines, it is recommended they be used as the basis for SPC documents also for publication purposes. In addition, the preparation guidelines for SPC files must be followed when creating tables, special characters and other content.

News

Swedish summary of product characteristics for medicinal products