Marketing authorisations

Package leaflet

Package leaflet

Package leaflet (PL) refers to the leaflet provided with a medicinal product, which includes information relevant to the user. The package leaflet is to be available in both Finnish and Swedish. It has to be based on the approved QRD template. For common European procedures (CP, MRP, DCP), the Finnish and Swedish package leaflets must be a translation of the English common PL approved in the process.

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

The package leaflet should 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. In addition, the preparation guidelines for PL files must be followed when creating tables, special characters and other content.

Package leaflet Preparation guidelines for PL files