A summary of product characteristics (SPC) is an agreement between the marketing authorisation holder and regulatory authorities on how and for what purpose a product is to be used. The summary of product characteristics contains the key information on how the efficacy and safety of the product have been proven, as well as on product quality. The package leaflet (PL) is provided with the medicine package, and it contains product information relevant to the user of the medicinal product. The applicant of the marketing authorisation or registration prepares these documents as part of the marketing authorisation application process. Regulatory authorities check these documents before approval of the application.
For products approved through national, mutual recognition and decentralised procedures, approved summaries of product characteristics as well as package leaflets in Finnish and Swedish are published on Fimea’s website.
For products approved through the centralised procedure, product information is published on the website of the European Medicines Agency (EMA).
In addition to the summary of product characteristics and the package leaflet, the proposed package mock-ups are checked and approved during the marketing authorisation processes.