Swedish summary of product characteristics for medicinal products

Medicinal products with a marketing authorisation and registration must have a summary of product characteristics in Swedish after 9 February 2022. In its Administrative Regulation 4/2019, Fimea added a requirement that all medicinal products must have a Swedish summary of product characteristics after a transition period of three years. This three-year transition period will expire on 9 February 2022. By 2 December 2021, a Swedish summary of product characteristics has been submitted and approved for 58.3 per cent of all medicinal products for human use and for 44.7 per cent of veterinary medicines. Both the Finnish and Swedish package leaflets and summaries of product characteristics available for medicines are published on Fimea’s website.

The Swedish summary of product characteristics must be submitted to Fimea by filing a national Type IB variation application if the marketing authorisation does not already include an approved Swedish summary of product characteristics. The absence of a Swedish summary of product characteristics is not an exemption from the marketing authorisation. Therefore, there are no grounds for submitting an exemption application because of a missing Swedish summary of product characteristics.

Read more:

Summary of Product Characteristics is to be available also in Swedish – frequently asked questions on Fimea’s website

Product information page on Fimea’s website

Summary of product characteristics page on Fimea's website

Finnish Medicines Agency Administrative Regulation 4/2019: Applying for and maintaining a marketing authorisation for a medicinal product (PDF)