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null Swedish summary of product characteristics for medicines to be provided within a transition period

Swedish summary of product characteristics for medicines to be provided within a transition period

5.8.2020

Fimea reminds marketing authorization holders to submit a Swedish summary of product characteristics

For Marketing Authorization applications submitted after 9.2.2019, a Swedish summary of product characteristics is required, and Marketing Authorization has not been granted without it.

A 3-year transition period is allowed for submitting of a summary of product characteristics in Swedish for Marketing Authorizations that have already been issued and for Marketing Authorization applications submitted before 9.2.2019. This transition period will end on 9.2.2022.

For Marketing Authorization applications submitted before 9.2.2019, a Swedish summary of product characteristics can be submitted using a national IB variation after the Marketing Authorization has been issued. The Swedish summary of product characteristics can also be submitted at the national phase of the Marketing Authorization application.

By July 2020, a Swedish summary of product characteristics had been approved for 18.9% of all medicines for human use and for 7% of veterinary medicines.

Summaries of medicines’ product characteristics in Finnish and Swedish a well as packaging insert leaflet texts are published on Fimea’s website.

For more detail:

Summary of Product Characteristics is also to be available in Swedish

Product information

Summary of Product Characteristics

Administrative Regulation 4/2019 (pdf)

Ask more

  • Minna Heinäheimo-Valkonen, research-coordinator tel. 029 522 3055
  • E-mail address format: firstname.lastname@fimea.fi