Medicines with a marketing authorisation and traditional herbal medicinal products with a registration must have a summary of product characteristics also in Swedish by 9 February 2022
Fimea reminds marketing authorisation and registration holders of the requirement to also submit a Swedish summary of product characteristics for all medicinal products with a marketing authorisation and a registration of traditional herbal medicinal product by 9 February 2022.
The expiry of the transition period on 9 February 2022 applies to medicinal products that have been granted a market authorisation and registration on or before 9 February 2019. Under Administrative Regulation 4/2019, Fimea has required all marketing authorisation and registration applications submitted after 9 February 2019 to include a Swedish summary of product characteristics already at the application stage. The marketing authorisation or registration has not been granted without a Swedish SPC.
If the marketing authorisation or registration application for a product was submitted before 9 February 2019 and is currently pending, the Swedish summary of product characteristics can be submitted by filing a national Type IB variation application after the marketing authorisation or registration has been granted. If they wish, the marketing authorisation or registration applicant may also submit the Swedish summary of product characteristics at the national phase of the application process.
To date, a Swedish summary of product characteristics has been submitted and approved for 37.8 per cent of all medicinal products intended for human use and for 23.2 per cent of veterinary medicines.
Both the Finnish and Swedish package leaflets and summaries of product characteristics available for medicines have been published on Fimea’s website.
- Minna Heinäheimo-Valkonen, Research-Coordinator tel. +358 (0)29 522 3055
- E-mail address format: email@example.com