Exemption for labelling and package leaflet
- Published: November 17, 2020
- Last updated: March 6, 2023
When a shortage situation occurs or is expected to occur for a medicinal product and there is no obvious treatment option, the situation can sometimes be resolved with an exemption. An application for exemption must then be sent to the Swedish Medical Products Agency.
An exemption is a temporary permission to sell an approved medicinal product in a package that does not meet the requirements of the Swedish Medical Products Agency's regulations regarding labelling and package leaflets for medicines (HSLF-FS 2021:96 for human medicines and HSLF-FS 2021:97 for veterinary medicines).
This may include, for example, the supply of medicinal products in packaging:
- with another language
- where the 2D code deviates
- which has an older package leaflet than the latest approved
Exemption is granted in case of a shortage situation o when it is considered a danger to public and animal health if the product is missing on the Swedish market.
Application for exemption
The application is made by the company (the marketing authorisation holder or the local representative) by sending the completed form attached by email.
Email: ric@lakemedelsverket.se