Fimea publishes guidance on applying for an expanded sales channel for non-prescription medicines

The Finnish Medicines Agency (Fimea) has published guidance on its website for marketing authorisation applicants and holders on how to apply for an expanded sales channel for non-prescription medicines. The guidance concerns medicinal products for which approval is sought for sales also at retail stores outside pharmacies. 

From the beginning of 2027, certain non-prescription medicines may be sold not only in pharmacies but also, for example, in grocery stores and other retail stores that hold a retail licence. Only non-prescription medicinal products whose ATC code is included in the list provided in the Medicines Decree may be approved for the expanded sales channel. 

Guidance supports marketing authorisation applicants and holders in preparing for the new procedure

The new guidance brings together key information on how to apply for an expanded sales channel and what must be considered in the application documentation. The expansion may be applied for either in connection with a marketing authorisation application for a non-prescription medicinal product or through a variation application for an already approved marketing authorisation. Applications may be submitted from 1 October 2026 onwards. 

The application must include a concise justification demonstrating that the risks associated with the product are low and that pharmacotherapy can be carried out safely without medicinal counselling. The guidance also addresses package labelling, pack sizes, and the procedures for marketing authorisation applications and variation applications. 

Fimea publishes information on approved non-prescription medicinal products and packages on its website. 

New guidance also published for operators planning retail sales

Fimea has also published new guidance for operators planning the retail sale of non-prescription medicines. New guidance pages have been published on applying for a retail licence, the distribution of non-prescription medicines and related medicinal wholesaling activities, as well as the supervision of retail stores.

All guidance pages concerning the retail sale of non-prescription medicines will be updated regularly throughout 2026 as details are further specified. 

Further information

Information on applying for an expanded sales channel for marketing authorisation applicants and holders of non-prescription medicinal products

Information on applying for a retail license

Information on the supervision of retail stores

Information on the distribution of non-prescription medicines