From the beginning of 2027, certain non-prescription medicines may also be sold at licensed physical retail outlets outside pharmacies in Finland. The reform introduces an expanded sales channel, but it does not apply automatically to all non-prescription medicines.
Only non-prescription medicinal products whose ATC codes are included in the restricted selection specified in Section 11 of the Medicines Decree may be approved for the expanded sales channel. The selection includes certain medicines used for heartburn, constipation, dry eye and minor skin injuries, as well as products used for vitamin and trace element replacement therapy.
Inclusion in the restricted selection does not automatically permit sale outside pharmacies. The marketing authorisation holder must apply to Fimea for approval of the expanded sales channel for the medicinal product. Applications may be submitted from 1 October 2026.
For an already authorised non-prescription medicine, the application must be submitted as a clinical Type II C.z variation. The application scope field must indicate that the variation concerns expansion of the sales channel. Approval may also be requested as part of an application for a new marketing authorisation.
The application documentation must include a concise justification in Module 1.2 demonstrating that the medicinal product presents low risks and that treatment with the product can be carried out safely without pharmaceutical advice. At a minimum, the justification must include a declaration confirming compliance with these requirements. Fimea may request additional information where necessary.
Clear package information is essential
Pharmaceutical advice will not be available at retail outlets outside pharmacies. Particular attention must therefore be paid to ensuring that the approved or proposed outer-package labelling complies with the applicable requirements, especially regarding the therapeutic indication, target population and instructions for use.
Marketing authorisation holders should review their portfolios to identify products that fall within the eligible ATC codes and assess whether the products meet the criteria for safe use without pharmaceutical advice. They should also review whether the current package labelling communicates the indication, intended users and instructions for use sufficiently clearly.
By default, an application for an expanded sales channel is processed as covering all non-prescription packs included in the marketing authorisation. If the marketing authorisation holder wishes to include only certain pack sizes, the packs to be included must be specified in the Module 1.2 justification. Packs approved for the expanded sales channel will also remain available in pharmacies.
Retail sales require a separate Fimea licence
Retail operators will need a separate Fimea licence for each physical retail outlet. Licence applications may be submitted from 1 January 2027. Sales can begin only after the licence has been granted and the decision has become legally binding. The licence permits sales only at the licensed physical retail outlet, and distance selling is not allowed.
Fimea has stated that its guidance will be updated regularly during 2026 as details are further specified. Companies considering the expanded sales channel should therefore monitor Fimea’s guidance and begin reviewing their portfolios, pack-size strategy, labelling and application documentation.
Medfiles can support marketing authorisation holders in preparing for the expanded sales channel, from assessing eligible products and pack sizes to preparing and submitting the required Type II variations. Our regulatory experts can also review and update package labelling to ensure that the indication, target population and instructions for use are communicated clearly and meet the applicable requirements.
Medfiles has over 30 years of experience in regulatory affairs. With strong local expertise in Finland and a team of more than 40 regulatory experts, we can support both individual products and larger portfolios.
Author: Tarja Ovaskainen
Senior Regulatory Affairs Expert
Tarja Ovaskainen has worked in pharmaceutical regulatory affairs for over 25 years. During her career, she has gained extensive experience in national, MRP and DCP procedures, as well as lifecycle management activities. She coordinates marketing authorisation applications, variations and renewals, and has strong expertise in medicinal product information management.
In addition, she has experience in product launches, regulatory authority interactions, and pharmaceutical wholesale operations in Finland.
Author: Heta Karvinen
Director, Pharma Regulatory Affairs
Heta Karvinen has worked at Medfiles since 2013. All in all, she has some 15 years of experience in pharmaceutical development, marketing application dossiers and post-approval changes. Before joining Medfiles, Heta was involved in drug product and drug substance development in the pharmaceutical industry.
She has experience from planning pharmaceutical and chemical studies needed for global marketing authorisation applications as well as the regulatory guidelines that govern such studies. Previously at Medfiles, Heta worked as a senior pharmaceutical chemical expert, utilising her skillset in various drug development projects as well as managing quality dossiers for human and veterinary medicines, post-approval variation applications and the studies required to support them. During the years, she has gained valuable expertise from active substance documentation in both the European Union and the United States. In February 2022, Heta was appointed Director of Pharma Regulatory Affairs at Medfiles.
