Fimea prepares for the expansion of non-prescription medicine sales channels

The Finnish Medicines Agency Fimea has begun preparations for the expansion of the sales channel of non-prescription medicines. In December, Parliament approved a legislative amendment which will allow certain non-prescription medicines to be sold outside pharmacies from the beginning of 2027. The reform will offer medicine users new options for purchasing the non-prescription medicines included in the approved selection.

As a result of the legislative amendment, non-prescription medicines included in the limited selection may also be sold in grocery stores and other retail sales outlets that have been granted the retail sales licence. Fimea approves medicinal products for sale outside pharmacies based on applications submitted by pharmaceutical companies. These applications may be submitted to Fimea from the beginning of October.

Licence and supervision processes and IT systems to be completed in the autumn

The legislative amendment requires extensive preparatory work within Fimea to ensure smooth implementation. The aim is to ensure that the sale of non-prescription medicines takes place in accordance with regulations and as safely as possible. 

Fimea has launched a project to build new licensing and supervision processes.

“These processes also require new IT systems so that we can start processing retail sales licence applications and supervising points of sale at the beginning of 2027,” says Project Manager Elsi Similä from Fimea.

According to Similä, Fimea will now begin to develop procedures for the administration of marketing authorisations of the non-prescription medicines for which the extended sales channel is applied for. In addition, licence and supervision processes, which will also include supervision of pharmaceutical marketing, will be created for new points of sale.

“At the same time, we are preparing to provide guidance and advice to new operators and planning measures for monitoring the impacts of the reforms.”

The schedule for the implementation of the act is tight. The processes and IT systems must be in place well in advance next autumn. Fimea intends to make use of practices existing in other supervisory sectors and further develop them in cooperation with various stakeholders.

“Fimea is already carrying out market surveillance of medical devices sold in grocery stores and other retail sales outlets. We aim to take advantage of these practices and competences when supervising the new operators that sell non-prescription medicines,” Similä explains.

Further information on changes related to the expansion of the sales channel of non-prescription medicines will be published on Fimea’s website and communicated directly to stakeholders.