Retail sale of non-prescription medicines – FAQ

Not all non-prescription medicinal products will be made available for sale outside pharmacies. Only certain non-prescription medicinal products intended for the treatment of heartburn, constipation, dry eye, and minor skin injuries, as well as products used for vitamin and trace element replacement therapy, may become available outside pharmacies. These medicinal products are specified in more detail in Section 11 of the Medicines Decree. Not all non-prescription medicinal products listed in the Medicines Decree will automatically become available for sale outside pharmacies. The decision to apply for an extension of the sales channel lies with the marketing authorisation holder.

The marketing authorisation holder must apply to Fimea for an extension of the sales channel. Applications may be submitted at the earliest on 1 October 2026.

Fimea will publish information on non-prescription medicinal products that are authorised for sale outside pharmacies as soon as such information becomes available.

At present, there is no information on new medicinal products or groups of medicinal products that would be made available for sale outside pharmacies.

Applications for a retail licence may be submitted as of 1 January 2027. Fimea will provide more detailed instructions on the application process on these websites during 2026.

A retail licence is granted per point of sale. A separate licence must be applied for for each point of sale.

Retailers and other operators may start selling non-prescription medicines only after a retail licence has been granted and has become legally binding. Applications may be submitted as of 1 January 2027, and they will be processed in the order in which they are received.

If a large number of applications are submitted at the initial stage, the processing of applications may become congested.

An appeal against the decision may be lodged within 30 days of receipt of the decision. The decision may not be enforced before it has become legally binding. This means that the decision becomes legally binding at the earliest after the appeal period has expired, if no appeal has been lodged.

Staff at retail stores outside pharmacies are not permitted to provide medicinal counselling.

Medicinal counselling refers to advice provided by pharmaceutical staff in a pharmacy with the aim of ensuring that the medicine user is aware of the correct and safe use of the medicine. In practice, medicinal counselling includes, for example, individual guidance on the use of a medicine, such as dosing instructions, assessment of the suitability of the medicine, and advice on adverse reactions or interactions.

If necessary, the customer must be referred to a healthcare professional.

Eye drops are available on the market both as medicinal products and as medical devices. Medical devices may already be sold in pharmacies and at other points of sale. The product category alone does not determine whether a product is classified as a medicinal product or a medical device. The manufacturer of the eye drops is responsible for the classification of the product. The classification is influenced by the intended purpose defined by the manufacturer and the principal mode of action of the product.

The classification can be checked from the package labelling. More information on the labelling of medicinal products is available on Fimea’s Medicinal product packs web page, and information on the labelling of medical devices is available on "Fimea’s How to identify a medical device?"  web page.