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.

Possible changes to this restricted selection of non-prescription medicines and the legal provisions concerning such changes are not decided by Fimea but are political decisions. If it is considered necessary to amend the selection, the Ministry of Social Affairs and Health will prepare a proposal to the Government to amend the selection.

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.

At present, information on purchased non-prescription medicines is not automatically transferred to the Kanta medication list, regardless of the place of purchase.

In future development phases, the medication list will be expanded to include the possibility for healthcare professionals to record information also on the use of non-prescription products.

The possibility for citizens to make their own entries via MyKanta will be introduced at a later stage.

More information about the Kanta medication list and its use is available on the Kanta.fi website.

The authorisation may be applied for by a business (a private trader or a company) that is entered in the Trade Register and sells products directly to consumers.
This includes all operators with a Business ID, such as grocery stores, health food shops, optician’s shops and petrol stations.

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 not product‑specific. One licence allows the sale of all non‑prescription medicines that may be sold outside pharmacies. The retail outlet may decide itself which of these non‑prescription medicines it includes in its own product range.

A retail licence is granted per point of sale. A separate licence is required 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.

Chargeable services related to the retail sale of non-prescription medicines will include at least the retail sales authorisation, inspections related to the operation, and an annual quality control fee.

The quality control fee is based on information reported by the authorisation holder, and its amount is determined in accordance with the criteria laid down in legislation.

These fees have not yet been updated in the currently applicable Decree on Fees.

No. A retail licence only allows the sale of non prescription medicines at a physical retail store.

The licence granted for a pharmacy service point only applies to non-prescription medicines sold through that service point. A store’s own sale of medicines always requires a retail licence for non-prescription medicines.

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

Medicinal counselling refers to the advice and guidance provided in accordance with Section 57 of the Medicines Act, which must aim to ensure that the user of a medicine is aware of its correct and safe use in order to ensure the success of the treatment. In practice, medicinal counselling includes, for example, individual guidance on the use of a medicine, such as instructions on dosage, assessment of the suitability of the medicine, and advice on adverse effects or interactions.

In self-care, medicinal counselling includes the assessment of the need for treatment and its suitability, including the selection of an appropriate treatment option together with the customer. The prohibition on medicinal counselling applies to all persons working at the retail outlet, including those who, as licensed healthcare professionals, would otherwise be authorised to provide such counselling or guide customers in the use of medicines.

In matters related to non-prescription medicines, customers should contact a healthcare professional practising elsewhere. In addition, customers may use other reliable sources of medicine information.

In principle, the same person may act as the responsible person for several retail outlets. However, this requires that they are in practice able to perform all their responsibilities at each outlet.

The duties of the responsible person, such as monitoring and documenting the storage conditions of non-prescription medicines and carrying out the outlet’s annual self-inspection, in practice require being present at the outlet.

Presence means physical presence to such an extent that the responsible person can observe operations, address deficiencies and participate in daily activities.

Unsold and expired non‑prescription medicines are disposed of as medicinal waste. Medicinal waste is handled and disposed of appropriately and kept separate from the sales stock. Please note that medicinal waste is classified as hazardous waste and must be sent to a hazardous waste treatment facility.

At retail stores outside pharmacies for non‑prescription medicines, the handling of medicinal waste is limited to unsold non‑prescription medicines only.

The pricing of non-prescription medicines included in the restricted selection is regulated in section 4a of the Medicines Tariff Decree. The retail price of a non-prescription medicine may be at most the retail price determined according to the calculation formula specified in section 4(1).

No, unless it holds a medicinal wholesaling licence. The retail store selling non-prescription medicines must carry out the purchase and payment of the medicines. In addition, the sale (including the receipt of payment) may only be carried out by an operator holding a medicinal wholesaling licence or a manufacturing licence. Only a pharmaceutical company holding a medicinal wholesaling licence (or a manufacturing licence) may sell the medicine.

If a retail chain’s purchasing organisation acts as an intermediary between the buyer of the medicine (retail store) and the seller, it must register as a broker of medicinal products. The registration is submitted to Fimea (Medicines Act (395/1987) section 34a (Finlex.fi) (in Finnish), European Commission Guidelines on Good Distribution Practice of medicinal products for human use, chapter 10 (EUR-lex.eu), Fimea’s administrative regulation 7/2019 (Finlex.fi) (in Finnish)).