Applying for a retail licence
Fimea grants retail licences for non-prescription medicines. It is possible to apply for a licence from the beginning of 2027. The licensing procedure is part of ex ante supervision. In connection with the processing of the license, it is ensured that the point of sale meets the requirements laid down by law before the start of operations.
What does a retail licence entitle the holder to?
The licence entitles the holder to sell to consumers those non-prescription medicines that have been approved for sale outside pharmacies (expanded sales channel).
Sales are only permitted at a physical retail store, meaning that distance selling is not allowed. A separate licence must be applied for each retail store, and the licence is valid until further notice.
With a retail licence, all non-prescription medicines approved for sale outside pharmacies may be sold, meaning that the retail store may decide which of these medicines to include in its selection.
Who can apply for a licence?
Obtaining a retail licence requires that the applicant is a sole trader or a legal entity (company). The applicant must be registered in the Trade Register (business ID) and must engage in direct sales to consumers.
What information must be included in the application?
Before granting the licence, Fimea processes the application, assesses whether the requirements for granting the licence are met, and requests additional information if necessary. Applications are processed in the order in which they are received. The application must include the information necessary for processing the licence, such as
- applicant information, i.e. the applicant’s name or business name, business ID and contact details, and, where applicable, the name and contact details of the applicant’s contact person
- information on the retail store, i.e. the address and contact details of the retail store
- billing information
- information on the responsible person, i.e. the name and contact details of the responsible person and a declaration that this person is familiar with non-prescription medicines as referred to in section 54f(2)(3)
- a description of the applicant’s sales and storage facilities and of the introduction planned for staff.
The more detailed content of the application is based on the legislation (Medicines Act (395/1987, sections 54f–i) and Medicines Decree (713/2013, section 12)).
When can the sale of non-prescription medicines begin?
The sale of non-prescription medicines may only begin once Fimea has issued a decision to grant the licence and the decision has become final. A decision becomes final once the appeal period has expired and no appeal has been lodged. The appeal period is usually 30 days. Non-prescription medicines may also not be procured or stored before the decision has become final.
What else is good to know about the licence?
Fees
Chargeable services related to retail sale include, for example
- a retail licence
- inspections related to the activities
- an annual quality control fee, which is based on the information provided by the licence holder and is determined in accordance with the legislation.
The fees have not yet been confirmed in the currently valid decree on fees.
Changes related to the licence
The licence holder must notify Fimea of any significant changes related to the licence. Reportable changes include, for example
- information on the holder of the retail licence
- information on the retail store
- billing information
- information on the responsible person.
In the case of significant changes, the licence lapses and must be applied for again. Significant changes include, for example, a change in the location of the retail store or the sale of the business to a new trader. The licence also lapses when the activities cease.
Processing time
The processing time refers to the period starting from the receipt of the application and ending when Fimea issues a decision on granting the licence.
At this stage, Fimea cannot provide an exact estimate of the processing time. The processing time is affected by the need for additional information related to the application and by a high number of applications received at the same time, which may cause delays in processing.
Public information related to the licence
Fimea publishes on its website (in Finnish) the retail stores that have been granted a licence and related information, such as
- the name and address of the retail store
- the identifier of the retail store
- the date on which the licence was granted
- the date on which the licence became final.
More detailed instructions on applying for a licence and the requirements will be published on this page during 2026.