Supervision of retail stores

Fimea supervises the retail sale of non-prescription medicines in Finland to ensure that it is carried out safely and in compliance with the applicable regulations. Supervision consists of, among other things, licensing and notification procedures, requests for information, and inspections carried out at retail stores selling non-prescription medicines. In addition, Fimea provides guidance and advice to operators.

Fimea’s supervision also covers the marketing of non-prescription medicines. Holders of a retail licence for the sale of non-prescription medicines must comply with the regulations governing the marketing of medicinal products. Further information on the requirements concerning the marketing of medicinal products is available on Fimea’s website.

How are retail stores supervised?

The licensing procedure is part of pre-market supervision. During the processing of a licence application, it is verified that the retail store meets the statutory requirements before commencing operations. Post-licensing supervision includes, among other things, the assessment of information and notifications received, requests for clarification, and inspections conducted at retail stores. The aim is to ensure that the sale of non-prescription medicines is safe and that operations comply with the requirements set out in legislation.

The supervision of retail stores is risk-based. Supervisory measures are targeted at operators and situations where compliance with regulatory requirements has weakened. The risk assessment takes into account previous findings and any changes made at the inspection site.

An inspection of a retail store may be carried out either on-site or remotely. As a general rule, inspections are announced in advance.

Inspections are carried out to ensure that the sale of non-prescription medicines complies with the Medicines Act and the provisions issued under it. During inspections, aspects such as the sales and storage practices for non-prescription medicines, the retail store’s internal instructions and supervision arrangements, as well as its documentation, may be assessed.

Inspections help identify any deficiencies in operations. Based on the deficiencies identified, the retail store determines and implements the necessary corrective actions. An inspection fee is charged for inspections of retail stores in accordance with the valid Decree of the Ministry of Social Affairs and Health on Fees. In addition, Fimea charges retail stores an annual quality control fee.

Self-monitoring and inspections at retail stores

The holder of a retail licence must ensure the quality and safety of operations at the retail store through monitoring and inspections. These measures help ensure that the operation complies with the applicable requirements and that any identified deficiencies are corrected.

The licence holder/retail store:

• regularly monitors and evaluates its own operations, carries out an annual inspection of the retail store, and documents the inspection. This helps ensure that operating procedures comply with regulations and guidance and that instructions remain up to date.
• maintains operating instructions for the sale of non-prescription medicines and ensures the training of personnel. All work processes that are critical to operations must be covered by written instructions. The operating instructions must cover all critical stages, and practical operations must correspond to the documented instructions. Personnel must be trained to work in accordance with the instructions, and their competence must be maintained on a regular basis. Personnel training must be documented.
• identifies risks and potential deficiencies (deviations) related to operations and implements the necessary corrective actions without delay to address identified deficiencies. Deviations are situations in which operations do not comply with established instructions or requirements. Deviations and near-miss situations must be addressed without delay. This includes investigating the causes and implementing any necessary corrective actions. The handling of deviations must be documented.
• ensures that the necessary measures are taken in cases involving product complaints, product defects, falsified medicines and product recalls (For more information on reporting product defects, see the Fimea website).

What consequences may result from deficiencies identified during an inspection?

During an inspection, Fimea may determine that the operation is non-compliant and issue an order requiring the identified deficiencies to be corrected within a specified time limit. A holder of a retail licence for non-prescription medicines may also be given an oral or written warning if it operates in breach of the regulations.

If the licence holder fails to correct the identified deficiencies, Fimea may temporarily suspend the sale of non-prescription medicines. In the most serious cases, the consequence may be the revocation of the retail licence. In such cases, the licence holder may no longer engage in the retail sale of non-prescription medicines.

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Medicines Act (395/1987) (Finlex.fi) (in Finnish)
Medicines Decree (693/1987) (Finlex.fi) (in Finnish)