Retail store responsibilities
What are the duties of the responsible person at a retail store selling non-prescription medicines?
A retail store selling non-prescription medicines must designate a responsible person. The responsible person is responsible for ensuring that the operations of the retail store comply with the applicable requirements.
In particular, the responsible person is responsible for the following duties:
- monitoring and documenting the storage conditions of non‑prescription medicines
- carrying out an annual inspection of the retail store (self‑monitoring)
- monitoring sales in order to prevent misuse and incorrect use of medicines
- acting as the contact person in matters involving authorities.
What should staff working at a retail store selling non prescription medicines know?
Staff working at a retail store must be trained in tasks related to the sale and handling of non prescription medicines. Staff at the retail store:
- must not provide medicinal counselling
- must not unlawfully disclose confidential information
- must be familiarised with the retail store’s own instructions and supervisory arrangements concerning the sale and storage of non prescription medicines.
What requirements apply to the sale and storage of non prescription medicines?
Retail stores must ensure that the sale and storage of non prescription medicines comply with the requirements laid down in legislation.
Retail stores must ensure that:
- the conditions in sales and storage areas comply with the product information (Summary of Product Characteristics) of the medicine
- staff at the retail store handle and store non prescription medicines appropriately
- unauthorised access to sales and storage areas and to medicinal waste is prevented by appropriate supervision
- only non-prescription medicines of acceptable quality are offered for sale
- medicinal waste is handled and disposed of appropriately; unsold non prescription medicines are disposed of as medicinal waste and kept separate from sale stock
- non prescription medicines are sold only in complete sales packages
- sales always take place under staff supervision.
What should be taken into account in the marketing of non prescription medicines?
Holders of a retail licence for non prescription medicines must comply with the regulations governing the marketing of medicinal products. Provisions on the marketing of medicines are laid down in Sections 91–93 of the Medicines Act and in Sections 25 and 25a–25b of the Medicines Decree. Marketing that encourages unnecessary use of a non prescription medicine is not permitted. This includes, for example, gifts, promotional items, prize draws and competitions.
The content of advertisements for non prescription medicines must be based on the information contained in the Summary of Product Characteristics. Advertisements must include the minimum information required by law, which may not be replaced by a QR code or similar means.
More information is available on Fimea’s website Supervision of pharmaceutical marketing.
What requirements apply to price indication and discounted prices of non prescription medicines?
In the sale and marketing of non prescription medicines, the following must be taken into account:
- pricing of non‑prescription medicines included in the restricted selection is free, but the price must not exceed the maximum retail price laid down in the medicines tariff
- selling two or more packs of medicines, or a medicine together with another product, at a reduced combined price is prohibited.
- the sale of a medicine or a discounted price must not be conditional on the purchase of another product.
- the holder of a retail licence for non prescription medicines must grant a 10 per cent veterans’ discount to persons entitled to it.
- marketing non prescription medicines in a way that emphasises a discounted price is not permitted; however, a price label may neutrally indicate the reduced price and the normal price of the product.
- a non-prescription medicine must not be sold at a reduced price on the grounds that it is approaching its expiry date.
- purchases of medicines must not accrue bonuses.
Value added tax (VAT) is always added to the retail price of a non prescription medicine. If the wholesale price of a medicine changes, this change affects the maximum retail price. In such cases, the retail price must be updated if necessary.