Special arrangements for fulfilment of the obligation to maintain mandatory reserve supplies
An importer may, in part, fulfil its obligation to maintain reserve supplies by stocking drugs or semi-finished products that pharmaceutical companies operating in Finland can use for manufacturing medicinal products in the required dosage forms that meet the acceptable quality requirements. However, the actual medicinal product must account for at least 20 per cent of the quantities required.
When applying for substitution of the regular mandatory reserve supplies, the importer must provide Fimea with information on the suitability of the drugs and materials to be stocked for the manufacture of the medicinal product including details and responsibilities regarding the stocks. The freely worded application must be accompanied by a copy of the agreement made with the pharmaceuticals company.
With permission of Fimea, a pharmaceuticals company may be released from the obligation to maintain mandatory reserve supplies in full or in part by providing an equivalent quantity of the medicinal product. The mutual substitution of drugs and medicinal products is determined according to the amount of drug contained in the product. The application filed with Fimea must provide data on the drug contained in the medicinal product and indicate the quantity of substitute preparation to be stocked.