The parties required to maintain mandatory reserve supplies must report the quantities involved to Fimea annually. The reports must be sent to the Fimea by 31 December of the year prior to commencing the mandatory reserve storage.
Pharmaceuticals manufacturing companies and importers
The quantities to be stocked are based on domestic sales during the period from 1 March to 31 August. Depending on the medicine group and drug involved, the quantity to be stocked is equivalent to 3, 6 or 10 months’ average consumption.
Health care units
The quantities to be stocked are based on consumption during the period from 1 January to 30 September. Depending on the medicine group and drug involved, the quantity to be stocked is equivalent to 6 or 3 months’ or 2 weeks’ average consumption.
The responsible operator of the health care unit may agree with the responsible operator of another such unit on the maintenance of mandatory reserve supplies. If so, both parties must report the arrangement to Fimea.
The National Institute for Health and Welfare
With regard to vaccines included in the national vaccination programme, the quantities to be stocked are based on the average vaccine consumption between1 January and 30 June, except for influenza vaccines.
Contents of the report
Reports concerning mandatory reserve supplies are made in tabular format, for example as Excel spreadsheets. The report must clearly indicate the name of the reporting party; the medicine groups as defined in section 1 of the Mandatory Reserve Supplies Decree; the drug specified for inclusion in the reserve supplies; trading title of the preparation; dosage form; packaging size; total consumption of the preparation during the period on which the stock level is based; and the quantity to be stocked.
The size of the mandatory reserve stock is not tied to a certain packaging size. If there are a number of packaging sizes for the same indication on the market in Finland, mandatory reserve supplies may be fulfilled with them.
Pharmaceutical manufacturing companies fulfilling their obligation to maintain mandatory reserve supplies in the form of drugs, excipients and additives and packaging materials instead of medicinal products must file their report in a similar tabular form. The report must clearly indicate the medicinal product governed by the obligation to stock reserve supplies; sales of the medicinal product during the period on which the amounts to be stocked is determined; the quantities of drugs, excipients and additives and packaging materials contained in the medicinal product; and the quantities of such materials to be stocked calculated on the basis of the consumption of these items.
If any material changes take place in the consumption of medicines (exceeding 30%) during the period from 1 October to 31 March, the party obligated to maintain reserve supplies must update the mandatory reserve supplies report accordingly by 30 June. The new obligation based on the updated report takes effect on 1 July of the same year.
Filing the reports with Fimea
The signed mandatory reserve supplies reports are addressed to the Finnish Medicines Agency Fimea, P.O. Box 55, 00034 Fimea, Finland. Additionally, the report must be submitted to Fimea in electronic format on a memory stick, CD or by e-mail to email@example.com.