Supervision

List of products to be stocked as mandatory reserve supplies

List of products to be stocked as mandatory reserve supplies

The Finnish Medicines Agency has confirmed a list of products to be stocked as mandatory reserve supplies on 10th of May 2021.

The list has been drafted on the basis of the Act of Mandatory Reserve Supplies of Medicines (979/2008, hereinafter the Act on Mandatory Reserve Supplies) and the Decree of Mandatory Reserve Supplies of Medicines (1114/2008, hereinafter Government Decree on Mandatory Reserve Supplies). The list also takes into account the Act 294/2012 and Decree 308/2012 given on 15 June 2012 and 14 June, which both came into effect on 1 July 2012. This legislation changed section 4 of the Act and section 1 of the Decree. List of products to be stocked as mandatory reserve supplies includes products which have a critical medical significance and which have active pharmaceutical ingredients listed in the Decree of Mandatory Reserve Supplies of Medicines. Supplies also include excipients and additives and packaging materials used in the manufacturing of medicinal, if the party subject to maintaining the mandatory reserve supplies, storages active pharmaceutical ingredients instead of medicinal products. The Finnish Medicines Agency may also decide, from active pharmaceutical ingredient to another, that the mandatory reserve supply does not include all pharmaceutical forms.

The list of products to be stocked as mandatory reserve supplies is for reference only and is not exhaustive. The Act and the Decree on Mandatory Reserve Supplies should be primarily observed.

There are 1372 medicinal products in the list of mandatory reserve supplies. The list prior to the current one had been confirmed on 4th May 2020. With this update 47 new medicinal products have been added. Due to the cancellation of marketing authorisations, 73 medicinal products have been taken out of the list. These medicinal products have been listed in a separate file.

The current updated list comes into effect on 1st of January 2022 and is valid for the whole calendar year. The parties required to maintain mandatory reserve supplies (pharmaceuticals companies, importers, health care units and the National Institute for Health and Welfare) have to inform the quantities to be stocked to Fimea at the latest by 31st of December 2021.

List of products to be stocked as mandatory reserve supplies will be updated next time in one year by Finnish Medicine Agency.

Medicinal products to be stocked as mandatory reserve supplies (10th May 2021, documents in Finnish)

Medicinal products taken out of the list due to the cancellation of marketing authorisation (10th May 2021, documents in Finnish)

Older files

Medicinal products to be stocked as mandatory reserve supplies (4th May 2020, documents in Finnish)

Medicinal products taken out of the list due to the cancellation of marketing authorisation (4th May 2020, documents in Finnish)

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Further information

Further information

  • Kotilainen Hanna
    Coordinator for Marketing Authorisations tel. +358295223371
  • Sorsa Paula
    Coordinator for Marketing Authorisations tel. +358295223498