Mandatory reserve supplies
The purpose of legislation concerning mandatory reserve medical supplies is to ensure the availability of medicines in circumstances in which such availability is restricted or prevented as a result of suspension of deliveries, a serious crisis or other equivalent reason. The Act on Mandatory Reserve Supplies (979/2008) applies to pharmaceuticals companies, importers, health care units and the National Institute for Health and Welfare.
The Government Decree on Mandatory Reserve Supplies of Medicines (1114/2008) identifies the drugs to be stocked; provides more detailed instructions for the organisation of mandatory reserve stocks in certain special circumstances; defines the grounds on which exemptions can be granted from the obligation to stock reserve supplies in special cases; and specifies the criteria for compensation and the supervision of stocks. When necessary, the Finnish Medicines Agency confirms the preparations to be included in the mandatory reserve supplies item by item.
The key government agencies responsible for mandatory reserve supplies are the Finnish Medicines Agency and the National Emergency Supply Agency that pays compensation to pharmaceuticals companies and importers for the cost of maintaining reserve supplies.
The Finnish Medicines Agency’s website provides answers to frequently asked questions concerning mandatory reserve supplies. Questions and comments can be addressed to: velvoitevarastointi@fimea.fi.
Further information:
Licenses and notifications; importers, pharmaceutical companies and the National Institute for Health and Welfare:
Julia Lehtinen, Senior Inspector, tel. +358 (0)29 522 3288
Importers in general:
Johanna Linnolahti, Senior Pharmaceutical Inspector, tel. +358 (0)29 522 3231
Health care units:
Eija Särkkä, Senior Pharmaceutical Inspector, tel. +358 (0)29 522 3240
Medical questions concerning mandatory reserve supplies:
Jukka Sallinen, head of unit, tel. +358 (0)29 522 3410
E-mail address format: firstname.lastname@fimea.fi.
Legislation:
Laki lääkkeiden velvoitevarastoinnista 979/2008
Valtioneuvoston asetus lääkkeiden velvoitevarastoinnista 1114/2008