Obligatory storing of medicines

The purpose of obligatory storing of medicines is to secure the availability of medicines in Finland in circumstances in which standard availability is restricted as a result of suspension of deliveries, a serious crisis or other similar reason. Another purpose of oobligatory storing of medicines is to ensure the security of medicines which have a critical medical significance and, consequently, to ensure patient safety. The obligation to maintain storage primarily applies to products that safeguard vital pharmacotherapy and extensive general surgery and intensive care activities. 

The parties required to maintain obligatory storage and the products to be stocked as obligatory storage specified in the Act on Obligatory Storing of Medicines (Laki lääkkeiden velvoitevarastoinnista, 979/2008). The parties required to maintain obligatory storage are pharmaceutical companies operating in Finland, importers of medicinal products, health care units and the National Institute for Health and Welfare. The products to be stocked as obligatory storage include medicinal substances and medicinal products as well as the excipients and additives and packaging materials used in the manufacturing of medicinal products. Under the law, obligatory storage must be located in Finland. 

Medicinal substances included in the obligatory storage are identified in the Government Decree on Obligatory Storing of Medicines (Valtioneuvoston asetus lääkkeiden velvoitevarastoinnista, 1114/2008). The Decree also provides more detailed instructions for the organisation of obligatory storing of medicines in certain special circumstances and defines the grounds on which exemptions can be granted from the obligation to maintain obligatory storage. Finally, the Decree also specifies the criteria for compensation and the supervision of stocks. The Government Decree on Obligatory Storing of Medicines refers to the Government Decree on Obligatory Storing of Medicines of Medicines (1114/2008) and the Government Decrees (308/2012) and (1106/2015) amending sections 1–3 of the original Decree.

The Finnish Medicines Agency Fimea supervises compliance with the obligation and confirms the medicinal products to be included in the obligatory storage. 

The National Emergency Supply Agency pays compensation to pharmaceuticals companies and importers for the cost of maintaining obligatory storage.