Stocks of critical medicines

From January 2025, all companies, with the exception of parallel importers and distributors, who market a medicinal product covered by Annex 1 to the Executive Order on medicinal products covered by mandatory stocks, must establish a safety stock of the medicinal product in question at package level.

The size of the stock must correspond to 6 weeks of expected sales. The quantity subject to stock is determined on 1 January and 1 July on the basis of the average sales in the last two quarters. The packages in stock must be Danish packages and located in Denmark. The company should be able to document which packages make up the warehouse.

The stocks are to cover the need for critical medicines in the event of short-termed supply difficulties so that patients are not affected. The stocks are also to give the Danish Medicines Agency and other actors time to take the necessary actions to mitigate the impact of long-term supply difficulties for which the stocks will be insufficient. 

In addition to the requirement to build stocks corresponding to six weeks’ expected sales, the new rules will commit the companies to report their stocks of critical medicines to the Danish Medicines Agency every other week.

The information on the mandatory stocks of critical medicines supplements the information already received by the Danish Medicines Agency from pharmaceutical wholesalers, the procurement service for the Danish regions (Amgros I/S), the pharmacies in the primary sector and the public hospital pharmacies.

The list of medicines

An initial 350 critical medicines will be comprised by the stockpiling obligation (these medicines will be defined based on active substance, pharmaceutical form and strength). They are the same medicines as the ones covered by a stockpiling agreement entered into between the Danish Medicines Agency and the wholesaler Nomeco in the autumn of 2023. The list of these medicines appears from the Danish executive order below. 

Danish Executive Order no. 870 of 26 June 2024 (retsinformation.dk - in Danish only)

It is expected that the list will be updated during the autumn and a new executive order will be issued on the 1^st of January 2025. We will keep this page updated on an ongoing basis. We will also share the new list as soon as it is ready.

Companies affected

The stockpiling obligation applies to companies which place critical medicines comprised by the executive order on the Danish market. Parallel importers and parallel distributors are not subject to the stockpiling obligation. If a company is the marketing authorisation holder for one or more medicinal products comprised by the scheme and is also a parallel importer or parallel distributor of one or several other medicinal products comprised by the scheme, the company is subject to the stockpiling obligation with respect to the medicinal products for which it holds a marketing authorisation.

Parallel distributors, parallel importers and marketing authorisation holders are otherwise all obliged to report their stocks to the Danish Medicines Agency.

Suspension of the stockpiling obligation

The companies’ stockpiling obligation will be suspended if a company is experiencing supply difficulties for the involved package and reports it to the Danish Medicines Agency. When the company is no longer affected by supply difficulties, it has three months to rebuild the stock.

The companies may also draw from the stock to avoid potential supply difficulties, provided the Danish Medicines Agency is notified, i.e. if the company estimates that it can prevent an actual supply shortage in Denmark from happening if it uses packages from the stock to supply the Danish market. The form for notification will be made available on this page from 1 January 2025.

What can be left to another party?

The company can entrust the task of building and maintaining the stock to another party, such as a wholesaler. However, the responsibility will at all times rest with the company regardless of the contract that is entered into.

In addition to stockpiling and maintenance, it is also possible to leave the reporting of the stock to another party.