Stockpiles of critical medicines

The new regulations on medicine stockpiles came into effect on July 1, 2024. The rules require companies that market a critical medicine in Denmark to establish a safety stock of the medicine in question. The size of the stock must correspond to 6 weeks of expected sales, and companies must have built up the stocks by January 1^st.

The purpose of the stockpiles is to meet the need for critical medicines in the event of short-term supply difficulties, so that patients are affected as little as possible. At the same time, the stockpiles should give the Danish Medicines Agency and other stakeholders time to implement necessary measures to mitigate the consequences of long-term supply difficulties that cannot be covered by the stockpiles.

In addition to building up stockpiles corresponding to 6 weeks of expected sales, companies are also required to continuously report their stock levels of the covered medicines to the Danish Medicines Agency every two weeks.

Information on the stock levels of the covered medicines supplements information from medicine wholesalers, the regional procurement organization (Amgros I/S), pharmacies in the primary sector, and public hospital pharmacies, which the Danish Medicines Agency already receives.

The law will be evaluated by the 1^st of January 2027.

Read more about the stockpile and reporting obligations, as well as dispensation and suspension options via the menu on the left.

List of medicines

On December 10^th, a new executive order was issued with a list of the medicines that are subject to stockpile and reporting obligations. The executive order comes into effect on January 1^st 2025, and can be found here (in Danish): 

Bekendtgørelse om lægemidler omfattet af pligtmæssige lagre og indberetningspligt for kritiske lægemidler.

The list includes 581 medicines (defined by active substance, dosage form, and strength) and replaces the previous executive order. Companies have 6 months to build up stockpiles of the new medicines added to the list in the new executive order.

Therefore, from January 1^st 2025, companies only need to maintain a stockpile and report their stock levels for the 263 medicines that appear in both the new executive order and the previous executive order.

For the new medicines that have been added and only appear in the new executive order, companies must report their stock levels from April 1^st 2025, and comply with the stockpile obligation by the July 1^st 2025.

At the link below, you can download an Excel file with the new list of medicines subject to storage and reporting obligations. The list indicates which medicines are new. Additionally, there is a sheet only containing the medicines which must be stockpiled and are subject to reporting obligations from January 1^st 2025.

New list of medicines subject to storage and reporting obligations.

Companies covered

The stockpile obligation applies to companies that market a medicine listed in the executive order on the Danish market. Parallel importers and distributors are not covered by the stockpile obligation. If a company holds a marketing authorization for one or more medicines covered by the scheme and is also a parallel importer or distributor of one or more other medicines covered by the scheme, the company has a stockpile obligation for the medicines that are not parallel imported or distributed.

Both parallel distributors, parallel importers, and marketing authorization holders are otherwise required to report their stock levels to the Danish Medicines Agency.

What can be delegated to another actor?

The company can delegate the task of building up and maintaining the stockpile requirement to another actor, such as a wholesaler. However, the responsibility will always lie with the company.

In addition to stockpile building and maintenance, it is also possible to delegate the reporting of stock levels to another actor. Read more under the reporting page in the menu on the left.