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 1st.
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 1st of January 2027.
Read more about the stockpile and reporting obligations, as well as dispensation and suspension options via the menu on the left.
Information meetings
The Danish Medicines Agency has held two information meetings about the requirements for the companies. The presentations can be found here.
List of medicines
On June 12th 2025, a new executive order was issued with a list of the medicines that are subject to stockpile and reporting obligations. The executive order came into effect on July 1st 2025, and can be found here (in Danish):
The medicinal products added to the executive order that entered into force on July 1st 2025 are subject to the reporting obligation as of October 1st 2025 and to the stockpiling obligation as of January 1st 2026.
The executive order includes an update to the list of critical medicinal products by adding new formulations and/or different strengths within the same substitution group as already listed products. These products have either not previously been included on the list or have entered the market after January 1st 2025 and have therefore not been subject to the stockpiling and/or reporting obligations prior to this executive order.
Accordingly, no entirely new medicinal products have been added, and the total number of products (defined by active substance, pharmaceutical form, and strength) remains at 581. This executive order replaces the previous one.
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 executive order and is also a parallel importer or distributor of one or more other medicines covered by the executive order, the company has a stockpile obligation for the medicines that are not parallel imported or distributed.
Parallel distributors, parallel importers, and marketing authorization holders are otherwise required to report their stock levels to the Danish Medicines Agency every other Monday when a new medicine price period begins.
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.
The Danish Medicines Agency does not regulate how an agreement between the company and another party is structured. However, the company is at all times responsible for ensuring compliance with the rules and for maintaining the mandatory stock levels.
This means that the company must at all times be able to control/manage the stock in the same manner as if the stock were held in their own facility. This only applies to stock subject to the mandatory stockpiling obligation and does not include any additional packs the company may have in storage.
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.