New regulations on Stockpiling of Critical Medicines effective on July 1 2024

It will soon be mandatory for companies behind the most critical medicines to maintain stocks to cover initially six weeks’ consumption and to report stocks regularly to the Danish Medicines Agency. The affected companies will have six months to prepare for compliance, and, in August, the Danish Medicines Agency is holding information meetings about the new rules.

On 4 June 2024, the Danish Parliament adopted the Danish Act on Stockpiling of Critical Medicines, which commits companies placing critical medicines on the Danish market to maintain a security stock of the concerned medicines.

The stocks are to cover the need for critical medicines in the event of short-termed supply difficulties to prevent patients from being 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.

The proposed bill contains a requirement for companies to stockpile volumes to cover up to eight weeks’ consumption.

Against this background, the first executive order will establish an initial requirement for companies to maintain stocks corresponding to six weeks’ consumption. After the entry into force, the effect of the stocks will be assessed regularly with the subsequent aim of raising the requirement to the stipulated eight weeks if needed.

Along with the requirement to build stocks to cover six weeks, the companies will be required to report their stocks to the Danish Medicines Agency every other week. The Danish Medicines Agency is working on a reporting system, the particulars of which we will announce later in 2024.

The information on the mandatory stocks of medicines will supplement 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. This will give the Danish Medicines Agency a total overview of the stocks of the comprised medicines in a wider part of the supply chain and better opportunities to evaluate the supply situation as regards critical medicines in the primary sector.

While the new act enters into force on 1 July 2024, the companies have until 1 January 2025 to comply with the new requirements. Over the coming six months, the companies must therefore prepare for compliance by building the needed facilities and resources for the mandatory stocks. The act is to be evaluated before 1 January 2027.

What medicines are comprised?

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 Danish executive order no. 870 of 26 June 2024. (in Danish only)

According to the bill, the Danish Medicines Agency must no later than in the autumn of 2024 evaluate if more/other medicinal products should be entered on the list of critical medicines subject to the stockpiling obligation. A new executive order will be issued after that. 

What companies are affected?

The act affects 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, but they must still report their stocks to the Danish Medicines Agency.

Are exemptions from the obligation possible?

Companies may seek an exemption from the stockpiling obligation and from the required location of the stock. This means, they may either seek an exemption from the stockpiling obligation in full or an exemption that will allow them to stock a smaller number of packages not corresponding to six weeks’ consumption. They may also apply for an exemption allowing them to maintain the entire stock or parts thereof outside Denmark in another EU/EEA country. The Danish Medicines Agency accepts applications for exemption from 1 September 2024 and will review each of them individually.

What happens in the event of supply difficulties?

After 1 January 2025, it will be possible for companies to have the stockpiling obligation suspended if they are affected by supply difficulties and report those difficulties to the Danish Medicines Agency. When they are no longer affected by supply difficulties, they have three months to rebuild their stock.

The companies may also draw from the stock to avoid potential supply difficulties as long as the Danish Medicines Agency is notified, i.e. if the company estimates that they can supply the Danish market by using some of the stock with no risk of a real supply failure.

How to get more information?

The Danish Medicines Agency will invite affected companies to information meetings and has created a dedicated email address for questions: lager@dkma.dk.

Two information meetings will be held on Tuesday 13 August and Thursday 22 August. We will be sending out invitations to affected companies directly. You may also sign up for the meetings via this link.

The Danish Medicines Agency is also going to prepare and publish a guideline on Retsinformation, the official Danish online legal portal, and will prepare and regularly update an FAQ at www.lmst.dk/lager.