Stocks of critical medicines

The new rules on stockpiling of medicines enter into force on 1 July 2024. The rules commit companies placing critical medicines on the Danish market to maintain a security stock of the medicine in question. At present, the size of the stock must correspond to six weeks’ expected sales.

The companies have until 1 January 2025 to build their stocks. Over the coming six months, the companies must therefore prepare for compliance by establishing the facilities and resources needed to build stocks corresponding to six weeks’ expected sales as of 1 January 2025. The act is to be evaluated before 1 January 2027.

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. 

[Link til bekendtgørelsen på Retsinformation] (in Danish only)

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.

Exemptions

Companies may seek an exemption from the requirement as regards the size of the stock and from the requirement that the stock must be located in Denmark. This means, they may seek an exemption from keeping a stock altogether or an exemption that will allow them to stock a number of packages corresponding to less than six weeks’ expected sales. The companies 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 application individually. The Danish Medicines Agency will create a form that the companies are to use to apply for an exemption. It will be made available on this page.

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.