Dispensation

Companies can apply for a dispensation from the requirement that the size of the stock must correspond to 6 weeks of expected sale. For example, a company may apply for a dispensation to maintain a stock corresponding to less than six weeks of sales, or for a full dispensation, meaning that no stock needs to be maintained at all. Under special circumstances, companies can apply for a dispensation to store all or part of the stock in another EU/EEA country.

Companies must provide a clear justification in their application, outlining the reason for their inability to meet the stockpiling requirements, including a detailed explanation. Furthermore, the application must state the requested start and end dates for the wished dispensation period.

Dispensation regarding the size of the stock

Companies can apply for a dispensation from the requirement to maintain stock corresponding to 6 weeks of expected sale.

In its assessment, the Danish Medicines Agency emphasizes how burdensome the stockpiling requirement is for the company in relation to the significance of the dispensation for the security of supply, including:

1. The company's ability to maintain stock

1. The company's market share in Denmark
2. Medicines with a very short shelf life

It is possible to apply for dispensation for several product numbers in one application for the same medicinal product if the justification for the application is the same. The form can be accessed via the link below.

Form for dispensation regarding the size of the stock

Dispensation regarding location of stock

Under special circumstances, companies can apply for a dispensation from the requirement that the stock must be located in Denmark, allowing it to be stored in another EU/EEA country.

In the event of special circumstances, the Danish Medicines Agency will, among other things, take into account how burdensome the requirement for stock in Denmark is for the company in relation to the significance of the dispensation for security of supply, including:

1. The company's ability to store the stock in Denmark

1. The company's market share in Denmark
2. The company's ability to move the stock in whole or in part to Denmark
3. Existing or risk of Export Restrictions

It is possible to apply for several medicinal products in the same application if the justifications are the same.

Practice for Assessing Special Circumstances in Applications for Exemption Regarding Stock Location

According to the general remarks in legislative proposal no. L 172, the Danish Medicines Agency may only grant a dispensation from the requirement that the mandatory stock must be located in Denmark under special circumstances, and instead allow the stock to be held in another EU/EEA country.

The Danish Medicines Agency’s ability to grant a dispensation that deviates from the legal requirement — that the mandatory stock must be stored in Denmark — is therefore contingent upon the existence of special circumstances.

At the time of the proposal's adoption, it was known that the new rules would result in financial and administrative costs for companies in connection with establishing and maintaining safety stocks in Denmark. For this reason, the Danish Medicines Agency has assessed that general and expected costs associated with establishing a stock in Denmark — including moving a warehouse from abroad — cannot, in themselves, be regarded as a special circumstance.

Form for dispensation regarding location of stock