Dispensation
Companies can apply for a dispensation from the requirement for the size of the stock and from the requirement that the stock must be located in Denmark. This means that companies can apply for a dispensation to be completely exempted from having a stock or for a dispensation to have a number of packages in stock that correspond to less than 6 weeks' expected sales. In addition, companies can apply for a dispensation to store all or part of the stock in another EU/EEA country.
The Danish Medicines Agency has since the 1st of September 2024 been able to recive dispensation applications, and the applications are processed individually by the Danish Medicines Agency. It is important that companies clearly state a reason for why they should be exempted from the requirements, as well as a date for when the dispensation should apply from and to.
Dispensation regarding the size of the stock
Companies can apply for an exemption from the stock obligation in whole or in part.
In the assessment, the Danish Medicines Agency emphasizes, how burdensome the requirement for stock is for the company in relation to the significance of the dispensation for security of supply, including:
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The company's ability to maintain stock
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The company's market share in Denmark
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Medicines with a very short shelf life
It is possible to enter 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
Companies can apply for a dispensation from the requirement that the stock must be located in Denmark, so that the warehouse is stored in another EU/EEA country.
In its assessment, the Danish Medicines Agency emphasizes, 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:
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The company's ability to store the stock in Denmark
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The company's market share in Denmark
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The company's ability to move the stock in whole or in part to Denmark
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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.