Content of the stockpile obligation
From January 2025, all companies, except for parallel importers and distributors, that market a medicine covered by Annex 1 to the executive order on medicines subject to mandatory stockpiles, must establish a safety stock of the medicine at package level. The size of the stock must correspond to 6 weeks of expected sales. The mandatory stock quantity is determined on January 1st and July 1st based on the average sales of the package in the last two quarters. The packages in stock must be Danish packages, and the stock must be stored in Denmark. Companies should be able to document which packages constitute the stock.
If the company has not had sales of a given package in the last six months, no stock needs to be established.
Below is a calculation example where a company sold 2000 packages in the last six months.
Example of calculation on January 1, 2025
It is assumed that 2000 packages of medicine X were sold from the 1st of July to the 31st of December 2024.
The stock size corresponding to 6 weeks of expected sales is calculated as follows:
2000 packages /26 weeks * 6 weeks = 461,54
Therefore, the stock must consist of 462 packages until the stock is recalculated on the 1st of July 2025.
Content of the stockpile obligation in case of shortage
If a shortage has been reported within the last two quarters, the calculation will be based on the sales of the last two quarters prior to the start of the shortage.
Example of calculation on January 1, 2025, after a shortage:
The company reported a shortage from the 1st of October to the 15th of November, 2024. The stock size must be calculated based on sales from the 1st of April 2024 to the 30th of September 2024.
Packages sold in the period [April 1st – September 30th] / 26 weeks * 6 weeks
The calculation will be valid until July 1st 2025, when the stock size is recalculated based on sales from the 1st of January to the 30th of June, 2025.
Deactivated packages
If a company has deactivated a package but still had sales in the last six months, the company is obliged to establish a stock even if the package is deactivated. It is only when the package is deregistered that the company is no longer obliged to establish a stock.