Hearing on new draft executive order on medicinal products subject to mandatory stockpiling and reporting obligations for critical medicinal products
The draft executive order determines which medicinal products are to be considered critical under Section 75 and Section 75 b of the Danish Medicinal Products Act and the supplementary rules in executive order No. 869 of 26 June 2024. The medicinal products are specified by ATC code, formulation, and strength.
The draft executive order aims to replace the current executive order No. 870 of 26 June 2024 on medicinal products subject to mandatory stockpiling and reporting obligations for critical medicinal products.
In accordance with the explanatory notes to the draft legislation underlying Sections 75 and 75 b of the Medicinal Products Act, the current executive order only provides a provisional list of medicinal products subject to stockpiling and reporting obligations. This provisional list was intended for a transitional period while the Danish Medicines Agency assessed which medicinal products to include in the final list and hence to be subject to stockpiling and reporting obligations.
According to the new draft executive order, the rules will enter into force on 1 January 2025.
A transitional period will apply for medicinal products on the revised list that are not currently subject to stockpiling and reporting obligations, so that the stockpiling obligation for these medicinal products applies from 1 July 2025, and the reporting obligation for these medicinal products applies from 1 April 2025.
The revised version is more extensive than the previous provisional list, and we therefore advise stakeholders to consult the draft executive order to ensure that a specific product has not been added or removed from the list.
The Danish Medicines Agency has set the deadline for submitting consultation responses to 26 November 2024.