In forceHealth
The Danish Medicines Agency can designate more critical entities
Official title (in Danish): Bekendtgørelse om delegation til Sundhedsstyrelsen og Lægemiddelstyrelsen af adgangen til at udpege kritiske enheder efter CER-loven
In short
Reading time: 1 min- What changes:
- The Danish Medicines Agency could already, on behalf of the Minister for Health, designate EU reference laboratories and entities researching medicines as critical entities under the CER Act.
- Now the agency can also designate manufacturers of pharmaceutical raw materials and preparations, manufacturers of medical equipment that is critical in a public health crisis, and holders of a marketing authorisation for medicines.
- Who: The rules apply to EU reference laboratories, entities that research medicines or manufacture pharmaceutical raw materials and preparations, manufacturers of critical medical equipment, and holders of marketing authorisations.
- When: The executive order entered into force on 15 October 2026.
Written by AI from verbatim quotes from the source and checked by code and AI. Dates, tables and the fact box are calculated by fixed rules. Unofficial translation. Always read the original.
Sources and original
Read the official text (in Danish) →
Source: Retsinformation.dk
Translated from Danish · The Danish version and the original source apply.
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- Issued · 9 October 2026
- Published in the Danish Law Gazette (Lovtidende) · 13 October 2026
- In force · 15 October 2026