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About the EU database of veterinary medicinal products (the Union Product Database)

The Union Product Database (UPD) was launched on 28 January 2022. The database will contain all authorised veterinary medicines in the EU. The Danish Medicines Agency and the other countries’ drug reg
Proposal for SPC harmonisation of a veterinary medicinal product

According to Article 69-72 of Regulation (EU) 2019/6, National Competent Authorities (NCAs) as well as Marketing Authorisation Holders (MAHs) may propose harmonisation of the SPCs of Reference Veterin
Sikkerhedsopdatering for COVID-19 vacciner (2022, nr. 7)
Opdateret vejledning for kliniske forsøg og ny protokol-template som opfølgning på Faglig Forum
Ændringer på hjemmesiden for virksomheder, der håndterer cannabis
Analysekontrol af lægemiddelbatcher kan efter et brexit undtagelsesvis udføres i Storbritannien
Anbefalinger for at undgå potentielt fatale doseringsfejl
Propylthiouracil filmovertrukne tabletter, 100 mg, er tilføjet listen over kritiske lægemidler
How to apply for a new substance to be included on the Nordic list of medicinal products in the Pilot project on English-language common Nordic packages

Application process for companies
Fra 1. september 2025 vil Lægemiddelstyrelsen anmode om at modtage bioækvivalensdata i CDISC-format

From September 1, 2025 the Danish Medicines Agency will request submission of bioequivalence data in CDISC format Based on a pilot study conducted by the Danish Medicines Agency during 2023 an