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Updating of summaries of product characteristics due to changed ATC codes for 2022
Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2022.
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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
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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
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Combined studies with a clinical trial and a performance study: Sponsors now have the opportunity to apply for approval through a national coordinated application process
The Danish Medicines Agency, in collaboration with Danish Medical Research Ethics Committees, has developed a new guideline on a national coordinated application process for combined studies with a cl
