News about licensing of medicines
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Updating of summaries of product characteristics due to changed ATC codes for 2025
| 02 January 2025 |
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 2025.
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The Danish Medicines Agency requires bioequivalence data in a better data format
| 03 July 2025 |
In future, the Danish Medicines Agency will request that data from bioequivalence studies be submitted in an additional data format to that used today. Businesses applying for approval of new medicines or submitting variation applications will be required to submit data in CDISC format from 1 September 2025.