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EU one step closer to electronic product information
| 16 January 2025 |
In 2023-2024, the Danish Medicines Agency participated in a pilot set to pave the way for using electronic product information (ePI) in favour of the printed package leaflets provided in the medicine package and the printed product information for healthcare professionals.
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Update: Information meeting on the revised ICH GCP guideline (ICH E6 R3)
| 16 January 2025 |
The Danish Medicines Agency will hold after-work meetings on the revised ICH GCP guideline (ICH E6 R3) on February 27 and 28, 2025, from 14:30 to 18:00.
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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.
