The Danish Medicines Agency
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Latest news from The Danish Medicines Agency about medicines, medical devices and life science.
The Danish Medicines Agency contributes to developing policies and regulations in the pharmaceutical area, both in Denmark and in dialogue with the EU's other regulatory authorities.
The Danish Medicines Agency
5d ago
The European Pharmacovigilance Risk Assessment Committee (PRAC) has reassessed if chronic urticaria could be a side effect after vaccination with the Spikevax vaccine from Moderna. This follows a review from the Danish Medicines Agency, which has investigated data and reports from patients across the European countries ..read more
The Danish Medicines Agency
1M ago
Give your valuable feedback to the European Pharmacopoeia (Ph. Eur.) in the field of setting standards for therapeutic mAbs. The survey will take about 20 minutes. Please complete the survey by ..read more
The Danish Medicines Agency
2M ago
EMA has organized in the series of the CTIS Bitesize Talk an event related to the transitional trial in CTIS Thursday, 29 February 2024, 16:30 (CET) - 18:00 (CET ..read more
The Danish Medicines Agency
2M ago
The Danish Medicines Agency’s Department for Control and Security of Supply resumes the work of checking whether readable leaflets have been uploaded to www.indlaegsseddel.dk ..read more
The Danish Medicines Agency
2M ago
ACT EU training for non-commercial sponsors Friday, 09 February 2024, from 10:00 AM (CET) to 1:00 PM (CET). The event will be live broadcast and no registration is required to follow the live broadcast on EMA’s website ..read more
The Danish Medicines Agency
3M ago
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 2024 ..read more
The Danish Medicines Agency
3M ago
According to Article 152 of Regulation (EU) 2019/6, product information for all veterinary medicinal products granted marketing authorization under Directive 2001/82/EC must comply with version 9 of t ..read more
The Danish Medicines Agency
5M ago
The Danish Medicines Agency will be closed over Christmas and New Year, from Saturday 23 December 2023 to Monday 1 January 2024, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2023 ..read more
The Danish Medicines Agency
5M ago
The Danish Medicines Agency is closed between Christmas and New Year, up to and including 1 January 2024. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines ..read more
The Danish Medicines Agency
5M ago
Applications for import/export certificates received via NDS Web must reach us by 15 December 2023 to be reviewed before Christmas. Applications submitted in any other way must reach us by 8 Decembe ..read more