An IB template for cell therapy products is now available on the Danish Medicines Agency’s website.

The update aligns with the common EU guidance and includes supplementary information relevant to the Danish context, including a section on cross-border participation.

EMA’s human medicines committee (CHMP), part of the European Medicines Agency, decided at its meeting this week to recommend approval of Wegovy in tablet form. It is now for the European Commission to make the final decision.

As the summer season approaches, we would like to draw your attention to the need for forward planning in connection with the holiday period. All case processing will continue as usual in CTIS. However, please note that Denmark’s initiative for expedited processing of Phase I and integrated Phase I/II trials will not be available during weeks 29–31, 2026. Please read more here.

The Danish Medicines Agency has reported 6 websites to the police as part of the INTERPOL operation, Operation Pangea XVIII, and the Danish Customs Agency has detained 19 consignments containing illicit medicines, narcotics and doping substances.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommends that the product information for semaglutide medicines should include information that the rare eye condition NAION could be a very rare side effect. Treatment should be stopped if symptoms of NAION occur.

See the Danish Medicines Agency’s guidance on the content of the Investigator’s Brochure for clinical trials with ATMPs

It is now possible to submit non-substantial modifications, where it earlier required submission of a substantial modification. It includes amongst others the prolongation of the clinical trial duration. See the full list of functionalities below and on our homepage.

Since 1 February 2021, the Danish Medicines Agency has been issuing decision letters on applications for marketing authorisations electronically and securely.

The Danish Whistleblower Act obliges authorities that are subject to the rules of the Access to Public Administration Files Act to publish, at least once a year, information on the activities they have carried out under the Danish Whistleblower Act – a so-called system of openness (offentlighedsordning).

The sponsor guideline is now available.

Compliance with dossier requirements GMP inspections. In 2026, the Danish Medicines Agency will have a special focus on whether GMP companies comply with the requirements laid down in the dossiers o

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 2026.

As of 1 January 2026, private individuals may legally import medicines to Denmark from any country. The medicine must have been sold legally, and you may only import medicines for personal use. The change does not apply to antibiotics, doping substances and medicines con-taining euphoriant substances.

The last day for submitting an application for a certificate of free sale to export a medical device  will be Friday 12 December 2025. Any application received after that will be considered recei

The Danish Medicines Agency will be closed from Wednesday, 24 December 2025, through Thursday, 1 January 2026. During this period, no support will be provided in connection with the submission of pric

As of 1 January 2026, a new structure will facilitate cross-disciplinary collaboration and prepare the agency for tomorrow’s tasks within especially four strategic areas. The new structure is also welcoming a new division for preparedness and supply.

The Danish Medicines Agency is closed for the Holiday Season, from December 24, 2025, until January 1, 2026, both days included.

The interactive map provides patients, healthcare professionals and everyone else with easy access to current information about clinical trials conducted throughout the EU, Norway and Iceland, and it has just been made available in all EU languages.

The European Pharmacopoeia is currently updating the monograph for Cannabis Flower. The proposed changes are now available for public consultation in Pharmeuropa Online, Issue 37.4. Deadline for comments: 31 December 2025