Medicines with stricter reporting requirements Individual reimbursement Danish drug interaction databases Compassionate use permits Healthcare professionals having a relationship with a company Report a side effect from medicines Reporting of incidents and accidents with medical devices Medicinal cannabis Veterinary medicines
Theme

Vaccines against COVID-19

Medicines agencies around the world are collaborating to approve and follow vaccines against COVID-19. Once the vaccines are approved, medicines authorities around the world follow up with monitoring of adverse drug reactions. Read about results, processes and new vaccines against COVID-19 in our three themes or in the question-and-answer below.

Go to theme

News and notifications

Updated version of the Danish Medicines Agency's guidance on risk-adapted recording and reporting of adverse events in clinical trials is now available on the website

23 October 2024

The Danish Medicines Agency’s guidance on risk-based recording and reporting of adverse events in clinical trials on medicinal products under Regulation (EU) no. 536/2014 has been updated and version 2.0 is now available on the website, in both Danish and English. The guidance has been updated with further clarification on the requirements, if risk-adapted adverse event management is implemented. For an overview of the changes, please refer to the change log in the guidance document.

Continued control of companies' uploading of leaflets to the Danish Medicines Agency's portal DKMAnet

16 October 2024

Nils Falk Bjerregaard new Director General of the Danish Medicines Agency

03 October 2024

Completion of the project regarding the control of anti-tampering devices (ATD) on medicinal product packages

12 September 2024