Inquiries to the Danish Medicines Agency about medicines
It is important to us that companies and industry associations feel they receive a prompt reply when they contact the Danish Medicines Agency.
Under the COVID-19 pandemic, the Danish Medicines Agency aims to give a quick response to the various inquiries made by companies and industry organisations.
To facilitate the fastest review possible, there are different mailboxes for the different areas of responsibility of the Danish Medicines Agency. These mailboxes ensure that the questions from companies and industry associations are channelled directly to the appropriate area for handling by employees who have the required competencies to respond to the inquiries as fast as possible.
We advise you to use the existing mailboxes whenever possible
If your inquiry concerns a COVID-19-related topic that does not fit any of the below categories, please send it to this mailbox for COVID-19.
Likewise, if other inquiries about medicines do not fit any of these categories, please send them to the main mailbox of the Danish Medicines Agency.
- All types of applications for approval of a clinical trial of medicines, the submission of new information related thereto in the form of amendments, adverse reactions, etc. should be sent to the clinical trials mailbox
- Questions about Good Clinical Practice (GCP) related to the practical conduct of a clinical trial should be sent to this mailbox
- Companies’ applications for the dispensing of medicines should be sent to the compassionate use permit mailbox
- Companies’ applications for authorisation of medicines and regulatory questions should be sent to the licensing mailbox
- Medicine prices should be sent to this mailbox
- Reports of product defects involving medicines, including non-compliance with GMP, should be sent to the Rapid Alert mailbox
- Companies that need to report product supply problems expected to affect the treatment of patients in Denmark should use this mailbox
- Companies’ applications for authorisation to handle medicines should be sent to the company authorisation mailbox
- Companies’ practical and regulatory questions about Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) should be sent to this mailbox
- Pharmacy-related inquiries should be sent to the pharmacies mailbox
- Reimbursement-related inquiries should be sent to reimbursement mailbox