Application for wholesale distribution of medicines within the EU/EEA
Please note that this website including guidelines has yet to be updated regarding the regulation (EU) 2019/6 on veterinary medicinal products. We refer to the Danish website for the updated information.
Here you can find guidelines and applications forms for authorisation to wholesale distribute medicines within the EU/EEA (wholesale distributor authorisation). The Danish Medicines Agency grants wholesale distributor authorisations according to section 39 of the Danish Medicines Act.
Companies authorised to distribute medicines by wholesale are supervised regularly by the Danish Medicines Agency. Inspections are carried out according to the GDP rules
Information about the frequency of inspections:
Companies authorised to distribute medicines by wholesale in Denmark (Excel file in Danish)
General guidance on applications for company authorisations, including the requirements and deadlines to be observed.
Submission of Wholesale Distributor Authorisations (WDA) to EudraGMDP
We regularly submit Danish WDAs to the EMA’s EudraGMDP database as they are issued. This means that Danish WDAs are publicly available at EudraGMDP and authorisations can be verified in the database.
You can read more about EudraGMDP on the EMA’s website under EudraGMDP database