Application for wholesale distribution of medicines within the EU/EEA

Updated 16 October 2017

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.

Inspection

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:

Inspection of authorised pharmaceutical companies

Lists

Companies authorised to distribute medicines by wholesale in Denmark (Excel file in Danish)

Guidelines

Guidelines on activities subject to a section 39 authorisation or company registration

Guidelines on applications for authorisation to wholesale distribute medicines within the EU/EEA

Wholesalers must not receive or buy medicines from non-EU/EEA countries (third countries) nor handle intermediate products

General guidance on applications for company authorisations, including the requirements and deadlines to be observed.

Company authorisations and registrations

Form

Application form for authorisation to wholesale distribute medicines within the EU/EEA (GDP) (Word file)

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

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