Here you can find guidelines and applications forms for authorisation to wholesale distribute medicines within the EU/EEA (wholesale dealer's authorisation). The Danish Health and Medicines Authority grants wholesale dealer's authorisations according to section 39 of the Danish Medicines Act.
Please see Company authorisations for general guidance on applications for company authorisations, including the requirements and deadlines to be observed.
In the box to the right, you can find a list of companies authorised to wholesale distribute medicines in Denmark. The list is in Danish only.
Guidelines
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Guidelines on activities subject to a section 39 authorisation (PDF file, opens in a new window)
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Guidelines on applications for authorisation to wholesale distribute medicines within the EU/EEA (PDF file, opens in a new window)
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Wholesalers must not receive medicines from non-EU/EEA countries (third countries) nor handle intermediate products
Form
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Application form for authorisation to wholesale distribute medicines within the EU/EEA (GDP) (Word file, opens in a new window)
Inspection
Companies authorised to distribute medicines by wholesale are supervised regularly by the Danish Health and Medicines Authority. In the box to the right, you can find information about the frequency of such inspections. Inspections are carried out according to the GDP rules
