Authorisations
We issue company authorisations for the following activities:
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manufacture and import of medicines and intermediates
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wholesale distribution of medicines within the EU/EEA
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distribution of medicines outside pharmacies, including over-the-counter medicines (HF, HX, HX18), V-marked medicines (HV), medical gases (GH) and medicines for production animals (HP, HPK)
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blood establishment activity
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tissues establishment activity
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handling of euphoriant substances
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radiopharmaceuticals in hospitals
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conduct of toxicological and pharmacological trials (non-clinical trials)
Registrations
Companies are required to register the following activities with the Danish Health and Medicines Authority.
Manufacture, import and distribution of active substances
Brokering of medicinal products Guidelines
Specific guidance, application and registration forms and other relevant information for the different types of company authorisations and registrations are available under their respective areas in the left-hand menu.
In the following guidelines, we describe which activities with active substances, medicinal products and intermediate products that require a company authorisation (section 39 authorisation) or company registration:
Guidelines on activities subject to a section 39 authorisation or company registration (PDF file, opens in a new window)
Fees
An application fee and annual fee are charged for certain company authorisations and company registrations. The fees are regulated in to the Danish Executive Order on Fees Payable for Medicinal Products, etc., cf Schedule 1, please see under Fees in the left-hand menu.
One fee is charged for each site (geographical locality) where activities take place. In certain cases, a reduced fee is charged when several authorisations for the same site is applied for. For further information, please see the Danish Executive Order on Fees Payable for Medicinal Products, available under Fees in the left-hand menu.
