Authorisation to produce cannabis bulk

21 August 2018, Updated 28 February 2019
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Production of cannabis products

On 1 January 2018, the four-year medicinal cannabis pilot programme was introduced. As a result, the Danish Medicines Agency is granting authorisations to produce cannabis intermediate products in accordance with section 9(1) of the Act on a Medicinal Cannabis Pilot Programme. Effective from 1 July 2018, the executive order on cultivation, processing and distribution of medicinal cannabis and production of cannabis primary products now gives companies the possibility of cultivating cannabis for medicinal use and producing cannabis bulk and cannabis primary products from Danish-grown cannabis. Read more about import, production and export of cannabis primary products and production of cannabis intermediary products.

Cultivation of cannabis for medicinal use and production of cannabis bulk are activities appearing on the authorisation to produce cannabis bulk. Cannabis bulk is a term used to describe any processed cannabis product, e.g. cannabis herbal substance, extract or other herbal preparations.

Application for authorisation to manufacture cannabis bulk

The documents to be submitted with your application appear from the instructions to the application form available below under Application guidelines. The guidelines also cover how to complete the form and lists the requirements for the competent person.

You can find the application form below under Application form. Please send the application form and accompanying documents to virksomhedstilladelse@dkma.dk.

Inspection of cannabis bulk manufacturers

Companies applying for authorisation to produce cannabis bulk must be ready for inspection when they submit the application. This applies to applications for a new authorisation and applications for variation of an existing authorisation. Before granting the authorisation to produce cannabis bulk, the Danish Medicines Agency will assess if it is necessary to inspect the applicant company before the authorisation can be granted. The authorisation will not be granted before the Danish Medicines Agency has verified that the company has followed-up sufficiently on any deficiencies identified by the inspection.

Companies authorised to produce cannabis bulk are supervised regularly by the Danish Medicines Agency.

Application guidelines

Guidelines on applications for authorisation to produce cannabis bulk (PDF) 

Requirements for and expectations to the competent person in a cannabis company (PDF), in Danish only

We provide general guidelines on applications for company authorisations, including requirements and deadlines for applications on our website under Company authorisations and registrations.

Application form

Application form for authorisation to produce cannabis bulk (Word) (in Danish only)

Legislation

Act on a Medicinal Cannabis Pilot Programme (in Danish only)

Executive order on cultivation, processing and distribution of medicinal cannabis and production of cannabis primary products (in Danish only)

Good agricultural and collection practice (GACP)

Good manufacturing practice (GMP)


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