Authorisation to manufacture cannabis bulk and cannabis primary products
Manufacture of cannabis products
The Danish Medicines Agency grants authorisations to manufacture cannabis bulk and cannabis primary products pursuant to section 9(1) of the Act on a Medicinal Cannabis Pilot Programme and on a Scheme for Cultivation, Production, etc. of Medicinal Cannabis.
Cultivation of cannabis under the pilot programme, production of cannabis bulk and production of cannabis primary products as well as export of these product types are activities appearing from the authorisation to manufacture cannabis bulk and cannabis primary products. Cannabis bulk designates a cannabis-based product, e.g. cannabis herbal substance, extract, other herbal preparation or formulated as a product form, intended for further processing. Cannabis primary product designates a cannabis-based product that contains one or more herbal substances or herbal preparations, is formulated as a product form and appears in a consumer-ready package.
Applying for an authorisation to manufacture cannabis bulk and cannabis primary products
The documents to be submitted with your application appear from the guide to the application form available below under Application guidelines. This guide also covers how to complete the form and lists the requirements for the competent person.
You can find the application form below under the heading Form. Please send the application form and accompanying documents to Send an email.
Inspection of manufacturers of cannabis bulk and cannabis primary products
Companies applying for an authorisation to manufacture cannabis bulk and cannabis primary products must be ready for the inspection at the time of submission. This applies to applications for a new authorisation and applications for variation of an existing authorisation. Before granting the authorisation to manufacture cannabis bulk and cannabis primary products, the Danish Medicines Agency will assess if it is necessary to inspect the applicant company before granting the authorisation. No authorisation is 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 manufacture cannabis bulk and cannabis primary products are supervised regularly by the Danish Medicines Agency.
Application guidelines
We provide general guidelines on applications for company authorisations, including requirements and deadlines for applications on our website under Company authorisations and registrations.
Form
Addendum to the form for applying for an authorisation to manufacture cannabis intermediate products.
Form for indicating lack of basic subjects for approval of competent person (in Danish only)
Security guidelines
Tool for assessing risk
Recommendations for security of companies that manufacture medicinal cannabis (PDF) (in Danish only)
Legislation
Executive order on cannabis bulk and cannabis primary products (in Danish only)
Good agricultural and collection practice (GACP)
Good manufacturing practice (GMP)
Fees
An application fee and an annual fee are charged for company authorisations under the pilot programme and development scheme.
You can see the current fees and find links to the rules on fees on the page Fees payable for medicinal cannabis and companies cultivating cannabis, etc.
One fee is charged for each site (geographical locality) where activities take place.
List of authorised companies
List of companies authorised to manufacture cannabis bulk and cannabis primary products (Excel)