Authorisation to manufacture cannabis intermediate products
Production of cannabis intermediate products
On 1 January 2018, the four-year medicinal cannabis pilot programme was implemented. This pilot programme has been extended for a further four years ending on 31 December 2025. In this context, the Danish Medicines Agency issues authorisations to manufacture cannabis intermediate 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 (Danish title: Lov om forsøgsordning med medicinsk cannabis og om ordning for dyrkning, fremstilling m.v. af medicinsk cannabis).
Cannabis intermediate products can be manufactured based on imported or Danish-made cannabis primary products.
Application for an authorisation to manufacture cannabis intermediate 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 cannabis intermediate product manufacturers
Companies applying for an authorisation to manufacture cannabis intermediate 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 intermediate products, the Danish Medicines Agency will assess if it is necessary to inspect the applicant company before the authorisation can be granted. 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 holding an authorisation to manufacture cannabis intermediate products are supervised regularly by the Danish Medicines Agency.
Guide to applying for an authorisation to manufacture cannabis intermediate products (PDF)
Requirements and expectations for the qualified person in a company authorised to manufacture cannabis products (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 for an authorisation to manufacture cannabis intermediate products (Word) (in Danish only)
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)
Tool for assessing risk
Recommendations for security of companies that manufacture medicinal cannabis (PDF) (in Danish only)
Act on a Medicinal Cannabis Pilot Programme and on a Scheme for Cultivation, Production, etc. of Medicinal Cannabis (Danish title: Lov om forsøgsordning med medicinsk cannabis og om ordning for dyrkning, fremstilling m.v. af medicinsk cannabis
Executive order on cannabis intermediate products
Guidance notes on the executive order on the import of cannabis primary products and manufacture of cannabis intermediate product
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 intermediate products (Excel)