Authorisation to produce cannabis intermediate products
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 cultivation of cannabis for medicinal use and production of cannabis bulk.
Import, production and export of cannabis primary products and production of cannabis intermediate products are all activities appearing on the authorisation to produce cannabis intermediate products.
Application for authorisation to manufacture cannabis intermediate products
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 Form. Please send the application form and accompanying documents to firstname.lastname@example.org.
Inspection of cannabis intermediate product manufacturers
Companies applying for authorisation to manufacture cannabis intermediate products 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 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. 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 manufacture cannabis intermediate products are supervised regularly by the Danish Medicines Agency.
We provide general guidelines on applications for company authorisations, including requirements and deadlines for applications on our website under Company authorisations and registrations.
Companies granted authorisation
Act on the medicinal cannabis pilot programme (in Danish only)