Admission of products to the medicinal cannabis pilot programme

Updated 01 May 2019
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Cannabis intermediate products and cannabis primary products must be admitted to the Danish Medicines Agency's list to be included in the pilot programme

The Danish Medicines Agency reviews applications from companies seeking to have cannabis intermediate products and cannabis primary products admitted to the Danish Medicines Agency’s list of products included in the pilot programme. Apart from the fact that cannabis intermediate products and cannabis primary products must be admitted to this list, the company must also notify information about the price of the packages, etc. to the Danish Medicines Agency (Medicine Prices) via DKMAnet. The cannabis products will not be available for prescription by a doctor before both these procedures have been completed.

Application for admission of products to the list

Cannabis primary products can either be imported to Denmark or produced in Denmark from Danish-grown cannabis.

For a cannabis intermediate product and its related cannabis primary product to be included on the list of products comprised by the pilot programme, an application must be submitted to the Danish Medicines Agency. The application form must be completed with all the relevant information and enclosed with relevant documentation on the cannabis intermediate product and its related cannabis primary product.

The completed application form and annexes should be sent to the Danish Medicines Agency to medicinskcannabis@dkma.dk.

The Danish Medicines Agency will acknowledge receipt of the application and will send its decision via digital post to the Danish company (applicant).

Questions regarding applications for admission of cannabis products to the list of cannabis intermediate products and cannabis primary products should be emailed to medicinskcannabis@dkma.dk

Application for admission of a cannabis intermediate product and related primary product if the primary product is imported

The requirements for admission of cannabis intermediate products and related cannabis primary products are laid down in the Act on a Medicinal Cannabis Pilot Programme. We specifically refer to section 5 of the act, which describes the requirements for the imported cannabis primary products.

From the links below, you will find the application form and a guidance document on how to complete the form and what documentation to enclose. It also provides further details about the requirements for cannabis intermediate products and their related cannabis primary product.

Links:

Application for admission of a cannabis intermediate product and related cannabis primary product if the primary product is produced in Denmark from Danish-grown cannabis

The requirements for admission of cannabis intermediate products and their related cannabis primary products are laid down in the Act on a Medicinal Cannabis Pilot Programme and the executive order on cultivation, production and distribution of cannabis bulk and production of cannabis primary products. We specifically refer to section 48 of the executive order, which describes the requirements for Danish-grown cannabis primary products.

Links:

Guidance for filling out this application form is being prepared. Until this guidance is available, please use the above-mentioned guidance for filling out the application form for imported cannabis products.

Notification of prices and packages of cannabis intermediate products via DKMAnet

When a cannabis intermediate product is admitted to the list of cannabis primary products and cannabis intermediate products comprised by the pilot programme, the company must notify information on prices and packages and give a supply estimate to DKMAnet – Prices & Packages before the product can be prescribed.

A price period runs for 14 days. This means that the price cannot be changed during this period, and changes in prices and packages can only be notified every fortnight. Companies can only submit prices and packages for their own cannabis intermediate products admitted to the list.

Access to DKMAnet 

If the company (the intermediate product manufacturer) does not have access to DKMAnet – Prices & Packages, the company will have to obtain an employee certificate. Read more about how to gain access.

We advise companies to apply in good time as it may take a couple of weeks to get DKMAnet privileges and access rights.

If you experience any problems with submitting notifications via DKMAnet, please contact DKMAnet Support for Prices & Packages at medicinpriser@dkma.dk or +45 4488 9694, open daily between 8:30 to 15:30. Extended opening hours: every other Monday until 16:30 (in weeks with notification deadlines for prices and packages).

Explanatory information on active ingredients and excipients allowed in products included in the pilot programme (Word) - In Danish only

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