Admission of products to the medicinal cannabis pilot programme
To be included in the pilot programme, cannabis intermediate products and cannabis primary products must be admitted to the Danish Medicines Agency's list
The Danish Medicines Agency reviews applications from companies seeking to have cannabis intermediate products and cannabis primary products admitted the agency’s list of products included in the pilot programme. There are several steps to complete before cannabis products can be prescribed by doctors: The company must have obtained the relevant company authorisations, its cannabis intermediate products and cannabis primary products must have been included on the agency’s list, the prices, etc. of its packages must be notified to the Danish Medicines Agency (Medicine Prices) via DKMAnet.
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.
These guidelines describe in detail the constituents and excipients permitted in the products: Ingredients and excipients permitted in products included in the pilot programme.
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 duly completed application form with appendices should be sent to the Danish Medicines Agency via email (Send an email) or via one of the options below:
Submission via Eudralink
Companies can register and find more information on the Eudralink page:
https://eudralink.ema.europa.eu/
The recipient of the application in a new Eudralink submission is:
Submission via Common European Submission Portal (CESP)
Companies can also register and find more information on CESP here:
Applications and responses to a request for more information (RMI) must be submitted via either of the above submission routes.
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 Send an email.
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 specified in 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). We specifically refer to section 5 of the act, which describes the requirements for the imported cannabis primary products. Reference is also made to the requirements for labelling, product sheet, and patient information sheet, etc. of the executive order on labelling, etc. of cannabis intermediate products.
You can download the application form below as well as guidelines for completing the form and the documentation to be enclosed.
Links:
- Application form for admission to the list of cannabis intermediate products and cannabis primary products comprised by the medicinal cannabis pilot programme – Imported products (Word) (in Danish only)
- Guidelines for completing the application form – Imported products (Word) (in Danish only)
- Product sheet template (in Danish only)
- Patient information sheet template (in Danish only)
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 related cannabis primary products are specified in the Act on a Medicinal Cannabis Pilot Programme and on a Scheme for Cultivation, Production, etc. of Medicinal Cannabis, and in the executive order on cannabis intermediate products and the executive order on cannabis bulk and cannabis primary products (Danish titles: Lov om forsøgsordningen med medicinsk cannabis og om ordning for dyrkning, fremstilling m.v. af medicinsk cannabis; Bekendtgørelse om cannabismellemprodukter; and Bekendtgørelse om cannabisbulk og cannabisudgangsprodukter). We specifically refer to section 21 of the executive order on cannabis intermediate products and section 10 of the executive order on cannabis bulk and cannabis primary products.
Follow the link below to download the application form and information about the documentation to be enclosed.
Links:
- Application form for admission to the list of cannabis intermediate products and cannabis primary products comprised by the medicinal cannabis pilot programme – Products produced in Denmark from Danish-grown cannabis (Word) (in Danish only)
- Guideline for completing the application form – Products produced in Denmark from Danish-grown cannabis (in Danish only)
- Product sheet template (in Danish only)
- Patient information sheet template (in Danish only)
We also refer to the Danish monograph for "Cannabis flower" in the "Danis Drug Standards". Danish Drug Standards
Assessment times for applications for admission of cannabis products
Our experience from the cannabis pilot programme has shown us that it is complicated to assess applications for both imported products and in particular products produced in Denmark from Danish-grown cannabis; and that time is needed to carry out a proper assessment of the submitted material.
To ensure uniform assessment times for all applicants and to let companies know what to expect from the administrative procedure after they have submitted an application, we apply the assessment times below.
The indicated assessment times apply and can be observed only if the submitted material is complete and of a sufficiently high quality. During the procedure, companies are not permitted to make any changes to the application and the enclosed documentation, unless these changes are directly related to any follow-up questions raised by the Danish Medicines Agency during the procedure.
Imported cannabis primary products
The estimated assessment times for the admission of imported cannabis primary products and related cannabis intermediate products for complete applications are:
- Validation: 14 days
- Assessment: 50 days
The assessment will not begin before the application has been accepted as valid.
If the Danish Medicines Agency finds that the application does not include the required information and documentation and as such is incomplete, a request for more information (RMI) will be sent to the company. This will result in a stop clock during which the administrative procedure and assessment time are paused while the applicant prepares responses to the RMI.
After receipt of the company’s response to the RMI, the estimated assessment time is:
- Assessment: 40 days
Please note that this is a circular process, and that several RMI rounds are likely.
Depending on the quality of the applicant’s responses and deficiencies remaining, it may be possible in certain cases to reduce the assessment time of several RMI rounds.
Cannabis primary products produced in Denmark from Danish-grown cannabis
The estimated assessment times for admission of cannabis primary products produced in Denmark from Danish-grown cannabis and the related cannabis intermediate products for complete applications are:
- Validation: 14 days
- Assessment: 70 days
The assessment will not begin before the application has been accepted as valid.
If the Danish Medicines Agency finds that the application does not include the required information and documentation and as such is incomplete, a request for more information (RMI) will be sent to the company. This will result in a stop clock during which the administrative procedure and assessment time are paused while the applicant prepares responses to the RMI.
After receipt of the company’s response to the RMI, the estimated assessment time is:
- Assessment: 60 days
Please note that this is a circular process, and that several RMI rounds are likely.
Depending on the quality of the applicant’s responses and deficiencies remaining, it may be possible in certain cases to reduce the assessment time of several RMI rounds.
Receipt of several applications from the same applicant
If we receive several applications from the same applicant, the new applications will not be assessed before completion of the first submission. This practice gives the applicant the opportunity to update and correct any errors and omissions in subsequent applications as a result of lessons learned from the first assessment.
However, this practice may be departed from in special circumstances if the Danish Medicines Agency considers it relevant in the specific case.
Notification of prices and packages of cannabis intermediate products via DKMAnet
When a cannabis intermediate product is admitted to the list of cannabis intermediate product and cannabis primary products comprised by the pilot programme, the company must notify information on prices and packages and give a supply estimate to DKMAnet – Prices & Packages. Only then can the product be prescribed.
A price period runs for 14 days. This means that the price cannot change during this period, and that changes in prices and packages only can 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 by sending an email or call +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).