5/6 June 2024
Following the extension of the medical cannabis pilot programme, the Danish Medicines Agency (DMA) released a new guideline for companies wishing to include cannabis products in the Danish pilot programme. The extension of the pilot entered into force in January 2022, and as part of this, the DMA has now prepared a guideline with regard to cannabis products made from cannabis grown in DK. The guideline describes, among other things, the application process and provides practical instructions for applications and the documentation required.
Based on the new guidelines – and the consultation responses the agency has received – the DMA has also updated the application forms that applicants must use if they want cannabis products to be included in the pilot programme. There are two application forms provided:
A copy of a valid authorization for the manufacture (and release) of cannabis products is required. A "valid authorization" is an authorization issued by the DMA and covers the specific activities and product types (e.g., herbal drug, herbal drug preparation, bulk and final product). The authorization must be valid until the application has been finalized. If the manufacturing authorization expires while the application is being processed, the authorization must be renewed and re-submitted. All involved manufacturers (including irradiators) and analytical laboratories must be indicated. As evidence for each laboratory either a copy of a valid authorization for the production of cannabis products or a copy of a manufacturing authorization according to the Danish Medicines Act or a copy of a foreign authorization which is equivalent to a manufacturing authorization must be attached.
Documentation must be submitted on the quality of each product stage (e.g., herbal drug, API, bulk & final product). If the final cannabis product contains several different active ingredients (e.g. different extracts), separate documentation must be provided for each active ingredient. If, during the production of the final product, a cannabis bulk product is produced, which is tested, stored and/or possibly resold before it is incorporated into the final product, documentation must also be provided for the cannabis bulk product. In those specific cases where, either for a herbal drug, a herbal preparation, a cannabis bulk or a final product, more than one manufacturer is to be used for the product step in question, separate documentation shall be prepared for each manufacturer and for each product stage (e.g. Certificates of analysis for the herbal drug, Certificates of analysis for the final product). The documentation shall cover pharmaceutical, chemical and microbiological aspects and shall ensure an overall satisfactory quality of the product, consistent with the specifications, as well as intra-batch and batch-to-batch homogeneity.
It is expected that the cannabis product meets the specification before use. Thus, the storage condition of the product shall be stated. Stability testing of the herbal drug (i.e., dried Cannabis Flower) will be particularly relevant in cases where the herbal drug itself is the active ingredient (i.e. the herbal drug is not the starting material for the manufacture of, for example, an extract, but instead it is used as a "dispensing drug") and where the herbal drug is stored prior to use. Stability testing shall be carried out in accordance with the EMA Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products. In addition to testing the stability-indicating parameters, fingerprint chromatograms (e.g. HPLC, UHPLC or TLC) and the applicant's comments on these shall be supplemented for an overall assessment of any changes in the analytical-chemical profile and hence in the degradation profile. Shelf-life results can, if desired, be used to determine a retest date and storage condition for the extract (API). Otherwise, it is expected that a given extract batch will be re-assayed immediately prior to use in the production of a final product batch.
More information is provided under New guidance for the pilot programme on cannabis products published on the agency´s website.