API, including cannabis API (Active Pharmaceutical Ingredient).

Amendment to the Order on the manufacture, import and distribution of active substances for the manufacture of medicinal products

The Order on the manufacture, import and distribution of active substances for the manufacture of medicinal products concerns the manufacture, import and distribution of active substances used in the manufacture of medicinal products for human use that are covered by a marketing authorisation.

The Ministry of the Interior and Health has assessed that the following provisions of the executive order should be notified: Sections 2, 4, 5, 6, 7, 9, 11, 12, 13, 14, 15, 17, 18, 19, 20 and 21.
Additionally, Section 13(2) has been added to the draft order, which enables the use of cannabis APIs in products under the Danish medicinal cannabis programme, cf. also the legislative proposal referred to below. Furthermore, Sections 11 and 15 have been added in order to describe the guidelines for manufacturers and distributors of active substances who wish to outsource manufacturing and distribution under contract.
With regard to impact assessments, reference is made to the legislative proposal amending the law governing the Medicinal Cannabis Pilot Programme, which includes a review of the economic and implementation consequences for the public sector, the economic and administrative consequences for the business community, etc. and the administrative consequences for citizens.