3 October 2017

New executive order regarding cannabis out for consultation

Last week, a draft executive order on import of cannabis starting materials and the subsequent manufacturing of cannabis intermediate products went out for consultation.

The executive order was issued according to the Act on experimental scheme with medicinal cannabis. The Act has not yet been adopted. However, if the Danish Parliament decides to adopt the Act, it will enter into force on 1 January 2018. The Act establishes a four-year experimental scheme where patients with specific therapeutic indications can be treated with medicinal cannabis prescribed by a doctor.

The executive order concerns imported cannabis starting materials and the subsequent manufacturing  cannabis products. These products are to form the basis for the imported end products.

The executive order defines cannabis starting materials as materials containing cannabis which are imported into Denmark according to the rules set out by the Act, for the purpose of manufacturing a cannabis end product (a cannabis product covered by the experimental scheme, which is manufactured on the basis of a cannabis intermediate product at a pharmacy after being prescribed to a patient by a doctor). A cannabis intermediate product is defined as a cannabis product, which is manufactured from imported starting materials and for the purpose of manufacturing a cannabis end product.

The consultation period ends on 20 October 2017. Any changes to the executive order will be published on Høringsportalens website after this date.

How to apply

According to section 9(1) of the Act, the Danish Medicines Agency can issue a permission for the manufacturing of cannabis intermediate products. Please note: an application must be sent no later than 25 October 2017. If the permission is granted, the permission will be valid from 1 January 2018.

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