New Information Sheet regarding Cannabis for Medical Purposes

The Swissmedic recently published an updated Version 2.0 of the Information Sheet on Cannabis for Medical Purposes (Merkblatt Cannabis für medizinische Zwecke). It now includes a new Appendix 3 - FAQ on Cannabis for Medical Purposes, providing clarifications (among others) on when Cannabis is an API (Active Pharmaceutical Ingredient), when it is a preparation according to a Formula Magistralis, and when it is a Medicinal Product.

Restrictions and Authorisation Requirements (Import/Export & Trade)

According to the new Annex 3, Cannabis for Medical Purposes can be an API, a non-ready-to-use intermediate product, or a ready-to-use medicinal product. Trading in medicinal products prepared according to a formula magistralis is not permitted. Moreover, the import/export of medicinal products prepared according to a formula magistralis is not permitted. The import/export of APIs is permitted only for companies holding an operating licence to handle controlled substances listed in Schedule A, and only after obtaining a Swissmedic import or export permit.

More informtion is available on the Swissmedic website "Cannabis for medical Purposes".