BfArM Guideline for the Application for a Licence to Cultivate Cannabis

Medical Cannabis – Cultivation, Processing, Systems & Technology

Recommendation

8/9 April 2025
Wiesbaden, Germany

Medical Cannabis – Cultivation, Processing, Systems & Technology
Part of PharmaCongress 2025

The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) has published guidelines on applying for a licence to cultivate cannabis for medicinal purposes in accordance with Section 4 of the German Medicinal Cannabis Act (MedCanG).

The guideline provides details on the information and documents that must be included with the application for a licence to cultivate cannabis. In addition to a cover letter, a variety of other information must be included, such as

Proof of the expertise of each responsible person in accordance with Section 7 (3) MedCanG,
A description of the cultivation and production process,
Information on germ reduction measures,
Confirmation of compliance with GACP guidelines (Good agricultural and collection practice)
A valid manufacturing authorisation / GMP certificate of the competent authority for the production steps (e.g. drying or further steps if necessary) of medicinal cannabis flowers associated with the cultivation.

More information is available on the BfArM website in the guideline "Leitfaden zum Antrag auf Erteilung einer Erlaubnis nach § 4 Medizinal-Cannabisgesetz (MedCanG) zum Anbau von Cannabis zu medizinischen Zwecken".