GMP for Cannabis - What is required?

As reported in INCB´s 2018 Report, more and more countries allow cannabis for medicinal purposes. In March 2017, the national German legislature expanded the options for prescribing medical cannabis products by passing a law amending provisions under the Narcotics Law and other regulations. These Cannabis products, however, must comply with the relevant requirements laid down under Medicinal Law, including GMP and GDP, and in addition, laid down under Narcotics Law. Therefore, the BfArM (the German Federal Institute for Drugs and Medical Devices) has taken over new responsibilities by establishing the Cannabis Agency. This agency is meant to help in ensuring supplies for medical-quality cannabis.

Unlike AGES in Austria, though, where cultivation of medical cannabis has already been established, cannabis will not be cultivated by the BfArM itself, but by commissioned companies. Cannabis is not meant to be stored directly at BfArM during any stage of the purchasing, harvesting or distribution process. These steps will be carried out by relevant producers or other commissioned companies (i.e. suppliers, importers). Hence, the agency will manage and monitor the cultivation, harvest, processing, quality assurance, storage, packaging and distribution of cannabis to wholesalers, chemists or manufacturers. The GMP inspectorates are responsible for issuing manufacturing and import licenses or GMP Certificates. Thus, they will perform inspections at the sites of manufacturers who apply for these certificates and licenses.

In summary the following applies for medical Cannabis in Germany:

  • The Cannabis Agency is responsible for ensuring that only medical grade cannabis is supplied,
  • The relevant requirements based on the underlying legal framework (including Pharmacopoeias) and the corresponding GMP, GDP and GACP guidelines must be complied with, and finally
  • Cannabis for medical purposes is also subject to the provisions of the German Narcotics Law (this lies in the responsibility of the German Federal Opium Agency). 

Learn more about the legal requirements and procedures at the conference on GMP for Cannabis, a pre-conference to the 8th European GMP Conference.

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