Qualification of medical-grade cannabis
In Europe, medical cannabis products must comply with the relevant requirements laid down in the Medicinal Law (including Pharmacopoeias, EU-GMP/GDP and GACP) and the Narcotics Law. In Germany, for example, the BfArM (the Federal Institute for Drugs and Medical Devices) has taken over new responsibilities by establishing the Cannabis Agency. The goal of the agency is to contribute to ensuring the supply of medical-quality cannabis.
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 only manage and monitor the cultivation, harvest, processing, quality assurance, storage, packaging and distribution of cannabis to wholesalers, chemists or manufacturers.
The EU-GMP inspectorates are responsible for issuing manufacturing and import licences or EU-GMP Certificates. Thus, they will perform inspections at production sites of manufacturers who apply for these certificates and licences. For example, the starting point for any German GMP certification is a German-based company that applies for such a certificate at their responsible local authority.
Table illustrating the application of Good Practices to the manufacturer of herbal medicinal products
Manufacturers should ensure that these steps are carried out in accordance with the marketing authorisation/registration. For those initial steps that take place in the field, as justified in the marketing authorisation/registration, the standards of Good Agricultural and Collection Practice for starting materials of herbal origin (GACP) is applicable. GMP is applicable to further cutting and drying steps.
Herbal medicinal product manufacturers must ensure that they use only herbal starting materials manufactured in accordance with GMP and the Marketing Authorisation dossier. Comprehensive documentation on audits of the herbal starting material suppliers carried out by, or on behalf of the herbal medicinal product manufacturer should be made available. Audit trails for the active substance are fundamental to the quality of the starting material. The manufacturer should ensure that the suppliers of the herbal substance/preparation are in compliance with GACP.
EU GMP guidelines:
EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines
Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.