5/6 June 2024
The answer to the question whether cannabis can be imported into the EU without GMP certification is: It depends.
Medical cannabis grown in Uruguay recently became available on the German market. In this case, the flower has been grown and harvested in Uruguay (in a facility with no EU-GMP certification) and then processed in an EU-GMP-certified site in Europe (Portugal). Thus, it is obviously possible to sell flower in Germany that was not harvested in an EU-GMP certified facility.
According to an article published in Marijuana Business Daily "the product in this case went through an EU-GMP-certified facility after harvest but before reaching the German market".
The overlap between Good Agricultural and Collection Practice (GACP) and Good Manufacturing Practice (GMP), provided in Annex 7 of the EU GMP Guide, "has created some confusion in the cannabis industry" - especially regarding the step of drying.
In addition, in Germany regional inspectorates are responsible for interpreting and implementing the applicable GMP requirements for medical cannabis. Sometimes they have different views, like, for example, relating to the classification of cannabis as an API or a medicinal product.
According to the BfArM, the German regulatory agency which authorizes finished medicinal products for the German market, herbal medicinal products are subject to the table in Annex 7 of the EU GMP Guide and not to the table provided in EU GMP Guide, Part II (APIs). This means, for example, that the preparation of a crude extract (for further use in a herbal medicinal product) would already fall under GMP and not under GACP rules (this is in contrast to Table 1 of EU GMP Part II, where initial extraction would not fall under GMP).
The responsible German GMP inspectorate in the case of the Uruguayan cannabis flowers imported from Portugal interprets the rules to mean that GMP is relevant only after harvest: “the cultivation and harvest of cannabis flowers are not subject to GMP monitoring and are therefore not the responsibility of the District Government of Düsseldorf.”
For more information please read the article Uruguay-grown medical cannabis available in Germany for first time published in Marijuana Business Daily.