25 November 2020
The answer to the question whether Cannabis is an API, a herbal drug or a herbal medicinal product is: It depends.
In Germany, for example, the classification is currently not harmonized between the federal states (Bundesländer). In some states cannabis flower is considered to be an active substance, in others it is classified as a medicinal product (herbal drug) or as a finished herbal medicinal product (HMP).
However, the classification defines which kind of GMP standard / certificate is needed for import. If you are a supplier, for example in Canada, and you want to export your Cannabis to Germany, you will either need to have a GMP certificate according to Part I (for medicinal products) or Part II (for active substances or active pharmaceutical ingredients, APIs) of the EU-GMP Guide. This can make a great difference, also in regard of the GMP inspection performed by the EU GMP inspectors. During an API GMP Inspection compliance with the requirements of ICH Q7 will be checked. However, there are some important differences in the GMP requirements for APIs (Part II EU GMP Guide) compared to GMP for medicinal products (Part I EU GMP Guide). For example: For APIs an EU Re-Testing / (QP-) Batch release is not necessarily required. But this has to be carried out in case cannabis flower is classified as a medicinal product. There are also some other differences for APIs / medicinal products, e.g. in the requirements regarding packaging, labeling, transport and distribution.
So, be aware if you have an EU GMP certificate according to ICH Q7 / Part II EU GMP Guide and you want to export / import Cannabis Flower into Germany - maybe there is a GMP Part I certification for Medical Cannabis required!
For more information please see GMP certification and GMP certificate in Europe – an overview and visit the ZLG website.