As the Hanseatic Higher Regional Court (OLG) in Hamburg has ruled, medical cannabis is not a finished or presentational medicinal product as defined by the German Medicines Act (AMG), but rather a formulation starting material as defined by § 3 number 2 AMG. More specifically, medicinal cannabis products are considered plants, plant parts and plant constituents in a processed or unprocessed state. However, this decision has far-reaching consequences for the import and distribution of Bedrocan varieties in Germany.
This is because, according to the requirements of the German Drug and Active Substance Manufacturing Ordinance (AMWHV), medicinal products that are not finished medicinal products may only be marketed in Germany if their containers are declared in compliance with the law.
According to the law, the following guidelines must be followed when declaring intermediates and active ingredients:
- Name or company name and in addition address of the manufacturer
- Name or identification code of the product,
- content by weight
- Batch designation
- expiry date
- special transport or storage conditions
However, Bedrocan cans do not meet these requirements. Therefore, relabeling is necessarily required to place Bedrocan on the market.