Is Medical Cannabis a Medicinal Product?

Recommendation

6/7 June 2023

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

In Germany, the classification of medical cannabis is not (yet) harmonized between the individual Federal States. In some Federal States, cannabis flowers are considered to be an active pharmaceutical ingredient (API), while in others they are classified as a medicinal product (in the form of the herbal drug) or as a finished herbal medicinal product (HMP). However, the classification defines what type of GMP standard / certificate is required for import.

Hanseatic Higher Regional Court (OLG) classifies medicinal cannabis flowers not as a medicinal product at the wholesale level

The Higher Regional Court (OLG) of Hamburg has decided, in the context of proceedings aimed at issuing an interim injunction against a wholesaler, that medical cannabis (cannabis flowers) at wholesale level is not (yet) a medicinal product.

According to the Hamburg Higher Regional Court, in the production of prescription medicinal products, "with the grinding, sieving, dosing and packaging in the pharmacy, essential processing steps still take place", so that cannabis flowers are not (yet) to be regarded as medicinal products, but as starting materials according to § 3 number 2 of the German Medicines Act AMG (plants, plant parts and plant constituents in a processed or unprocessed state).

However, the requirements for labeling according to § 24 AMWHV apply, that containers must be labeled in clearly legible writing and in a permanent manner at least as follows:

• Name or company name and additionally address of the manufacturer,
• Name or identification code of the product, and, as far as possible also its degree of purity;
• Content by weight;
• Batch number,
• Expiry date;
• Special transport or storage conditions, if necessary to maintain the quality of the API or substance.

In the event that the intermediate or API has subsequently been repacked, repackaged, relabeled, or released by an establishment other than the original manufacturer, the following shall also be provided:

• The name or company and address of the establishment,
• The new batch number on the container and the outer packaging.

The information must be provided in German language.

For more information, please see the article about OLG Hamburg: Medicinal cannabis flowers do not yet constitute medicinal products at the wholesale level.