BfArM Adjusts Specification for Medical Cannabis

Growers and importers of cannabis flowers have reported to the BfArM (German Federal Institute for Drugs and Medical Devices) that, in particular with low cannabinoid contents (i.e. CBD and THC), the specification requirements of the DAB (Deutsches Arzneibuch, German Pharmacopoeia) Monograph Cannabis Flower cannot be met. It was stated "that too many individual factors in cultivation that cannot be directly controlled influence the result".

BfArM compromise for Cannabis flowers used in magistral preparations

As a compromise solution, in case of applications for the 

• Authorization of a treatment with ionizing radiation according to AMRadV
• Granting of a License according to the BtMG (German Narcotics Law)

the BfArM has now developed a specification for cannabis flowers as "dispensing drug", which in the opinion of the BfArM should be acceptable for growers and importers. For the aforementioned applications and permits, the following approaches for cannabis flowers as "dispensing drug" for use in magistral preparations are accepted:

• For contents > 15.0%, the existing DAB approach of +/- 10% (relative) will continue to apply.
• For contents < 15.0%, an absolute deviation of +/- 1.5% is accepted.

For more information, see Adjustment of Specifications for Cannabis Flower as a Dispensing Drug on the Federal Opium Agency website.

Instructions for traders on how to apply for a permit under the BtMG

In addition, the instructions for traders to apply for a permit according to § 3 BtMG have also been updated. For medical cannabis, the following information is required, among others:

Cannabis flowers

• Indication of the full name, the country of cultivation and the grower as well as the source of supply.
• Additionally, for planned importation:
  - Proof that cultivation is under state control and for medicinal purposes
  - Indication of THC content:
  > 15.0 % max. +/- 10 % relative (e.g. at 22.0 %: 19.8 % - 24.2 %)
  < 15.0 % max. +/- 1.5 % absolute (e.g. at 8.0 %: 6.5 % - 9.5 %)
  - Import permit according to § 72 AMG for import from non-EU countries

Cannabis extracts

• Complete name and information about the manufacturer and the source of supply.
• Additionally in case of planned import:
  - Listing of all cannabis flowers used for the production of the extracts, stating the country of cultivation and grower.
  - For the cannabis flowers used, proof of cultivation under state control and for medicinal purposes (see above)
  - Confirmation of the manufacturer of the extracts that only cannabis flowers that meet the requirements of Annex III to the BtMG are used for the production of the extracts.
  - Indication of the THC content: max. +/- 10 % relative to the target content (analogous to the German DAB monograph Cannabis Extract, standardized)
  - Indication of the (theoretical) amount of cannabis flowers used in the production for extracts (intermediate and finished products) per divided form (in case of single doses) or per mass unit [g] (in case of bulk products)
  - Import permit according to § 72 AMG for imports from non-EU countries

Further information can be found online at BfArM under Narcotics-License.