BILLEV PHARMA EAST

NEWS

22 May 2023

Medical Cannabis Act in Germany

According to a draft version for the German Cannabis Law (Cannabisgesetz, CannG), cannabis for medical purposes will no longer fall within the scope of the Narcotics Law (Betäubungsmittelgesetz, BtMG). The working draft provides a separate chapter for this special cannabis. However, this is still under discussion.

 

It concerns medicinal cannabis, which is of plant origin, as well as synthetically produced cannabinoids, which correspond to the natural group of active ingredients, the cannabinoids found in the plant (e.g. Dronabinol). With the new law, it is expected that also Dronabinol is to be removed from the scope of the BtMG and then regulated in the CannG. Accordingly, the production of dronabinol (and of preparations / dosage forms containing dronabinol) will no longer be subject to BtMG authorization (a manufacturing authorization according to EU GMP is, of course, still required, e.g. for the manufacture of Dronabinol Capsules). In addition, the chapter contains regulations around prescription, import and export permission, cultivation and its supervision. However, the cultivation of cannabis for medical purposes in Germany is still expected to take place exclusively under the responsibility of the German Cannabis Agency. Within terms of operation of a public pharmacy or a hospital pharmacy, cannabis from a state-controlled cultivation for medical purposes may also be imported and exported without a (BtMG) permit.

 

In Europe medical grade Cannabis must comply with the relevant requirements laid down under Medicinal Law (including Pharmacopoeias, EU-GMP/GDP and GACP) and the Narcotics Law. The EU GMP inspectorates are responsible for issuing manufacturing and import licenses or EU GMP Certificates. Thus, performing inspections at the production sites of manufacturers who apply for these certificates and licenses.

 

Since there is currently no harmonized legislation globally and/or in the EU (e.g. regarding pharmacopoeias etc.), some of the topics listed above are very relevant for EU as well as non-EU growers/ suppliers and ex -/importers. For example, the EU-GMP guidelines include principal requirements for

 

  • The Pharmaceutical Quality System (PQS),
  • Personnel,
  • Premises and Equipment (including Qualification),
  • Documentation (including Records and Data Integrity),
  • Validation (including Manufacturing, Computer System, and Analytical Validation),
  • Production,
  • Quality Control (including Stability Programme),
  • QP Batch Release,
  • Outsourced Activities (including Audits),
  • Complaints and Product Recall, and
  • Self Inspection.

 

In addition, the EU-GMP of Annex 7 – Manufacture of Herbal Medicinal Products provides guidance for the application of GACP. GACP gives appropriate guidance and defines basic rules which can be adapted to specific conditions. The Principle of GACP is different to highly regulated GMP; levels and requirements for GACP need to be defined on a case-by-case basis. According to Annex 7 for primary steps that take place in the field the standards of GACP is applicable. GMP is applicable to further cutting and drying steps. In Canada, for example, GPP (Good Production Practices) for cultivation of medicinal cannabis have to be applied. So far, the GPP framework regulates the cultivation and processing of all cannabis products for both medicinal and recreational use. The major components of GPP concern facilities and equipment, sanitation, quality assurance, quality control, record keeping, and security requirements.

 

There are a number of areas where the two standards EU-GMP and GPP do not align. The EU-GMP guidelines “are more detailed, providing principles and interpretation” on what must be included in a PQS to comply, “while the GPP standard provides less detail and is therefore more open to interpretation. This difference makes it difficult to directly compare the two standards”. For example, stability testing is not required under GPP. Under EUGMP, the stability programme designed in accordance with the ICH Q1 Guidelines is required to establish the shelf life of a product. In addition, EU-GMP requires full validation as part of the PQS, while this is currently not required under GPP. Since there are some substantial differences (which still have to be identified in detail) between GPP and EU-GMP, non-EU suppliers will have to implement EU-GMP standards if they want to supply medical cannabis to the EU market. However, since there is currently no harmonized EU standard for medical cannabis (e.g. Ph. Eur. monograph), national legislations, guidelines and monographs will have to be followed and applied in addition to EU-GMP.