INSIGHTS ON THE CANNABIS INDUSTRY FROM REGULATORY BARRISTER MATTHEW (MATT) LAWSON
Matthew (Matt) Lawson, a UK Regulatory Barrister has penned a series of discussion pieces under the rubric “Insights on the Cannabis Industry”.
In Part 1 of Insight into the Industry: Cannabis Industry Regulation, barrister Matthew (Matt) Lawson looked at the Canadian Regulatory Framework. In Part 2 we looked at the US regulatory position relating to adult-use and medicinal cannabis. In Part 3 we looked at the US Regulatory Framework in respect of CBD. In this Part 4, barrister Matthew (Matt) Lawson looks at the European Medicinal regulatory structure.
Regulations regarding producing medical cannabis extracts in Europe vary. Each country has its own regulator(s) to grant licences, however, they follow the same general procedures for medical cannabis products that are unlicensed and do not have marketing authorization.
Companies need to hold a licence that allows them to handle and produce controlled substances and hold additional licences from the nation’s health authority to manufacture unlicensed medicines. Companies aiming to produce cannabis extracts as an API, need to gain an API production licence within the country of production and an API distribution licence in the country of commercialisation.
In Germany, the regulatory body that provides licences for medical and pharmaceutical extractors is the German Federal Institute for Drugs and Medical Devices (BfArM). Although Germany is one of the largest medical cannabis markets, only a few players have received a licence to extract cannabis including.
In the UK, a medical or pharmaceutical grade extractor needs to obtain a domestic Controlled Drug Licence from the Home Office to be allowed to handle controlled substances. Additionally, the company needs to obtain a “Specials” licence for the manufacture/importation of licensed medicinal products for human use for a certain premises from the Medicines and Healthcare Products Regulatory Agency (MHRA).
As a general rule, all extractors looking to produce medical and pharmaceutical cannabis extracts in Europe need to be EU GMP certified as an API or herbal medicine. To attain EU GMP certification, extractors have to implement standard operating procedures for record keeping, sanitation, equipment handling, labelling and error minimisation. Medical cannabis extractors are also required to use compliant equipment and batch tests for initial outputs to test compliance as well as developing ongoing testing procedures.
With regard to product regulations on the quality of medicines, the European Pharmacopoeia and the pharmacopoeia of individual states need to be referred to when implementing manufacturing methods including standards of source material, buffers, reagents, solvents permitted for use and the control of impurities.
Germany is currently the largest medical cannabis market many companies follow its product requirements. Currently the requirements include:
- levels of THC: minimum 1% and maximum 25% (mg/ml) for the extract and 90-110% of the nominal content indicated on the label
- levels of CBD: maximum 10% (mg/ml) for the extract and 90–110% of the nominal content indicated on the label
- limit for CBN (cannabinol) of maximum 2.5%
- the extract must be obtained by a suitable extraction process, such as heptane, ethanol or CO2 extraction. Supercritical CO2 extraction is the preferred method
- products must be stored at room temperature, i.e. 25°C or below
- all active ingredients and cannabinoids in medicinal cannabis products must be manufactured from the cannabis plant only
- the formulated medicine and any of its ingredients must not be adulterated with undeclared substances
- manufacturers must ensure that the cannabis plants used to manufacture medicinal cannabis products meet the requirements of toxin, heavy metal and impurity levels.
Matthew (Matt) Lawson is a UK Barrister who has advised Governments and Corporations for over 25 years in respect of human impactors – Food & Ingestibles, Medicines, Medical Devices and inhalation mediums. He provides worldwide Cannabis advice to clients who stem from Governments, to some of the largest multinational CPG corporations, to pharmaceutical giants, through to niche pre-IPO Start-Ups in the CPG and medical fields.