Market regulation overview
Most EU countries now allow, or are considering allowing, the medical use of cannabis or cannabinoids in some form. However, the approaches taken vary widely in terms of both the products allowed and the regulatory frameworks governing their provision. For example, Dutch regulations demand that medicinal cannabis contains no more than 100 CFU yeast a mold (colony-forming units) per gram of final product, which is close to sterility.
Under the Canadian program, limits are somewhat higher with a maximum of 10000 CFUs total microbial load per gram, followed by European or US Pharmacopoeia standards for inhaled preparations, certain specific pathogens that must be completely absent, i.e., Staphylococcus aureus, Pseudomonas aeruginosa and any bile-tolerant Gram-negative bacteria such as E.
coli. The absence of fungal mycotoxins must be confirmed by additional quality control testing. National regulatory frameworks are also complicated and there may sometimes be a lack of clarity regarding both the details of the various approaches and how they operate in practice. In addition, they evolve over time, and experts sometimes disagree on how such frameworks should be interpreted legally.
Regulation varies between states; The issue of regulation usually requires the approval of the party responsible for cannabis in the Ministry of Health. Nova Green will assist regulatory advisory and will act to comply with regulatory standards in each target market.
