Although it could look like a simple issue, a difficult thing to decide about the Medical Cannabis is the classification of the product from a pharmaceutical process and GMP point of view.
But, what is Cannabis? Cannabis is a plant, and more specifically it is referred to the cannabis flowers coming from the female plant of Cannabis sativa L.
In the explanatory notes at Annex 7 of the EU GMP, dedicated to the Manufacture of Herbal Medicinal Products, it is stated that the GMP classification is dependent on the final intended use and it is the responsibility of each manufacturer to ensure that the appropriate classification is applied, being this classification crucial in order to know what quality and regulatory requirements and procedures are applicable.
So, in the medical Cannabis scenario and specifically for Cannabis flos product, it can be treated as a raw material, a drug substance, an intermediate, a drug product…. In addition, taking into account the THC content, Cannabis is also a controlled substance under Narcotics Laws regulation.
The key point is to have a thorough understanding of the manufacturing process, from the very initial step to the final use of the product, with a clear view of the final market distribution, as currently regulatory landscape is very country dependent.
TDV can help you from the very beginning to understand the GACP, GMP and Narcotic Laws regulations and to clarify which requirements are applicable to your product.
If you need information, you can contact us.