Khaled Ait Taleb, Minister of Health and Social Protection, issued a circular restricting the registration of medicines for human use manufactured from Cannabis under conditions.
The new document lists the nature of these medicines and the documents needed to prepare an application for authorization to place on the market (AMM), to be submitted to the Ministry’s Directorate of Medicines and Pharmacy.
The new circular was based on Law 13.21 on the legitimate uses of Cannabis, Law 17.04 on the Code of Medicines and Pharmacy, and its associated implementing texts, to define the nature of medicines manufactured from Cannabis and intended for human use, stipulating the use of a THC content of more than or equal to 1%, responsible for psychoactive effects.
The document explained that the drug will undergo pharmaceutical processing from drugs in plant form, as the active ingredient of the drug will be prepared by relying on the concentration technique when preparing a part of the Cannabis plant, whether leaves, roots or others, or the plant as a whole; while the process of registering the drug with the Directorate of Medicines and Pharmacy will be subject to the requirements of Decree 2-14-841; regarding the authorization to place on the market for medicines for human use.
The medical cannabis market represents about 60% of the global legal market, while Morocco has the infrastructure to easily access international markets, especially after the adoption of Decision No. 1297-22 of May 12, 2022, concerning the determination of the levels of “tetrahydrocannabinol” stipulated in Articles 6 and 17 of the law on the legitimate and authorized uses of this plant.
The circular outlined two procedures for obtaining market authorization for the registration of medicines made from cannabis, explaining that the standard procedure for registration states that the application file is considered complete when it includes five modules related to administrative data and information on the clinical and non-clinical quality, as well as the chemical, pharmaceutical and biological components of the drug. the chemical, pharmaceutical and biological components of the drug, in addition to a fourth module on non-clinical reports and a fifth module on clinical reports; while the simplified registration process exempted applicants from the restrictions of the fourth and fifth modules, which confirm the use of the active ingredient for therapeutic purposes, and its efficacy and safety when used.
The Cannabis plant offers a number of different possible pharmaceutical forms of cannabis extracts, through the production of sublingual solutions or tinctures (tubes or sprays), dissolving tablets, or mucoadhesive tablets; they can also be included in vaporized oils, topical skin treatments (lotions and ointments), soft capsules, as well as transdermal patches.
A feasibility study prepared by the Ministry of Interior earlier revealed that the medical and pharmaceutical uses of cannabis are expected to provide growing annual revenues from MAD 4.2 billion to MAD 6.3 billion by 2028, if Morocco manages to reach a European market share of between 10 and 15%.
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