On 16 October 2020, the French Ministry of Health published the specifications and quality requirements for medical cannabis in the pilot phase. The document covers flowers, extracts and finished products for oral, sublingual and inhalation use (including devices).
Documents to be submitted
The requirements complement the essential requirements of Module 3 of the marketing authorization dossier (CTD) that must be submitted for the registration / marketing authorization of herbal medicinal products.
The European Pharmacopoeia (Ph. Eur.) provides general monographs for many tests and dosage forms. Individual monographs for "cannabis flowers" exist in some national pharmacopoeias of the European Union (e.g. Germany, Netherlands, Denmark) as well as in Switzerland. For "cannabis extract" there is a monograph in the German Pharmacopoeia (Deutsches Arzneibuch, DAB 2020). Those available monographs as well as monographs prepared by manufacturers or suppliers themselves can be used for the control of raw materials and products. Alternative control methods can be used if justified.
Manufacturers must provide at least the information specified in this document of 16 October 2020, including
Information concerning suppliers, including status of certifications (FDA, ISO, GACP, GMP, HACCP...)
Requirements relating to the production process of raw materials and finished products - Information on manufacturers (growers and processors) - Production of the herbal drug - Production of extracts - Production of finished products
Characterization and control of the herbal drug (cannabis flowers)
Characterization and control of cannabis extracts
Requirements for the finished product: - Information to be provided in the application - Information to be provided with each batch of the final product: (a) For inhalative dosage forms; (b) For oral and sublingual dosage forms
Requirements for Devices (for inhalation use)
Specifications and control of the herbal drug
The herbal drug must meet the requirements of the Ph. Eur. monograph "Herbal Drugs". In the absence of a harmonized Ph. Eur. monograph for cannabis flowers, the supplier may, for example, comply with the requirements of the monograph of the German Pharmacopoeia (Deutsches Arzneibuch, DAB). The supplier can also define his own specifications. Requirements are, for example:
Microbiological control according to Ph. Eur. 2.6.31 and 5.1.4 or 5.1.8 or USP;
Aflatoxins and ochratoxin: according to Ph. Eur. 2.8.18 and 2.8.22 or according to the supplier's specification (with sampling details), and with justification;
Pesticide limits: according to Ph. Eur. 2.8.13 or according to supplier's specification (with sampling details), in the latter case with justification;
Limit values for heavy metals (cadmium, lead, mercury) and testing according to Ph. Eur. 2.4.27 and 2.4.20 or according to the supplier's specification, with justification;
Specification of the cannabinoid-composition and, if applicable, mono- and sesquiterpenes (according to part 5 of the French document);
Description and validation of all analytical procedures and test methods not listed in Ph. Eur.
Indication of storage conditions;
Summary of stability characteristics;
The Labelling indicates the cannabinoid content, batch number and the expiry date.
Import of medical cannabis during the pilot phase
Cannabis can be imported into France during the pilot phase. The form to be used for the import of cannabis products is called "Application for authorization to import medical cannabis". The following points should be particularly observed and specified:
The exact composition of the product in terms of THC / CBD content per dose
In addition, for all dosage forms except flowers, the supplier must specify the quantity of cannabis that was required to produce the quantity of the imported finished product.
If applicable, the trade name of the product,
The detailed contact details of the provider / supplier.