France is finally moving forward on the medical use of cannabis. At the end of 2019, Law No. 2019-1446 indicated that French law would allow for a trial for medical use of cannabis-based products. The decree and implementing ministerial order [arrêté] establishing the parameters of the trial were released last week.

Published to JD Supra
In a nutshell, for a two-year period, France is authorizing the use of certain cannabis-based medicinal products in relation to certain therapeutic indications and clinical situations, for maximum 3,000 patients (Trial). The objective is to see, in real world conditions, if medical use of cannabis is an option for the future.
Stringent conditions apply to every element of the Trial: the cannabis-based products, the patients and the healthcare professionals participating to the Trial, and the suppliers and distributors of the cannabis-based products. A national register will be set up to collect the Trial data.
Although cannabis-based medicinal products included in the Trial must be provided for free for the duration of the Trial, it is expected that many of the products in the trial will be among the first to be authorized for marketing in France (should France decide to accept medical use of cannabis).
The Trial will start on 31 March 2021 at the latest. Companies interested in supplying cannabis-based medicinal products for the French trial must submit their application and product samples to the French Medicines Agency by 24 November 2020. This period is very short given the information and documents to be provided with the application and the obligations imposed on suppliers.
A. Legal Background
In France, cannabis is classified as a narcotic, and Article R 5132-82 of the Public Health Code prohibits the production, manufacture, transport, importation, exportation, holding, offer, transfer, purchase and use of:- cannabis, its plant and its resin; products that contain them or are obtained from them;
- tetrahydrocannabinols, except delta 9-tetrahydrocannabinol, their esters, ethers, salts as well as the salts of derivatives and products containing them.
- research and control, as well as for the manufacturing of derivatives authorized by the French Medicines Agency (ANSM);
- cultivation, importation, exportation and industrial and commercial use of varieties of cannabis without narcotic properties or of products containing such varieties as may be authorized by a ministerial arrêté;
- manufacturing, transport, importation, exportation, holding, offer, transfer, purchase or use of medicinal products containing one of the substances mentioned above that have been granted a marketing authorization in France.
B. Legal Regime for March 31, 2021 Trial of Cannabis-Based Medicinal Products
- Duration of the Trial
- Trial Products
- Trial Products are finished medicinal products containing delta-9-tétrahydrocannabinol (THC) and cannabidiol (CBD) dosed in accordance with ratio margins specified in Part I of the Specifications.
- They may only take the following pharmaceutical forms:
- A vaporization device, which qualifies as a medical device, must be used for inhaled forms.
- Trial Indications and Clinical Situations
- Trial Patients
- Trial Doctors, Pharmacists and Hospitals
- Trial Companies
- National Trial Register
C. Implementation by the French Medicines Agency
The ANSM has published documents on its website to help companies apply to participate to in the Trial, including: – web pages with detailed explanations of the conditions of participation and selection; – the Specifications; – a Framework for Technical Response; – a statement of partnership with a French exploitant; – a statement about a later submission of missing documents; – a Q&A on medical use of cannabis. The relevant dates for the applications are as follows: – 18 November to ask questions relating to the application; – 24 November to submit the application and the samples; – 15 December to submit the last supporting documents, in particular the exploitant’s authorizations relating to the import of the Trial Products. Applications, which must be in French language, contain two parts:- Admissibility: the application is admissible if the following compliance criteria are met:
- Selection: the application must meet selection criteria
- Requirements for the supplier
- Requirements for the production of raw materials and finished products 2.1. Information on manufacturers (producers and transformers) 2.2. Production of the vegetal drug 2.3. Production of extracts 2.4. Obtaining finished products
- Characteristics of the vegetal drug
- Characterization and controls of extracts
- Requirements for finished products 5.1. Elements to be provided for application purposes 5.2. Elements to be provided for each batch of finished products
- Requirements for devices designed for vaporization