- 1. The specification of future drugs could treat 5 disease
- 2. 3 patients for 000 therapeutic indications
The specification of future drugs could treat 5 disease
Medicines will come in the form of oils, capsules and dried flower spray. They will only be administered to patients with serious illnesses as part of experimentation. Medicines will be prescribed in the event of insufficient relief, significant side effects of drug therapy or in the event of therapeutic failure.
3 patients for 000 therapeutic indications
The list of therapeutic indications or clinical situations refractory to the indicated and accessible treatments, for which the medical use of cannabis is authorized during the experiment, is limited to the following:
- - neuropathic pain refractory to accessible therapies (medicinal or not);
- - certain forms of drug-resistant epilepsy;
- - certain intractable symptoms in oncology linked to cancer or anticancer treatment;
- - palliative situations;
- - painful spasticity from multiple sclerosis or other pathologies of the central nervous system.
Who is responsible for distribution and manufacturing?
The cannabis-based drugs used during the experiment will be manufactured in compliance with good manufacturing practices according to the public health code or any internationally recognized standard. They will meet the pharmaceutical quality criteria as set out in the specifications, which describes the technical specifications and the expected quality as well as the necessary controls for these drugs.
The distribution of cannabis-based drugs used during the experiment is part of a partnership entered into by the supplier of the drugs with an operating, importing pharmaceutical establishment. The National Agency for the Safety of Medicines and Health Products is the competent authority in charge of the call for applications aimed at selecting providers for the free supply and distribution of cannabis-based medicines for patients who will participate in the experimentation of the medical use of cannabis.
The supplier will ensure throughout the duration of the experiment, on the one hand, the supply of cannabis-based medicinal products used during the experiment and, if applicable, a vaporization device adapted to the pharmaceutical form concerned and, on the other hand part, the supply of a pharmaceutical establishment responsible for exploiting the drugs used during the experiment.
ANSM regulator of cannabis in France
Concerning places of culture, ANSM reserves the right to request a visit to the said places from the supplier. In the event of a breach of good agricultural practices (GAP) or equivalent standard in the country of origin, the ANSM will report this or these breaches to the competent authority of the country concerned.
In the event of non-compliance of medical cannabis, delay, negligence, total or partial non-performance, improper performance of these specifications or purchase orders, the ANSM may take two types of measures: temporary recourse or definitive to the alternate supplier and / or the termination of the specifications with regard to the supplier at the origin of the breach. As such, the ANSM may, depending on the case, institute an adversarial procedure with the supplier to determine the causes of the breach, require corrective measures and prevent their recurrence.
The cannabis-based drugs used during the experiment will come in one of the following three pharmaceutical forms
- A form for inhalation by vaporization such as dried flowering tops or granules, containing THC and CBD;
- Oral form based on extracts solubilized in an oily matrix in the form of capsules or in an equivalent pharmaceutical form containing THC and CBD;
- An oral or sublingual form based on extracts solubilized in an oily matrix containing THC and CBD.
The supplier may present different THC RATIO: CBD
Dominant THC ratio "indicative THC 20: CBD 1
Flower THC> 8%, CBD <1%;
THC Oil> 5 mg / ml, CBD <1 mg / ml;
oral form to ingest THC> 5 mg / ml, CBD <1 mg / ml.
Balanced ratio "indicative THC 1: CBD 1"
THC and CBD flower> 5%;
THC and CBD oil> 5 mg / ml;
oral form to ingest THC and CBD> 5 mg / ml.
Dominant CBD ratio “indicative THC 1: CBD 20”
Flower THC <1% CBD> 5%;
THC oil <1 mg / ml, CBD> 5 mg / ml;
oral form to ingest THC <1 mg / ml, CBD> 5 mg / ml;
Flower THC <5% CBD> 5%;
THC oil <5 mg / ml, CBD> 5 mg / ml;
oral form to ingest THC <5 mg / ml, CBD> 5 mg / ml.
A "patient" notice in French must be attached to each packaging and made available electronically (QR code). It will include in particular the following information (in French): labeling information, dosage, mode of administration, contraindications, adverse effects, drug interactions, warnings (symptoms and instructions in the event of overdose, etc.) and precautions for use. employment (eg ability to drive or use machines), pharmacovigilance contact, manufacturer's address.
The contents of the notice will be validated beforehand by the ANSM.
In detail : Order of October 16, 2020 fixing the specifications of cannabis-based medicinal products used during the experiment provided for in article 43 of law n ° 2019-1446 of December 24, 2019