The object of the contract is the supply and delivery of a medical cannabis vaporization device and its accessories for patients who will participate in the French experiment on the provision of medical cannabis. The vaporizer must be portable and it must not have a prefill system (cartridge) by the manufacturer. The supplier undertakes to deliver a product that complies with the standards in force on the European Union market in terms of consumer safety. In accordance with article IV.1 of the CCP, the proposed vaporizer must imperatively respect the required characteristics which are listed (paragraph entitled “Required characteristics”), under penalty of elimination for irregular offer.
France is launching an experiment aimed at evaluating the efficacy and safety of cannabis for medical use in patients who will benefit from it and the feasibility of the circuit for making cannabis-based medicines available, i.e. drug supply, prescription by doctors, dispensing by pharmacists and patient follow-up. Dried flowering tops are made available during the experiment. Since the smoked route after combustion is completely excluded for medical cannabis, the only possible and authorized mode of administration of cannabis in the form of dried flowering tops is therefore the inhaled route by vaporization with a suitable system and which must imperatively meet the following criteria:
- the vaporizer must not have a pre-filling system (cartridge) by the manufacturer;
- compliance with low voltage electrical standards (or directive 2014/35 / EC) and electromagnetic compatibility (EMC directive 2014/30 / EU);
- the exterior walls in contact with the user must not heat up;
- the heating temperature of the dried flowers must not exceed 215º C;
- the vaporizer is portable;
- a system for pre-setting the heating temperatures;
- automatic switch-off of the vaporizer;
- a capacity of the filling chamber of at least 100 mg of dried flowers;
- a convection heating system;
- the supply of a herb grinder or "grinder".
The vaporizer must not allow the vaporization of cannabis oils or resins (prohibition to provide the accessory allowing it).
The holder ensures throughout the duration of the experiment:
- the supply of medical cannabis vaporizers described in the CCP and the technical response framework;
- delivery of vaporizers to dispensing pharmacies and Pharmacies for internal use (PUI) who have ordered them and who are participating in the experiment;
- after-sales service in the event of a malfunction of a device delivered during the experiment.
The purchases of vaporizers and their accessories are made as and when the needs of patients by pharmacies and PUIs, established throughout the French national territory (including in the overseas departments and regions) and participating in experimentation. They are the only ones authorized to issue orders to the contract holder according to the price agreed in the contract. As such, after inclusion of the patient in the experiment, the pharmacies / PUI are empowered, in support of a first prescription of flower heads (made by a trained doctor and registered in the register), to issue an order tending to the supply and delivery of the vaporizer and its accessories. The list of these pharmacies authorized to issue an order will be communicated to the contract holder and will be regularly updated by the ANSM during the market. The market is concluded without minimum or maximum, for each period, in quantity or in value.