ANSM (National Agency for Medicines and Health Products) this week published an information point on e-cigarette regulations. After a simple reminder of the status of the e-cigarette, the Agency does not forget to ask that the personal vaporizer be considered as a drug and that its sale is then reserved for pharmacists.
BIG PHARMA MAKES THE "HEALTH PRODUCT" CARD
Ansm therefore asks the question: "Can an electronic cigarette be a health product?" "
In practice two situations can arise:
1- An e-cigarette may automatically enter the health product field as a drug if at least one of the following criteria is met:
- Claiming help with smoking cessation[3]
- Nicotine content of the liquid above the threshold for vaping products (20 mg / ml)
In this case, the product would be requalified by the agency as a medicine and could remain on the market only if it obtained a marketing authorization (AMM).
2- An application for marketing authorization (MA) for a cartridge or a refill bottle is submitted to the ANSM by the producer, it will be examined carefully as any application for marketing authorization.
However, to date, no electronic cigarette or refill bottle has, in France, an Marketing Authorization as a drug, no manufacturer having filed an application in this direction.
In the event that a cartridge or refill bottle intended for smoking cessation obtains an Marketing Authorization as a drug, the device for administering this drug would then fall under the status of a medical device, as a medical device of administration of a drug, in application of article R.5211-2 of the aforementioned code. It should therefore have a CE marking under Directive 93/42 / EEC relating to medical devices.
The wholesale, retail sale of these drugs and their dispensation to the public would then be reserved for pharmacists (Article L.4211-1 Code Public Health).
Source : Ansm.sante.fr (Thanks to M.Hammoudi)
