There is a great interest in the regulation of nicotine-containing products (NCP), either to help smokers break their dependence to nicotine that comes from tobacco products or simply as a replacement. A relatively recent newcomer is the eCigarette.
Two directives apply in the regulation of Nicotine Containing Products:
Only one directive can be applied for any particular product and the appropriate directive will be determined by the manufacturer’s claims and specifications.
Tobacco Products Directive
The Tobacco Products Directive (TPD) applies if the eCigarette manufacturer doesn’t make medical claims and the following criteria are satisfied:
- Maximum cartridge / tank size 2 ml
- Maximum refill container volume 10 ml
- Maximum concentration 20 mg/ml nicotine.
In this case, the European Member States are required to apply the measures set out in the TPD from May 20, 2016. The Member State’s nominated Competent Authority will be responsible for regulation and oversight. There is no requirement for Notified body involvement with eCigarettes regulated under the TPD.
To read further advise please visit the MHRA website - E-cigarettes: regulations for consumer products: www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products
Medicinal Product Directive
Addiction to a chemical substance is a medical condition and any product which claims to treat an addiction with supportive clinical data falls under the Medicinal Product Directive (MDP). eCigarettes which do not meet the criteria set above for the TPD are regulated under the MPD.
The manufacturer must obtain a marketing authorization for medicinal products for human use (http://ec.europa.eu/health/human-use/legal-framework/index_en.htm) for the nicotine-containing product (NCP). The Notified Body has no involvement in the approval of the marketing authorization for medicinal product. However, as an electronic cigarette contains components such as a battery and heating element, legislation relating to medical devices is also relevant. Since, in many cases, the delivery / administration part of the electronic cigarette supplied separately from the nicotine-containing product will be regarded as a medical device, it will require to be CE marked under the medical device regulations.
Applications for the NCP (medicinal product) and the delivery system supplied separately to NCP (device) may run in parallel.
A CE certificate can be issued once all Notified Body and Medicines Agency conformity assessments have been successfully completed.