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 (MPD).
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 for the nicotine-containing product (NCP) - see Legal Framework. 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.