Guidance on how to licence electronic cigarettes and similar nicotine-containing products (NCPs) as medicines in the UK.

Nicotine-containing products (NCPs) that are presented for cutting down, quitting and reducing the harms of smoking are considered to be medicinal products. MHRA is responsible for regulating NCPs that are medicinal products, including electronic cigarettes, and continues to encourage and actively support companies to submit medicines authorisation applications for electronic cigarettes and other nicotine containing products. Potential applicants who are not familiar with medicines legislation are strongly advised to contact us for regulatory and scientific advice.

The European Tobacco Products Directive (TPD) introduced new rules for nicotine-containing electronic cigarettes and refill containers (Article 20). The UK Tobacco and Related Products Regulations 2016 implemented the TPD in the UK and came into force on 20 May 2016. Information on the TPDrequirements for consumer electronic cigarettes can be found on our consumer products guidance page.

The following guidance provides information about the licensing procedure for electronic cigarettes that do not fall within the scope of the TPD and other NCPs as medicines. Standards dealing with quality and safety aspects for consumer electronic cigarettes and nicotine liquids have been developed by BSi and AFNOR (the French standards association) and European and international standards are in the process of being developed by CEN (European Committee for Standardisation) and ISO (International Organization for Standardization) respectively. For medicinal electronic cigarettes and similar NCPs, MHRA would expect the product to meet these standards, where relevant, although additional requirements may be needed to meet safety, quality and efficacy criteria under medicines regulations.

Electronic cigarettes regulated as medicines could be available in strengths and volumes greater than those permitted under the TPD (i.e. containing more than 20mg/ml nicotine, more than 2ml for single use cartridge/disposable products or more than 10ml for refill containers), as well as lower-strength, and lower volume products. This is intended to ensure products are available which meet appropriate standards of safety, quality and efficacy to help users cut down their smoking and to quit.

A good starting point for information on the licensing procedure is our marketing authorisations, variations and licensing guidance

Further information can be found in:

Since, in many cases, the delivery/administration part of the electronic cigarette will be regarded as a medical device, it will need to be CE marked under the medical device regulations. As an electronic cigarette contains components such as a battery and heating element, standards relating to electrical components are also relevant.

A good starting point for medical device regulation can be found in our guidance

The relevant Medical Devices Directive is Directive 93/42/EEC although it should be noted that new regulations on medical devices will be effective in spring 2020

The content and layout of any marketing authorisation application needs to follow the common EU standards. Further information can be found in EudraLex – Volume 2B

Posted on the UK MHRA website on 14 December 2017