MHRA e-cigarettes in the UK are applying for a marketing license, and MHRA is responsible for regulating nicotine containing products (NCP) as pharmaceutical products in the UK. These aim to alleviate or prevent tobacco smokers who wish to quit smoking or reduce their addiction and nicotine withdrawal symptoms. MHRA seeks to encourage the licensing of e-cigarettes and other inhaled NCPs as drugs, with the aim of supporting companies in submitting marketing authorization applications for these products. In addition to drug authorization, if e-cigarettes are refillable and reusable, they also need to comply with the 2002 UK Medical Device Regulations (as amended). It is strongly recommended that potential applicants who are not familiar with drug legislation contact MHRA for regulatory and scientific advice. MHRA promises to provide the necessary assistance to ensure that potential applicants understand the process and feel able to submit applications that meet their objectives in a timely manner. For applicants whose products are undergoing the Pre Market Tobacco Product Application (PMTA) process under the US FDA, MHRA can discuss which data may be relevant to the UK marketing license application.

Since nicotine is not a new chemical entity, the so-called deletion application can be submitted as a general application under Article 51 (formerly Article 10.1 of Directive 2001/83/EC) or a mixed application under Article 52 (formerly Article 10.3 of Directive 2001/83/EC), the human drug regulation, as amended. These legal grounds allow for the submission of a brief dossier related to safety and efficacy, relying on pharmacokinetic (PK) studies to compare new products with appropriate reference pharmaceutical products.


Considering the expected route of administration, approved inhaled nicotine products (such as Nicorette 15 mg inhalers) will be suitable reference and comparative drugs.

For applications submitted under Article 51, the proposed product shall have bioequivalence with the reference product. For example, when developing inhaler products based on established inhaler reference products, this may be the most appropriate method. For applications submitted under Article 52, the proposed product does not need to have bioequivalence with the reference product, but the nicotine PK curve of the proposed product should demonstrate its "position" compared to the reference product and combustible cigarettes. For example, when developing e-cigarette products based on established inhaler reference products, this may be the most appropriate method. PK data should be supplemented by a discussion of the safety and effectiveness of the proposed product through references.

All marketing authorization applications (MAAs) must be supported by a risk management plan. This must cover the identified and potential risks of the product, as well as the measures to be implemented to minimize these risks. More information can be found in our Good Pharmacovigilance Guidelines (GpVP).

When assembling the files for the marketing license application, it is necessary to consider guidelines related to the quality, safety, and effectiveness of pharmaceutical products. The archives need to follow the format published by the European Commission in EudraLex Volume 2- Drug Legislation Notices to Applicants and Regulatory Guidelines for Human Medicinal Products. In particular, Volume 2B - Introduction and Content of Archives provides a useful overview of the data that constitutes marketing authorization, and specifically refers to many guidelines that should be referenced when compiling data to support marketing authorization. These guidance documents can also be found on the MHRA website.

More information about applying for marketing authorization can also be found in our licensing guide. This will provide relevant information, such as the program route to follow, cost, drug naming, and submission method. Applications shall be submitted using electronic General technology documents (eCTD).

In the UK, Great Britain (England, Scotland, and Wales), or Northern Ireland, there are multiple ways to obtain listing permits. The National 150 Day Program is an accelerated program suitable for high-quality applications selling drugs in the UK, Great Britain, or Northern Ireland. If considering alternative submission methods, applicants are encouraged to contact MHRA.