On October 29, 2021, the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its earlier "Guidelines for the licensing of e-cigarettes and other inhaled nicotine-containing products (NCPs) as medicines" on its official government website. It means that the UK may take the lead in becoming the first country in the world to implement medical product licensing for medical e-cigarettes.

MHRA registration certification for different types of e-cigarettes

Medical devices and drugs are co-packaged or provided separately

If the electronic smoking article and the nicotine-containing medicine are separate products and the smoking article may be reused or refilled, the smoking article should be CE/UKCA marked as a medical device. Since e-cigarettes contain components such as batteries and heating elements, standards related to electrical components are also relevant.

Two or three e-cigarettes or one refillable e-cigarette

The MHRA believes that e-cigarette parts containing batteries and any associated charging accessories should be Class IIa active therapeutic medical devices unless managed in a potentially hazardous manner, in which case they should be Class IIb. This means that a separate application needs to be submitted to a duly appointed Notified Body/UK Approval Body to assess the device components of the e-cigarette and then CE/UKCA marked (where applicable). While usually containing a heating element, cartridges containing nicotine solutions are considered part of the drug product.

"The heating element part is still subject to the relevant essential requirements in Annex 1 of the Medical Devices Directive (93/42/EEC) applicable to the United Kingdom, or the Medical Device Regulations applicable to Northern Ireland or the whole of the United Kingdom from 26 May 2021 ( EU 2017/745) with the relevant essential requirements in Annex 1 and need evidence to prove this. It is assumed that the safety and performance of the battery box will also be checked by the notified body/UK Approval Body at the same time as the inspection of the battery, as there is a gap between the two Intrinsically linked. The company needs to consider the interaction of the 'device' and the heating element inside the cartridge."

Integral portfolio of pharmaceutical products and medical devices - Disposable electronic cigarettes

If the device and drug product form a single integrated product, specifically designed for a given combination, and not refillable, the entire product will be regulated as a drug product and require marketing authorization. However, the "device" element shall meet the relevant essential requirements of Annex I of the Medical Devices Directive 93/42/EEC (SI 2002 No. 618), as amended (existing on 1 January 2021) through the UK Medical Devices Regulations 2002 form).

“From 26 May 2021, the European Union Medical Devices Regulation (EU 2017/745) is fully applicable in Northern Ireland and the European Union. The 'device' element must meet the general safety and Performance requirements and apply to UK-wide applications for marketing authorisation. In this case, separate compliance with the essential requirements of the Medical Devices Directive is not required. These regulations also require device components to be assessed by an EU notified body to demonstrate general safety in compliance with the regulation and performance requirements, and the assessment by the EU-designated notified body needs to be submitted with the MAA. In effect, the notified body/approval body will assess the device components, just as it also needs the CE marking/CE UK(NI) marking.”

E-cigarettes without nicotine

If an e-cigarette does not contain nicotine or any other active substance, it is not considered a medicinal product under the definition of the Human Medicines Regulations 2012, as amended, and does not require a marketing authorisation. If data can be provided to demonstrate that a nicotine-free product can be used to treat a specific nicotine addiction, the product can be considered a medical device under the Medical Devices Regulations and must therefore be authorized as a medical device. The medical claim is limited to the treatment of nicotine addiction.

E-liquid or nicotine liquid only

1. If a medical claim is made, it is possible to apply for a marketing authorization for nicotine liquid only. However, it is necessary to demonstrate that the liquid is safe and effective in a designated e-cigarette or other vaporizing device. In addition, such e-cigarette or vaping devices need to be registered as medical devices and carry the CE/UKCA mark (where applicable).

2. As nebulizer manufacturers may change their products at any time, an agreement is required to notify the nicotine liquid manufacturer/supplier and the Notified Body/UK Approval Body of all relevant changes to their e-cigarette or nebulizer. Applicants for nicotine liquid MAAs need to consider the potential for liquid abuse (overdose).

Electronic cigarette MHRA registration certification process

1. Communicate the specific situation of the product (whether it has e-liquid, how many flavors and models);

2. Determine the cost of product testing and the number of samples;

3. Sign the contract;

4. Send samples and fill in the application form;

5. The laboratory receives samples for testing;

6. Issue a draft report after passing the test;

7. Confirm the draft report and make MHRA notification materials;

8. Register an MHRA system account;

9. Upload the test report and other notification materials, and pay the notification fee;

10. After the notification is passed, the product will be displayed in MHRA.

Notice! Manufacturers of new e-cigarette and refill container products must submit a notification to MHRA 6 months before they intend to place their products on the UK and/or Northern Ireland market. Once your notice is posted on MHRA's website, you can launch products in the notice area. If the notification has been issued, there is no need to wait for the remainder of 6 months before placing the product on the market in the notification area.