MHRA certification for e-cigarettes in the UK refers to the certification of e-cigarette products by the Medicines and Healthcare Products Regulatory Agency. This institution is the competent authority for the Electronic Cigarette and Reclamation Container Notification Program in Great Britain and Northern Ireland, responsible for implementing most of the provisions of Part 6 of the "Tobacco and Related Products Regulations (TRPR)" and "Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020".

The regulatory regulations for e-cigarettes in the UK include:

Part 6 of the Tobacco and Related Products Regulations (TRPR) Tobacco Products and Nicotine Inhalation Products (Amendment) (EU Export) Regulation 2020

Regulatory requirements:

The storage capacity of electronic cigarettes should not exceed 2ml;

The capacity of the refill bottle containing nicotine and tobacco oil should not exceed 10ml;

The concentration of nicotine in tobacco oil should not exceed 20mg/ml;

Products containing nicotine and their packaging should be able to prevent children from opening and tampering with them;

Prohibit the addition of colorants, caffeine, and taurine;

● Products launched in GB (Great Britain) must include new labels and warnings;

Before the product is launched into the GB market, it must be notified to the Medical and Healthcare Products Regulatory Authority (MHRA) in advance.

Starting from January 1, 2021, e-cigarettes exported to GB (England, Wales, Scotland) in Great Britain require notification to be submitted through the MHRA portal website; Exported to Northern Ireland (NI), notifications are still submitted through the EU CEG of the European Union.

(Regarding the packaging warning images submitted in the e-cigarette notice: Northern Ireland still refers to the EU TPD, and Great Britain refers to the warning images in TRPR Appendix A1. If your e-cigarette product does not contain nicotine when sold, but can be used to contain nicotine, you must still use the warning statement: "This product contains nicotine which is a high additive substance.")

Manufacturers, importers, and distributors of electronic cigarettes are required to comply with the restrictions on harmful substances in RoHS.

TRPR does not have any requirements for the location of the notifier for testing electronic cigarettes and refilling containers. But the announcer is responsible for the testing standards, as they must submit a statement stating that they are fully responsible for the quality and safety of the product. Manufacturers must submit their product information to MHRA through the MHRA submission portal and the European Common Entry (EU-CEG) notification portal for supply within the UK. Starting from August 23rd, products that submit successful notifications through MHRA will be directly formulated on MHRA.

On October 29, 2021, the Medicines and Healthcare Products Authority (MHRA) in the UK updated its previously released "Guidelines for the Licensing of Electronic Cigarettes and Other Inhalable Nicotine Containing Products (NCP) as Medicines" on its government website, which means that the UK may become the first country in the world to implement medical product licensing for medical electronic cigarettes.

MHRA registration and certification for different types of e-cigarettes:

Medical devices and drugs are packaged together or provided separately

If electronic cigarette sets and nicotine containing drugs are separate products and the cigarette set may be reused or refilled, then the cigarette set should be labeled as a medical device with CE/UKCA. Due to the fact that electronic 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

MHRA believes that electronic cigarettes containing batteries and any related charging accessories should be classified as IIa level active therapeutic medical devices, unless there is a potential danger in their management, in which case they should be classified as IIb level. This means that a separate application needs to be submitted to the officially designated notification agency/UK approval agency to evaluate the device components of electronic cigarettes, and then marked with CE/UKCA (if applicable). Although usually containing heating elements, cartridges containing nicotine solution are considered part of the drug.

The heating element section still needs to comply with the relevant basic requirements of Annex 1 of the Medical Device Directive (93/42/EEC) applicable to the UK, or the medical device regulations applicable to Northern Ireland or the entire UK from May 26, 2021 (EU 2017/745) The relevant basic requirements in Annex 1 require evidence to prove this. Assuming that while checking the battery, the safety and performance of the battery box will also be checked by the notified agency/UK approval agency, as there is an inherent connection between the two. The company needs to consider the interaction between the "equipment" and the heating elements inside the smoke bomb

The overall combination of pharmaceutical products and medical devices - disposable e-cigarettes

If the device and drug form a separate integrated product specifically designed for a given combination and cannot be repeatedly filled, the entire product will be regulated as a drug and marketing authorization will be required. However, the 'equipment' element should meet the relevant basic requirements of Annex I of the Medical Equipment Directive 93/42/EEC, which was converted through the UK Medical Equipment Regulations of 2002 (SI 2002 No. 618), as amended (in its form as of January 1, 2021).

Starting from May 26, 2021, the EU Medical Device Regulations (EU 2017/745) fully apply to Northern Ireland and the European Union. "Equipment" components must meet the general safety and performance requirements of the Northern Ireland market as set out in Annex I of this regulation and apply to marketing authorization applications within the UK. In this case, there is no need to comply with the basic requirements of the medical device directive separately. These regulations also require equipment components to undergo an evaluation by the EU notified body to demonstrate compliance with the general safety and performance requirements of the regulations, and the evaluation by the EU designated notified body needs to be submitted together with the MAA. In fact, the notifying/approving agency will evaluate the equipment components, just as it also requires the CE mark/CE UK (NI) mark

Nicotine free e-cigarettes

If e-cigarettes do not contain nicotine or any other active substances, according to the revised definition of the 2012 Human Drug Regulations, e-cigarettes are not considered pharmaceutical products and do not require marketing authorization. If data can be provided to prove that nicotine free products can be used to treat specific nicotine addiction, then according to the Medical Device Regulations, the product can be considered a medical device and must therefore be authorized as a medical device. The medical statement is limited to treating nicotine addiction.

Electronic cigarette liquid or nicotine liquid only

If a medical declaration is submitted, only the sales license for nicotine liquid can be applied for. However, it is necessary to prove that the liquid is safe and effective in designated electronic cigarettes or other evaporation devices. In addition, such electronic cigarettes or evaporation devices need to be registered as medical devices and bear the CE/UKCA logo (if applicable).

2. As atomizer manufacturers may change their products at any time, it is necessary to reach an agreement to notify the nicotine liquid manufacturer/supplier and the notified agency/UK approval agency of all relevant changes to their electronic cigarettes or atomizers. Applicants for nicotine liquid MAA need to consider the possibility of liquid abuse (excessive).


MHRA registration and certification process for electronic cigarettes:

1. Communicate the specific situation of the product (whether it contains tobacco oil, how many flavors and models);

2. Determine product testing costs and sample quantity;

3. Sign a contract;

4. Send samples and fill out 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 create MHRA notification materials;

8. Register an MHRA system account;

9. Upload test reports and other notification materials, and pay notification fees;

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

Attention! Manufacturers of new e-cigarettes and supplementary container products must submit a notice to MHRA six months before planning to launch their products in the UK and/or Northern Ireland markets. Once your notification is posted on the MHRA website, you can launch the product in the notification area. If the notification has been issued, there is no need to wait for the remaining 6 months before placing the product on the market in the notification area.