MHRA e-cigarette group August briefing notes

Recently, the e-cigarette notification team of the Medicines & Healthcare products Regulatory Agency (MHRA), an executive government agency under the Department of Health & Social Care (DHSC), issued its August monthly briefing.

The briefing covers three topics: how to bring safe products to the UK market, notification requirements for novel products, and marketing statements.

1

How to bring safe products to the UK market?

MHRA encourages companies to abide by the PAS 7050:2022 specification. Because the specification provides manufacturers (Manufactures), importers (Importers), distributors (Distributors) and retailers (Retailers) with a comprehensive code of conduct to ensure product safety; at the same time, the specification also provides detailed advice to help companies develop a Product Safety Management Plan (PSMP). MHRA recommends that companies should ensure that their products comply with all applicable relevant legislation, maintain safety program documents, and strengthen employee training on the importance of product safety.

All these assurance procedures and documents are necessary for both consumer protection and self-protection of companies.

2.

Novel Product notifications

The implementation of the UK Tobacco and Related Products Regulations (TRPR) is jointly supervised by multiple UK agencies. MHRA is only responsible for notification compliance review.

The novelty of a new product mainly lies in the product design. In view of the emergence of a large number of new designs, MHRA will continue to work with the Chartered Trading Standards Institute Vaping Expert Panel (CTSI VEP), legislators and the industry to provide guidance and feedback to applicants of new products.

1) What is a new product?

MHRA and the e-cigarette expert group believe that the product has the following characteristics:

The device can accommodate more than one tank/cartridge/pod at the same time and the total e-liquid volume of the product exceeds 2mL (such as N in 1 products)

The device does not contain a rechargeable battery or a charging port (such as a large battery or a replaceable battery product)

Rechargeable device, but the product is sealed - that is, it cannot be refilled or replaced

The device is designed to refill the tank through a refill container (whether it is designed with a dedicated docking system or a universal refilling system), or even the refill container directly delivers oil to the core, cotton, heating wire or similar structure

The refill container is designed to dock with or refill other products

Special note:

MHRA pointed out: It is necessary to recognize that the notification submission product types 2 (Electronic cigarette – Rechargeable, placed on the market with one type of e-liquid (fixed combination)) and 3 (Electronic cigarette – Rechargeable, device The term "rechargeable" used in the context of a smokeless device does not mean that the battery is rechargeable, but rather that the oil tank/cartridge or equivalent component can be replaced. Therefore,

a) If a device has several fixed, non-replaceable oil tanks/cartridges, it is a disposable product

b) If a device is designed to dock with an oil bottle, but the oil tank of the device itself (or its heating wire) cannot be replaced, it is a disposable product

c) Oil bottles designed to be used with products must be announced separately and must comply with the requirements for announcement and supply of oil bottles

2) Necessary documents for new products

a) Opening and refilling files

For new products, reasonable guidance (including schematics) must be provided for consumers to use (including filling and changing cartridges) in the leaflet/manual/instruction

b) Production file

√ Should include technical product schematics of all relevant components

√ Should include Bill of Material (BOM) documents and their use in the production of finished products

√ Describe the standards or publicly available specifications (PAS) followed when ensuring quality management QM, quality assurance QA, and quality control QC. Such as ISO 9001:2015, PAS 8855:2024, PAS 7050:2022, etc.

√ Product images (including all relevant components designed for use with the product)

√ If the separately notified product is intended to be sold as a kit, it needs to be stated in the production file when separately notified, listing the ECIDs of the relevant products and annotated images

√ Labels, packaging and instructions in PDF format (can be uploaded as one file to the production file, no need to upload again in the flylet file)

III

Packaging, display and marketing statements

MHRA does not endorse the safety of any product.

The use of "MHRA Approved", "TPD Compliant", "TRPR Compliant", "Harm reduction technology platform", "Harm reduction innovation" or any similar statements is prohibited. Such practices are not in line with the Consumers Protection from Unfair Trading Regulations 2008 (CPRs) and are explicitly prohibited - including, of course, certain provisions in Regulation 38 of the TRPR.

Additional Notes:

CTSI, as a chartered trading standards association, has published many guidelines that can be used as a reference for the safety and compliance of e-cigarette products. Refer to the following link:

https://www.businesscompanion.info/focus/chemical-safety-of-vapes

https://www.businesscompanion.info/focus/vaping-products