MHRA August 2024 News

The theme of the MHRA e-cigarette team's briefing for August 2024 includes how to ensure safe product launch on the market, registration of new e-cigarette products, and some issues with marketing statements.

How to ensure the safe launch of products into the market

PAS 7050:2022 Bringing Safety Products to the Market "is a publicly available specification that provides comprehensive operational guidelines for manufacturers, distributors, importers, and retailers to ensure the safety of products launched in the UK market. This specification details the necessary steps and processes to reduce product risks, thereby protecting consumers and enhancing brand reputation. It also provides guidance on meeting legal requirements and reducing reputation, business, and compliance risks. Adhering to this standard can ensure the safety of products launched in the UK market.

2. Registration of new electronic cigarette products

Given the ongoing issues with the registration of new electronic cigarette products in the market, MHRA has collaborated with multiple parties to provide guidance and feedback to submitters of these new products.

What is a new type of electronic cigarette product?

MHRA and VEP (Electronic Cigarette Expert Group) may consider the following products as new electronic cigarette products:

The equipment can accommodate multiple fuel tanks or cartridges, and the total capacity of the product's e-liquid exceeds 2ml (such as a 4-in-1 multi cartridge replacement electronic cigarette)

Devices that do not include rechargeable batteries and charging ports

Rechargeable, but it is sealed and cannot be refilled with e-liquid or equipped with smoke cartridges through refilling containers

Equipment designed for use with supplementary containers (such as open devices)

A container designed for docking with another product and refilling it with e-liquid (specialized refill container)

- Attention: When submitting registration, please note that the term "Rechargeable" mentioned in product types 2 and 3 (Rechargeable and Rechargeable device only) does not refer to the charging of the product's battery. This term refers to the replacement of smoke bombs or similar components used with equipment.

- Equipment with multiple fixed and non replaceable oil tanks or smoke bombs, which is disposable

Equipment that is connected to a supplementary container but cannot replace the oil tank or atomization core is considered disposable

Any supplementary containers (supplementary containers and cartridges) designed for use in the product must be registered separately

What documents need to be submitted when registering a new product?

Opening Refill File

Removable and open electronic cigarettes require uploading an Opening Refill File, which should provide detailed instructions on how to replace the cartridge or refill the oil. The steps can be described in text or images.

Production file

 It should include technical diagrams of the product, including all related components (exploded view)

A BOM table should be provided, and the role of these materials in the finished product should be explained

List the standards and publicly available specifications (PAS) used, such as ISO 9001:2015, PAS 7050:2022, etc

Product images (including pictures of all relevant components designed and used together with the product)

If the product is intended to be sold as a set, it should be stated in the document, listing the ECID of the relevant product and pictures with annotations (explaining the purpose of this section).

Packaging and instruction manual PDF (this information can be uploaded as part of a file to the "Production file" without the need for repeated uploads in the "Leaflet file").

3. Some issues with marketing statements

The use of non compliant statements on product packaging, such as "MHRA Approved", "TPD compliant", "TRPR compliant", "Harm reduction technology platform", "Harm reduction innovation", etc., is prohibited

You can refer to the following guidelines to understand some packaging restrictions and requirements for electronic cigarette products

https://www.gov.uk/government/publications/chapter-5-presentation-guidance-great-britain

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

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

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