Guidance

General advice on vigilance - electronic cigarette devices and refill containers

Updated 16 August 2024

Applies to England, Scotland and Wales

• Publication for Northern Ireland

Introduction

Part 6 of the Tobacco and Related Products Regulations 2016 (TRPR) places obligations on the producers of electronic cigarettes including the requirement to submit a notification to the MHRA of such products they intend to market.

Regulation 39 of the TRPR sets out the vigilance requirements for producers of e-cigarettes and e-liquids (refill containers). This requires that the producer must establish and maintain a system for collecting information about all of the suspected adverse effects on human health of the product.

Where the producer has reason to believe that an electronic cigarette or refill container which it intends to or has supplied is not safe, not of good quality, or fails to conform with Part 6 of the regulations, they must (as appropriate):

• immediately take the corrective action necessary to bring the product into conformity with Part 6 of the regulations

• withdraw the product

• recall the product

They must immediately inform MHRA (and the competent authority of any other member state in which the product has been supplied or is intended to be supplied), giving details of:

• the risk to human health and safety

• any corrective action taken

• the results of any corrective action taken

Regulation 37 requires that each unit packet of the electronic cigarette or refill container must include a leaflet with information on the contact details of the producer, and if the producer is not based in Great Britain, a contact person in Great Britain.

Practical advice on compliance

Information that may impact on the safety, quality or compliance of a product may come in various forms, including:

• reports of adverse effects from users
• complaints about the product from retailers or customers
• internal quality testing results

You must have an address in the UK where you are responsible for receiving this information. You must include details of how to contact you on the leaflet of each product sold (or on the label if there is no leaflet).

When information is received, this should be reviewed promptly in order to consider if it suggests any problems with your product and if any action is required to protect public health. New reports should be correlated with previous information to see if any pattern is emerging. It is considered good practice to follow up with reporters of adverse events/product complaints (where permission has been given) to obtain further event/product details.

You should maintain records of:

• customer complaints and outcomes, including any corrective action required
• adverse event reports, tracking and outcomes, including any corrective action required
• safety reports/ongoing screening, including any corrective action required

Although you hope it will never be used, you will need to develop and test procedures to quarantine products, to contact your customers and users to seek withdrawal or recall of products supplied.

If action is required, you must implement this promptly and tell MHRA by email: TPDsafety@mhra.gov.uk. The email should give details of the problem and steps taken to manage this. 

MHRA actions

We review each report of a safety concern submitted by suppliers and assess the corrective action to evaluate the suitability of the action. We may then request further information regarding the safety concern or further action to minimise risk to public health.

We collate suspected adverse event reports reported via the Yellow Card Scheme. We maintain an ongoing review of these reports to detect potential safety concerns. Where a report has been made for an identifiable product or manufacturer, we will share an anonymised copy of the report with the supplier. You must record this report in your vigilance system. We will follow up all adverse event reports associated with e-cigarettes for additional information (where permission has been granted by the reporter). If we receive additional information we will also share it with the supplier.

We review the information we receive alongside other safety data which may include published literature and other sources of information to determine whether there is a risk to human health, and the seriousness of this risk.

Where a safety risk has been identified and validated using established vigilance procedures, we will inform the company of the identified risk and immediate corrective action must be taken in accordance with the requirements set out by MHRA and regulation 39 of the TRPR.