Guidance

Chapter 7 – advice on submitting annual reports for electronic cigarettes 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 Product Regulations 2016 (TRPR) places an obligation on the manufacturers and importers of electronic cigarettes to submit a notification to MHRA of such products they intend to market.  

Regulation 32 requires manufacturers and importers to submit annual reports on sales of their notified products. 

Regulation 32 states the following.         

(1) A producer of electronic cigarettes or refill containers must submit the following information to the Secretary of State:

(a) comprehensive data on the producer’s sales volumes in the United Kingdom, by brand and variant name

(b) any information available to the producer, whether published or not, on the preferences of consumer groups in the United Kingdom, including young people, non-smokers and the main types of current users

(c) the mode of sale of the producer’s products in the United Kingdom, and

(d) executive summaries of any market surveys carried out by the producer in respect of paragraphs (a) to (c).

GB annual reporting requirements

You should submit reports each year by 20 May. The report should cover the whole of the preceding calendar year.

What to include in annual reports

You must provide the following information:

• product EC-ID or GB-ID – the ID of each product being reported on (where a product has been modified and this has resulted in a new ID number, you can add the report for previous variants under the current ID number if preferred, rather than reporting each separately)

• product type – as declared on the notification

• brand – each brand variant on the notification should be listed separately

• mode of sale – indicate the type of retail arrangement, for example, internet only, retail shops

• sales volumes – you should provide these separately for each brand variant if possible  (where e-cigarette products are sold in different pack sizes, for example a pack containing a single product unit or a pack of three product units, calculate the total number of units of the product sold and report that)

• for refill containers, you should provide the sales data as a total volume sold in millilitres (ml)

• market surveys – a summary of the findings of any market surveys undertaken during the reporting period

• additional information – including any information held about the main types of current users during the reporting period and the preferences of various consumer groups

• details of the submitter company and contact details for any enquiries – this is not required if it is the same as the company contact details recorded on the MHRA portal

How to submit annual reports

You can submit UK sales figures via the MHRA portal in the third tab which is the product presentation (see Chapter 5 - presentation guidance - Great Britain - GOV.UK (www.gov.uk)). Additionally, you may choose to send your annual sales data directly to the TPD Notifications team via email using a simplified excel template which allows you to report across a range of products.

Any additional information required such as summaries of market surveys or consumer preferences can be attached to the email as a PDF file. If you require a copy of this annual sales template, send a request to TPDnotifications@mhra.gov.uk. This is the same email address you should return the report to on completion.

If you have completed the MHRA spreadsheet to cover all your products, you can submit this spreadsheet for each EC-ID without amendment. Alternatively, you can produce individual sheets for each product and upload them onto the MHRA portal with any additional information required.

Confidentiality

MHRA is subject to the Freedom of Information Act, but its view is that all annual reports submitted under regulation 32 are commercially confidential. We will not publish individual reports but may in the future make aggregated information available for research purposes in a format where sales of individual products and companies are not identifiable.