# Advice for producers of e-cigarette and vape products

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/6f6516ff-ca47-4ecc-8a1c-0a46d1984741
Type: Guidance
Published: November 13, 2024

> This guidance document from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory notification requirements for producers of e-cigarettes and refill containers. Under Part 6 of the Tobacco and Related Products Regulations (TRPR) 2016, any entity that manufactures, imports, or re-brands these products must submit detailed information before placing them on the UK market. Although this is a general guidance document rather than a specific inspection report, it identifies potential compliance issues regarding improper registration and incorrect fee payments across different UK regions. The regulatory framework is supported by Commission Implementing Decision (EU) 2015/2183, which dictates the format and content of these notifications. To remain compliant, producers must first verify if a supplier has already submitted a notification to avoid duplicates. Required actions include registering for an account on the MHRA Submission Portal, managing user access via provided tutorials, and submitting product data through the European Common Entry Gate (EU-CEG). Producers must ensure their Submitter ID remains consistent with their European ID to qualify for reduced fees in Great Britain and Northern Ireland. While the MHRA does not offer an XML creation tool, it accepts manual uploads and existing XML documents. Technical issues should be reported directly to the MHRA submissions team with supporting evidence.

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## Content

On this page we provide advice for producers of E-cigarette and vape products. A producer is anyone who manufactures or imports e-cigarette or refill container products and anyone who re-brands them as their own. If you qualify as a producer, please see the guidance below for putting a new product onto the UK market. Introduction If you import or re-brand products, check with your supplier whether they have already made a UK notification for the specific product you sell. If they have done so, you do not need to submit a duplicate notification. Part 6 of the Tobacco and Related Products Regulations (TRPR) 2016 sets out the requirements for e-cigarettes and refill containers. Producers must submit information about their products to us through the MHRA Submission Portal and European Common Entry Gate (EU-CEG) notification portal for UK wide supply. Before getting started Registering to make submissions to the MHRA this page provides guidance on how to make submissions to the MHRA, this includes information for e-cigarette submissions. Ensure that you have watched our videos below and have referred to the user reference guides prior to clicking on the link in the Getting Started section. Three short video demos are provided below which cover all aspects of the user access management process - these steps will enable your organisation to gain access and manage user permissions for using MHRA Submissions. You can access all three videos on Sharefile . User registration - the end to end process for adding an initial company administrator Add a new user - how to add an internal colleague as a user or company administrator Add a new external user - how to add a third party consultant/consultancy as a user or company administrator User reference guides There are two user reference guides which contain step-by-step guidance on the processes: Gaining Access to MHRA Submissions Managing users on MHRA Submissions Application Once you have an MHRA Submission Portal account, you can continue with the application process. Our submission portal provides an option to generate new submitter ID instead of pre-populating your EU submitter ID, please report this to us via the ‘Help and Support’ tile on MHRA submission portal before completing any submissions. Once you have validated the submitter ID assigned by the MHRA submission portal and it corresponds with your EU submitter ID, you will have an option to raise a request to update your company display name. A request can be raised via the ‘Help and Support’ tile. Please note: The company name displayed on the MHRA submission portal is also used in the extract published on our website. If your company ownership has changed and you require a new company ID on the MHRA submission portal then you can raise a ticket via the ‘Help and Support’ tile for a change of ownership. The MHRA does not provide an XML creator. Notifications to the MHRA can be provided via existing XML documents or manually using our bulk uploader or online form. Fee reduction To receive fee reduction for both Northern Ireland and Great Britain products must retain the same ECID in both regions. The regulations enable submitters to pay a single fee for Great Britain and Northern Ireland. Changes to the ECID between regions will result in two unique product identifiers which will be charged accordingly. Contact Should you encounter technical difficulties, please contact submissions@mhra.gov.uk (include a screenshot of the error). The format and content of notifications will remain in line with those set out in the Commission Implementing Decision (EU) 2015/2183 on e-cigarettes. Details of the information notifications are required to contain, are set out by the Commission in the Data Dictionary (PDF, 888KB, 37 pages). If you make your product available in Great Britain under several brand names, you will be able to include all brand names for identical products in a single notification, for no additional fee. Each brand should be listed on the notification as a separate presentation.

## Attachments

- [Advice for Producers of E-Cigarette and Vape Products](/government/publications/advice-for-producers-of-e-cigarette-and-vape-products/advice-for-producers-of-e-cigarette-and-vape-products)
