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Detailed guide: Placing an e-cigarette on the market from 1 January 2021

Medicines Healthcare Products Regulatory Agency

November 24
14:30 2020

The Tobacco Products Directive is listed in Annex 2 of the Northern Ireland Protocol. Article 5(4) states Union law listed in Annex 2 shall also apply in Northern Ireland.

The MHRA will remain the competent authority for the notification scheme for e-cigarettes and refill containers in Great Britain (GB) and Northern Ireland.

From January 2021 producers of nicotine-containing electronic cigarettes and refill containers will be required to:

  • submit notifications for Great Britain using the MHRA Submission Portal
  • submit notifications for Northern Ireland using the European Common Entry Gate (EUCEG)

A producer is anyone who manufactures or imports these products or who re-brands any product as their own.

Retailers do not need to submit information for any products they sell unless they also qualify as a producer.

Guidance on the submission and content of notifications for Great Britain

Registering to make submissions to the MHRA from 1 January 2021 provides guidance on how to use MHRA Submissions, including for e-cigarette information.

Before getting started

Ensure that you have watched the below videos and have referred to the user reference guides prior to clicking on the link in the Getting Started section.

These three short video demos cover all aspects of the user access management process.

  • 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

These steps will enable your organisation to gain access and manage user permissions for using MHRA Submissions.

There are two user reference guides which contain step by step guidance on the processes:

Once you have an MHRA Submission Portal account, you can continue with the application process.

User reference guide E-cigarettes Submissions (PDF, 1.03MB, 19 pages)

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.

To receive a fee reduction for both Northern Ireland and Great Britain, products must retain the same ECID in both regions.

Contact

Should you encounter technical difficulties, please contact submissions@mhra.gov.uk (including in your message a print screen of the window where the problem appears)

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 which notifications are required to contain are set out by the European Commission in the Data Dictionary (PDF, 888KB, 37 pages) .

Technical requirements for refill mechanisms, and information that must be included in the instructions for use of the product will remain aligned with the Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes.

Guidance on the submission and content of notifications for Northern Ireland

The format and content of notifications are set out in the Commission Implementing Decision (EU) 2015/2183 on e-cigarettes. This will remain aligned with the current MHRA guidance publications.

Details of the information which notifications are required to contain are set out by the Commission in the Data Dictionary (PDF, 888KB, 37 pages).

Technical requirements for refill mechanisms, and information that must be included in the instructions for use of the product are set out in the Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes.

Published 24 November 2020

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