Guidance on the submission and content of notifications for Great Britain
Guidance to aid producers of e-cigarettes and refill containers to prepare notifications for their products.
Before getting started
Registering to make submissions to the MHRA provides guidance on how to use MHRA Submissions, including for e-cigarette information.
Ensure that you have watched the 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:
Application
Once you have an MHRA Submission Portal account, you can continue with the application process. The MHRA have published to help you with this:
If the MHRA submission portal is providing an option to generate new submitter ID instead of pre-populating your EU submitter ID please report this to the MHRA 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 is in line 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 MHRA gov 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.
Guidance
The following guidance is to aid producers of e-cigarettes and refill containers to prepare notifications for their products. It was developed by the UK regulators and other member states and discussed at the European Commission Working Group on notification of e-cigarettes and refill containers.