New rules for e-cigarette sales in the Great Britain and Northern Ireland from 1st January 2021
Dec 01, 2020

On 1st January 2021, Britain will leave the EU. We recently shared a post about how Brexit is likely to affect the current Tobacco Products Directive , and the UK Medicines and Healthcare products Regulatory Agency (MHRA) recently published new guidance for submitting a TPD notification in Great Britain and Northern Ireland.

TPD notifications will be submitted differently in Great Britain and Northern Ireland

From 1st January 2021, TPD notifications for Northern Ireland will continue to be submitted through the European Common Entry Gate (EUCEG), while notifications for Great Britain will be submitted through a new MHRA Submission Portal.

This is because the Republic of Ireland will remain in the EU, and the UK and EU have agreed that this situation “should not lead to new checks or controls on goods crossing the border between the two parts of Ireland”. To achieve this, Northern Ireland will continue to follow the EU rules on manufactured goods.

The MHRA have confirmed that they will continue to be the competent authority for both Great Britain and Northern Ireland.

UK TPD notifications will be submitted through the new MHRA portal from 1st January 2021

Any new TPD notifications for Great Britain must be submitted through the new MHRA portal from 1st January, with a cut-off period for amendments to migrated data starting from 4th January.

The submission process is very similar, with the use of XML and bulk submissions still permitted. MHRA have published a user guide to the new portal, which you can access here.

Once a notification has been submitted, the user will receive a confirmation email from MHRA which includes a unique reference number. Users will still be able to amend existing notifications and the fees for doing so will stay the same as they are at present.

TPD notification standards will remain the same after Brexit

MHRA confirmed that the standards for TPD notifications will remain the same for Great Britain even after they leave the EU. The document requirements and continued acceptance of XML files means that manufacturers and their agents will be able to use the same file to submit a notification to both the EUCEG and the new MHRA portal.

If you need support in getting your ENDS on the market, we can help. Our bespoke services are fully tailored to your needs. Whether you require the full TPD notification service or something in particular, our expert regulatory affairs team and fully-equipped lab will ensure that your TPD notification includes the necessary information for EU approval. Click here to learn more about how we can support you in getting your ENDS on the market in Europe.

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