Latest Newsletter from UK MHRA: Takeaways

The UK e-cigarette regulator, MHRA (Medicines and Healthcare products Regulatory Agency), recently sent out a newsletter to e-cigarette producers, covering various important topics. In this blog post, we will highlight some of the key points discussed in the newsletter, including Adverse Reaction reporting, brand name regulations, and the requirement for a UK Affiliate.

Initial Comments on Key Topics

Here are some initial comments on key topics:

Adverse Reaction Reporting (URGENT)

Producers must promptly report any adverse reactions occurring between January 1st, 2021, and June 30th, 2023. If there are no adverse reactions to report, an email to TPDsafety@mhra.gov.uk stating “no Adverse Reactions” with your submitter ID suffices . For cases with adverse reactions, there are specific information requirements. See below for email template (for your convenience). The deadline for submitting the information is 31st July 2023!

Email Template

For your convenience we have prepared an email to help you meet the requirement for reporting adverse reactions to MHRA.

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Dear Sir/Madam,
In respect of the UK market, please be advised that we have no Adverse Reactions to report.

[Company name]
Submitter ID: [XXXXX]

Please let us know if you have any questions.

OR

Dear Sir/Madam,
In respect of the UK market, please be advised that we have the following Adverse Reactions to report:

[Capture the following information for each case]
Age:
Sex:
Adverse Reaction:
Onset time:
Level of use:
Outcome:
Reporter type: [member of public or healthcare professional]

[Company name]
Submitter ID: [XXXXX]

Please let us know if you have any questions.

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‘Energy,’ ‘Light,’ and ‘Mild’ in Brand Names

Products with terms like ‘Energy,’ ‘Light,’ or ‘Mild’ in the brand name must be updated for the UK market on packaging and in the MHRA submission as these terms are not permissible under UK (and EU) law. Notifications should be updated via the MHRA portal before 1st September 2023. Your notification may be withdrawn should you fail to update the names.

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Include Full Product Name in Notification

To help authorities identify products accurately, the full product names should be included in the EU TPD and MHRA submission. The provided example demonstrates the recommended format.

Example

Brand: My Vape

Sub-Brand: X

Flavour: Banana

Strength: 20mg

Type: Disposable

MHRA recommend including the brand under ‘Brand’ and all details in ‘sub-brand’ (tick the sub-brand option to allow you to add full name. 

In Brand: My Vape

In sub-brand: My Vape X Banana 20mg Disposable

Requirement of a UK Affiliate

Producers must ensure their notifications include a UK affiliate by 1st September 2023. Failure to do so may lead to the withdrawal of their products by the MHRA. Read on to learn how we can help our EU partners in this regard.

Introducing Our UK Affiliate Service

Are you an EU-based producer looking to comply with the MHRA’s UK Affiliate requirement? We recently introduced our UK Affiliate Service. Click here to learn more.

TPD Compliance Tools

In addition to our UK Affiliate Service, we also offer a comprehensive range of TPD Compliance Tools to streamline the compliance process. These tools are designed to help you navigate the intricate regulations efficiently, saving you time and money. Explore all tools here.

The MHRA’s newsletter serves as a vital resource for e-cigarette producers, providing valuable insights on various regulatory aspects. Adhering to these guidelines is essential for a successful business in the UK market and gives clues to the requirements in the EU where guidelines are generally lacking.

Download Newsletter

For more information and to download the full MHRA newsletter, click here.