MHRA TPD Update Email #5: Guidance Documents & Cross Border Sales

Hi, this post is purely a copy/paste of the 5th MHRA update email for those who haven't yet signed up for updates (please see end of email). #VapeOn


The documents mentioned in the below email can be found here

Hello from the MHRA e-cigarettes team.

We have been preparing a number of guidance documents to help producers of e-cigarettes and e-liquids ensure their products are compliant with the Tobacco Products Directive (TPD) and to submit notifications for them.

The attached documents will be uploaded to our website tomorrow, along with information on how to submit notifications, fees guidance, reporting problems with e-cigarettes, and advice for retailers, but we wanted to share them with you first of all.

Below is a brief description of what each document contains. Whilst the documents are still in draft form, we do not expect them change significantly.

Guidance on labelling and e-liquids

This document clarifies our understanding of the labelling requirements for e-liquids under the TPD.

E-Cigarette Transition Periods for Producers

This updated flowchart sets out the transition periods UK producers are required to abide by during the initial implementation of the TPD. The requirements for retailers will be uploaded on our website tomorrow.

The following four guidance documents have been developed by the UK and other member states and discussed at the European Commission Working Group on notification of e-cigarettes and refill containers.

Product Type Guidance Draft

This document describes the types of product that can be notified, and what they should be listed as.
Submission Type Guidance Draft

This document describes whether a submission should be counted as a new product, a substantial modification, an update or a withdrawal.

Nicotine Dose Guidance Draft

This document describes the requirements for nicotine dose testing, and how such testing should be undertaken.

Emissions Guidance Draft

This document lists key emissions to be reported, and sets out how testing should be undertaken.

Cross Boarder Sales

From 20 May 2016, you need to register your business if you supply tobacco products and/or e-cigarettes via cross-border distance sales, for example online sales. 
This applies to:

·         businesses established in the UK selling tobacco products and/or e-cigarettes to consumers in another EEA state (European Economic Areas – the 28 EU Member States plus Iceland, Liechtenstein and Norway)
·         businesses established in the EEA or third country selling to UK consumers.

Business to business sales, that is sales not direct to consumers, do not need to be registered.
Registration is a legal requirement under the TPD.  Without confirmation of registration businesses must not supply a relevant product to a consumer via a cross-border distance sale. 
You can find more information, along with a link to the online registration form to be completed, at https://www.gov.uk/government/publications/tobacco-products-and-e-cigarette-cross-border-sales-registration.

Get in touch

As ever, if you have any suggestions for anything you would like to see in future emails, or would like to be added to the mailing list, please contact mark.wilcox@mhra.gsi.gov.uk (though I will be on leave from the 29th April to the 4th May)

If you have any technical enquires about the notification process, please send them to our official enquiries inbox:  info@mhra.gsi.gov.uk .

Thank you for your time in reading and sharing this email with your contacts. We look forward to hearing from you.

Kind regards

Mark Wilcox
Campaigns Specalist


Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK
Telephone: 020 3080 
6069

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