MHRA TPD Update Email #2: Transition Periods, Industry Meetings & FAQs

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


Hello,

Welcome to the second update email from MHRA’s e-cigarettes team.

Thank you for all your responses to the last email. We are especially grateful to those of you who tweeted about our guidance page, and shared the email with your contacts.

In this email we will address some of the concerns you have sent to us regarding the Tobacco Products Directive (TPD).

Who needs to notify?

The requirement to notify falls on ‘producers’ of e-cigarettes and refill containers (e-liquids).  ‘Producers’ refers to any manufacturer or importer of these products and/or those who re-brand any of these products as their own. 

Retailers do not need to notify the products they sell unless they also qualify as a ‘producer’ of e-cigarettes and e-liquids. 

Transition Periods

We have put together a transition period flowchart that sets out our current proposals for notifying products.  The flowchart and updated information on these deadlines will be made available on our guidance page shortly, but we wanted to share this with you as soon as possible, and have attached it to this email.

This flowchart provides new information on when a notification is required.  It particularly affects products which are not on the market prior to 20 May, but will be launched between 20 May and 19 November 2016.

If you plan to sell your product for the first time between 20 May and 19 November 2016, and intend to keep selling it after 19 November 2016, you must notify your product at least one day before you sell it for the first time. If you do not intend to sell your product after 19 November 2016, then no notification is required.

You are welcome to share the PDF with your contacts. Please note however that although we expect these to be the final deadlines, the dates are currently proposals, and we will update you if necessary.

Industry Meetings 

You have also told us of your concerns about the lack of information in the TPD regarding product types, submissions, emissions data and nicotine dose.

To address this, we have been holding a series of meetings with independent trade associations, and the e-cigarette divisions of tobacco firms. In these meetings we discussed our proposals for guidance on these topics, and sought input on how best to implement them in a fair and pragmatic way.

These meetings were held in line with the World Health Organisation’s Framework Convention on Tobacco Control (FCTC), and were limited in scope to address only regulation of the e-cigarette industry.

More details about the guidance we have produced will be released soon, which we hope will answer many of the outstanding questions you have about the TPD.

Producers Survey

We have put together a short survey for producers of e-cigarettes and e-liquids to help us see what you would like from the notification website. 

The survey can be accessed here: https://www.surveymonkey.co.uk/r/LGP2HYH

FAQs

If you want to ask a specific question about the TPD, or MHRA’s work regarding e-cigarettes, you can contact us through the dedicated enquiries inbox: e-cigarettes@mhra.gsi.gov.uk

Below are some examples of the most common questions we receive, and their responses. If you have a question you would like to see answered in this section, please send them to mark.wilcox@mhra.gsi.gov.uk.

Q: Will I need to submit a full toxicology report on each flavour and strength?

A: The toxicology of each flavour will need to be reviewed, but there will not be a requirement for a new toxicology report to be made for each nicotine strength of the same flavour. The same report should be suitable for a range of nicotine strengths, when all other ingredients are the same.

Q: Which labs should we use for our testing?

A: The TPD does not include any requirements as to which labs should be used for testing.  The notifier will need to be satisfied as to the standards of any testing carried out, as they have to submit a declaration that they bear full responsibility for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions.

Get in touch

If you have 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

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

Email: mark.wilcox@mhra.gsi.gov.uk

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