MHRA Update Email #14: Invoicing, Publishing, Marketing and CLP

This is a repost of the email sent by the MHRA today, for those that don't subscribe to the updates.

Medicines and Healthcare Products Regulatory Agency

Hello from the MHRA e-cigarettes team

We would like to start this email by thanking all of you who have submitted information on your products via the EU-CEG. We are aware that for some of you it has been a difficult and time consuming process, but we are pleased have had so many of you working with us to comply with TPD requirements ensure compliance. Most of the companies who were unable to submit information by 21 November have now completed the process and we currently have over 18,000 UK submissions.  
If you have still not completed the process of notifying your products, we urge you to do so as soon as possible. If you have any questions about the process, please look at the information on our website, or contact us via the customer services inbox details at the bottom of this email.
If you realise you should have submitted notifications but have not yet done so or previously contacted us with details of the products concerned and why submissions have not yet been made, please email TPDnotifications@mhra.gsi.gov.uk as soon as possible so that we can discuss how to resolve the situation.  We and local Trading Standards teams are working with companies across the sector to promote compliance.
Our TPD notification team now has a list of over 200 producers who have submitted information to notify products on the UK market.  We will correspond directly with producers about notification-related issues.

Invoicing notifications

We have started downloading summary information about your submissions from the EU-CEG portal and sending out invoices.  We have sent out three batches of invoices so far covering the periods up to 31 October, up to 21 November and up to 11 December.  A single invoice will cover all your products submitted in the relevant period. 
Please check your invoice(s) to ensure that all the products you expect to see have been included.  If recently submitted products are not included, please be patient - you are likely soon to receive another invoice from a later batch download which contains the remainder of your products.
If you made submissions to the EU-CEG before 10 December but have not received an invoice, please check that the submission of your products was completed on the EU-CEG portal and a UK presentation was included.  We are aware of a small number of cases where there are products missing from your invoice and companies had not realised that submission on the EU-CEG had not been successfully completed.  If submission was successful for the UK, please email us with details of the product IDs that are missing so we can check them. 

Publishing notifications

We are today publishing the first list of UK notified products.  Please note that under the Tobacco and Related Products Regulations, a notification is not made until payment is received.  This list is only a small proportion of the numbers of submissions we have received.  We are processing them in date order and will be adding more products to the list  each week in the New Year. 
We expect the list to be useful for retailers, consumers and Trading Standards bodies to be able to verify the companies and brands of e-cigarettes and refill containers (e-liquids) that have been notified to MHRA. 
The list has only limited details at present and some of the products listed are also available under other brand names.  We expect to be able to publish fuller information from the EU-CEG portal about each product in the future.
It is the responsibility of producers to ensure your products meet the required standards of quality and safety.  Producers are able to continue selling notified non-compliant products manufactured before 20 November 2016 until the end of the transition period on 20 May 2017.  Retailers can continue to sell all products until that date. 
We have not yet been able to check each notification listed for completeness or to verify TPD compliance.  We are publishing this list at an early stage to give retailers and other interested parties the opportunity to check that producers have notified the products they are offering for sale.  We are also aiming to minimise the time before new products can be introduced onto the market (see below). 

Marketing your products

Several of you have asked us about whether you can continue to market your products before the details are published on our list of notified products.  The answer depends on the type of product as shown below:
  • For products first marketed before 20 November 2016, you may continue to sell your product.
  • For new products you want to market after 20 November 2016, you must wait until the notification is listed.   
  • If you wish to make a substantial modification to a product, you must wait until the notification with a new product ID number is listed.

Guidance on CLP (Classification, Labelling and Packaging)

A number of you have requested information on the CLP (Classification, Labelling and Packaging of substances and mixtures) regulations which run parallel to the Tobacco and Related Products Regulations for e-cigarette products. CLP is regulated by the Health and Safety Executive (HSE) and we have worked with them to produce some guidance which we have placed on our website.
Technical queries about the CLP Regulation that are not addressed in the guidance may be directed to the HSE CLP Helpdesk at ukreachca@hse.gov.uk . The HSE CLP Helpdesk provides information and responds to enquiries about the provisions of this legislation but is not able to solve business-specific problems or provide tailor-made information on how to meet CLP Regulation obligations.

Any other queries

As ever, if you have any technical enquires about the e-cigarette notification scheme under the Tobacco Products Directive, or the work of the MHRA, please send them to our enquiries inbox:  TPDnotifications@mhra.gsi.gov.uk.

Mark Wilcox

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

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