Thursday, 20 April 2017

MHRA Update Email #16: 20th May deadline, annual reporting and email contacts

This is a post of the email sent out today by the MHRA for those who aren't subscribed.

Medicines and Healthcare Products Regulatory Agency
 

Hello from the MHRA E-cigarettes team

In this email we will cover the final 20th May deadline, annual reporting and email contacts.

Transition period

We are now only a month away from the end of the transition period on 19 May 2017. Starting from 20 May 2017, only TPD-compliant products can be sold and retailers will need to remove from sale any remaining stocks of products that do not comply. 
Most manufacturers, importers and re-branders have successfully completed the submission process to notify their existing products and we now have well over 20,000 UK products listed on our website.  If there are outstanding issues in getting all your existing products included on our published list, please contact TPDnotifications@mhra.gov.uk urgently and we will assist you in completing the process.
More of the products now being notified are new products coming to market.  Once your new product is included on our published list, you can launch it in the UK. 
We are working with notifiers on their submissions and expect to update the TPD compliance status of all notifications before the end of the transition period.  Where notifications are found to be complete, we will accept the declaration of compliance provided by the producer. 
If for any reason you have reason to believe that a listed product is not compliant, please send details of the problem to TPDsafety@mhra.gov.uk and we and Trading Standards will investigate as necessary.

Annual Reporting

Under Regulation 32 of the Tobacco and Related Products Regulations 2016, all producers must submit information on the sales of their e-cigarette and refill container products each year.  The first report covering the period from 20 May to 31 December 2016 is due by 20 May 2017.  We have developed new guidance to set out what is required and this is available on our guidance page.  Information can be submitted via the EU-CEG portal using the correction submission type.  A spreadsheet is also available to assist in providing these data for 2016 only on a per company basis if you have difficulty submitting via the EU-CEG. 

Substantial modifications

Due to the initial limitations of the EU-CEG portal, we have not charged a fee for substantial modifications during the transition period.  For all submissions from 20 May, the fee of £80 will be invoiced before processing begins.  Please ensure any remaining updates to bring products into compliance are submitted before this date.
A reminder that a substantial modification is defined in our submission type guidance as: 
  • any change to the qualitative or quantitative composition of the nicotine-containing liquid 
  • any change to the volume of a refill container, tank or cartridge 
  • any change to the composition, design or power output of a device which would be likely to affect emissions

E-cigarette enquiries - updated email addesses

All MHRA email addresses have been amended to remove the .gsi.  Please update your contact list as follows:
General enquiries - Please contact the customer services team at info@mhra.gov.uk
Invoices, notification status and publishing - Please contact the MHRA notification and finance teams at TPDnotifications@mhra.gov.uk
Safety concerns – Please send details to the vigilance team at TPDsafety@mhra.gov.uk.


Kind regards

MHRA e-cigarettes team
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK
Telephone: 020 3080 6000

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