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

Monday, 20 February 2017

MHRA Update Email #15: 20th May deadline, advertising and ongoing enquiries


Medicines and Healthcare Products Regulatory Agency

Hello from the MHRA E-cigarettes team

In this email we will cover the final 20th May deadline, advertising and ongoing enquiries.

Transition period

We are now only three months away from the end of the transition period on 20 May 2017. Non-compliant products cannot be sold past this date and on 19 May 2017 retailers will need to remove from sale any remaining stocks of products that do not comply with the TPD. 
Most people who had trouble submitting information on their products via the EU-CEG in November have now successfully completed the process.  If you have still not been able to submit your products, please contact TPDnotifications@mhra.gsi.gov.uk  urgently and we will assist you in completing the process as soon as possible.  Please also get in contact if you think you have submitted information via the EU-CEG but have not been contacted by MHRA about your products.  In a small number of cases this has revealed that submissions were unsuccessful and we have been able to help to get this resolved.

New products

A reminder that if you are submitting information about a new product you intend to launch or you are making a substantial modification to your product, you cannot market it until the product is listed on our website.  Provided invoices are paid promptly, we have been able to download, process, and publish submissions within a month of receiving them.  

Published notifications

The list of submitted products that we announced in our last update email is now being published weekly.  We hope from next week to be able to add more information on brand names and include all variants listed on a notification.  Please check our list to find out which products have been notified and can be sold by producers in the UK.
We would also remind you to ensure that you include enough information in the brand name and sub brand name fields to identify your product.  The list will be used by retailers and customers as well as Trading Standards to identify if a product has been notified.

Advertising

Earlier this month, the Committees of Advertising Practice (CAP) announced the creation of a new rule regarding the advertising restrictions on e-cigarettes. This rule was based on the responses to a consultation by CAP, the details of which were sent out in our previous update emails.
To read about the rule, please see the report on the CAP website, along with their newly published Advertising Guidance. A copy of the regulatory statement on e-cigarette advertising restrictions, and supporting materials can be found here.

E-cigarette enquiries

To help direct your query to the right place, please use the list below to decide who would be best to answer your question.
General enquiries:
Please contact the customer services team on info@mhra.gsi.gov.uk
Invoices, notification status and publishing:
Please contact the MHRA notification and finance teams on TPDnotifications@mhra.gsi.gov.uk
EUCEG Technical difficulties:
Please contact the European Commission on SANTE-EUCEG-ITSUPPORT@ec.europa.eu
Advertising:
Please contact the Department of Health on tobaccoproductsdirective@dh.gsi.gov.uk
Enforcement:
Please contact your local trading standards, which can be found via https://www.gov.uk/find-local-trading-standards-office
Other EU Member States:
Please contact the designated authority of the Member State(s) in question via http://ec.europa.eu/health/euceg/contacts_en
Many of you have also been contacting me directly to answer your questions regarding the submission process, and it has been a pleasure to work with you in order to better understand your needs and support you with your notifications. This will be my last month at the MHRA, as I am moving departments to take on another role at the end of February.  Please make sure you use the email addresses above for all future enquiries to ensure we can continue to answer your questions. 
Kind regards
Mark Wilcox
Campaigns Specialist
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK
Telephone: 020 3080 6069

Monday, 13 February 2017

Wednesday, 21 December 2016

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

Friday, 25 November 2016

MHRA Update Email #13: EU-CEG, Non-compliant products, Invoices, Publications and new products

Repost of the latest MHRA email for those that don't get it directly.

Medicines and Healthcare Products Regulatory Agency
 

Hello from the MHRA e-cigarettes team

Thank you to everyone who worked hard to get their submissions into us last week. Up until the deadline of 21 November, we received over 10,000 product notifications on the EU-CEG portal, though are aware that some of you are still experiencing difficulties with the submission process.
In this email, we discuss the EU-CEG, non-compliant products, invoices, publications and submitting new products. 

The EU-CEG

We have received a significant number of emails to TPDnotifications@mhra.gsi.gov.uk telling us about difficulties with submissions via the EU-CEG portal and late receipt of submitter IDs.  Please keep us informed of progress and confirm when you have successfully completed all your submissions.
If you realise you should have submitted notifications but have not yet contacted us, 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.

Non-compliant products

We would like to remind you that products which do not comply with the regulations may no longer be produced (manufactured or imported) in the UK.  Manufacturers and importers may only continue to sell non-compliant products if they have been notified.  This does not affect products in the retail supply chain.  Retailers who are not manufacturers or importers may continue to sell products they have in stock until 19 May 2017.

Invoicing notifications

We have sent out invoices for all submissions received up to 31 October and will soon be sending out invoices for those received by 21 November.  Invoices will be sent out each week thereafter for new notifications.  MHRA bank details are:
MHRA
Sort Code 60-70-80
Account No 10004386
Swift Code NWBKGB2L
IBAN GB68NWBK60708010004386 

Publication of notifications

MHRA intends to publish a simple spreadsheet listing of all notifications received.  This is an interim solution until we can download, check and publish full details of notifications from the EU-CEG portal. We expect the spreadsheet to list:
  • Date notification made to EU-CEG
  • Submitter company name
  • Product type
  • Product ID number
  • Brand name(s)
  • Product launch date
  • TPD compliance status

We expect to publish the first spreadsheet before Christmas and will update it regularly after that.  

Introducing new products after 21 November

From 22 November, notifications must be made for all new products six months before you intend to place the product on the market.  We intend to publish details of new notifications on the same spreadsheet as above.  Once your product is listed on the spreadsheet, you can launch your product in the UK.  You do not need to wait for the remainder of the 6 month period to elapse before you place your product on the UK market.

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:  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.

Mark Wilcox

Campaigns Specialist
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK 

Thursday, 17 November 2016

MHRA Update Email #12: Submission Deadline

This is a repost of the latest MHRA email on e-cig/vaping regs for those not subscribed to the mails.

Medicines and Healthcare Products Regulatory Agency
 


Hello from the MHRA e-cigarettes team.

Thank you to all of you that have worked hard to complete your submissions and send them to us via the EU-CEG. We have seen a huge spike in activity recently, and yesterday received 1,000 notifications in one day! 
Although most of you have managed to make submissions successfully, we have had reports that some are having difficulty with the EU-CEG, and are worried that due to issues with the portal, submissions may not be able to be entered in time to take advantage of the transitional period deadline.
In light of this, we have issued the following guidance:

Submission Deadline

As the official transitional period deadline of 19 November is a non-working day (Saturday) we are prepared to accept submissions on the next working date.
Therefore, all submissions received by 23:59 on Monday 21 November 2016 will be judged as if they were submitted on 19 November.   
If you are unable to make a submission before the deadline due to a technical issue with the portal or for another reason, please send an email to TPDnotifications@mhra.gsi.gov.uk using your Submitter ID as the subject line.  The email should provide the following information:

  • Submitter company name
  • Submitter ID
  • List of product brand names
  • Reason for delay

We encourage you to keep trying to submit your notifications, and expect that all submissions will be made as soon as possible after that date.

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:  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.

Mark Wilcox

Campaigns Specialist

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