MHRA Update Email #11: non-compliant products, toxicology reports, ingredient notifications, and contact details



Medicines and Healthcare Products Regulatory Agency

Hello from the MHRA e-cigarettes team.

Thank you to those of you who have been in touch to let us know your progress regarding the notification process. We are receiving new notifications daily and encourage you to continue notifying your products as soon as you can.
In this email we address some of the concerns you have raised regarding the sale of non-compliant products past 19 November, toxicology reports, ingredient notifications, and contact details of the competent authorities in other Member States.
Sale of non-compliant products
We would like to remind producers (a term which includes manufacturers, importers and those who re-brand products) that after 19 November 2016, only products that comply with all the requirements of the Tobacco and Related Products Regulations 2016 (TRPR) can be manufactured or imported.  All aspects of the product must comply; this includes requirements relating to the quality and characteristics of the product and its labelling.
Producers cannot sell any remaining stocks of non-compliant products to retailers and trade customers after 19 November 2016, unless those products have been notified.
Retailers will still be able to sell non-compliant products to customers until 19 May 2017, as set out in the advice for retailers section of our website.   
A simplified method for notifying non-compliant products can be found below.
Notifying Non-compliant Products
Producers who wish to continue selling non-compliant products (that were manufactured on or before 19 November 2016) to retailers after 19 November 2016 need to submit a notification for the non-compliant products, with the intention of modifying them to bring them into compliance with the TRPRs by 19 May 2017.
In order to simplify this process, we advise you to make a notification for the compliant product by 19 November.  This will allow you to meet the requirement to notify the modified product six months before marketing it.  In the Product Presentation section of the notification you should include a statement in the National Comment field (item 33 in the Commission’s data dictionary) that:
‘Until [enter date] this product is currently being sold as [describe the non-compliant product highlighting the differences between this and the compliant product notified].’ 
This will save the need to further modify the notification and pay the associated fee.  Once the non-compliant product is no longer marketed you should update the comment field to remove the reference to the non-compliant product.  This update will not attract a fee.  If you have already submitted a notification for the non-compliant product, you can amend the notification by submitting a correction notification by 19 November for no additional fee.
Toxicology reports for confidential ingredients
After our last email regarding the confidentiality of flavour ingredients, we have updated our UK ingredient guidance to incorporate the new information on flavour ingredients. We have also received a number of requests for clarification of this guidance.
We can confirm that this change only applies where companies are unable to obtain full details of flavour ingredients, and this should be explained in the ingredient function other field (field 58 in the data dictionary) or in an attached document.
We can also confirm that available toxicological data must be submitted for each ingredient declared in the notification.  Where details of ingredients present at levels below 0.1% are not submitted with the notification, toxicological data on each ingredient must be provided if requested by the competent authority in the event of a safety problem with the product. 
We remind you that e-cigarette and e-liquid producers need to make an assessment of the safety of each product in order to meet their responsibilities under the TPD and general consumer safety legislation.  This should include assessment of all the ingredient toxicology and emissions data available.  The notifier and flavour supplier should in particular consider the safety of the flavour ingredients when used in an e-cigarette.
Member State Contact Information
The European Commission has updated its EU-CEG pages, and now includes a contacts page.
On this page you can access a pdf which lists the competent authority and contact point of each Member State.
If you have any questions regarding the notification process in other Member States, please use this form to find their contact details.
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 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.
Mark Wilcox
Campaigns Specialist
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK 
Telephone: 020 3080 6069

No comments:

Post a Comment

All comments are the responsibility of the poster and may be subject to moderation before release.