MHRA TPD Update Email #8: Notifications, labelling, leaflets, safety and cross border sales

This is a repost of the email received today from the MHRA for those who aren't on the mailing list. #VapeOn

Medicines and Healthcare Products Regulatory Agency

Hello from the e-cigarettes team
In this email we cover information for producers on the notification process, ingredient labels, information leaflets, safety information and cross border sales.

Notifications

Thank you to everyone who has submitted a notification so far, we have already received hundreds of applications from a range of large and small companies. Our IT team are developing a system to streamline the process of downloading notifications from the EU-CEG, and we are planning to publish them on our website in November.
We encourage all companies to begin the process of submitting notifications as soon as possible. So as not to provide an incentive to delay making notifications, we are not planning to send out invoices for submissions received until October. 
As a reminder, before 20 November, our transition periods mean that you can start to sell a new product the day after you have submitted your notification, and do not have to wait for us to publish it first. You must notify products already on the market before 20 November 2016, if you wish to continue manufacturing and selling them after that date.
If you make your product available in the UK under several brand names, you will be able to include all the brand names for the identical products in a single notification, for no additional fee. Each brand should be listed on the notification as a separate presentation.
Information on how to notify is available on our website and from the European Commission.  

Ingredients labelling – new information

Since our previous statement (update email #6) on ingredients labelling, we have looked at how ingredients are described on the label in a way that is meaningful to the consumer. Our interpretation of article 20(4) of the Tobacco Products Directive (TPD) is that all ingredients in the product should be listed on the label where they are used in quantities of 0.1% or more of the final formulation of the e-liquid.  Where a flavour ingredient contains several component chemicals, we consider that it is acceptable to describe the ingredient on the label by the name of the flavour, for example ‘strawberry flavour’.  For confidentiality reasons companies may choose to describe individual ingredients used in quantities below 0.1% of the final formulation by category, for example ‘other flavourings’. 
This advice only applies to product labels, and a full list of ingredients in the flavouring must be included in notifications through the EU-CEG. 

Information Leaflets

If you can fit all the required leaflet information on your product’s labelling, you may not need to include a separate leaflet in the pack.
Where all the required information can be fitted onto the unit pack and other labelling within the packwithout loss of legibility to the consumer, our interpretation of the TPD is that the packaging can be considered to include the leaflet, and a separate leaflet insert is not required. Be aware however that additional statutory labelling requirements may also apply, such as the European Regulation (EC)No 1272/2008 on classification, labelling and packaging of chemical substances (CLP).  

Safety information

The TPD requires information on the use and storage of e-cigarettes to be included in the package leaflet given to consumers. We encourage you to ensure your leaflets include appropriate advice on product storage, particularly on how to ensure the battery does not malfunction.
If you have reason to believe that one of your products is unsafe or not of good quality you must tell MHRA and provide us with details of the risk to human health and safety and any corrective action taken. Reports should be sent by email to TPDsafety@mhra.gsi.gov.uk.

Cross border sales

The Department of Health have uploaded a list of EEA Member States that have either confirmed they are permitting cross-border distance sales of e-cigarettes and/or tobacco products or are yet to confirm domestic rules in this area.
All other Member States have banned cross-border distance sales, and it would contravene the law to trade in those countries.
Businesses who intend to trade in countries where the sales confirmation, registration website or contact details are yet to be confirmed (TBC) are advised to contact the national authorities before commencing supply.

Any other queries

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.
Kind regards
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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