IBVTA was invited to attend an important engagement event organised by the Medicines & Healthcare products Regulatory Agency (MHRA) on Friday 12th February 2016. Whilst the Department of Health (DH) retains overall responsibility for TPD implementation, the MHRA has responsibility for the parts of TPD pertaining to vape products; in short this means the notification process.
- Welcome and introductions
- MHRA update on status of TPD implementation
- Notification process workshop session
- DH update - advertising
- Communication channels
TPD implementation update
- The MHRA addressed the ambiguity of the 2ml tank capacity limit both in TPD Article 20 and in the draft Tobacco and Related Products Regulations. MHRA has consulted DG SANTE about this matter, and have been told that the intention of the regulations was that tank capacity can be no more than 2ml whether it is sold containing nicotine or not, and that UK regulations should be in accordance with this intent.
- The MHRA made clear that the number of notifications expected far exceeds their own initial estimate. MHRA will consequently re-evaluate their proposed costs for notification. MHRA do though appear to have a good feel for the size of each individual notification, and were asked to ensure DG SANTE appreciate the volume of data that will need to be handled. MHRA also appear to have a good understanding of the risks DG SANTE are imposing on themselves by running so late with the test programme for the “Common Entry Gate” notification IT system.
- Questions were asked concerning the purpose of a Common Notification Format, when although it is proposed that common notifications can be made for multiple Member States with a single submission, it seems that every responsible authority will charge a separate fee for notifying in the territory for which they are responsible. MHRA were unable to comment beyond stating that they believe this to be the case.
Notification process workshop session
- A theme that came through strongly was that it would be grossly unfair on legitimate businesses not to police the notification scheme, and ensure that traders importing products that have not been duly notified through grey and black market channels are stopped.
- It was made clear that Trading Standards bodies throughout the UK do not appear to be sufficiently resourced to carry out this work.
- All that intend to make notifications expressed that they did not expect the submission of a notification by one party should make it acceptable that any importer can then place the same product on the market under the same notification.
- The issue of what should be “confidential information” once it has been submitted to MHRA in a TPD notification was raised. All industry delegates agreed that Toxicological Risk Assessments will be costly, and should be considered as protected IP of those submitting, as should any emissions or e-liquid testing methods and results.
- The question of IP protection for ingredient notification was raised, and the idea that ingredients could be published in overall content “bands” rather than have their exact recipes published was put forward.
- MHRA was asked whether it would be willing to sign non-disclosure agreements, but representatives were unable to comment at the time of the meeting.
Department of Health update – Advertising
- DH made clear that it understood frustrations surrounding the definitions to be applied to web marketing restrictions, but that they were trying to work within the legal framework of the TPD whilst enabling e-commerce based businesses to make customers aware of new and existing products and prices.
- Clarification was given that whilst “cold” email advertising to non-customers will not be allowed under the new rules, customers that have “opted in” to receiving further information about products and promotions may be contacted freely via email.
Channels of communication
The MHRA sought suggestions as to the communications channels they should be using to inform the industry of new rules and obligations. Suggestions included Twitter, Vaping forums (particularly UK-based), larger manufacturers, trade associations such as IBVTA, and key Facebook pages.
IBVTA will be working closely with the MHRA and DH in the coming weeks to ensure that the genuine concerns of the independent sector regarding the implementation of the TPD and in particular, the notifications process are addressed.
IBVTA Scientific and Regulatory Technical Committee