With only a couple of weeks left until the 19th of November we have helped many clients ensure their products are TPD compliant and we are still seeing a significant number of enquiries from both new...
Nicotine
Emily Saunders, Regulatory Operations Manager, takes a look at the potential delay to the Tobacco Product Directive (TPD3) and the future of TPD notifications.
As far back as May 2020 and as detailed in the minutes from the ‘meeting of the group of experts on tobacco policy’ in June 2020 there have been murmurings that there may be a delay to the latest TPD update due to the Covid-19 pandemic. The European Commission will still be working towards the initial proposed deadline of May 2021 but the various organizations that will be contributing to TPD3 legislation are likely to be delayed in delivering their reports and conclusions meaning the final deadline may not be met as originally projected. This potential delay was also deliberated at the recent Global Tobacco Nicotine Forum (GTNFR) virtual event.
MHRA Surveillance
Regulatory Officers at the Medicines and Healthcare products Regulatory Agency (MHRA) have instigated a process of reviewing previously notified products and it appears they are now focusing efforts on market surveillance. Broughton has always taken a comprehensive approach with our full-service offering to ensure all available data (both from an analytical and regulatory perspective) is present to enable the MHRA to make informed decisions on all submitted products.
Some companies have taken a somewhat light approach due to TPD being a notification process, submitting minimal data. The deficiencies in their applications that have been highlighted by the MHRA is something that Broughton has been contacted to support in rectifying due to our high standard and level of compliance.
More guidance for TPD
According to the discussion papers on ‘general advice on vigilance and due diligence’, which was released after the TPD deadline, TPD currently incorporates a range of additional information to show that companies are supplying products of an acceptable quality and safety through the shelf-life of the product. They also need to ensure that they are maintaining and monitoring products and production standards for every batch. Information can be expected to be compiled in a technical dossier for review by a Regulatory Officer. As well as this further guidance, going forward there is speculation that TPD3 could include flavor bans and further restrictions on packaging and advertising.
On October 5th a webinar is being held by The Independent European Vape Alliance specifically focusing on ‘The Revision of the EU TPD’ which may give us further insight into what the revisions may contain. Unfortunately, until these guidelines are released there is no definitive news about what may or may not be changing. With Brexit looming on the horizon, there is also uncertainty about the future of TPD in the UK, however the UK government has left room for the opportunity to revisit the regulations post-Brexit. Broughton will keep abreast of all developments as they are released and ensure that all our clients are kept updated.
Preliminary Data
As of the 23rd September, one of the organizations who will be advising the European Committee for TPD3 have released their preliminary opinion on electronic cigarettes. The role of the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) is to assess the most recent scientific technical information available and report their findings back to the European Committee. They have been tasked amongst other things, with looking at the short and long-term effects of e-cigarette use, the role it may play as a gateway to smoking (focusing on youth) and their role in the cessation of smoking.
SCHEER Report Summary
The conclusions reported in their preliminary opinions suggest that there is moderate evidence to suggest that e-cig use has harmful health effects, but that more long-term studies are needed. According to the report, there is also strong evidence indicating that e-cig use is a gateway to smoking for young people. Clearly, additional work will be required in this area as there is universal agreement that these products should not be attractive to youth that do not smoke. With regards to the cessation of smoking, SCHEER have stated that the evidence is weak with regards to the effectiveness of e-cigs however they also explain that there is a lack of trials and wide confidence intervals contributing to this opinion. By their own admission, much of the data used for these studies has been generated from the US and they state that ‘conclusions drawn for the US may not be directly transferable to the EU.’
These are not the final conclusions from SCHEER (they are due at the end of this or next month) and what this means for the final TPD3 updates is as yet unknown. However, this publication gives us a strong insight into their findings and the probable outcome of their final report.
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Broughton have deep CRO capabilities and an experienced team of scientific and regulatory professionals to manage full service global regulatory projects. Our knowledge of global regulatory pathways offers significant insights that can be incorporated into your project plans. Our mission is to accelerate safer nicotine-delivery products to market; advancing a smoke-free future.
Book a meeting with us today to discuss your requirements.
