Report

May 13

We’ve officially left the EU, but what does Brexit mean for ENDS Manufacturers?

Broughton Nicotine Services Director of Product Safety and Compliance, Yvonne Wilding, discusses implications of Brexit on the international ENDS market. 

UK leaving the EU

The UK recently left the EU – so what does that mean for British-based and overseas Electronic Nicotine Delivery Systems (ENDS) manufacturers who have a share of the UK ENDS market?

So far, there have been no significant changes to requirements for product development or sale of ENDS and tobacco products. For medical device purposes, however, Great Britain (GB) now acts independently, separate from Northern Ireland who continue to follow European guidance.

Immediate Changes

A minor change that has been implemented by the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 is the introduction of a new portal. Manufacturers will now need to notify the Great Britain Domestic System to sell e-cigarettes in GB.

To enter the Northern Ireland market, manufacturers will still need to notify the EU Common Entry Gate system.

In terms of medical device legislation, new EU regulations are due to take effect in May but as GB has left the EU, these changes will not be applicable, and GB will continue to work under the existing medical device directive.

Future Changes

The British government has already announced a new certification scheme that will be introduced, called the UK Conformance Acceptance (CA) mark. Manufacturers will need the UK CA mark to sell ENDS products in the UK. The UKCA pathway was introduced in January 2021 but the EU CE mark will be acceptable for products marketing in UK for some time.

Additionally, the medical device and product approval bill which is currently going through parliament will impact the development of consumer and medical products. However, as it has not yet been passed, this will have no significant impact on manufacturers in the near future. 

In terms of product development requirements, it is unlikely that the Medicines and Healthcare products Regulatory Agency (MHRA) will stray from current International Conference for Harmonisation (ICH) guidelines in the short term. However, laws around the sale and marketing of cigarette replacement products may become stricter once reviewed.

Both the Tobacco and Related Products Regulations 2016 and Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 are also due for review in May this year, however, it is possible that the update will be postponed until 2022 due to the pandemic.

Potential Opportunities for ENDS

Following Brexit, there are several opportunities apparent for ENDS manufacturers based in the UK or selling to the UK market:

  • Great Britain can now form legislation that is appropriate for the protection of the public health of Britain
  • The British Government is likely to be able to pass new laws quicker than EU’s multiple members who have to gain agreement across multiple member states
  • Public Health England’s dedication to reducing cigarette consumption is likely to favour safer alternatives
  • British Government’s desire to promote the UK as a great place to do scientific research and development

Advice for ENDS Manufacturers

For medical products, manufacturers should make efforts to engage with MHRA during the product development stage and maintain regular dialogue to understand safety and quality requirements. 

Manufacturers should also seek to engage a notified body for developing the ENDS device (drug-device combination product). There is a shortage of appropriate notified bodies so if you can recruit one and liaise regularly to align the product components (liquid and device), this will be advantageous for conformance assessments.

Broughton Nicotine Services can offer expert guidance to manufacturers during product development and help simplify the regulatory application process. Contact us to arrange a meeting to discuss how we can help you achieve MHRA-compliant products.

 

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Broughton Nicotine Services 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.

 

About the Author

Yvonne Wilding is the Director of Product Safety and Compliance. She has over 10 years of broad regulatory toxicology experience and 20 years of pharmaceutical drug development Research & Development leadership. She has been responsible for numerous MAA and NDA submissions, for both small molecules and biologics and has experience stretching from early candidate selection through life cycle management of new medicines. Her toxicology experience was gained with GlaxoSmithKline's (GSK) large portfolio of respiratory products in a specialized inhalation toxicology department. Yvonne began her career as a regulatory toxicologist for GSK responsible for designing the strategic drug safety evaluation programs to satisfy all global markets using both in-vivo and in-vitro approaches; for operational delivery both with an in-house team and with Contract Research Organisations (CRO). This involved working closely with clinical teams and key opinion leaders to ensure patient safety at each stage of development. She has extensive experience of interacting with regulatory agencies. Following on from Toxicology, Yvonne was responsible for managing and leading drug development programs encompassing all functional disciplines to ensure delivery of successful marketing applications and to maximise the commercial opportunity for each product. Yvonne’s clinical experience encompasses clinical program strategy, study management, clinical portfolio management and pharmacovigilance. Most recently, Yvonne worked with AstraZeneca in the Precision Medicine department to develop new diagnostic tests and submit PMA applications for companion diagnostics devices evaluating genetic biomarkers of disease susceptibility in collaboration with major diagnostic companies.