Skip to content

MENU

TPD/TRPR Notification

Ensuring E-cigarettes and E-liquids are High Quality and Compliant in the EU and the UK

Helping you understand your e-cigarette regulatory notification obligations for the European Union (EU) and United Kingdom (UK) to build regulator trust and consumer confidence.

Click here to learn about our TPD/TRPR Notification Support Service

 

 

assorted generic vape devices in various colours

What is the EU TPD? 

The Tobacco Products Directive (TPD) sets out the rules for selling and manufacturing all tobacco and tobacco-related products, including next generation nicotine delivery products (NGPs) such as e-cigarettes and e-liquids, in the EU. All products must comply with TPD regulations before being placed on the EU market. 

Since the Tobacco Product Directive (TPD) (2014/40/EU) came into force in 2016, it has been transcribed into individual EU Member States’ legislative systems, each with varying additional regulatory requirements. This makes notifying in the different Member States a complex process, as each member state has its own notification requirements.  

The EU TPD notification system is the EU-Common Entry Gateway (EU-CEG) utilized by all EU Member States; data is submitted in an electronic format following the Official Journal of the European Union 2015/2183.

 

What is the UK TRPR? 

In May 2017, the Tobacco & Related Products Regulations (TRPR) brought the European TPD (Tobacco Products Directive) regulations into UK law. 

In 2020, the UK government amended how the TRPR applies in Great Britain (GB) and Northern Ireland (NI), and this came into effect for new product notifications as of 1 January 2021, the date the UK officially left the EU. The UK Medicines and Healthcare Regulatory Agency (MHRA) has a new notification system for all tobacco and tobacco-related products, including NGPs such as e-cigarettes and e-liquids, that covers Great Britain (GB). Northern Ireland (NI) still uses the EU-CEG notification system. 

  • Products placed on the NI market must be notified using the EU-CEG system.
  • Products placed on the GB market must be notified on the GB MHRA domestic system.
  • Notifiers will be required to pay one fee for placing products on one of the GB or NI markets and the same fee for placing products on the two markets.
team sat working at a desk

Our TPD/TRPR Notification Support Service

No nicotine product is allowed onto the market in the UK or EU member states unless it has been notified. We offer a comprehensive package of analytical testing, scientific consultancy, and regulatory support to ensure your TPD or TRPR notification is executed smoothly and on time.  

TDP/TRPR Analytical Testing

High-quality device performance and e-liquid testing in our in-house GxP accredited laboratories.

Our experienced laboratory scientists can conduct a variety of analytical tests to support your notification.

 

  • Nicotine dose consistency
  • Carbonyls in aerosol
  • Metals in aerosol
  • Challenge Testing
  • Stability testing over various time points (nicotine stability, e-liquid degradation, pH, water content, and microbial burden)


Scientific and Toxicology Support

Our in-house toxicologist will support with product risk assessment and ingredient screening.


  • Flavor disclosure and ‘Flavor File’ creation
  • Screening for banned substances
  • Toxicology assessment on all compounds
  • Classification, Labelling, and Packaging (CLP) review and Safety Data Sheet (SDS) completion

Regulatory Support

Our TPD/TRPR regulatory experts have years of experience filing notifications for global nicotine brands and will be available at each step of the process to ensure your project's success.

 

  • PCN Notification
  • EU Common Entry System (EU-CEG) Set-up
  • EU TPD and UK TRPR Notification submission (for EU member states and Northern Ireland)
  • UK Medicines and Healthcare Regulatory Agency (MHRA) submission (for Great Britain)
  • Annual Reporting
  • Guidance on Electronic Medicines Compendium(EMC), The Restriction of Hazardous Substances Directive (RoHS), and The Waste Electrical and Electronic Equipment Directive (WEEE) compliance

Project Management

Your TDP/TRPR project will be allocated a dedicated project manager to ensure timely communication and efficient delivery. They will manage the project on your behalf and coordinate all elements of the notification process.

TPD/TRPR Notification

No nicotine product is allowed onto the market unless it has been notified in the UK or member state where it is distributed. Our regulatory experts will ensure the smooth delivery of your TPD/TRPR notification project.

 

  • EU-CEG Set-up
  • EU TPD and UK TRPR Notifications
  • Annual Reporting

Which NGP Requires Notification Under TPD/TPRP?

The regulatory environment is highly dynamic and regularly amended by the different EU member states and the UK government. Speaking to a regulatory consultant about your market introduction plans will ensure you have the most up-to-date regulatory information and can make informed decisions about your product roadmap and business strategy.

While all tobacco and tobacco-related products fall under the remit of TPD/TPRP, the regulatory landscape is more complicated for non-e-cigarette NGPs, with each member state having the ability to stipulate different notification or submission requirements. If you have a new NGP product ready for the market, please contact our team of regulatory experts, who can design a bespoke strategy for you to launch your products in your desired markets.

 

pod device vape system with pods

TPD and TRPR Notification Requirements 

A TPD or TRPR notification must be submitted electronically at least six months prior to the intended date for introducing the NGP product, device, or e-liquid to the market in question.  

The Notification

Restrictions and Requirements

Additional TRPR Requirements

The Notification

A TPD or TRPR notification must include:

 

  • Submitter details
  • Product details
  • Product ingredients
  • Emissions
  • Production process
  • Product annual sales data
  • Labelling and packaging

Speak to a Regulatory Expert 

Speak to a regulatory consultant about your new NGP project and learn how we can help ensure regulatory notification and compliance.



Speak to an Expert

Nicotine Consultancy Services Resources 

Learn more about how we can help bring your nicotine delivery product to market through our scientific and regulatory consultancy services.

A-Guide-To-TPD-and-TRP

A Guide To TPD and TRP

An overview of the Tobacco Products Directive and Tobacco-Related Products Regulations. Get the straightforward answers you’re looking for when it comes to TPD and TRPR analysis.

Click to download

PMTA-Guide-For-NGP-businesses

PMTA Guide For NGP businesses

At Broughton, our consultants have deep industry knowledge across all the elements required for a PMTA. We guide you through and generate the required data, to ensure that FDA finds your applications strong and compelling.

 

Click to download

Nicotine Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

Visit the blog