We understand the challenges faced when interpreting both the UK Tobacco and Related Products Regulations (TRPR) and the EU Tobacco Products Directive (TPD). Our expertise and easy to follow on-boarding process will allow us to align your business goals to the legal requirements set out in the regulations. This will allow us to deliver a cost-effective strategy to take your business to the next level whilst maintaining compliance.
The EU Tobacco Products Directive for Tobacco Related Products (including E Cigarettes) first came into force on the 20th of May 2016 introducing new regulations to the industry to ensure products on the market are of high quality and safe for the consumers.
The directive lays down the minimum requirements for regulating tobacco and tobacco related products, from this each member state creates national legislations which creates some variation between requirements.
In Great Britain, the Tobacco and Related Product Regulations (TRPR) introduced rules which ensure minimum standards for the safety and quality of all e-cigarettes and refill containers (or e-liquids). In the post-Brexit environment, the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 set of new requirements for the notification of Vape Products from January 2021.
Our end-to-end process:
Future Regulatory Services offers a full service for both manufacturers and importers who are wishing to submit a TPD (EU) and/or TRPR (UK) notification.
Our services are tailored to your business needs and we will assist you to achieve full compliance whilst supporting with every step of the process. Our easy to follow process will ensure your products are safe to market and ready for sale in the most efficient and cost-effective way. Our method of delivery provides you with full transparency of the whole process, allowing innovation and speed to market to ensure your customers loyalty and satisfaction.
|ON-BOARDING||PRODUCT SUBMISSION||POST MARKET ACTIVITIES|
|Customer setup||Laboratory Testing & Analysis (Nicotine dose consistency & Carbonyl/|
|Annual Sales Submission|
|Formulation Pre-Screening||Toxicological Risk Assessments (TRA’s) for each individual flavour compound|
|Information Collation||Packaging Information|
|Notification to relevant submission portal|
|Engagement with relevant authority|
To ensure compliance set out in both the TPD and TRPR regulations, product notifications should contain the following information:
- Contact information on the manufacturer/importer
- Composition of the formulation
- Chemical Abstracts Service (CAS) numbers for each ingredient and Classification, Labelling and Packaging (CLP)
- A Toxicological Review related to the carcinogenicity, mutagenicity, reproductive health toxicity, addictiveness, emissions toxicity, cardiopulmonary toxicity and any further known toxicological information
- Results from the Laboratory Testing including Nicotine Dose Consistency, Carbonyls and Metal Emissions (for e-cigarettes only)
- Instructions on the refilling of the vape device
- An overview of the production process used to manufacture the product
- Declarations detailing the quality and safety of the products
Our TPD/TRPR Services:
- Pre-screening of formulations to ensure compliance with relevant regulations
- Toxicological reports for ingredients
- Packaging review to ensure compliance with Classification, Labelling and Packaging Regulations
- Product Notifications to MHRA Portal
- Product Notifications to EUCEG (EU) Portal
- Worldwide Notifications – PMTA & UAE
- Annual Sales Notifications
- Technical File Dossier Compilations
- Adverse Effects & Reporting
- Laboratory Services – Nicotine Dose Consistency, Carbonyls/Aldehydes in aerosol, Metals analysis in e-liquids and aerosol