Case Study 1

[vc_row][vc_column][vc_column_text]

Providing comprehensive e-cigarette Regulatory support to an EU manufacturer/distributor

Company profile

• Large UK manufacturer and distributor of e-cigarette products
• E-liquid manufacturer of around 50 flavours for own brand and rebranded (OEM) products
• Distributor of a range of imported e-cigarette devices
• Supplier to retailers and distributors in UK, France and Germany and other EU states.

Background

We started working with this manufacturer and distributor in 2015. Since then we have provided comprehensive regulatory support in all aspects of e-cigarette regulation from notification preparation, TPD testing to dealing with anti-competitive issues.

Work carried out

1. Advise on notification preparation and submission including:
   • Notification requirements
   • Arrange e-cigarette and e-liquid testing at a specialist UK lab
   • Convert formula of e-liquid into mg (required)
   • Advise on declarations: What they mean and how to comply
   • Provide toxicology profile on each ingredient
   • Technical guidance on submission through eTrustex portal
2. Prepare packaging and labelling for own brand and OEM products for UK and 9 other EU markets
3. Vigilance: Prepare documentation and implement (in case of suspected adverse events)
4. Report regulatory developments in UK and other EU states
5. Arrange e-liquid testing (non-emission) at analytical laboratory for compliance/safety purposes
6. Address anti-competition issues
7. Take general questions on the future of the e-cigarette regulatory requirements and cost of compliance

Outcome

We successfully supported this client with the notification preparation and submission of a large range of e-liquids in time for the November 2016 deadline. We continue to provide regulatory support to ensure they are compliant with UK and EU state country-specific regulations as they expand into Europe.[/vc_column_text][/vc_column][/vc_row]