The medical route to market approval in the UK – the pros and cons



  • Executive summary
  • Introduction
  • Why the medical path?
  • Scope
  • EU regulatory framework overview
  • Legal requirements in the UK
  • Market authorisation for medicinal products
  • MHRA’s recommended type of application
  • Content of the application
  • Procedure for a medical device CE marking
  • Age restrictions
  • Product restrictions
  • Consistent dose
  • Other ingredients
  • Voluntary standards
  • Labelling and packaging
  • Health claims
  • Packaging
  • Retail channels restriction
  • Advertising and marketing
  • Taxation
  • Relevant laws
  • Relevant bodies


The MHRA, Britain’s pharmaceutical regulator, is currently encouraging and supporting companies to submit medicines authorisation applications for e-cigarette products. Here ECigIntelligence explains what that process entails.