Regulatory data protection
Produced in partnership with Elisabethann Wright BL of Cooley (UK) LLP , Fabien Roy of Hogan Lovells , Jane Summerfield of Hogan Lovells and Richard Welfare of Hogan Lovells

The following Life Sciences practice note produced in partnership with Elisabethann Wright BL of Cooley (UK) LLP, Fabien Roy of Hogan Lovells, Jane Summerfield of Hogan Lovells and Richard Welfare of Hogan Lovells provides comprehensive and up to date legal information covering:

  • Regulatory data protection
  • Introduction to the concept of regulatory data protection
  • EU regime—the '8+2+1 rule'
  • EU regime—additional year of market protection
  • New therapeutic indication
  • Significant clinical benefit
  • EU regime—scope of application of the ‘8+2+1’ rule
  • EU regime—the concept of a ‘Global Marketing Authorisation’
  • New active substance
  • Medicinal products containing a new combination of active substances
  • More...

Regulatory data protection

Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code establishes a period of ‘data exclusivity’ from the initial authorisation of innovative medicinal products during which the pre-clinical and clinical trial data generated and used to support the authorisation of an innovative medicinal product cannot be referred to by an applicant for a marketing authorisation (MA) for a generic product. Data exclusivity therefore serves to offer a guarantee to innovative companies that scientific data generated for the MA of the innovative medicinal product is protected and will not be used to assess applications from manufacturers of generic or biosimilar medicinal products until after expiry of the data exclusivity which the innovative medicinal product enjoys. This period of data exclusivity is also known as regulatory data protection (RDP).

This Practice Note provides an overview of the applicable EU provisions governing RDP of MAs for innovative medicinal products and explores how it impacts on the entry of generic and biosimilar medicinal products into the market. It also explains how RDP is governed in the UK.

Introduction to the concept of regulatory data protection

An ‘innovative medicinal product’, referred to also as a ‘reference medicinal product’ due to its role in the authorisation of subsequent generic or biosimilar medicinal products, is commonly understood as a medicinal product in relation to which an MA has been granted by either the competent

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