Regulatory data protection in the EU: an update | Practical Law

Regulatory data protection in the EU: an update | Practical Law

Under European pharmaceutical law innovator pharmaceutical companies are granted a period of regulatory data exclusivity in which a generic applicant cannot refer to the innovator's data to obtain a marketing authorisation. The European legislation was amended in 2004 and currently contains a period of eight plus two (plus one) years of regulatory data protection (RDP). This article sets out a brief description of RDP under European law, the main changes to the legal system introduced in 2004 and an update of recent developments regarding the interpretation of European RDP law.

Regulatory data protection in the EU: an update

Practical Law UK Articles 9-518-1152 (Approx. 11 pages)

Regulatory data protection in the EU: an update

by Carla Schoonderbeek, Bart Jong and Hein van den Bos, Hogan Lovells International LLP
Law stated as at 01 Nov 2011 • European Union
Under European pharmaceutical law innovator pharmaceutical companies are granted a period of regulatory data exclusivity in which a generic applicant cannot refer to the innovator's data to obtain a marketing authorisation. The European legislation was amended in 2004 and currently contains a period of eight plus two (plus one) years of regulatory data protection (RDP). This article sets out a brief description of RDP under European law, the main changes to the legal system introduced in 2004 and an update of recent developments regarding the interpretation of European RDP law.
This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.