A medicinal product containing only one of two active substances contained in an earlier product is not part of the global marketing authorisation and is, therefore, entitled to its own data protection period....more
The European Commission and the United Kingdom government announced on Monday that they have come to agreement on measures to alleviate the remaining practical difficulties in the supply of medicines to Northern Ireland that...more
The Medicines and Healthcare products Regulatory Agency has extended the EC Decision reliance procedure (EC DRP) to apply until 31 December 2023....more
The European Commission has responded to pressure from the medical devices industry and has proposed an amendment to the In Vitro Diagnostics Regulation (“IVDR”, Regulation 2017/746) to introduce amended transitional...more
The European Commission has moved to the next phase in its evaluation of the current EU pharmaceutical legislation and the potential for its reform by opening a 12 week online public consultation....more
The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022....more
This note discusses regulatory data protection (or data exclusivity) and market protection (marketing exclusivity). It identifies their legal bases, defines relevant legal terms and case law, and explains why these forms of...more