In April 2023, the European Commission adopted regulatory proposals introducing a Unitary Supplementary Protection Certificate (SPC) and a centralised assessment procedure for SPCs for medicinal products. This study analyses the potential impacts of these proposals on access to medicines, the administrative burden to applicants and the cost to national health systems.
This document was prepared by Policy Department for Citizens' Rights and Constitutional Affairs at the request of the JURI Committee.Source : © European Union, 2023 - EP