Introductory cover note to the List of European Union reference dates and frequency of submission of
The list of Union reference dates and frequency of submission of periodic safety update reports (referred to as the “EU reference dates (EURD) list” in the GVP Module VII) consists of a list of active substances and combinations of active substances sorted in alphabetical order, for which Periodic Safety Update Reports (PSURs) shall be submitted in accordance with the EU reference dates and frequencies determined by the Committee for Medicinal Products for Human Use (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) following consultation with the Pharmacovigilance Risk Assessment Committee (PRAC) [DIR Art. 107c(4)1 ].
