The Article 2 (7) of Directive 2001/83/EC as amended specifies that “Until the Agency can ensure the functionalities agreed for the repository of the periodic safety update reports, the marketing authorisation holders shall submit the periodic safety reports to all Member States in which the medicinal product has been authorised.” This document aims at making publicly available the submission requirements of all Member States as regard Periodic Safety Update Reports (PSURs) during the transitional period, starting from July 2012 until 12 months after the functionalities of the PSUR repository have been established and announced by the European Medicines Agency (EMA). Therefore, until centralised submission to the repository, PSURs will be sent directly to the National Competent Authorities (NCAs) of the Member States where the products/substances are authorised.
In February 2012, the EMA published a plan for the implementation of the new Pharmacovigilance Legislation requirements. Following the December 2012 EMA Management Board meeting, the EU single assessment of substances contained in both centrally and nationally authorised products (CAPs and NAPs) with involvement of the PRAC will start with the substances with a Data Lock Point in April 2013, corresponding to the entry into force of the list of Union reference dates and frequency of submission of PSUR, also called “EURD list”. The centralised submission of PSURs is a key element for the optimisation of the functioning of the EU single assessment procedure. As a consequence, MAHs of CAPs and NAPs subject to an EU single assessment are requested to submit their PSURs to all the PRAC and CHMP members representing the National Competent Authorities (NCAs) of the countries where the medicinal products have been authorised, to the PRAC rapporteur of the procedure, and to the EMA. For the details regarding submission requirements, reference should be made to the table below. For the list of PRAC and CHMP members, please refer to the “Dossier requirements for Centrally Authorised Products (CAPs)”.