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 EMA. Therefore, until centralised submission to the repository, PSURs will be sent directly to the NCAs of the Member States where the products/substances are authorised.
Note: For medicinal products with documentation previously submitted in eCTD format, PSURs should also be presented as a separate eCTD sequence in the respective eCTD submission of the concerned product.