20.03.2015

EMA updates information to PSUR repository, facing technical issues with some NAPs

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The European Medicines Agency has released new information related to the central PSUR Repository.

  1. As part of the new information EMA announces that it will be mandatory to use the XML delivery files for PSUR submissions sent via eSubmission Gateway / Web client from 01 September 2015. A corresponding Statement of Intent has been published by EMA.
  2. In addition a new version (01.01) of the PSUR Repository will be available starting next Monday, March 24th. This new release will consider change requests enhancing the system and will fix defects identified after the User Acceptance Testing performed at the end of 2014 or since the start of the pilot phase.
  3. EMA further informs that the Agency currently deals with some technical problems related to the submission of PSURs for National Authorized Products (NAPs) via the PSUR Repository. The problems can occur in cases where multiple eCTD sequences are uploaded because the corresponding PSUR is applicable for multiple individual procedures / lifecycle dossiers. A workaround solution (MS Powerpoint) is presented by EMA for the interim phase.
  4. A further short Powerpoint presentation has been published that describes some PSUR submission requirements during the transitional period (i.e. until the use of the PSUR Repository is mandatory, which is planned for June 2016 at the earliest).

[Source: EMA website]

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