15 May 2012

RAPS: Irish Medicines Board Announces Transition to Fully Electronic Submission System

The Irish Medicines Board (IMB) is announcing its adherence to a 2005 agreement between the Heads of Medicines Agencies to transition to a fully electronic system for submitting applications, including the electronic Common Technical Document (eCTD) and Non-eCTD electronic Submissions (NeeS).

IMB said in a statement the transition confers several advantages, including reduced costs, consistency of applications and information viewed across agencies, improved lifecycle management and improved ability to search and assess submissions.

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