29 June 2012
Irish Medicines Board (RB): Mandates Electronic Submissions
It was agreed by the Heads of Medicines Agencies (HMA) in Reykjavik on 28 February 2005 that by an agreed end-2009 deadline, the European regulatory agencies must have the infrastructure and processes in place to handle electronic-only eCTD submissions to successfully support the related decision-making processes for the authorisation of medicinal products within the European Union.
The IMB has fully adopted the European Guidance for eCTD (electronic Common Technical Document) and NeeS (Non-eCTD electronic submissions). The transition to electronic submissions brings with it several advantages, not only the obvious reduction in printing, archiving and transportation costs, but also facilitates consistency in information viewed across agencies, the ability to manage the lifecycle of the product, and improved navigation and assessment of documentation.
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