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Workshop on E-Submission Key Aspects of e-submission in the Veterinary Sector Melanie Leivers

Workshop on E-Submission Key Aspects of e-submission in the Veterinary Sector Melanie Leivers. E-submission Deadline of 1 January 2010 for all competent authorities to be “e-submission ready” (Heads of Agencies agreement in 2007) E-submission is optional for applicants/MAHs

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Workshop on E-Submission Key Aspects of e-submission in the Veterinary Sector Melanie Leivers

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  1. Workshop on E-Submission Key Aspects of e-submission in the Veterinary Sector Melanie Leivers

  2. E-submission • Deadline of 1 January 2010 for all competent authorities to be “e-submission ready” (Heads of Agencies agreement in 2007) • E-submission is optional for applicants/MAHs • Aim to keep e-submission simple – i.e. NOT e-CTD Guidance currently available – seehttp://esubmission.emea.europa.eu/tiges/vetesub.htm for • E-submission guideline • E-submission Q & A web page • Structure of document remains as per Notice to Applicants (NTA) • NTA Volume 6B currently being updated to reflect • new Annex I to Directive 2001/82/EC (Annex I will enter into force on 6 September 2009)

  3. E-submission • Telematics Impementation Group • On e-submission – Veterinary sub-group • (TIGesVET) • Drafted guidance for vet electronic submissions - Aim is to keep it simple! • Members: IFAH Europe/EGGVP/AVC/MSs/EMEA • Group has contributed to the recently started project on the “eApplication form”; this will be EU-wide and cover Vet and Human applications

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