23.03.2015

New versions of electronic Application forms released

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New versions of the electronic application forms have been released. The update, dated 23 March 2015 concerns all forms available for human and veterinary products:

  • Initial MAA - Human
  • Initial MAA - Veterinary
  • Renewal Form (Human)
  • Variation Form (Human)

Each update comprise the new form, a corresponding release note as well as updated Data Exchange Standards and XML Schema Definition files.

The new electronic application form versions provide "improvements to the existing forms in preparation for the mandatory use of the electronic application forms for all centralised procedure human and veterinary submissions from 1 July 2015 as per the HMA eSubmission Roadmap and the related annex to the roadmap describing the steps to the mandatory use". As part of that, numerous issues were fixed in the forms as detailed in the corresponding release notes.

[Source: EMA eSubmission website]

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