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New electronic submission validation criteria

Published date: 

On Thursday 1st September a new version of the validation criteria for electronic submissions for human medicines will come into effect.

The European Medicines Agency will be applying new electronic common technical document (eCTD) validation criteria (version 3.1) upon technical validation of all eCTD sequences received. The Agency has collaborated with the regulatory authorities in European Union (EU) Member States to agree the new standards  and applications which fail to adhere to the new requirements could lead to a negative technical validation.

At Wainwright Associates, the published output conforms with the latest eCTD format and bears the high quality and user-friendly finish that creates the right impression and facilitates review through validation, assessment and approval. If you require assistance with your marketing applications and submissions,  please contact us at or telephone +44 (0)1628 530554.


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