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New requirements for the technical validations of Marketing Authorisation Applications

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The current EU- eCTD v3.1 validation criteria came into force on 1st September 2011 for the technical validation for all electronic submissions received from that day to the national competent authorities in the EU and the European Medicines Agency (EMA).  Recently, in the UK, the MHRA has also announced that from 3 January, it will be technically validating all new MAA eCTD submissions for procedures where the UK is Reference Member State (RMS) on behalf of the Concerned Member States (CMS).  For procedures where the UK is RMS, applicants will be either provided with a valid report which is to be sent together with their dossiers to the CMS or, if there is a deficiency, a report detailing the deficiencies.

At Wainwright Associates, we use state-of-the-art publishing and eCTD validation technology to ensure that your submission is compliant with the requirements of the receiving regulatory authorities.   For further information regarding eCTD and how we can help with your MAA or perhaps switch a dossier to eCTD in the post-authorisation phase, please contact us on +44 (0)1628 530554 or email

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