4. Submission

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3. Validation

Initial MAAs submitted to the EMA in the centralised procedure are subject to validation. The objective as stated by EMA is to make sure all essential regulatory elements required for scientific assessment are included in the MAA. Initial MAA validation has been centralised and is performed by a dedicated service within the EMA.

There are two elements to validation:

  • the first is technical validation. This ensures that the structure of the submission is compliant with the EU CTD Module 1 Specification. An automated 'acknowledgement' email is sent from the system confirming:
    •  whether the submission has passed the relevant technical validation criteria
    • has been uploaded to the EMA's review tool and
    • made available via the Common Repository.
    • If the eCTD submission results in an invalid Technical Validation the submission will not be accepted.
  • the second element is regulatory and administrative content validation, which can only commence once the application has successfully passed technical validation.

If EMA requires additional data, information or clarification in order to complete its validation of the dossier, it will contact the applicant requesting to supply this information within a specific time limit.