From January 2012 there is a requirement on all EU member states acting as Reference Member State (RMS) for new MA applications to perform a technical validation of eCTD submissions. This RMS validation will also be accepted by all Concerned Member States (CMS) – it is not envisaged that CMS carry out their own independent eCTD validation.To comply with this requirement, from 3 January, the MHRA will be technically validating all new MAA eCTD submissions for both National procedures and where the UK is RMS.
We will be using the Extedo EiY tool to carry out the validation and these submissions will be validated against the current EU- eCTD v3.1 validation criteria as published on the eSubmissions website.
For RMS procedures, applicants will be either provided with a valid report which is to be sent together with their dossiers to the Concerned Member States (CMS) or, if there is a deficiency, a report detailed the deficiencies. In the case of a failed validation, the applicant will be required to resubmit a corrected application. We expect to provide these reports within 7 days of submission and they will be sent by email to the applicant.
For National submissions, a report will be provided if there are deficiencies but, in the case of a valid submission, we will simply continue processing.
The MHRA will not perform technical validation on the CMS submissions and will only upload these submissions if they are accompanied by a Technical Validation report from the RMS.
Applicants are reminded of the MHRA national requirements for SPC being submitted in the MHRA word template and for consolidated label and leaflets still apply. As these documents are specific to the UK they should be included in the working documents folder which is outside of the eCTD sequence folder.
For further guidance on making submissions in the eCTD format please see the CMDh Best Practice Guide on the use of eCTD in the MRP/DCP.
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