Medicines regulatory news
20 January 2012
Amendment to article published 23 December 11
From 3 January 2012, the MRHA will be performing a technical validation of all new MAA eCTD submissions.
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 (external link).
A report will be provided if there are deficiencies but, in the case of a valid submission, we will simply continue processing.
Applicants are reminded of the MHRA national requirements which require SmPCs to be submitted in the MHRA word template and for the provision of 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 (external link) on the use of eCTD in the MRP/DCP.
This validation procedure will not apply to NeeS applications or variations although it is likely that is will be expanded to include these applications in 2012.
To find more information please use the below mentioned weblink
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