The RMS-led technical validation as the main point. CMSs will rely on the technical validation done by the RMS. Applicants need to check CDs/DVDs for readability to identify burning problems. It was noted that in general, problems with technical validation seem to decline.
The timelines for technical validation and the use of CTS are still subject to further discussion within the CMDh. It was stressed that the changed procedure should apply to eCTD and NeeS. There will also be further discussion on the submission date for technical validation with regard to data exclusivity.
Applicants are encouraged to technically validate their submissions in advance with the appropriate and publicly available validation tools. A technical validation by the applicant on behalf of the RMS will not yet be an option. The intention is to extend the procedure to all submission types after successful implementation for new MAAs.
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