Transcript Submissions to the PSUR Repository using EMA

NAP eCTD submissions – technical issue and workaround
solution:
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A technical issue with EMA eCTD review tool can cause a negative
acknowledgement when sending PSURs for multiple NAP products in eCTD
format belonging to one PSUSA procedure
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Example: PSUSA/001100XX/2015XX. MAH has 3 products, each product has it’s own
lifecycle in the member state where it has been authorised via MRP/DCP e.g. A (seq
20), B (seq 30) and C (seq 5).
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As eCTD submissions cannot currently be bundled, 3 separate xml delivery files are
required with 3 separate submissions
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Please send the submissions in ascending order of the sequence numbers, i.e. send
first product C, followed by submission of product A and finally product B to allow a
workaround solution
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EMA is looking for technical solution for this issue – meanwhile if any concerns please
contact us via [email protected] or [email protected]