AMC1 ARA.MED.315(a) Review of examination reports
ED Decision 2012/006/R
GENERAL
(a) The process to review examination and assessment reports received from AeMCs, AMEs and GMPs should aim to check all reports received.
(b) The licensing authority should take account of the proportion of inconsistencies or errors found in the assessment process and adapt the sample size accordingly and to review all reports if necessary.
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