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Version 9.1, 03/201306/2015 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS NOTE: the following are those items of information required by Article 11 of Directive 2001/83/EC, as amended, and current practice
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Quality review of documents involves evaluating and assessing the accuracy, completeness, and compliance of documents to ensure high standards.
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Information such as document name, date of review, reviewer's name, findings, recommendations, and any corrective actions taken must be reported on quality review documents.
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