EMA

How to Correctly Manage Quality Defects and Recalls?
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How to Correctly Manage Quality Defects and Recalls?

In Europe, The EMA coordinates the assessment of reports of product quality defects of centrally authorized medicines.   Medicinal products with a quality defect are not of the correct quality as defined by their marketing authorization.   It is important to report these defects in a timely manner because sometimes it is necessary to implement…