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Regulatory authorities worldwide carry out pharmacovigilance (PV) inspections to ensure that marketing authorization holders (MAHs) and their partners comply with all applicable PV regulations, obligations, and standards. These inspections assess both products and operational processes. National competent authorities appoint inspectors to perform these evaluations, which may be either announced or unannounced. In the case of announced inspections, authorities notify MAHs and related organizations of the inspection schedule in advance.
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