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Marketing Authorisation Holder Responsibilities

Marketing Authorisation Holder Responsibilities

by elena@investinu.ie | Jul 20, 2023 | Acorn Regulatory News

Background MA Holding entities are subject to Market Compliance Inspections by any Health Authority, in any EU country where they hold an MA. The HPRA carry out multiple MAH Market compliance inspections each year. These inspections are in addition to GxP inspections...
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