A Marketing Authorization Holder (MAH) is the legal entity responsible for a medicinal productís authorization and regulatory compliance in a given market, particularly in the EU and UK.
The MAH is accountable for pharmacovigilance, quality oversight, labeling maintenance, and regulatory communications throughout the product lifecycle. Clinical development activities may be managed by the MAH or delegated, but responsibility for compliance remains with the authorized entity. In global programs, clear MAH identification supports consistent safety governance, reporting obligations, and product stewardship across regions. MAH responsibilities are central to maintaining regulatory trust and ensuring ongoing benefitñrisk management after approval.