What is a marketing authorisation holder, and who should fill that role?

The marketing authorisation holder is the legally responsible entity named on an approved product authorisation in markets that use this framework. Its obligations can include maintaining the dossier, pharmacovigilance, variations, renewals, quality oversight and regulatory communication. Establishment requirements may apply; for example, European procedures include EEA-related requirements. The commercial agreement should state who owns the dossier and trademarks, who pays regulatory costs and what happens to authorisations if distribution ends.