Marketing Authorization Holder
/ˈmɑːrkɪtɪŋ ɔːθəraɪˈzeɪʃən ˈhoʊldər/
Definitions
- (n.) The legal entity or individual responsible for holding and maintaining the authorization granted by a regulatory authority to market a medicinal product or pharmaceutical within a specific jurisdiction.
The marketing authorization holder must comply with all post-market surveillance obligations.
Forms
- marketing authorization holder
- marketing authorization holders
Related terms
See also
Commentary
The marketing authorization holder bears legal responsibility for the product’s compliance with regulatory standards throughout its market life.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.