MAH

Marketing Authorization Holder.

Marketing Authorization Holder (MAH) is a legal entity responsible for the authorization, marketing, and distribution of a medicinal product in a specific country or region. The MAH may be a pharmaceutical company, a distributor, or a third-party organization authorized by the regulatory agency to act on behalf of the product owner.

The MAH is responsible for ensuring that the medicinal product is manufactured, stored, and distributed in compliance with the regulatory requirements of the country or region in which it is authorized. This includes ensuring the product’s safety, efficacy, and quality, as well as complying with labeling and advertising requirements. The MAH is also responsible for pharmacovigilance activities, which involve monitoring the safety of the product throughout its life cycle and reporting adverse events to the regulatory agency. In addition, the MAH is responsible for maintaining the product’s authorization by submitting the required periodic reports and renewals.