Marketing Authorisation Holder

The MAH is responsible for the marketing of a medicinal products within the European Union (EU).

The MAH is the legal entity that holds the marketing authorization for a medicinal product. The MAH may be a pharmaceutical company, a hospital or other institution authorized to market medicines, or an individual person.

The MAH is responsible for ensuring that the medicinal product is manufactured in accordance with good manufacturing practice (GMP) and made available on the market in a safe, effective and high-quality manner.

The MAH is also responsible for monitoring the safety of the medicinal product after it has been placed on the market and for keeping track of any adverse events that occur.