MAH

Origin

The concept of the Marketing Authorization Holder is a fundamental principle of modern pharmaceutical regulation, establishing a single, traceable point of responsibility for a drug on the market. This framework emerged in European legislation and has been adopted globally to clearly delineate accountability for product quality and safety, a necessary structure for complex international supply chains.

Mechanism

The MAH is required to submit the initial regulatory application, maintain all product documentation, manage pharmacovigilance (safety monitoring), and ensure that manufacturing sites comply with Good Manufacturing Practices (GMP). This mechanism of centralized responsibility guarantees that regulatory agencies can hold a single party accountable for any issues related to the hormonal product, thereby protecting the public from potential risks.