Everything You Need to Know About Marketing Authorization Holders |...

Everything You Need to Know About Marketing Authorization Holders

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Postado 2025-01-14 10:46:04

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Summary

The Marketing Authorization Holder (MAH) ensures drug quality, safety, and compliance with local regulations.

The MAH maintains a pharmacovigilance system for collecting and processing safety data.

The MAH submits Periodic Safety Update Reports (PSURs) and a Risk Management Plan for ongoing safety and compliance.

The MAH must report adverse events (AEs) and adverse drug reactions (ADRs) within prescribed timelines.

Under Emergency Use Authorization (EUA), the MAH closely monitors and reports safety concerns.

Short Description

Marketing Authorization Holders (MAHs) are responsible for the safety, quality, and compliance of pharmaceutical products. They must comply with local regulations and ensure continuous monitoring of the safety and efficacy of drugs. In Emergency Use Authorization (EUA) cases, MAHs are also required to report adverse events for ongoing risk assessment.

Eligibility Criteria for Marketing Authorization Holders

To become a Marketing Authorization Holder (MAH), the individual or company must meet specific eligibility criteria, as follows:1,2

Legal Responsibility: The MAH must be the entity under whose name the marketing authorization is granted, taking full responsibility for the product, including its quality and compliance.

Local Compliance: The MAH must adhere to the legislation of the country issuing the marketing authorization, ensuring alignment with local regulatory standards.

Physical Presence: It is typically required for the MAH to have a physical presence in the country of authorization to facilitate regulatory oversight and accountability.

Comprehensive Oversight: The MAH is responsible for ensuring the product complies with all conditions of the marketing authorization throughout its lifecycle.

Training for Pharmacovigilance

The MAH staff involved in pharmacovigilance activities should undergo induction within one month of joining, followed by continued training at regular intervals.

Performance evaluations should accompany these training sessions. The organisation must maintain detailed records of all training activities and consistently assess ongoing training needs to ensure its personnel remain up-to-date on regulatory requirements, safety monitoring practices, and reporting standards.

This proactive approach helps ensure compliance and effective risk management throughout the product lifecycle.

Responsibilities Across the Product Lifecycle

MAHs are in charge of a drug's quality, safety, and efficacy throughout its full lifespan, from approval to marketing. They are required to collect and process comprehensive safety information, including adverse events (AEs) and adverse drug reactions (ADRs), and report this data to regulatory authorities within specified timelines.

MAHs must maintain a system for this process and guarantee that the product’s safety profile remains consistent. In addition, they must continuously monitor and assess the drug’s efficacy, ensuring compliance with regulatory requirements and taking necessary actions to address any emerging safety concerns.