This blog covers:
- What is a Marketing Authorization Holder (MAH)?
- A clear definition and explanation of who qualifies as an MAH in the pharmaceutical industry.
- Key Roles and Responsibilities of an MAH
- An overview of the MAH’s obligations, including regulatory compliance, pharmacovigilance, and product oversight.
- Key Takeaways
- A concise summary of the most important points to remember.
Table of Contents
MAH: Definition
A Marketing Authorization Holder (MAH) is the legal entity authorized to market a pharmaceutical product in a specific region. The MAH is responsible for ensuring that the product complies with all regulatory, safety, and quality requirements.
A single company can have multiple MAHs across different regions or for different products, depending on regulatory strategies and market presence.
Who Are MAHs?
A Marketing Authorization Holder (MAH) is the legal entity that holds the official marketing authorization for a pharmaceutical product. This entity is legally responsible for ensuring that the product is developed, manufactured, and marketed in accordance with all applicable regulatory requirements.
Who Can Act as an MAH?
An MAH can be:
- A pharmaceutical company — either the product’s manufacturer or another company designated to hold the authorization.
- A contracted third-party entity — such as a regulatory consultancy or service provider (even individuals or small firms with proper setup).
- A non-profit organization — particularly in the case of public health programs, humanitarian efforts, or academic research initiatives.
“A Marketing Authorisation Holder is more than a regulatory title—it’s the trusted guardian of product integrity, patient safety, and compliance across every market it serves.”
Appointing an MAH
When appointing a Marketing Authorization Holder (MAH), it is essential to formally document the agreement through a Reflection Paper or similar written arrangement that clearly outlines the MAH’s responsibilities.
It is important to note that many MAHs are not directly involved in the manufacturing of medicinal products. Therefore, the Reflection Paper should explicitly define the scope of the MAH’s obligations, including compliance, oversight, and coordination with manufacturing partners.
This document should aim to clarify the relevant responsibilities and legal requirements, ensuring all parties understand what these entail in practical, day-to-day terms.
Responsibilities of a MAH
The Marketing Authorization Holder (MAH) is ultimately responsible for the safety, quality, and efficacy of a medicinal product throughout its entire life-cycle.
While certain tasks may be delegated to third parties (such as Contract Research Organizations or Pharmacovigilance service providers), legal accountability remains with the MAH.
Key Responsibilities of the MAH
1. Pharmacovigilance (PV) Oversight
MAHs may delegate PV activities to a Contract Research Organization (CRO), but must ensure clear and documented oversight, including:
- To setting up and hire a PV company for activities
- The pharmacovigilance organizational structure
- The name and affiliation of the organization(s) performing PV tasks
- Clear delegation of responsibilities through written contracts and technical agreements
- Monitoring of PV regulatory deadlines
- Ensuring compliance with data integrity, robustness checks, and validity checks (e.g., placebo validation)
2. Qualified Person for Pharmacovigilance (QPPV)
- A QPPV must be appointed as per legal requirements.
- The MAH is responsible for maintaining a compliant QPPV model and ensuring it meets both GVP (Good Pharmacovigilance Practice) and GMP (Good Manufacturing Practice) standards.
- QPPV must be available for inspections and serve as the regulatory contact for safety-related matters.
3. Manufacturing and GMP Compliance
Although GMP compliance is primarily the manufacturer’s duty, the MAH plays a critical role, including:
- Providing information to competent authorities, manufacturers, and Qualified Persons
- Collecting and coordinating quality-related information from actors in the supply and distribution chain
- Overseeing technical agreements and ensuring audit and qualification activities are in place
- Evaluating results from Product Quality Reviews and agreeing on specifications such as irradiation cycles
4. Regulatory and Commercial Responsibilities
- Maintaining product labeling and up-to-date regulatory documents
- Meeting all regulatory commitments
- Ensuring two-way communication systems are in place for compliance and safety reporting
- Monitoring and managing non-compliance issues
- Coordinating product recall activities when necessary
- Managing distribution and supply continuity, including notifying authorities in case of shortages
- Complying with the Falsified Medicines Directive (FMD)
5. Clinical Trial Responsibilities
- Ensuring that clinical trials are designed and conducted ethically
- Coordinating with CROs or other entities responsible for trial execution and monitoring
6. Supply Chain and Distribution
- Overseeing the importation of products
- Obtaining necessary licenses
- Ensuring that a Local Authorized Representative (LAR) or In-Country Representative is appointed as the local regulatory contact
- Monitoring continuous supply and handling logistics disruptions
7. Inspection and Audit Readiness
- Acting as the coordination point for pharmacovigilance inspections
- Ensuring all delegated activities are audit-ready and fully compliant with local and international regulations
Key Takeaways
- While certain MAH responsibilities may be delegated to third parties (e.g., manufacturers or CROs), the MAH retains full legal responsibility for regulatory compliance and product oversight.
- Maintaining regulatory compliance is the sole and ongoing responsibility of the MAH.
- The MAH must appoint a Qualified Person for Pharmacovigilance (QPPV) and ensure that the QPPV model is suitable and compliant with legal requirements.
- A company can have more than one MAH, depending on the product portfolio and regulatory strategy across regions.
- The MAH is expected to act as the central coordination point during pharmacovigilance inspections.
- The MAH must ensure that the QPPV role is implemented appropriately, using a model that fits the company’s operational setup.
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Conclusion
This article aimed to provide a comprehensive overview of the roles and responsibilities of a Marketing Authorization Holder (MAH)—many of which are often overlooked or not clearly explained elsewhere. If you are an MAH, or planning to become one, this guide should help clarify the expectations and obligations involved.
If you’re considering becoming a license holder or need support in pharmacovigilance operations, we also offer consultation services to help you navigate regulatory requirements confidently and efficiently.
If you found this article helpful, please share it with your colleagues and peers.
Like, comment, and spread the word to support awareness in the pharmaceutical and regulatory community.
Interested in becoming a Marketing Authorisation Holder (MAH) in the EU? Check out this link to get started:
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