A Marketing Authorization Holder (MAH) is an entity—whether an individual, company, or non-profit organization—that holds the regulatory approval to distribute, sell, and commercialize pharmaceutical products. Essentially, they are the gatekeepers who ensure that a medicinal product reaches patients safely and effectively. Here are the key points about MAHs:
Authorization Responsibility: The MAH is responsible for obtaining and maintaining regulatory approvals to market and distribute their products in a specific region or country.
Legal Rights: Once granted, the marketing authorization allows the MAH to legally introduce the product into the market. It’s like receiving a green light to sell your innovative drug or medical device.
Ongoing Compliance: MAHs must adhere to strict regulatory requirements, including safety monitoring, quality control, and post-marketing surveillance. They play a critical role in ensuring patient safety throughout a product’s lifecycle.
Responsibilities of a Marketing Authorization Holder
(may vary depending on requirements)
The services provided by MAHs vary, but they generally encompass the following:
Regulatory Submissions: MAHs prepare and submit applications for marketing authorization to health authorities. These submissions include detailed data on the product’s safety, efficacy, and quality.
Quality Assurance: MAHs oversee manufacturing, packaging, and distribution processes to maintain product quality. They collaborate with contract manufacturers and suppliers to ensure compliance with Good Manufacturing Practices (GMP).
Pharmacovigilance: Monitoring adverse events and ensuring timely reporting to regulatory agencies is a crucial responsibility. MAHs track safety signals, manage risk minimization plans, and communicate safety updates.
Labeling and Packaging: MAHs create product labels, patient information leaflets, and packaging materials. Clear and accurate labeling is essential for patient safety.
Supply Chain Management: From production to distribution, MAHs manage the supply chain. They ensure product availability, handle recalls if needed, and maintain inventory levels.
Post-Marketing Studies: MAHs conduct post-authorization studies (e.g., Phase IV trials) to gather additional safety and efficacy data.
Benefits of Having an MAH
The advantages of having an MAH extend beyond regulatory compliance:
Global Market Access: In the European Union (EU), for instance, a central marketing authorization granted by the European Medicines Agency (EMA) allows the MAH to market the product across all EU Member States, Iceland, Norway, and Liechtenstein1. Similarly, in other regions, MAHs facilitate international expansion.
Expertise and Efficiency: MAHs specialize in navigating complex regulatory landscapes. Their expertise streamlines the approval process, reducing time-to-market.
Risk Sharing: Collaborating with an MAH allows innovators (such as small biotech companies) to share the regulatory burden. MAHs absorb the complexities, allowing the innovator to focus on research and development.
Local Presence: MAHs often have local affiliates or partners, providing insights into regional markets, cultural nuances, and healthcare systems.
Continuity: Even if the original developer or manufacturer changes, the MAH remains constant. This ensures product continuity and patient access.
In summary, MAHs play a pivotal role in bringing life-changing therapies to patients. Their services span regulatory affairs, quality control, and safety monitoring, ultimately benefiting both healthcare providers and the public. Whether you’re a pharmaceutical established company or a startup, partnering with an MAH can be a strategic move towards accessing new markets.
Artixio supports pharmaceutical, medical devices, cosmetics, supplements and animal health companies from around the world through Marketing Authorization Holder services in countries across Asia, LATAM, North America and Europe. For more details, please email us at info@artixio.com
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