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What Is a Marketing Authorization Holder (MAH)?

A marketing authorization holder (MAH) is a person, company or non-profit organisation licensed to distribute, sell, and commercialise its pharmaceutical products. They are responsible for obtaining and maintaining regulatory approvals to market and distribute their products in the target region. MAHs play an integral role in ensuring that their products are safe, effective and maintain compliance with the applicable regulations. Thus, MAHs must ensure they have a deep understanding of regulatory processes and are committed to ensure product quality, and vigilance to address emerging concerns throughout the lifecycle of the product. The MAH’s role varies depending on the region as each country has its own regulatory requirements set by the respective agency. Some of the key responsibilities of a MAH are outlined below.

Key Responsibilities of a Marketing Authorization Holder(MAH)

Regulatory compliance: MAHs must ensure they adhere to the relevant regulatory requirements for the country they want their product to be marketed in. They must submit the appropriate and required detailed documentation to regulatory authorities of their target country. MAH is tasked to notify any significant changes to the health authorities and maintain proper licensing to ensure the legal compliance.

Product safety & quality: MAHs must ensure that their product is manufactured, stored, and distributed in accordance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) in order to maintain the safety and high-quality of their pharmaceutical product.

Labelling & packaging: MAHs should ensure that their product labels are accurate, & informative, and packaging is compliant with applicable regulatoryrequirements. It is crucial for them to ensure that the labels for their products provide the essential information to healthcare professionals and patients.

Renewals and variations: MAHs should be able to manage the renewal of their product’s marketing authorization including submitting the variations to authorization of the products when making changes. For example, new indications or dosage forms.

DDReg’s Capabilities

As a leading regulatory and pharmacovigilance service provider, DDReg offers end-to-end services that cover the entire drug product lifecycle. With over 14 years of industry experience, rich subject-matter expertise, and robust knowledge of regulatory requirements, DDReg has successfully provided compliant solutions to its customers for successful product registration and post-approval lifecycle management including post-market safety surveillance.

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