Responsibilities of a Marketing Authorization Holder (MAH)

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A Marketing Authorization Holder (MAH) is a local company appointed by the Principal/Manufacturer to be responsible for all registration and licensing matters related to the distribution of pharmaceutical or medical products in the market.

As a Marketing Authorization Holder, the key responsibilities include (non-exhaustive):

1. Maintenance of product licences issued by the Health Authority, including renewals, dossier updates (quality and safety), and responses to authority queries
2. Pharmacovigilance activities such as adverse event reporting, batch recall management, safety signal monitoring, literature review, and safety report updates
3. Due diligence activities including internal audits, annual product reviews with Principals, and regulatory intelligence to ensure continued compliance both locally and with Principal requirements

A Marketing Authorization Holder can be either a local distributor or an independent licence holder such as TRC.

It has been observed that established distributors are becoming more selective in the principals they work with, depending on product type and commercial viability. From the Principal’s perspective, this may result in delays in product launches if a suitable distributor cannot be identified, or potential disruption in supply and compliance for products already in the market.

For distributors managing multiple product lines across different principals, resource constraints may arise, particularly when multiple regulatory activities occur concurrently, such as internal audits, product variations (e.g. artwork changes, site additions), or tender-related requirements.

In such situations, it may be useful to consider additional support, either from the distributor’s or Principal’s end, by engaging an independent licence holder or regulatory consultant to ensure continuity of regulatory activities.

TRC offers a regulatory subscription plan that may support the following:

• Reduce time required to identify and hire suitable regulatory personnel
• Minimise internal resources required for onboarding and training
• Provide access to experienced local regulatory expertise aligned with your operational objectives
• Offer cost predictability through a structured model with defined scope and hours

A structured regulatory strategy is critical to ensure successful submission and lifecycle management. You may refer to our pharmaceutical regulatory support services for further details.

In some cases, companies may only recognise these challenges after delays in regulatory timelines or increased internal coordination burden.

Where there are constraints in managing MAH responsibilities or maintaining consistent regulatory support, alternative models may be considered to ensure continuity.

You may reach out to TRC for a discussion to assess the most suitable approach based on your current regulatory setup.

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