Pharmaceuticals

Marketing Authorization Holder

Marketing Authorization Holder

Who Is MAH ?

A natural person, a limited business, or another entity like a partnership or charity may be the MAH. Marketing of the product is the responsibility of the MAH holder. The MAH is still legally liable even after designating a representative, such as a local agent or designated distributor.

The MAH serves as the main point of contact for the business producing or distributing the product and the regulatory bodies. In addition to answering regulatory questions and supplying any needed data or documentation, they oversee submitting applications for marketing authorization.

Generally, marketing, sales, and distribution rights for the product are owned by the MAH. They oversee the product’s marketing, price, distribution contracts, and other commercial factors.

The MAH, an organization takes over the product’s legal liability. This covers accountability for any injury or unfavourable outcome resulting from using the product.

Role of MAH

OMC Medical possess extensive knowledge in managing regulatory obligations. We able to effectively manage the regulatory submission procedure and guarantee that the product satisfies all applicable criteria. OMC Medical will assist in reducing the risks related to product liability and regulatory compliance by making sure that all procedures are carried out in accordance with the most recent guidelines and standards.

Related Blogs

Stay updated with the latest regulatory updates and insights

A Strategic Guide to Pharmaceutical Product Registration in Senegal by OMC Medical

November 07, 2025

A Strategic Guide to Pharmaceutical Product Registration in Senegal by OMC Medical
Learn More
Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process

October 14, 2025

Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process
Learn More
Overhauling Drug Registration: The Indonesian Food and Drug Authority’s Progressive Amendment

October 14, 2025

Overhauling Drug Registration: The Indonesian Food and Drug Authority’s Progressive Amendment
Learn More
LinkedIn Message on LinkedIn WhatsApp Start WhatsApp chat Call Call us