Transfer of Marketing Authorization

The transfer of marketing authorization is a process by which the ownership or responsibility for marketing authorization of a medicine is transferred from one marketing authorization holder (MAH) to another. This change typically occurs when there is a need to transfer the rights, obligations, and responsibilities associated with the authorization from one entity to another.

The transfer of marketing authorization may arise due to various reasons, such as corporate acquisitions, mergers, licensing agreements, or changes in the organizational structure of pharmaceutical companies. It allows for the seamless continuation of the marketing and distribution of the medicine while ensuring compliance with regulatory requirements and maintaining patient safety.

The transfer process involves obtaining the approval of the relevant regulatory authority responsible for granting the marketing authorization. The specific requirements and procedures for transfer vary depending on the regulatory framework of the country or region where the transfer is taking place. Generally, it involves submitting a formal application to the regulatory authority, along with the necessary supporting documentation, to demonstrate the legitimacy and compliance of the transfer.

The regulatory authority evaluates the application and assesses the suitability and qualifications of the new MAH to assume the responsibilities associated with the marketing authorization. This evaluation ensures that the new MAH has the necessary capabilities, expertise, and resources to meet the regulatory obligations and maintain the quality, safety, and efficacy of the medicine.

Throughout the transfer process, it is essential to ensure the uninterrupted supply of the medicine to patients. Regulatory authorities may require a transition period during which both the current and new MAHs collaborate to ensure a smooth transfer of responsibilities. This period allows for the proper transfer of regulatory documentation, quality control processes, batch release procedures, and pharmacovigilance activities.

The transfer of marketing authorization involves a comprehensive and coordinated effort between the current and new MAHs, as well as cooperation with the regulatory authorities. It ensures the continuity of the medicine’s availability on the market, the adherence to regulatory requirements, and the preservation of patient safety.