Who is a marketing authorization holder

Jump to navigation. As per the EU guidelines, it is the ultimate responsibility of an MAH to ensure that the product placed in the market is safe and effective for use.

You are here Home » Resource Center » What is? Your browser does not support the audio element. Regulatory Compliance: MAHs should ensure process and controls are in place to guarantee the registered Marketing Authorisation remains current. Changes to the approved dossier, specifically Modules 1 and 3 concerning product labelling and quality must be communicated in a timely manner between the MAH and manufacturer s to enable compliance with the MA.

Supporting processes should also ensure all required changes to an MA are appropriately communicated to the competent authority and implemented within the required timelines. Likewise, there must be a process to ensure manufacturers communicate with the Marketing Authorisation Holder prior to making any changes to their manufacturing processes and the related controls. Regulatory compliance can be facilitated through a robust change management process.

MAHs should also ensure that any updates to the GMP guide are incorporated at manufacturing site level. Regulatory commitments: Regulatory commitments are agreed between an MAH and a relevant competent authority. The management of these commitments is critical to maintaining MA compliance. MAHs need to implement effective processes for communicating and tracking all commitments with the relevant manufacturing sites.

Failure to implement a commitment risks significant MA non-compliance. The management of regulatory commitments can be anticipated to assume increased importance in the changing regulatory environment where there is a move towards greater flexibility in the area of post-approval change management. The MAH systems include management both internally and also externally, with all manufacturers and third parties to whom activities are delegated.

The MAH must identify a qualified person contact for release of the commercial product. If the MAH is not the product manufacturer or distributor, the MAH must sign a written agreement that guarantees the quality of these outsourced operations. The MAH must establish a pharmacovigilance system to ensure the detection, assessment, understanding, and prevention of adverse effects, or any other product-related problem.

The MAH must also submit an annual report to list any changes that have occurred in the prior year. However, in the case of any major change, the change must be reported before it becomes effective. If any safety-related problems are reported for one of its products, the MAH must stop the sale and distribution and recall that product. The MAH must ensure the supply of drugs for urgent needs. Regulatory and Legislative Perspectives.