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A Marketing Authorization Holder (MAH) is a local company that is assigned by the Manufacturer to be in charge of all licensing matters.

Regulatory affairs management in the pharmaceutical industry is important to ensure compliance with regulatory guidelines.

Managing a successful therapeutic product licence transfer consists of 3 steps:  Seeking inform consent with Distributor , Selection of an independent license holder and Transfer operation.The licence transfer operation will require some preparation from Product Owner , current marketing authorization holder ( Existing Registrant) and new current marketing authorization holder (new Registrant) .Once the above is completed and a final confirmation from existing registrant that there is no pending renewal nor variations tied to the licences to be transferred, the existing registrant can log on to the online system known as: PRISM to execute the transfer inputting the details provided by Product Owner. Once the initiation of the transfer is performed, the new registrant will receive an email notification to log on to the system to accept the transfer to upload all the relevant documents and details provided by Product Owner. The process takes about 14 working days and both the new registrant and existing registrant will be notified of the outcome. There is currently no cost tied to this operation officially.

Managing regulatory obstacles is a key essential factor in expediting the approval of the products

5 quick questions to check before regulatory filing of pharmaceutical products in ASEAN

Regulatory classification can definitely put your product at an edge over your competitor if you are able to evaluate and understand the intended market audience and your product positioning.