Marketing Authorization Holder.

Responsibilities of a Marketing Authorization Holder (MAH)


A Marketing Authorization Holder (MAH) is a local company that is assigned by the Principal /Manufacturer as the responsible party to be in charge of all registration and licensing matters pertaining to the right to distribute the pharmaceutical or medical products in the market. As a Marketing Authorization Holder, the common responsibilities are set out as below and is a non-exhaustive list :

  1. Maintenance of the product licenses issued by the Health Authority which includes renewal, performing quality and safety updates to the dossier submitted to the authority and responsive to the Health Authority queries concerning the products
  2. Pharmacovigilance responsibilities like Adverse Event Reporting, Batch Recall Activities, Safety Signals Alert , Literature review and safety report update if required.
  3. Performing due-diligence activities such as internal audit, annual product review exercise by the Principals, regulatory intelligence activities to ensure that the rights to market the product would not be jeopardized by any non-compliance both locally and to the Principal.

A Marketing Authorization Holder can be either a local distributor or an independent license holder such as TRC. It is observed recently that  established distributor firms are more selective towards the principals that they want to work with depending on the nature of the product and the profit that could be generated if the portfolio is taken up. From the Principal’s perspective, it could delay product launches if a suitable distributor firm could not be found or  even a potential disruption in supply and  non-compliance issues for products that are already in the market. For assigned local distributor who have multiple product lines with different principals, it could be hard to manage at times due to lack of internal resources such as  “untimely “requests that are introduced all at once such as : internal audit , multiple variations to be introduced for multiple products such as artwork change , addition of site that could affect product supply in the market especially if they are tied up with tender season.

It could be handy  to consider having an alternative  support be it from a distributor’s end or Principal’s end to engage an Independent License Holder or Regulatory Consultant  to  alleviate this stress to  perform the work required to get the situation moving.

TRC has launched a subscription plan that could :

  • Reduce your time in looking for a suitable staff
  • Reduce internal resources and time to train before the work can be performed
  • Allows you to leverage and utilize experienced local regulatory expertise to perform the work for you based on your objectives within the set timeframe within plan you purchased
  • Eliminate the worry of rising cost in utilizing outsourced support with capped hours.

If you think that it would be worthwhile to understand more about the plan, please check out the link.

Thank you!

 

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If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!

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