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Any company, firm or non-profit organization, which holds a marketing authorization granted by the European Medicines Agency (EMA), is called a Marketing Authorization Holder (MAH). An MAH is allowed to distribute and sell its medicinal products in one or more European Union (EU) member states.

Responsibilities of an MAH

  • Clinical Trials – MAH is responsible for designing and executing the clinical trials ethically, as per the EU regulations
  • Manufacturing – MAH must ensure that all the products manufactured are in accordance with Good Manufacturing Practices, while having full overview of the supply chain
  • Complaints and Recalls – It is the responsibility of an MAH to ensure all the complaints and quality issues related to the products are investigated thoroughly. In case of recalls, MAH must work alongside the competent authority to co-ordinate the product recall and following procedures
  • Pharmacovigilance – The pharmacovigilance is a major part of MAH’s responsibilities. MAH is required to monitor the product post the market-entry to detect any adverse event occurred. In case of adverse event, MAH must report it to the concerned Health Authority in the form of a Periodic Safety Update Report (PSUR).
  • Supply and Distribution – MAH is responsible to monitor the continuous supply of the product. In case of shortage of supply, an MAH must notify it to the competent authority.

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. To know more about MAH’s key responsibilities, reach out to Freyr at sales@freyrsolutions.com.