The HPRA have been active in inspecting MA Holders in Ireland for over 15 years, carrying out 3-5 Market Compliance Inspections a year. These inspections are distinct from GMP, GDP or PV audits and can encompass all Regulatory, Quality and Pharmacovigilance responsibilities of an MAH holder, as well as commercial activities such as advertising and promotion.
Since the publication of the EMAs “Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders” the responsibilities of MAHs not involved in manufacturing activities and so-called “virtual MA Holders” are clearer, with an emphasis on clearly documented outsourcing and delegation arrangements.
It is expected that these Market Compliance Inspections will increasingly focus on “virtual MAHs”, and there is ongoing work to roll out this inspection process across other EU markets.
At Acorn Regulatory, we have supported numerous MAHs, including virtual MAHs, in understanding their regulatory responsibilities. We assist them in developing Quality Management Systems tailored to their business model and provide practical support to ensure compliance across all their activities.
For more information go to https://acornregulatory.com/marketing-authorisation-holder-responsibilities/
