MAH Responsibilities Guide


The guide includes:

1.0 Summary of Regulatory Obligations of the MAH
1.1 Maintaining an Accurate and Current Product Registration Dossier
1.2 MA Renewal
1.3 MA Compliance
1.4 Batch Release
1.5 Specific Obligations with Respect to License Terms & Dossier
1.6 Technical Agreements Required
1.7 Pharmacovigilance

*Guide will be available as an instant download upon purchase. 



This guide outlines the essential responsibilities of a Marketing Authorisation Holder (MAH) and is a perfect introduction for those considering becoming a MAH, those new to this side of the industry or who don’t work in a technical function. When working with new clients, we use this guide to help them through the essential information and obligations they will be taking on.

A common issue identified by inspectors is that many MAHs simply lack awareness about what is required of them. As a MAH ourselves, this guide represents our condensed expertise, however, does not remove your need to study in detail the EU Directives and the Formal Guides that your Regulatory Agency publish.

Note: The development of standing operating procedures (SOPs) is a critical task that all MAH are obliged to undertake. You will be inspected by your local regulatory authorities, and noncompliance places your company at risk. You will need Technical Agreements, change control processes, a Qualified Person and a number of other essential documents. IPG has the expertise to assist you with everything you need to ensure compliance. Contact us here to discuss your requirements.