The AMRH Green Book is a publicly available resource that provides information on medicines scientifically evaluated for safety, efficacy, and quality by the Evaluation of Medicinal Products Technical Committee (EMP-TC) in collaboration with the Good Manufacturing Practices Technical Committee (GMP-TC) through the Continental Procedure for Evaluation and Listing of Human Medicinal Products. It is intended to assist national regulatory agencies, healthcare professionals, industry stakeholders and the public by offering details on products that have undergone continental-level evaluation and received a positive opinion regarding safety, efficacy, and quality. This resource supports national marketing authorization decisions across AU member states through reliance principles. Additionally, the book includes information on the assessment of Good Manufacturing Practices (GMP) standards and compliance for the manufacturing sites of listed products, as assessed and established by the GMP-TC).
The listed medicinal products in this book have been positively recommended by the EMP-TC and approved by the AMRH Steering Committee for Continental Listing. These continental listings do not imply national registrations or marketing authorization, as that remains the mandate of each member state's national regulatory agency.
