ABOUT EAC - MRH HARMONIZED GUIDELINES
The EAC harmonized guidelines, requirements and standards for Medicines Evaluation and Registration (MER), Good Manufacturing Practices (GMP) and Quality Management Systems (QMS) were approved by the 29 th Ordinary meeting of the EAC Council of Ministers on 20 th September 2014 through its Decision
The Decision directed the EAC Partner States’ National Medicines Regulatory Authorities (NMRAs) to begin domesticating and implementing the approved EAC harmonized guidelines, requirements and standards for MER, GMP and QMS from 1 st January 2015.
Components of MRH
- Medicines Evaluation and Registration
- Good Manufacturing Practice
- Quality Management System
- Information Management Systems