East African Community Mutual Recognition Procedures(EAC-MRP)
East African Community Mutual Recognition Procedures (EAC-MRP)
EAC- MRP was adopted by the EAC Council of Ministers on 28th November, 2014 in order to harmonizes the registration procedures of Immunological Veterinary Products (IVP) within the Region. The initiative is implemented by the National Bodies regulating Veterinary Medicines in the EAC.
The EAC Secretariate, the Technical Working Group (TWG) and the Coordination Group for Mutual Recognition (CGMR) with financial and technical support from GALVmed initiated the procedure on 27th September 2019.
- To harmonize Immunological and Pharmaceutical veterinary medicines registration systems within the region
- To reduce duplication of effort and maximize resources through:
- Joint assessments
- Joint site inspections
- Standard Operating Procedures (SOPs)
- Guidelines on Submission of Documentation for Registration Veterinary Products
- Dossier structure Guide for registration of Veterinary Product
- Guidelines on variations
- Guideline for repeated use of Mutual Recognition Procedures in the East Africa Region
- Best Practice Guide for Veterinary Mutual Recognition Procedure in EAC
- Guidance for pre-submission Meeting
For more detailed requirements Applicants should refer to the EAC Guidelines on Procedural Aspects for Applications for Marketing Authorization of Veterinary Immunological and Pharmaceutical Products. The guidelines can be accessed at EAC website