Mutual recognition procedure for the registration of veterinary medicines in the East Africa
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Date
2021
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East African Community
Abstract
This version was issued in October 2021 to incorporate changes adopted as a result of a survey conducted in June-July 2021 whose objectives was to obtain feedback from industry, National Regulatory Agencies (NRA) and the EAC secretariat on regulatory obstacles around the implementation of MRP in areas such as adherences to MRP timelines, communication during the MRP process, GMP inspections, MRP sustainability, Stakeholders involvement and national regulatory fee policy. The results were subsequently discussed by the EAC MRP Technical Working Group (TWG) who recommended extension of MRP timelines to reflect internal NRA approval processes. The revised timelines are more realistic as they include the internal time taken by NRA Boards and Councils to ratify the recommendations of the technical staff/committee regarding issuing MAs, which had not been factored in during the setting of previous timelines.
TWG also noted the importance of continuous stakeholders’ involvement during the implementation of MRP.
A consultative workshop was held with the global animal health industry in February 2021 during which questions were raised and clarifications provided. This version seeks to be comprehensive and incorporates the questions raised by industry and the answers provided by the EAC -MRP Technical Working Group (TWG).
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East African Community. (2021). Mutual recognition procedure for the registration of veterinary medicines in the East Africa. East African Community