East African Community Mutual Recognition Procedures(EAC-MRP)


Introduction

The East African Community is an inter-governmental organization which was first established in 1967 then re-established again in 2000. The EAC comprise of six partner states namely Tanzania, Kenya, Uganda, Burundi, Rwanda and South Sudan.

MRP for veterinary Medicine is the registration Process in which only one partner state, selected as the Reference Country (RC), performs an assessment of the registration dossier and the assessment report is shared and recognized by partner state named as Concern Country (CC) in the Mutual Recognition Procedure for issuing the approval based on the National approval procedure.

EAC- MRP was adopted by the EAC Council of Ministers on 28th November, 2014 in order to harmonise the registration procedures of Immunological Veterinary Products (IVP) within EAC.

Pursuant to the Council decision, the Sectoral Council of Agriculture and Food Security directed the EAC Secretariat to constitute the Technical Working Group (TWG) and the Coordination Group for Mutual Recognition (CGMR) to operationalize MRP.

The Secretariat, with Technical and Financial support from GALVmed convened a meeting in March 2015, in Arusha, Tanzania where the TWG and CGMR were constituted. Implementation of the EAC – MRP is done by the National Bodies regulating Veterinary Medicines in the Country.

Furthermore, Sectoral Council of Agriculture and Food Security on 27th September, 2019, directed the Secretariat to communicate to the Partner States to start processing applications for registration of Pharmaceutical Veterinary Products under MRP.

Submission of application under EAC MRP

An applicant send an identical application form and dossier to the selected RC and CCs and with registration fees payable to the RC and the CCs. The fees payable is the same as the current fees published by the respective Partner States. For Tanzania Fees and Charges Click here

The objectives of MRP are as follows:-

MRP was established with overall goal of improving access to quality of Immunological and Pharmaceutical Veterinary Product at lesser cost to customers.

The main objectives set to meet this goal were:

  • To establish harmonized Immunological and Pharmaceutical veterinary medicines registration systems within the East Africa Community (EAC) in accordance to the national and international recognized standards and best practices; and
  • To reduce duplication of effort through joint assessments and joint site inspections.


Progress made so far:-

Under EAC MRP several documents have been developed and adopted by TMDA as follows: -

  • Standard Operating Procedures (SOPs) for Registration of Veterinary Products,
  • Guidelines for Submission of Documentation for Registration Veterinary product which has also been assimilated and rolled out in all partner states.
  • Dossier structure Guide for registration of Veterinary Product
  • Guideline for variations to marketing Authorizations for Registered Veterinary Products Approved through MRP
  • 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

Other deliverable that have been achieved so far include successful completion of 3 joint assessment sessions and 2 GMP jointly inspection under EAC- MRP

This resulted in one product being granted conditional approval by TMDA to date.

TMDA’s role in EAC – MRP Programme

Tanzania Medicines and Medical Devices Authority (TMDA) continues to implement activities related to Mutual Recognition procedures (MRPs) for Veterinary Products mainly in documents development and review through meetings of the Technical Working Group, joint dossiers assessment, capacity building and communication of the programme.

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: http://www.eac.int/documents/category/livestock