TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

3^rd October, 2019

East African Community Mutual Recognition Procedures (EAC-MRP) for Immunological Veterinary Medicines

Introduction

The East African Community is an inter-governmental organisation 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 assessment of the registration dossier and the assessment report is shared and recognised by other partner states regarded and selected as Concern Countries for issuing approval based on the National approval procedure.

East Africa Community - Mutual recognition procedures 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 Sectorial 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 Countries.

Submission of application under EAC MRP

An applicant sends an identical application form and dossier to the selected RC and CCs and with registration fees payable to the RC and the CCs. The amount of fees is as published by the respective Partner States.

The objectives of MRP are as follows:-

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

The main objectives set to meet this goal were:

• To establish harmonized Immunological veterinary medicines registration systems within the East Africa Community (EAC) in accordance with the national and international recognized standards and best practices; and
• To reduce duplication of efforts 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 Pharmaceutical Products,
• Guidelines for Submission of Documentation for Registration Immunological Veterinary Product which has also been assimilated and rolled out in all partner states,
• Dossier structure Guide for registration of an Immunological Veterinary Product,
• Guidelines for Variations to Marketing Authorisations of Registered Veterinary Immunological Products Approved through MRP,
• Guidelines for Repeated Use of Mutual Recognition Procedures in the East Africa Region,
• Best Practise 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 joint inspection under EAC- MRP

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

TMDA’s role in EAC – MRP Programme

TMDA continues to implement activities related to Mutual Recognition Procedures (MRPs) for Immunological Veterinary Products (IVPs) mainly in documents development and review through participation in 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 Pharmaceutical Products. The guidelines can be accessed through our TMDA website or at EAC website (Click here).