The 2018 Open Session of the EuFMD Standing Technical Committee was held in Borgo Egnazia - Italy, 29-31 October 2018 . The session theme was on global vaccine security The European Commission for the Control of Foot-and-Mouth Disease (EuFMD), one of FAO’s oldest Commissions, came into being on the 12th June 1954, with the pledge of the sixth founding member state to the principles of a coordinated and common action against Foot-and-mouth Disease.

1. OS18
MUTUAL REGISTRATION OF VACCINES IN
EAST AFRICA: PROGRESS AND ISSUES FOR
BETTER ACCESS TO EFFECTIVE FMD
VACCINES?
Noel M. Aineplan
Uganda National Drug Authority

2. OS18
Scope
• Background
• Mutual Recognition Procedure(MRP)
• Establishing MRP in EAC
• Progress towards MRP
• Benefits of MRP

3. OS18

4. OS18
Background- EAC Member States
EAC Member State National Medicine Regulatory
Authority(NMRA)
Burundi Ministry of Agriculture & Livestock
Kenya Veterinary Medicines Directorate ;
Pharmacy/Poisons Board
Rwanda Rwanda Food and Drug Authority;
Ministry of Agriculture & Animal
Resources
South Sudan South Sudan Food and Drug Agency
& Ministry of Animal Resources and
Fisheries
Tanzania Tanzania Food and Drug Authority
Uganda National Drug Authority

5. OS18
Background- Start of the process
• Workshop for African regulators organised by
Global Alliance for Livestock Medicines (GALVmed)
in Cape Town in 2010. Requested for
 Development of a harmonised registration system
for immunologicals
 Training for their regulators in registration of
veterinary vaccines
 Establishment of a system of Mutual Recognition

6. OS18
Mutual Recognition Procedure
A vaccine registration application is assessed by one
country i.e. Reference Country (RC) on behalf of the
other countries, an assessment report is sent to the
Concerned Countries which then mutually recognize
it leading to Marketing Authorisation(MA) in all the
countries simultaneously
Two types of MRP:
1. For new product applications
2. For expansion of existing MAs

7. OS18
Establishing MRP in EAC: Harmonised Documents
• EAC Technical Working Group’s harmonised
documents:
• Dossier structure
• Technical Guideline
• Templates for labelling and Summary of Product
Characteristics (SPC)
• Harmonised Application Form for use in National
or MRP applications
• 20+ other technical documents harmonised

8. OS18
Establishing MRP in EAC: Training & technical meetings
 Training completed
• Dossier preparation training (to vaccine
manufacturers)
• Dossier assessment training
• GMP inspection training
 Numerous technical workshops(13)
 Engagement with policy makers, private sector &
other stakeholders through stakeholder meetings
in 5 EAC countries

9. OS18
Progress towards MRP
1.Article 108 of the EAC Treaty forms the legal basis for harmonization of
regulations for veterinary medicines registration within the EAC Partner States
2 The Sectoral Council on Agriculture and Food Security adopted the Concept
of Mutual Recognition Procedures on the 5th September, 2014, in Kigali,
Rwanda
3. These decisions were adopted by the EAC Council of Ministers on the
28th of November, 2014 in Nairobi, Kenya resulting in a Decision Number:
EAC/CM 30/Decision 34.
4. The 34th meeting of the Council of Ministers on 5th September 2016
Ministers directed Partner States to implement the Mutual Recognition
Procedure (MRP) for IVPs & develop harmonised GMP guidelines for
conducting joint assessments: EAC/CM 34/Decision 35
5. The 10th Meeting of the Sectoral Council on Agriculture and Food Security
directed the EAC Secretariat and Partner States to convene stakeholder
sensitisation meetings on MRP in all Partner States and directed the
Secretariat to set up a coordination office and mobilise resources to
finance MRP activities

10. OS18
Progress towards MRP

11. OS18

12. OS18
Progress towards MRP
Effective implementation of MRP requires:
• The commitment of Partner States’ NRAs.
• Sensitisation of stakeholders & their buy in
• Willingness of applicants to use new MRP system

13. OS18
Progress towards MRP
The system is now open for business
 One product has been registered; two are
under assessment
 EAC MRP Coordinator office established
 Documents to support MRP for vet
pharmaceuticals completed
 Interests by other RECs – SADC &
ECCAS/CEMAC

14. OS18
Benefits of MRP
• Predictable and time bound
• Reduces on duplication- Joint Assessment and GMP
inspections
• Builds experience, trust and confidence between
regulators
Very crucial to the availability of quality, safe and
efficacious vaccines for Transboundary Diseases like
FMD

15. OS18
Acknowledgment
• EAC IVP TWG & Secretariat
• Dr. Lois Muraguri and team at the Global Alliance
for Livestock Medicines

16. OS18
THANK YOU