Home Work Enabling Environment Regulatory harmonisation for registration of veterinary products

the East African Community Mutual Recognition Procedure (MRP)

Availability of quality, safe and efficacious veterinary medicines in countries for use by livestock keepers depends on a reliable system of registration. In sub Saharan Africa, the process of registration is often unpredictable, lengthy, resource-intensive and a key barrier to investment by the private sector.

Since 2010, GALVmed and its partners, AU-PANVAC and HealthforAnimals, has been supporting the East African Community (EAC) to implement a mutual recognition procedure (MRP) in the EAC Partner States (Burundi, Kenya, Rwanda, South Sudan, Tanzania, Uganda and more recently Democratic Republic of Kenya) that allows for simultaneous application of marketing authorisations in multiple countries. This saves time and allows countries and applicants to use their resources more efficiently. MRP increases the likelihood for the sustainable supply of quality, safe and efficacious registered veterinary medicines in the region. MRP is available for registration of veterinary pharmaceuticals and vaccines and will soon be extended to include registration of veterinary pesticides.

The MRP system does not replace the national system of registration and can be used for:

  1. New product applications: When an applicant wishes to obtain a marketing authorisation for a new product in more than one Partner State simultaneously.
  2. Expansion of markets into MA other EAC Partner States: When an applicant already has a marketing authorisation in one Partner State and wishes to expand sales of the registered product into one or more additional Partner States.

MRP runs to a specific timetable and all participating national regulatory agencies in the EAC Partner States have agreed to prioritise MRP applications over those received through the national process.

Resources

  1. Mutual Recognition Procedure for the registration of Veterinary Medicines in the East Africa. Download here.
  2. Working together to uniformly license veterinary medicines in East Africa: How the East African Community’s Mutual Recognition Procedure works. Download here.
  3. MRP technical guidelines including application forms and templates are available here.