Veterinary pharmaceutical companies can now register veterinary ectoparasiticides (pesticides) within the East African Community (EAC) under the Mutual Recognition Procedure (MRP).
This follows decision number EAC/CM45/Decision30 of the 45th EAC Council of Ministers held in June 2024 that approved the EAC guidelines for registration and testing of veterinary ectoparasiticides, and directive number EAC/CM45/Directive68 that instructed the EAC Secretariat and urged EAC Partner States to implement the approved guidelines in line with article 108 (e) of EAC Treaty.
This article calls for the EAC Partner States to adopt common mechanism to ensure safety, efficacy and potency of agricultural inputs including chemicals, drugs and vaccines.
Until recently, obtaining approval to place veterinary medicines on the market required a marketing authorisation (licence) from the National Regulatory Authority in each country where the product is to be sold.
This involved applying for a licence separately in each country.
The EAC’s MRP submission pathway has improved accessibility to quality veterinary medicines in shorter timelines, resource sharing and the process has become more predictable within the region.
The MRP system was first developed in 2014 and the first marketing authorization certificates were issued in 2018.
Veterinary ectoparasiticides were not included in the initial scope of products for harmonisation – immunological and pharmaceutical veterinary products.
In September 2019, the 13th EAC Sectoral Council on Agriculture and Food Security (SCAFS), the organ responsible for setting out priorities and implementing programmes in the agriculture sector, expanded the mandate and scope of MRP to include veterinary ectoparasiticides and medical devices.
With support from GALVmed and other partners, the EAC Secretariat have now developed harmonised guidelines for registration of veterinary ectoparasiticides in the region.
The guidelines and other technical documents were approved in June 2024, thereby allowing companies to submit these products for registration through the MRP.
“Registering veterinary ectoparasiticides under the MRP is another milestone in creating a functioning and harmonised regulatory environment for veterinary medicines that will make much needed quality products available to livestock keepers sooner thereby improving animal health and livestock production.” Said Dr Lois Muraguri, GALVmed’s Senior Director, Enabling Environment & Partner Engagement.
Since 2010, GALVmed and its partners, AU-PANVAC and HealthforAnimals, have been supporting the EAC to implement the MRP in the EAC Partner States. The first product was submitted for registration in 2017.
Since then, a total of 37 products have been submitted through MRP; seventeen (17) products have been evaluated and released to respective regulators for registration.
Fahari Marwa, Principal Agricultural Economist at the EAC said “the MRP initiative has achieved significant progress, and we are looking forward to having veterinary pesticides products registered through this innovative MRP regional system. We will also be sharing knowledge and best practices across countries.”
