Breaking new ground in the regulatory environment: the EAC Mutual Recognition Procedure expands its product scope to include veterinary ectoparasiticides

In sub-Saharan Africa, obtaining approval to sell veterinary medicines in the market requires applying for a marketing authorisation separately in each country where the product is to be sold. This is often a lengthy, resource-intensive process that discourages private sector investment, hence limiting the sustainable supply of veterinary medicines.  

Since 2010, GALVmed and its partners, AU-PANVAC and HealthforAnimals, have been supporting the East African Community (EAC) to implement a mutual recognition procedure (MRP) in the EAC Partner States 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.

In 2022, GALVmed contracted a consultant to conduct a landscape analysis of veterinary ectoparasiticides (pesticides) regulation in six Partner States (Burundi, Kenya, Rwanda, south Sudan, Uganda, Rwanda and the United Republic of Tanzania). The analysis reported several areas of divergence in the region in the regulation of these products. This informed the need to harmonise the veterinary ectoparasiticides regulation and in order to implement the EAC Council of Ministers directive, EAC secretariat with support from GALVmed, TradeMark Africa (TMA)  and The United States Agency for International Development (USAID) developed working documents under the MRP initiative to harmonise regulation.

 As of June 2024, this novel initiative has been extended to also include registration of veterinary ectoparasiticides, thereby allowing companies to submit these products for registration through the MRP system. The draft guidelines and other key technical documents have been approved, and current efforts are aimed at capacity building related to initial training of veterinary ectoparasiticides dossier assessors.

An initial six days workshop took place in Dar Es Salaam, Tanzania on 18th-24th July to build institutional capacity and application of best practices for the evaluation and registration of veterinary ectoparasiticides to safeguard human health, animal health and the environment. This will enhance capacity of veterinary pesticides assessors on risk assessment and dossier evaluation to improve public trust in the MRP process, which will attract submission of safe, quality and efficacious veterinary pesticides in the region.

The meeting was attended by MRP members from veterinary medicine regulatory authorities drawn from Democratic Republic of Congo, Burundi, Kenya, Rwanda, Tanzania, Uganda and South Sudan. The training was conducted by representatives from Australian Pesticides and Veterinary Medicines Authority and EAC Secretariat.

MRP represents a key advancement in harmonising and strengthening veterinary product registration by reducing the time, costs, and resources needed to bring these medicines to market. By streamlining approvals and extending to new product categories like ectoparasiticides, this initiative enhances availability and access to essential animal health solutions, supporting animal health, livestock production, strengthening the livelihoods of farming communities, and contributing to sustainable development.