The East African Community (EAC) Medicines Regulatory Harmonisation (MRH) programme was established to strengthen the regulation of medicines across the region through common technical requirements and shared assessments. While much of the focus in the early years was on human medicines, veterinary medicines remained under-regulated despite their importance for livestock health, food safety, and controlling zoonotic diseases.

With support from partners such as the Global Alliance for Livestock Veterinary Medicines (GALVmed), this gap is now being addressed. GALVmed has played a central role in ensuring that veterinary products are not overlooked, contributing to the development of the first dedicated Good Manufacturing Practice (GMP) guidelines for veterinary medicinal products under the EAC framework.

Veterinary medicines: Illustration created with the assistance of AI (OpenAI, 2025).  

Previously, veterinary manufacturers had to rely on human GMP guidelines, which did not always reflect veterinary realities. For example, animal premixes and medicated feeds pose specific challenges such as dust control, homogeneity testing, and bulk sampling. Ectoparasiticides, widely used in livestock management, present hazards closer to pesticides than medicines and raise issues of flammability, worker safety, and environmental protection. Beta and non-beta lactam antibiotics also require careful consideration: while human GMP typically mandates completely separate facilities, veterinary contexts may permit shared facilities where rigorous risk assessments and controls are in place.

The newly published EAC GMP veterinary guidelines take these realities into account. They include special provisions for premixes and medicated feeding stuffs, recognising the need for pragmatic sampling and dust management. They dedicate annexes to biological products such as animal vaccines and sera, which often rely on tissue or embryo sources, and they set specific standards for ectoparasiticides, requiring segregation or dedicated facilities while emphasizing environmental and occupational safeguards. The guidelines also provide flexibility in sample retention, allowing representative sampling for large-volume premixes where retaining final packaged samples is impractical.

By codifying these unique provisions, the EAC framework provides manufacturers with a clear and practical pathway to compliance. For regulators, it creates a harmonised inspection standard that can be applied regionally, reducing duplication and fostering confidence in veterinary supply chains. Ultimately, this should improve the availability of safe, quality veterinary medicines in East Africa.

In Uganda, the publication of these guidelines comes at a time of policy transition. Under the proposed National Drug and Health Products Authority Bill, veterinary medicines will be removed from the mandate of the National Drug Authority (NDA) and placed under the Ministry of Agriculture, Animal Industry and Fisheries (MAAIF) through the forthcoming Agriculture and Food Safety Bill. This shift will likely mean that implementation of the EAC veterinary GMP framework will be led by the Ministry of Agriculture in the forthcoming years, reinforcing the need for careful coordination to avoid regulatory gaps.

As the new standards take hold, veterinary manufacturers will need to adapt quickly to ensure compliance.  This is where Regulix can provide value.

How Regulix Supports Veterinary Manufacturers

• Interpretation of guidelines: Tailored training for technical and regulatory teams to break down the new veterinary GMP requirements and map them against facility operations.
• Mock inspections & gap assessments: Facility-wide GMP audits aligned to the EAC framework, with detailed reports, risk prioritisation, and practical corrective action plans.
• Process optimisation: Guidance on managing shared beta/non-beta lactam facilities, sampling strategies for bulk premixes, and occupational/environmental safety measures for ectoparasiticides.
• Quality system strengthening: Development and revision of SOPs, quality manuals, and pharmacovigilance systems specific to veterinary medicines, embedding compliance into daily operations.
• Capacity building & sustainability: Hands-on workshops, mentorship for QA/QC teams, and strategies for sustaining compliance beyond a single inspection cycle.
• Regulatory liaison &, market access: Support in preparing regulatory submissions, engaging with national and EAC joint assessment teams, and positioning veterinary products for regional and international markets.

The publication of the EAC veterinary GMP guidelines marks an important milestone in regional harmonisation, giving veterinary products the dedicated attention they deserve. With GALVmed’s backing and the EAC’s commitment to stronger regulation, the framework provides both clarity and opportunity. For manufacturers, the task now is to embed these requirements into their operations. Regulix stands ready to guide the industry through this transition, ensuring compliance today while strengthening competitiveness for the future.