March 02, 2025

The veterinary pharmaceutical industry in Kenya is governed by strict regulations to ensure the safety, efficacy, and quality of veterinary products. These guidelines, enforced by the Veterinary Medicines Directorate (VMD) and other relevant authorities, are crucial for manufacturers, importers, and distributors to comply with legal requirements. Below is a detailed overview of the key regulations for the veterinary pharmaceutical industry in Kenya.

1. Registration of Veterinary Medicines

Application Process

To register a veterinary medicine in Kenya, applicants must submit a dossier that includes:

  • A cover letter and completed application form.
  • Comprehensive product information, including active ingredient details.
  • Batch certificates of analysis.
  • Good Manufacturing Practice (GMP) certification for the manufacturing facility.
  • A non-refundable registration fee and, if applicable, a GMP inspection fee for facilities not previously inspected by the VMD.

Documentation Requirements

The application must also include:

  • A Site Master File detailing the manufacturing plant.
  • A pharmacovigilance plan for new chemical entities.
  • Six samples of the smallest commercial pack from a single batch for quality verification.

Review and Approval

The Veterinary Medicines Registration Committee evaluates applications for safety, efficacy, and quality before issuing a registration certificate.

2. Manufacturing and Importation

Manufacturing Permits

Before manufacturing veterinary medicines in Kenya, companies must obtain a manufacturing permit from the VMD. Compliance with Good Manufacturing Practices (GMP) is mandatory, and facilities are subject to regular inspections.

Importation Regulations

  • Importers must ensure that veterinary medicines are registered with the VMD and meet Kenyan standards.
  • Additional documents such as a Certificate of Pharmaceutical Product (CPP) may be required.
  • Imported products must adhere to the same quality and safety requirements as locally manufactured medicines.

3. Quality Assurance and Control

Good Manufacturing Practice (GMP)

All manufacturing facilities must adhere to GMP standards recognized by international bodies such as the World Organisation for Animal Health (WOAH) or the Kenya Bureau of Standards (KEBS).

Pharmacovigilance and Market Surveillance

The VMD conducts routine market surveillance and pharmacovigilance inspections to ensure veterinary medicines meet quality and safety standards. Companies must report any adverse reactions or defects.

4. Classification and Categorization

Classification of Veterinary Medicines

Veterinary medicines are categorized based on their use, safety profile, and dispensing requirements. Some require a prescription, while others can be sold over the counter.

Orphan Veterinary Medicines

Special provisions exist for medicines that are not commercially viable but are crucial for treating specific diseases in animals.

5. Distribution and Dispensing

Wholesaling and Retailing

  • Only licensed wholesalers and retailers can distribute veterinary medicines.
  • Products must be handled in their original packaging and stored under proper conditions.
  • Adherence to Good Distribution Practices (GDP) is mandatory.

Prescription and Dispensing

  • Only registered veterinary professionals can prescribe certain medicines, particularly antimicrobials, controlled substances, and vaccines.
  • Dispensing must align with regulatory guidelines to prevent misuse and antimicrobial resistance (AMR).

6. Advertisement Guidelines

Regulated Advertising

  • The promotion of veterinary medicines must be based on approved product information and VMD guidelines.
  • Misleading or unsubstantiated claims are strictly prohibited.
  • Any direct-to-consumer advertising is subject to regulatory scrutiny.

7. Regulatory Bodies and Compliance

Veterinary Medicines Directorate (VMD)

The VMD is the primary regulatory body overseeing veterinary medicines in Kenya. It works in collaboration with:

  • The Pharmacy and Poisons Board (PPB) for drug safety regulations.
  • The Kenya Bureau of Standards (KEBS) for product quality and GMP enforcement.
  • International organizations such as the WOAH and the Codex Alimentarius to align with global safety and efficacy standards.

Conclusion

Kenya's veterinary pharmaceutical regulations aim to protect animal health, ensure public safety, and maintain industry integrity. By complying with these guidelines, stakeholders—including manufacturers, importers, and distributors—can contribute to a robust and ethical veterinary pharmaceutical sector that supports agriculture, food safety, and sustainable animal health solutions.