Regulatory and Commercial Guide for Manufacturers, Importers, Warehouses, and Labs

In the United Arab Emirates, establishing and operating a business involving veterinary medical products requires strict licensing and regulatory compliance. With the issuance of Federal Decree-Law No. (21) of 2025 Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, the UAE has modernized its legal framework to ensure comprehensive oversight, quality assurance, and public health protection across animal-related pharmaceutical activities.

This guide explains the licensing requirements, identifies who must be licensed, and outlines the good practices that govern the manufacturing, storage, and distribution of veterinary pharmaceutical products in the UAE.

1. Why Licensing Matters?

Licensing is a legal requirement for any entity involved in veterinary pharmaceutical activities in the UAE. It ensures that products and establishments meet the high standards of quality, safety, and efficacy required by federal regulation. Operating without proper licensing carries significant administrative and criminal consequences, including fines and potential facility closure.

2. Who Needs a License? Veterinary Establishments Defined

Under the federal veterinary products law, the following entities qualify as Veterinary Pharmaceutical Establishments and must obtain appropriate licenses from the Emirates Drug Establishment (EDE) (or relevant competent authority):

a. Veterinary Medical Warehouses and Storage Facilities

These facilities are licensed to store and transport veterinary medical products. They must have a full-time licensed veterinarian or pharmacist managing operations, and are required to meet specific storage and handling criteria, such as controlled temperature, clean environment, and secure storage of hazardous substances.

b. Manufacturing Facilities & Contract Manufacturing Organizations (CMOs)

Companies that manufacture veterinary medical products — or provide contract manufacturing services for others — must obtain a manufacturing license from the EDE. Licensing conditions include:

• Appointment of a full-time licensed veterinarian or pharmacist to manage operations
• Obtaining a valid Good Manufacturing Practice (GMP) certificate
• Meeting all technical, health, and facility requirements as set out in the law and executive regulations

c. Veterinary Pharmacies

Retail establishments dispensing veterinary medical products directly to the public must be licensed and staffed by a full-time licensed veterinarian. Pharmacies that want to engage in compounding practices must also obtain a separate Good Compounding Practice (GCP) certificate.

d. Marketing Offices, Research Entities, and Labs

The law also covers marketing offices, contract research and development organizations (CRDOs), bioequivalence centers, and pharmaceutical laboratories — all of which must be licensed to conduct their respective activities within the UAE.

3. Licensing Process: Key Steps and Requirements

Although specific procedures may vary slightly depending on the establishment type, the general licensing workflow includes:

a. Initial Approval

Applicants typically start with an initial approval application, which verifies the facility’s location, business activity, and management credentials.

b. Documentation

For most facilities, documentation includes:

• Copy of a valid commercial license
• Proof of trade name approval from local authorities
• Property lease or ownership documents
• Credentials of the licensed professional (veterinarian or pharmacist) responsible for operations

c. Good Practice Certificates

Depending on the establishment type:

• GMP Certificate — required for manufacturing facilities and CMOs
• Good Storage and Distribution Practice (GSDP) Certificate — required for warehouses and storage facilities
• Good Compounding Practice (GCP) Certificate — required for compounding pharmacies

These certificates confirm the facility has structures, procedures, and quality systems aligned with internationally recognized standards.

d. Approval and Issuance

After submission, authorities review the application, inspect the premises if necessary, and issue the license with clear terms and validity. Licenses must be renewed periodically according to EDE regulations.

4. Good Manufacturing and Distribution Practices (GMP and GDP)

Good Manufacturing Practices

GMP compliance is crucial for obtaining a manufacturing facility license. It ensures that products are consistently produced and controlled according to quality standards. While GMP certification is issued by the EDE, audited facilities must demonstrate:

• Quality management systems
• Controlled production environments
• Documented standard operating procedures (SOPs)
• Qualified personnel and training programs

A GMP certificate is essential for manufacturing veterinary products intended for local market distribution or export.

Good Distribution and Storage Practices

Warehouses and storage facilities must demonstrate that they can preserve product integrity throughout the supply chain. This includes:

• Proper temperature control and monitoring
• Segregation of hazardous or controlled substances
• Secure storage areas
• Clean, ventilated, and pest-controlled environments

These standards are vital for ensuring that products remain safe and effective until they reach veterinarians, pharmacies, and end users.

5. Compliance and Enforcement

Operating outside the scope of a license or failing to maintain good practice standards is strictly prohibited. Establishments engaged in unlicensed activities or non-compliant practices face significant penalties, including fines and, in severe cases, criminal liability.

Conclusion

For businesses in the veterinary pharmaceutical sector, understanding and complying with the UAE’s licensing framework is foundational to lawful operations and commercial success. From warehouses and manufacturers to pharmacies, marketing offices, and laboratories, each establishment must secure the appropriate license and demonstrate adherence to GMP, GSDP, and other relevant good practice standards.

Ensuring compliance not only protects public and animal health but also positions companies to operate efficiently, avoid legal exposure, and compete in the UAE’s growing veterinary market.