Colombia Tightens Veterinary and Pharmaceutical Product Oversight Under New Compliance Framework

Colombia has implemented comprehensive regulatory measures to ensure compliance with Andean Community standards for veterinary and pharmaceutical products, including requirements for manufacturing, processing, and quality control, through the enforcement of ICA Resolution No. 00015843¹, the draft resolution on minimum indispensable complementarity², and the draft resolution on good practices in veterinary product facilities³.

COLOMBIA – VETERINARY PRODUCTS

Colombia Tightens Oversight of Veterinary and Pharmaceutical Goods

A new framework aligns manufacturers and importers with Andean Community standards.

What changed

Compliance with Andean rules is now mandatory for all manufacturing, processing, importation, and storage of pharmacological and veterinary products¹.

New registration procedures are established for companies and labs to standardize product approval and control².

Good manufacturing and storage practices are required for all facilities to prevent contamination and disease³.

Who it affects

Manufacturers and processors of veterinary products must adhere to new hygiene and safety protocols³.

Importers and storage facilities must ensure all products meet the Andean Community technical standards¹.

Testing laboratories must follow new procedures for product registration and renewal².

What to do

Ensure all operations comply with Andean Community Decision No. 960 of 2025¹.

Implement and document good manufacturing and storage practices across all facilities³.

Colombia — veterinary and pharmaceutical product compliance framework

Colombia has established a unified regulatory framework for pharmaceutical and veterinary products, including antiseptics, disinfectants, and insecticides, to align with the Andean Community’s technical standards and ensure animal health and safety. The country has issued ICA Resolution No. 00015843 to mandate compliance with Decision No. 960 of 2025 and its technical manual, covering all stages from manufacturing to storage, for both domestic and foreign entities¹. Additionally, a draft resolution on minimum indispensable complementarity outlines administrative procedures, documentation, and timelines for product and laboratory registration, reinforcing transparency and risk control². A third measure, a draft resolution on good practices, requires manufacturers, contract processors, and storage facilities to adhere to strict hygiene and safety protocols to prevent contamination and disease spread in animal production³.

Compliance with Andean Community Standards

Colombia has formalized the implementation of Andean Community Decision No. 960 of 2025 through ICA Resolution No. 00015843, which establishes mandatory requirements for all entities involved in the manufacturing, processing, importation, and storage of pharmacological and biological products, as well as veterinary antiseptics and disinfectants¹.

Registration and Administrative Procedures

A draft resolution establishes standardized administrative procedures for the registration, updating, renewal, and control of companies and laboratories producing veterinary products, ensuring alignment with the Andean sanitary framework and minimizing health risks to animals².

Good Manufacturing and Storage Practices

Colombia proposes to enforce good manufacturing and good storage practices across all facilities involved in the production, semi-processing, or storage of veterinary products, including pharmacological, biological, and disinfectant-based items, to reduce biological and chemical risks to animal health³.