Jinan Zhuocheng Bio-Tech Co., Ltd.

Colombia has recently issued two regulatory notices (SPS-COL-421 and SPS-COL-422) introducing stricter requirements for veterinary drug production, storage, registration, and market circulation. The new measures significantly raise market access thresholds and strengthen overseas inspection and registration renewal controls, drawing close attention from exporting companies.

According to SPS-COL-421, Colombia has implemented mandatory certification requirements across veterinary drug manufacturing and storage activities. Veterinary pharmaceutical manufacturers, contract production facilities, and semi-finished product processors are now required to obtain Good Manufacturing Practice (GMP) certification, while third-party warehousing providers must obtain Good Storage Practice (GSP) certification. The regulation also introduces detailed compliance requirements covering personnel management, facility operations, documentation and notarized translation, transitional arrangements, and penalty mechanisms. Notably, the Colombian Agricultural Institute (ICA) is authorized to conduct on-site inspections of overseas facilities, with all related costs borne by the companies, reflecting an expanded regulatory reach across global supply chains.

Under SPS-COL-422, Colombia further strengthens the management of veterinary product registration, renewal, and distribution. Companies, exported products, and third-party testing laboratories are required to complete registration renewals in phases based on product categories and timelines. The regulation also clarifies review timelines, supplementary documentation requirements, on-site inspection procedures, and renewal conditions. Importantly, company-level registration renewal is established as a prerequisite for product registration renewal, and failure to comply within the specified timeframe may result in the cancellation of registration status.

Analysts note that the two regulations together form a comprehensive regulatory framework covering the entire supply chain—from production and storage to market authorization. The introduction of overseas inspections, strict renewal linkage mechanisms, and phased compliance deadlines will significantly increase operational requirements for exporters in terms of regulatory management, documentation compliance, and supply chain responsiveness.

Industry experts advise that relevant companies should promptly align with the new requirements by completing GMP/GSP certification preparations, advancing registration renewal planning, strengthening Spanish-language documentation systems, and optimizing compliance timelines to ensure uninterrupted access to the Colombian market.