On September 30, 2025, the Andean Community (CAN) Commission published Decision 960, a regulation that establishes harmonized requirements for the registration, control, commercialization, importation, manufacturing, and use of veterinary products in the Member Countries. Its main objective is to facilitate intra-community trade while reducing risks to animal health, public health, and the environment.
Below is a summary of the most relevant aspects that directly impact manufacturers, importers, storage facilities, laboratories, and distributors in the veterinary sector.
1. Scope of application and exclusions
The regulation applies to the registration and control of natural or legal persons engaged in the manufacturing or production, contract manufacturing or production, semi-processing, importation, storage, and quality control of pharmacological and biological products; ectoparasiticides, insecticides, and repellents; antiseptics; and disinfectants, sanitizers, and detergents for veterinary use, as well as their raw materials, intended for terrestrial and aquatic animals. It also covers the registration and control of these products in the Member Countries of the Andean Community.
The decision does not apply to the registration and control of foot-and-mouth disease vaccines, autogenous vaccines, animal feed, phytotherapeutic medicines, homeopathic products, cosmetics, compounded preparations, officinal preparations, and floral essences for veterinary use. However, the pharmacovigilance provisions established in the Decision do apply to these products.
Regarding the registration and control of the commercialization of veterinary products sold in retail establishments, only the provisions in force in each Member Country shall apply.
2. Registration of companies (manufacturers, importers, storage facilities, and laboratories)
Mandatory registration before the National Competent Authority (ANC) is required for every establishment that manufactures, imports, stores, or performs quality control of veterinary products.
3. Registration of veterinary products
Every veterinary product must be registered beforehand with the ANC of each Member Country to be manufactured, marketed, imported, or used. The exception applies to products manufactured in Member Countries that are exclusively intended for export and are not marketed in the country of origin; however, the manufacturer must be registered and must notify the ANC of the country of origin annually.
4. Validity and renewal of registrations
- Company registration: valid for 10 years.
- Product registration: valid for 10 years.
5. Importation of veterinary products
To import a veterinary product, the product must be registered in the Member Country, and the company must be registered as an importer or be the holder of the product registration.
Exceptional cases allowed without product registration:
- Importation for individual use with veterinary prescription
- Importation for research or experimental testing
In both cases, commercialization is not permitted.
6. Transitional provisions and entry into force
- Companies and products registered under previous regulations have 5 years to update their registrations, extendable for an additional 5 years only for products.
- A 5-year period is granted to implement quality management systems where they do not yet exist.
- The Decision enters into force 12 months after its publication in the Official Gazette.
- It repeals Decisions 483, 769, 813, 838, and 904, with a partial exception for Peru.
7. Practical recommendations for companies in the sector
Companies are advised to:
- Review all current registrations and plan updates within the transitional deadlines;
- Verify the implementation of quality management systems;
- Ensure that contracts with laboratories or storage facilities comply with the requirements of the Decision.
We would be delighted to provide further information. For more details, please contact us at:
María Rosa Fabara Vera: mrfabara@bustamantefabara.com
Andrés Becdach Fierro: abecdach@bustamantefabara.com
Luis Rivadeneira Pinargote: lrivadeneira@bustamantefabara.com
Tomás Bonilla Sevilla: tbonilla@bustamantefabara.com