Federal Decree by Law No. 21 of 2025 regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments.

This Decree by Law, comprising 94 articles, regulates the importation, manufacture, circulation, and licensing of Veterinary Medical Products, as well as the establishment and operation of Pharmaceutical Establishments engaged in activities related to such products. The Veterinary Medical Products regulated under the Decree by Law include (i) biological products and injectable supplements; (ii) raw materials; (iii) complementary products; (iv) medical devices; and (v) genetically modified organism (GMO) products intended for veterinary medical use. The Pharmaceutical Establishments licensed to operate in the field of Veterinary Medical Products in the State include (i) veterinary medical warehouses and storage facilities; (ii) manufacturers of Veterinary Medical Products and contract manufacturing organizations (CMOs); (iii) contract research and development organizations (CRDOs); (iv) veterinary non-clinical and clinical research entities; (v) pharmaceutical laboratories; (vi) bioequivalence centres; (vii) pharmaceutical consultancy offices; (viii) veterinary pharmacies; (ix) veterinary biobanks; and (x) marketing offices.
Under the Decree by Law, the Establishment (i) is responsible for classifying Veterinary Medical Products intended for importation, local manufacture, or circulation in the State based on their nature, composition, intended use, and potential risks to animal, human, and environmental health, in accordance with the applicable standards and controls; (ii) issues marketing authorizations for veterinary vaccines; (iii) may grant exclusive marketing authorizations for Veterinary Medical Products to eligible entities operating in the State, subject to the periods, conditions, and controls established by the Board of Directors; (iv) grants marketing authorizations for the importation, exportation, distribution, possession, display, sale, re-marketing, or manufacture of Veterinary Medical Products in the State for the purpose of circulation therein; (v) may issue conditional marketing authorizations for certain Veterinary Medical Products, including orphan products, products intended for the treatment of serious or life-threatening diseases, products unavailable in the State for which no equivalent alternative exists, and other products specified under the Executive Regulations, as well as veterinary vaccines; and (vi) may issue emergency use authorizations for certain Veterinary Medical Products required by the State in cases of public health emergencies, epidemics, or pandemics.
The Decree by Law establishes a regulatory framework for Veterinary Medical Products and Veterinary Pharmaceutical Establishments. Article 20 provides regulatory protection for documents and data relating to innovator Veterinary Medical Products and products containing new active ingredients, without prejudice to intellectual property legislation. Articles 33 and 34 regulate the importation, exportation, and re-exportation of Veterinary Consignments by requiring prior approval or permits from the Establishment, subject to applicable authorization, licensing, and compliance requirements, with the Establishment empowered to inspect, restrict, or prohibit products posing risks to human or animal health. Article 41 regulates the prescription and sale of Veterinary Medical Products by requiring prescriptions to be issued by licensed veterinarians, restricting the use of veterinary antibiotics, and requiring record-keeping by Veterinary Establishments. Articles 49 and 50 apply federal controls on controlled substances and regulate prohibited and restricted substances by limiting their manufacture, importation, exportation, re-exportation, and use in accordance with applicable requirements. Articles 52 and 53 require the maintenance of data, specifications, and approvals relating to Veterinary Medical Products and Veterinary Pharmaceutical Establishments in the relevant regulatory databases. Article 54 establishes the veterinary pharmacovigilance framework, requiring safety monitoring, reporting of adverse events, recalls, fraud, illicit trade, and quality defects, and authorizing the Establishment to investigate cases and take regulatory measures, including suspension or withdrawal of products. Articles 57 and 61 regulate the licensing of Veterinary Pharmacies and Veterinary Biobanks, respectively, requiring approval from the relevant authorities, compliance with technical and health requirements, and adherence to ownership and operational conditions. Article 57 also addresses compounding pharmacy activities and electronic services, while Article 61 regulates biological sample management systems and licensing of related units operating in artificial insemination centres.