On May 16, 2025, Resolution No. 333/2025 (the “Resolution”) issued by the National Service for Agrifood Health and Quality (“SENASA” after its spanish acronym) was published in the Official Gazette. The Resolution establishes the procedure for authorization by equivalence for veterinary products that are registered, manufactured, and marketed in the countries listed in the annex to the Resolution.
The Resolution applies to all veterinary products, except for:
-Products containing agents targeting exotic or eradicated diseases not included in national health programs,
-Attenuated strains not circulating in Argentina,
-Circulating attenuated strains that are recombinant Genetically Modified Organisms (GMOs),
-Diagnostic kits for diseases not covered by national health programs.
To obtain authorization by equivalence, documentation must be submitted, which will be treated as a sworn statement.
Depending on the product, the required documentation includes:
– A valid Certificate of Free Sale (“CFS”), and
– The registration dossier submitted to and approved by the competent authority in the country of origin.
Additionally:
– If the product contains high-risk raw materials, supporting documentation must be submitted.
– For veterinary biological products containing replicative microorganisms, an epidemiological impact study must also be submitted to ensure the microorganism does not revert to virulence.
Once the equivalence authorization process is completed, a Certificate of Use of Veterinary Products (“CU”) will be issued, authorizing the company to market the product in the Argentine Republic.
Any product previously registered and marketed under the former regulatory framework that requires renewal and/or presents modifications to its approval conditions must renew the CU.
This measure came into force on May 16, 2025.
