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Argentina Authorizes FMD Vaccine Imports by Equivalence, Allows Testing in Country of Origin

Officials project sizable producer savings from new competition.

Overview

  • Senasa published Resolutions 749/2025 and 750/2025, putting the new import framework into force via the Boletín Oficial.
  • Resolution 749/2025 amends 609/2017 to add Article 57 bis, exempting FMD vaccines entering under the equivalence pathway from long‑standing local habilitation requirements.
  • Resolution 750/2025 creates Article 4 bis to accept official control of commercial batches in the manufacturing country under recognized international standards once a CUC is granted.
  • The measures were signed by Senasa president María Beatriz Giraudo, and Minister Federico Sturzenegger said potential savings could reach about USD 100 million a year if prices align with Paraguay.
  • Domestic laboratory groups showed tension over the opening, and prior technical hurdles remain relevant, including a February Senasa report that halted Tecnovax’s Ourovac batch over thermal stability failures.