Title
Rules on Veterinary Drugs Regulation
Law
Joint Doh And Da Administrative Order No. 2013-0026
Decision Date
Sep 24, 2013
The DOH-DA Joint Administrative Order No. 2013-0026 establishes rules and regulations for the regulation of veterinary drugs and products, ensuring the safety and efficacy of these products in the Philippines, while also outlining the responsibilities of the FDA and BAI in monitoring and licensing veterinary drug establishments.

Law Summary

Objectives

  • Facilitate licensing and registration of veterinary drugs, biological products, and establishments.
  • Avoid overlapping of regulatory functions between FDA and BAI.
  • Set policy direction for regulating veterinary drugs/products used exclusively for animals or both animals and humans.

Scope

  • Covers veterinary drugs, veterinary biological products, and establishments manufacturing, importing, or distributing such products under FDA jurisdiction.

Definition of Terms

  • "Registration": Approval process ensuring veterinary drugs/products are safe, effective, and of good quality.
  • "Veterinary Drugs and Products": Substances administered to animals for therapeutic, prophylactic, diagnostic, or physiological purposes.
  • Establishments classified as manufacturers, traders, distributors, importers, exporters, and veterinary drug outlets.
  • "Dosage Form": Pharmaceutical preparation form as per official pharmacopoeia.

General Guidelines

  • FDA registers veterinary drugs in pharmaceutical dosage forms (excluding feed-intended products).
  • BAI registers veterinary drugs/products intended solely for animal use, including biological products.
  • Both agencies license establishments involved in manufacturing, distributing, importing, exporting, and selling these products.

Specific Guidelines

A. Food and Drug Administration (FDA)

  • Registers finished pharmaceutical dosage forms (oral, injectables, external preparations, ophthalmic/otic).
  • Regulates active pharmaceutical ingredients and excipients for these products.
  • Licenses manufacturers, traders, distributors of these FDA-regulated products.
  • Monitors products and establishments under its jurisdiction except veterinary drug outlets.
  • Issues import permits for active pharmaceutical ingredients and raw materials for these products.

B. Bureau of Animal Industry (BAI)

  • Registers pre-mixes, feed additives, veterinary vaccines, biological products, grooming products, disinfectants, probiotics, and similar items intended solely for veterinary use.
  • Regulates active pharmaceutical ingredients and raw materials for BAI-classified products.
  • Licenses veterinary drug manufacturers, traders, importers, distributors, exporters, wholesalers, and outlets under its regulatory scope.
  • Monitors licensed establishments and products; responsible for regulation of veterinary outlets regardless of product classification.
  • Issues import permits for all veterinary products specified and their active pharmaceutical ingredients.

C. Procedure and Requirements

  • DA-BAI adopts FDA's existing licensing and registration procedures and requirements.
  • BAI provides technical inputs for any gaps, recommending policies and guidelines to FDA.

D. Continuing Collaboration

  • Both agencies, via Technical Working Groups, conduct joint activities and periodic reviews to ensure effective implementation.

Administrative Actions and Penalties

  • BAI assists FDA in investigating and hearing cases of violations related to manufacture, importation, distribution, and sale.
  • Procedures for enforcement follow existing Rules of Procedure under Republic Act No. 9711.
  • Penalties conform to those under Republic Act No. 9711 applicable to the covered veterinary products.

Suppletory Clause

  • Other existing applicable laws supplement provisions of this order.

Repealing Clause

  • This order supersedes the prior 1991 MOA between DOH-BFAD and DA-BAI.

Separability Clause

  • Invalidity of any part does not affect the remaining provisions' validity and effect.

Effectivity and Duration

  • Effective upon publication and filing, valid for five years or until mutually terminated.
  • Periodic reviews by Technical Working Groups ensure timely updates and recommendations.

Transitory Provision

  • Existing licensing and registration systems remain operative until new guidelines and regulations are fully established.

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