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.