Question & AnswerQ&A (BFAD BUREAU CIRCULAR NO. 07, S. 2004)
Republic Act No. 3720, also known as the Foods, Drugs and Devices, and Cosmetics Act, as amended by Executive Order No. 175.
The Bureau of Food and Drugs (BFAD) has jurisdiction over the registration of veterinary drug products.
The MOA was entered into to identify the responsibilities of each bureau to avoid redundancy and improve efficiency in the regulation of veterinary products.
Veterinary products under BFAD jurisdiction include oral dosage forms (tablets, capsules, syrups, suspensions, solutions, powders), injectable preparations (except biological products), external preparations with therapeutic claims (creams, ointments, shampoos, liniments, powders, oral paste/gel), accessories or devices with therapeutic claims (e.g., dog collars), and disinfectants directly used or applied to animals.
Biological injectable products are not under BFAD jurisdiction; they remain under the jurisdiction of the Bureau of Animal Industry (BAI).
Veterinary products not listed under BFAD jurisdiction are considered to be under the jurisdiction of the Bureau of Animal Industry (BAI).
Effective July 2004, all finished veterinary pharmaceutical products, including devices and accessories, must be applied for initial registration with BFAD.
Companies were directed to simultaneously apply for an extension of the validity of their registration at BAI until December 2005 while applying for registration with BFAD.
No, raw materials for veterinary products are not included under BFAD jurisdiction according to the circular.
BFAD Bureau Circular No. 07, series of 2004, adopted the guidelines regarding the registration of veterinary products effective 03 June 2004.