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(NAR) VOL. 15 NOS. 3-4 / JULY - SEPTEMBER 2004

[ BFAD BUREAU CIRCULAR NO. 07, S. 2004, June 03, 2004 ]


R.A. 3720 (Foods, Drugs and Devices, and Cosmetics Act) as amended by E.O. 175 defines drug products to include both veterinary and human use.  Therefore, registration of these products is under BFAD jurisdiction.

A Memorandum of Agreement (MOA) between the Bureau of Food and Drugs and the Bureau of Animal Industry was entered into in 1991 to identify the responsibilities of each Bureau to avoid redundancy and improve efficiency.

To clarify, the following veterinary products shall be under BFAD jurisdiction, which do not include raw materials:

§ Oral dosage forms but not limited to tablets, capsules, syrups, suspensions,solutions, powder, powder for solution/suspension

§ Injectable preparations except biological products

§ External preparations such as creams, ointments, shampoo, liniments, powder, oral paste/gel, and the like with therapeutic claims

§ Accessories, devices such as dog collars with therapeutic claims

§ Disinfectants that are directly used or applied to the animal

Products, which are not included in the list above, shall be considered within the jurisdiction of BAI.

Effective July 2004 all finished products in pharmaceutical dosage forms including devices and accessories must be applied for initial registration to BFAD.  Companies with current registration of veterinary products in pharmaceutical dosage forms at the Bureau of Animal Industry (BAI) which are due for renewal are directed to simultaneously apply for extension of the validity of registration until December 2005 at BAI.

For information and guidance.

Adopted: 03 June 2004

(SGD.) Prof. Leticia Barbara B. Gutierrez, M.S.
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