Title
BFAD: Register vet products, excl. raw mats
Law
Bfad Bureau Circular No. 07, S. 2004
Decision Date
Jun 3, 2004
Effective July 2004, the Bureau of Food and Drugs (BFAD) mandates the registration of veterinary products, including oral and injectable forms, external preparations, and therapeutic devices, while delineating responsibilities with the Bureau of Animal Industry to enhance regulatory efficiency.
A

Memorandum of Agreement Between BFAD and Bureau of Animal Industry (BAI)

  • A MOA was established in 1991 to delineate responsibilities between BFAD and BAI.
  • The MOA aims to prevent duplication of efforts and improve regulatory efficiency.

Scope of Veterinary Products Under BFAD Jurisdiction

  • Veterinary products regulated by BFAD exclude raw materials.
  • Included products are:
    • Oral dosage forms: tablets, capsules, syrups, suspensions, solutions, powders, and powder for solutions/suspensions.
    • Injectable preparations, excluding biological products.
    • External preparations with therapeutic claims: creams, ointments, shampoos, liniments, powders, oral pastes/gels.
    • Accessories and devices with therapeutic claims: e.g., therapeutic dog collars.
    • Disinfectants applied directly to animals.

Products Under BAI Jurisdiction

  • Veterinary products not listed under BFAD jurisdiction are regulated by BAI.

Registration and Renewal Procedures

  • Effective July 2004, all finished veterinary products in pharmaceutical dosage forms, including devices and accessories, must be initially registered with BFAD.
  • Companies with existing registrations at BAI must apply simultaneously for extension of registration validity until December 2005 during renewal.

Regulatory and Administrative Notes

  • The circular serves as guidance and information for concerned stakeholders.
  • Issued on June 3, 2004, under the authority of Prof. Leticia Barbara B. Gutierrez, M.S., Director.

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