REVISED BUREAU CIRCULAR NO. 4, S. 1999 “NEW PROTOCOL FOR REGISTRATION OF DRUGS, FOODS, COSMETICS, AND MEDICAL DEVICES
National Administrative Register [ BFAD BUREAU CIRCULAR NO. 6, S, 1999, February 15, 1999 ]
Effective immediately, the following changes in the registration protocol will be implemented:
- Samples for physico-chemical analysis are not required. However, sample product in commercial presentation shall be submitted for physical evaluation or specification verification;
- Complete documentation to support claims of safety, efficacy, indentity and quality must be submitted. Approval/disapproval by Product Services Division will be after evaluation based on completeness and accuracy of submitted documents.
- No follow-up by regulatory officers or company representative will be entertained before the 90 day period following acceptance of the application as provided by PAICS.
For your guidance.
Adopted: 15 Feb. 1999
(SGD.) WILLIAM D. TORRES, PH.D.
Director