BFAD BUREAU CIRCULAR NO. 6, S, 1999, February 15, 1999
REVISED BUREAU CIRCULAR NO. 4, S. 1999 “NEW PROTOCOL FOR REGISTRATION OF DRUGS, FOODS, COSMETICS, AND MEDICAL DEVICES
National Administrative Register 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