BFAD BUREAU CIRCULAR NO. 6, S, 1999, February 15, 1999

[ 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

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