BFAD BUREAU CIRCULAR NO. 4, S. 1999, February 03, 1999

[ BFAD BUREAU CIRCULAR NO. 4, S. 1999, February 03, 1999 ]

NEW PROTOCOL FOR REGISTRATION OF DRUGS, FOODS, COSMETICS, AND MEDICAL DEVICES

Effective February 4, 1999 the following changes in registration protocol will be implemented:

Samples for physico-chemical analysis are not required. However, samples may be submitted for physical evaluation or specification verification;

Complete documentation to support claims of safety, efficacy, identity, and quality must be submitted. Approval/disapproval will be based on completeness of submitted documents.

For your guidance.

Adopted: 3 Feb. 1999

(SGD.) WILLIAM D. TORRES Director