BFAD BUREAU CIRCULAR NO. 4, S. 1999, February 03, 1999
NEW PROTOCOL FOR REGISTRATION OF DRUGS, FOODS, COSMETICS, AND MEDICAL DEVICES
National Administrative Register February 3, 1999
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