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(NAR) VOL. 10 NO. 2 / APRIL - JUNE 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:
  1. Samples for physico-chemical analysis are not required. However, samples may be submitted for physical evaluation or specification verification;

  2. 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
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