FDA Circular No. 2011-003-A
REVISION TO THE SCHEDULE OF FEES LISTED IN FDA CIRCULAR NO. 2011-003 DATED 24 JUNE 2011 ON THE COLLECTION OF LEGAL RESEARCH FEE IMPOSED BY REPUBLIC ACT NO. 3870, AS AMENDED BY PD 200 AND FURTHER AMENDED BY PD 1856
(NAR) VOL. 23 NO. 1, JANUARY - MARCH 2012)
[ FDA CIRCULAR NO. 2011-003-A, July 07, 2011 ]
REVISION TO THE SCHEDULE OF FEES LISTED IN FDA CIRCULAR NO. 2011-003 DATED 24 JUNE 2011 ON THE COLLECTION OF LEGAL RESEARCH FEE IMPOSED BY REPUBLIC ACT NO. 3870, AS AMENDED BY PD 200 AND FURTHER AMENDED BY PD 1856
Below is the revision to the Schedule of Fees listed in FDA Circular No. 2011-003 incorporating the corrections to the affected services and their corresponding Fee and Legal Research Fee.
A. Licensing of Establishment (In page 4) AO 50, s. 2001 Initial Renewal Fees for Licensing of Fee LRF Total Fee LRF Total Establishment 16. Others 16.2 Clearance to Import 300.00 10.00 310.00 Antibiotics 16.3 Amendment of LTO or Re- 500.00 10.00 510.00 Issuance B. Product Registration (In Pages 5 & 6) 1. Drugs 1.1 New Drug/Monitored20,000.00 200.00 20,200.00 Release 7.5 Re-Issuance of CPR (Lost 300.00 10.00 310.00 Reconstruction) 7.8.3 Review by ACB g. Protocol Amendment h. Extension of Monitored Release 1,000.00 10.00 1,010.00 i. Compassionate Special Permit except drugs for 6,000.00 60.00 6,060.00 cancer, HIV/AIDS, and other life threatening diseases) 500.00 10.00 510.00C. Laboratory Analysis (In Page 7) CLASSIFICATION 1.1 Drugs Vitamins Vitamin C ( Ascorbic Acid) 500.00 10.00 510.00 Adopted: 07 July 2011
(SGD.) SUZETTE H. LAZO, M.D., FPSECP Acting Director IV