FDA CIRCULAR NO. 2011-003-A, July 07, 2011

[ 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 Establishment Fee

LRF

Total

Fee

LRF

Total

16. Others

16.2 Clearance to Import Antibiotics 300.00

10.00

310.00

16.3 Amendment of LTO or Re-Issuance 500.00

10.00

510.00

B. Product Registration (In Pages 5 & 6)

1. Drugs

1.1 New Drug/Monitored Release

20,000.00

200.00

20,200.00

7.5 Re-Issuance of CPR (Lost Reconstruction)

300.00

10.00

310.00

7.8.3 Review by ACB

g. Protocol Amendment

h. Extension of Monitored Release

i. Compassionate Special Permit except drugs for cancer, HIV/AIDS, and other life threatening diseases)

1,000.00

10.00

1,010.00

6,000.00

60.00

6,060.00

500.00

10.00

510.00

C. 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