[ 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