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FDA - Required Documents for Licensing of Establishments

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					TYPE OF ESTABLISHMENTS:            Manufacturer/ Trader/ Packer/ Repacker
PRODUCT TYPE:                      Medical Device/ Drug/ Cosmetics




I.        APPLICATION TYPE: Initial/ Opening

          1. Checklist of Requirements Cosmetics, Drugs, Food, HHS, Medical Device and
              Diagnostic Reagents of manufacturers/ Outlets
          2. Sample Forms
             a. Petition to Open Cosmetic, Drug, HHS, Medical Devices and Diagnostic Reagents
                Establishments
             b. Joint Affidavit of Undertaking
          3. Fees for Manufacturer/ Trader/ Packer/ Repacker of Cosmetic, Drugs, HHS, Medical
             Device and Diagnostic Reagents


Fees for Licensing of Establishments Regulated by BFAD (LTO)
As per AO 50 s. 2001

                                                              Initial (1 Year Validity)

                                                                            Fees (Pesos)
                          Classification


1. Drug Manufacturer
   1.1 20 Million and below                                                  10,000.00
   1.2 over 20 Million but below 50 Million                                  15,000.00
   1.3 50 Million and above                                                  20,000.00
2. Drug Trader
   2.1 20 Million and below                                                   3,000.00
   2.2 over 20 Million but below 50 Million                                   5,000.00
   2.3 50 Million and above                                                   7,000.00
3. Cosmetics Manufacturer
   3.1 20 Million and below                                                   5,000.00
   3.2 over 20 Million but below 50 Million                                  10,000.00
   3.3 50 Million and above                                                  15,000.00
4. Cosmetics Trader
   4.1 20 Million and below                                                   3,000.00
   4.2 over 20 Million but below 50 Million                                   5,000.00
   4.3 50 Million and above                                                   7,000.00
5. Medical Device Manufacturer
   5.1 20 Million and below                                                   5,000.00
   5.2 over 20 Million but below 50 Million                                   7,000.00
   5.3 50 Million and above                                                  10,000.00
6. Medical Device Trader
   6.1 20 Million and below                                                   3,000.00
   6.2 over 20 Million but below 50 Million                                   5,000.00
   6.3 50 Million and above                                                   7,000.00
7. Others
   7.1 Pre-Site Inspection of Establishments                     - 500.00 +cost of transportation &
                                                                 accommodation if outside M.Mla.

     7.2 Clearance to Import Antibiotics                         - 300.00
     7.3 Amendment of LTO or Re-issuance (if lost)               - 500.00
     7.4 Addition or deletion of sources                         - 50.00 / source; 300 if > 5
                                                                 sources
     7.5 Certification/Clearance for BOC purpose and             - 300.00
         Donation
     7.6 Change of business name/address of supplier             - 300.00
Note:
1. The fees charged for manufacturers and traders of products regulated by BFAD are based on the
capital invested.
2. Renewal of LTO shall be on the anniversary of its issuance and shall be valid for two years.

II.     APPLICATION TYPE: Renewal

        1. Process Flow Chart – Renewal of LTO for Cosmetics, Drugs, Food, HHS, Medical Device and
           Diagnostic Reagents
        2. Application Form for the Renewal of LTO Cosmetics, Drugs, Food, HHS, Medical Device and
           Diagnostic Reagents


III.    APPLICATION TYPE: Amendment/ Changes of Circumstances

        1. Checklist of Inclusion/ Deletion of Toll Manufacturer/ Repacker/ Trader/ Source/ Product/
           Activity for Cosmetics, Drugs, Food, HHS, Medical device and Diagnostic Reagents


IV.     OTHER SAMPLE DOCUMENTS:

        1.   BOC Checklist of Requirements
        2.   GMP Authentication
        3.   GMP Certification
        4.   LTO Sample 1st page with expiry date
        5.   LTO Sample 2nd page
        6.   Pharmacist Affidavit Clearance and Sample Lay-Out
        7.   SEC Activity
        8.   SEC Address
        9.   SEC Business Name

				
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Description: Food and Drug Administration - Required Documents for Licensing of Establishments