Drugs BFAD Registration | Pharmareg Inc | Philippines SEC Processing Company


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BFAD/FDA

SERVICES OFFERED (BFAD/FDA)

F.D.A. (Food and Drug Administration)(F.D.A.)


FORMERLY KNOWN AS THE BUREA OF FOOD DRUG (B.F.A.D.)

We provide the most comprehensive service to enable you, our client, to obtain the Certification of Product Registration (C.P.R.) in accordance with the current requirements. The C.P.R. is the initial legal requirement to enable our client to import distribute their pharmaceutical products throughout the Philippines. The following list the various categories for which a C.P.R. is required.

Pharmaceutical Regulatory Services:

    I. Registration Pharmaceutical (Drugs) ( Generic or Branded)
        1) Adoption of the Association of Southeast Asian Nations Common
Technical Documents (ACTD)
        2) Registration of Vaccines/Biologic Products
        3) Registration of Herbal Medicines
        4) Registration of Traditionally-Used Herbal Products
        5) Registration of Veterinary Use
        6) Registration of Medical Oxygen
        7) Availing of Compassionate Special Permit (CSP)
        (except for cancer, HIV/Aids, and other life threatening disease)

    II. Registration Food Products
        Registration of Imported Food Products (Category I & II)of Locally Manufactured Food Productsof Food Supplement of Virgin Coconut Oil (VCO)for Water Purification Equipment and Device


    III. Registration Cosmetics
        Registration of Cosmetic Specialtiesof Hazardous Substancesand Export of Cosmetic Products


    IV. Registration of Medical Devices
        1) Registration of Medical Devices and Diagnostic Reagents


C) Application for License to Operate (FDA) referred to as Establishment Licensing
Certificate being issued to a licensed manufactured/trader/importer/distributor for the
Distribution and/or sale of a cosmetic specialty qualified for listing.

    I. Manufacturer/Trader/Packer/Repacker
        1) Food
        2) Drug/Medical Device/Cosmetic
        3)House Hazardous Substances

    II. Distributor/Importer/Drug Outlets
        FoodSaltReagentDevice & CosmeticHazardousPharmacy/RONPD

D) Application for Philippine Drug Enforcement Agency (PDEA) to handle Dangerous Drugs/ Dangerous Drug Preparation/s/ Controlled/s used in the manufacture of drug preparation &/or their Drug Preparation/s.

    I. Permits & License
        1) Retail Dealer of Dangerous Drug Preparations(DDPs)
        2) Wholesaler Dealer of (DDPs)
        3) Manufacturer/Repacker of (DDPs)
        4) Importer/Exporter of (DDPs)
        5) Importer/Exporter Of Controlled Precursors and Essential Chemicals (CPECS)


        

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