tinuod ni ug tested nasab ni nga produkto, daghan na ang naghulat niani nga mapalit sa tindahan kaso lang wala pa kini na-aprobahi sa BFAD tungod kay wala ko'y sapi para i-gastos niining mga halos 1-ka kilometer nga requirements.
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The FDA Philippines (Formely the Bureau of Food and Drugs) was created under the Philippines Department of Health as the regulatory and enforcement organization for all food, drug, cosmetic, meadical equipment, and related products.
If you are looking to import, retail, wholesale, distribute, manufacture, or export food, pharmaceuticals, food, or health and beauty products most likely will need to register with BFAD for your License to Operate LTO and register any products you wish to work with. An LTO must be secured before you are able to do any product registration with BFAD.
Each product that you wish to work with must undergo a separate product registration process. Depending on the classification, food, food supplement, drug, or cosmetic, there is a vastly different registration requirement and processing time.
Triple i Consulting has a full time pharmacist on staff to consult with BFAD, one of the most stringent government offices in the Philippines. Below you will find the requirements and procedures for applications. Contact Us for complete registration information.
Requirements for License to Operate
Please see our guide on License to Operate
Accomplished Petition Form/Joint Affidavit of Undertaking Duly Notarized.
List of Products to be distributed identified by generic names and brand names intended for use.
Copies of Pharmacist Board Registration Certificate, PRC_ID, valid PTR, ID picture, Duties and Responsibilities.
Certificate of Attendance of Owner/Pharmacist to a BFAD seminar on Licensing of Drug Establishments and Outlets in the Philippines.
Locational Plan and Floor Plan (Office and Storage Room) with dimensions.
If a corporation, Certificate of Registration with SEC and Articles of Incorporation/Partnership.
If single proprietorship, a Certificate of Business Name Registration with Bureau of Trade Regulation and Consumer Protection (BTRCP)
Contract of Lease for the space to be occupied.
If Importer
A duly authenticated (by the Territorial Philippine Consulate), Foreign Agency Agreement FAA from each supplier.
Certificate of Registration of manufacturer and its conformity with Good Manufacturing Practices From Health Authority authenticated by Philippine Consulate.
If Wholesaler
A Valid current contract with BFAD licensed supplier/manufacturer
A certificate that the products supplied are registered with BFAD
Copy of LTO from supplier/manufacturer
If Exporter
A Valid current contract with BFAD licensed supplier/manufacturer
A certificate that the product supplied are registered with BFAD
Copy of LTO from supplier/manufacturer
The Following Must also be Presented Upon Application for LTO
Reference materials:
Philippine National Drug Formula
- R.A. 3720, Food, Drugs, Devices & Cosmetic Act
- R.A. 6675, Generics Act of 1988 and relevant implementing rules and regulations
- R.A. 5921, Pharmacy Law as amended and relevant implementing rules and regulations.
Any one of the following reference books:
- United State Pharmacopoeia/National Formulary (USP/NF) latest edition
Remington’s Pharmaceutical Sciences (latest edition)
- Goodman & Gilman Pharmacological Basis of Therapeutics (latest edition)
Batch Distribution Record Book
Procedure for Securing LTO
Gather application and all requirements and submit to BFAD registration department.
Interview with Food and Drug Registration Office FDRO.
Licensing Department will review requirements and application to make sure complete.
Receive Order for Payment to FDRO and receive completed application.
Physical inspection of office and facility. Submit report to licensing section of BFAD.
Director Approval of LTO.
Release of documents to applicant
Total Process Time For the Registration of LTO is 2-3 weeks but can take up to 1-2 months for processing
Requirements for Product Registration with BFAD
Please see our guide on Product Registration from BFAD
Accomplished application form No.1 and No. 8 Duly Notarized.
Copy of valid contract between manufacturer and trader/distributor/seller/exporter/importer.
Copies of valid LTO's for manufacturer/trader/distributor/seller/exporter/importer.
Unit Dose and Batch Formulation in Metric System.
Technical specification on all Raw Materials.
Certificate of Analysis on raw materials and finished product from manufacturer.
Technical Specification on finished Product.
Master manufacturing procedure, Production equipment, Sampling and In-process controls, Master packaging procedure.
Assay on test procedures and data analysis if applicable.
Stability study in accordance with Philippines national guidelines and ASEAN guidelines.
Representative sample of packaging and labeling materials for commercial market.
Copy of ACB approval
For foreign manufactured products, a copy of the Original Product Registration in the manufacturing country.
Procedure for Product Registration with BFAD
Submission of application and all requirements to Public Assistance Information and Compliance Section of BFAD for assessment.
Accounting and billing department to asses registration fees to be paid at cashier.
Product services division of BFAD will evaluate all the requirements and prepare endorsement for Certificate of Registration.
Director signs Certificate of Registration and Product Registration documents can be picked up from BFAD.
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