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The Bureau of Food and Drugs BFAD was created under the Philippines Department of Health as the regulatory and enforcement organization for all food, drug, cosmetic, and related products.
If you are looking to import, retail, wholesale, distribute, manufacture, or export food, pharmaceuticals, 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 help consult with BFAD, one of the most complicated government office in the Philippines. Below you will find the requirements and procedures for applications. Contact Us for complete registration information.
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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 single proprietorship , a Certificate of Business Name Registration with Bureau of Trade Regulation
If Importer
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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
If Exporter
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Reference materials:
o R.A. 6675, Generics Act of 1988 and relevant implementing rules and regulations
o R.A. 5921, Pharmacy Law as amended and relevant implementing rules and regulations.
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Gather application and all requirements and submit to BFAD registration department.
Licensing Department will review requirements and application to make sure complete.
Physical inspection of office and facility. Submit report to licensing section of BFAD.
Total Process Time For the Registration of LTO is 2-3 weeks but can take up to 1-2 months for processing
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Master manufacturing procedure, Production equipment, Sampling and In-process controls, Master packaging procedure.
Stability study in accordance with Philippines national guidelines and ASEAN guidelines.
For foreign manufactured products, a copy of the Original Product Registration in the manufacturing country.
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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.
Entire product registration process can be completed in 2-4 weeks* from submission of requirements
*Depending on type of Product: Cosmetic 2-4 weeks, Food 1-2 months, Pharmaceutical 8 months - 1 year
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