Food, drugs, cosmetics, and medical devices are highly regulated industries in the Philippines because these are products used by Filipino consumers on their own person which can affect their health and safety. For this reason, the Food and Drug Administration (FDA) was created to regulate these products.
Food, Drugs, Cosmetics, and Medical Devices in the Philippines
Food and Drug Administration (FDA)
The following establishments need a License to Operate (LTO) from the FDA before engaging in their designated activities: (1) manufacturers, traders, and distributors (importers, exporters, and wholesalers) of processed foods, drugs (including vaccines, biologics, and veterinary drugs and products), cosmetics, medical devices, in-vitro diagnostics devices and reagents, household/urban pesticides, toys, and child care articles; and (2) drugstores / pharmacies / boticas (including hospital pharmacies and institutional pharmacies), and retail outlets for non-prescription drugs. A valid LTO is required to register a product with FDA (Certificate of Product Registration).
The most highly-regulated products in FDA are drugs because these are ingested by humans. To sell, import or distribute an FDA-regulated product, a Certificate of Product Registration (CPR) is required for food, drugs, and medical devices, while a Cosmetic Product Notification (CPN) is needed for cosmetics. A valid LTO is required in order to apply for a CPR or CPN.
Product Importation and Registration
In order to jumpstart your business, we can help you:
- Register a company with SEC;
- Obtain a License to Operate from FDA;
- Obtain a Certificate of Product Registration or Cosmetic Product Notification from FDA; and
- Introduce you to national distribution, warehouse, and logistic companies, and national retail chain outlets and stores.
FDA License to Operate (LTO) Requirements
- Accomplished Application Form
- Proof of Payment of Fees
- Proof of Business Registration
- Proof of Occupancy (lease contract and duly notarized warehousing agreement for distributors)
- Product List (includes proposed brand name and label, business name and address of direct source, unique global identification number if applicable, etc.)
- For Food Manufacturers and Distributors: location map and floor plan/layout with dimensions
- Photocopy of Notarized Fixed Asset & Operating Capital or Financial Statement
- Credentials of Food Safety Compliance Officer or Regulatory Officer (Certificate of Attendance to FDA Licensing Seminar and Certificate of Attendance to GMP, HAACP, or Food Safety Seminar)
- Risk Management Plan
- Other requirements, depending on whether the entity is a manufacturer / processor, repacker, toll manufacturer, importer of raw materials for own use, importer-distributor of raw materials / finished products / ingredients / additives for distribution, distributor-exporter, distributor-wholesaler, and/or food trader
- Accomplished Application Form
- Proof of Business Registration
- Credentials of Pharmacist (Valid PRC ID, Certificate of Attendance to QPIRA)
- Risk Management Plan
- Location Plan
- Proof of Occupancy
- Picture of Drugstore with Display of Signage
- Site Master File
- Proof of Payment
- Self-assessment Toolkit
- Additional requirements for drugstores and retail outlets of non-prescription drugs to be verified upon inspection: agreement between francishor and franchisee if applicable; records or e-file of distribution records; prescription books; senior citizen and persons with disability record books; display of information; education and communication materials.
- Additional requirements for drug manufacturers to be verified upon inspection: quality management system; quality manual and standard operating procedures; contract agreement (e.g. manufacturing/packing/repacking agreement for manufacturer-trader, packing for manufacturer-packer, repacking for manufacturer-repacker); qualification and validation documents; master and batch production records; specifications; credentials of other qualified personnel; relevant reference materials; other procedures, protocols, records, and reports as required by PIC/s-GMP
- Additional requirements for drug distributors to be verified upon inspection: quality management system; quality manual and standard operating procedures; distribution agreement with foreign source/supplier/manufacturer authenticated by the territorial Philippine consulate; GMP certificates or equivalent document of contracted foreign manufacturers issued by the drug regulatory authority in the country of origin; credentials of other qualified personnel; relevant reference materials.
- Accomplished Application Form
- Proof of Business Registration
- Proof of Occupancy (lease contract and notarized warehousing agreement for third party logistics)
- Vicinity / Location Map, Floor Plan, Lay-out
- For Manufacturing Plant: Blueprint
- Credentials of Pharmacist or Any Health Science Professional with Relevant Training (PRC Board Certificate, Current Professional Tax Receipt, Certificate of Attendance to QPIRA, Certificate of Attendance to Training on the 13 ASEAN Cosmetic GMP Modules)
- Site Master File
- Risk Management Plan
- Proof of Payment of Fees
- Other requirements, depending on whether the entity is an exporter, cosmetic trader, and/or cosmetic manufacturer
- Accomplished Application Form
- Proof of Business Registration
- Proof of Occupancy (lease contract)
- Vicinity / Location Map, Floor Plan, Lay-Out
- Site Master File
- Risk Management Plan
- Credentials of Pharmacist or Any Other Qualified Professional (PRC ID, attendance to medical device QPIRA)
- Proof of Payment