FDA Product Registration in the Philippines: What Manufacturers Must File

Under Republic Act No. 9711, the Food and Drug Administration (FDA) Act of 2009, no health product may be manufactured, imported, exported, sold, offered for sale, distributed, transferred, promoted, advertised, or sponsored unless it is registered with the FDA. Registration is the process of approval of an application to register a health product before any of those commercial activities may lawfully begin. It is separate from licensing, which is the approval to operate the establishment itself. Both are required, and both are issued by the FDA.

What counts as a health product

Under Section 10 of Republic Act No. 9711, health products means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, and household or urban hazardous substances, or any combination or derivative of these. It also covers products that may affect health and that the FDA determines require regulation.

Food is defined as any processed substance intended for human consumption, including drinks, beverages, and chewing gum, as well as any substance used as an ingredient in the manufacture, preparation, or treatment of food. Food and dietary supplements are treated as a distinct category — processed food products intended to supplement the diet that contain vitamins, minerals, herbs or other botanicals, amino acids, or dietary substances, usually in capsule, tablet, liquid, gel, powder, or pill form.

Who must file

The FDA regulates establishments as well as products. Under Section 10, an establishment includes a sole proprietorship, partnership, corporation, institution, association, or organization engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of health products, including the facilities needed for those activities.

A manufacturer is an establishment engaged in any and all operations involved in producing health products — preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing, and labeling — with a view to storage, sale, or distribution. The term does not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. A trader is categorized as a manufacturer. A trader is a registered owner of a health product that procures raw materials and packaging components, provides production monographs and quality control standards, but subcontracts manufacture to a licensed manufacturer.

The registration and licensing path

Registration and licensing are two distinct approvals under the law, and the FDA's Centers handle them through their Licensing and Registration Division, which evaluates health products and establishments for the issuance of authorizations.

1. Determine the product category. The FDA has separate centers per major product category: the Center for Drug Regulation and Research (including veterinary medicine, vaccines, and biologicals), the Center for Food Regulation and Research, the Center for Cosmetics Regulation and Research (including household hazardous and urban substances), and the Center for Device Regulation, Radiation Health, and Research.
2. Secure the license to operate. Section 11 makes it a prohibited act to manufacture, import, export, transfer, or distribute food, cosmetics, or household or urban hazardous substances — or to manufacture, import, export, sell, offer for sale, distribute, transfer, or retail drugs, devices, or in-vitro diagnostic reagents — without the license to operate required under the Act.
3. Register the product. Section 11 likewise prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any health product which, although requiring registration, is not registered with the FDA.
4. Expect testing where applicable. Under Section 5, the FDA conducts appropriate tests on all applicable health products prior to issuing authorizations, to ensure safety, efficacy, purity, and quality. The Laboratory Support Division handles tests, calibration, analyses, and trials, including assays.

An authorization under Section 10 is the permission granted by the FDA to a person who has submitted an application. It may take the form of a permit, a license, a certificate of registration, of accreditation, of compliance, or of exemption, or any similar document.

Penalties for selling unregistered products

Section 11 prohibits dealing in any health product that is adulterated, unregistered, or misbranded. Under Section 12, a violation carries imprisonment of one to ten years, a fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00), or both.

If the offender is a manufacturer, importer, or distributor of a health product, the penalty is heavier: at least five years but not more than ten years of imprisonment and a fine of at least Five hundred thousand pesos (P500,000.00) but not more than Five million pesos (P5,000,000.00). An additional fine of one percent of the economic value or cost of the violative product, or One thousand pesos (P1,000.00), whichever is higher, is imposed for each day of continuing violation.

Administrative penalties may be imposed separately. Under Section 29-A, after notice and hearing, the director-general may cancel or suspend an authorization for up to one year, impose a fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00) with an additional fine of not more than One thousand pesos (P1,000.00) per day of continuing violation, and order destruction or disposition of the product or closure of the establishment.

Frequently asked questions

Is FDA registration required before I can sell my food product in the Philippines? Yes. Section 11 prohibits the manufacture, importation, sale, offering for sale, distribution, or transfer of any health product which, although requiring registration, is not registered with the FDA. Food is a health product under Section 10.

What is the difference between an FDA license to operate and product registration? Licensing is the approval of an application to operate or establish an establishment before engaging in regulated activities. Registration is the approval of an application to register the health product itself. Both are required.

What happens if I sell an unregistered health product? The FDA may issue a cease and desist order, and both criminal and administrative actions may be instituted separately and independently of each other under Section 26.

Practical takeaways

• Registration is mandatory before manufacture, importation, sale, distribution, promotion, or advertising of any health product.
• Licensing of the establishment and registration of the product are separate approvals; both must be secured.
• The applicable FDA center depends on the product category — food, drug, cosmetic, or device.
• Penalties for unregistered products reach up to ten years of imprisonment and Five million pesos for manufacturers, importers, and distributors.
• Administrative sanctions, including cancellation of authorization and fines, may run alongside criminal cases.

Primary sources

The rules discussed above are drawn from the following primary sources, as published in the Official Gazette and the national statute book.

• REPUBLIC ACT NO. 9711 - AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED, AND APPROPRIATING FUNDS THEREOF

This article is general information and not legal advice. For your specific situation, consult a lawyer or ask ASG Legal AI.