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Manila, November 2025. The Philippine Food and Drug Administration (FDA) has released a draft Circular that standardizes how human medicines are classified and reclassified nationwide. The proposal replaces legacy “ethical/OTC” labels with a risk-based framework comprising prescription products and two non-prescription tiers: pharmacist-only and general-sales (which includes household remedies). The draft implements the FDA Act of 2009 and the Philippine Pharmacy Act and aligns with Department of Health Administrative Order 2024-0013 on registration rules.

Scope and policy basis

The Circular applies to all FDA-licensed pharmaceutical establishments handling medicines for human use. It links classification to product risk and intended patient access, and sets operational rules for both initial classification and subsequent reclassification.

The three access categories

a. Prescription pharmaceutical products

Assigned where medical supervision is necessary due to risks such as misuse or dependency, the need for additional safety monitoring, parenteral administration, or radiation-emitting characteristics. Dispensing requires a valid prescription and a licensed pharmacist.

b. Pharmacist-only non-prescription products

Covers medicines that do not meet prescription criteria but still require professional oversight. Supply is restricted to licensed retail pharmaceutical establishments under a pharmacist’s direct supervision.

c. General-sales non-prescription products (including household remedies)

Intended for self-selection when warnings are readily understood and the risk of misuse or misdiagnosis is minimal. A subset may be designated household remedies if they contain common actives used for minor ailments.

Classification at registration

Applications must indicate the correct class at submission; filings under the wrong class are not accepted because documentation differs. New actives not yet on FDA’s list are assigned a class during pre-assessment. Fixed-dose combinations are classified conservatively based on the most stringent active, and drug kits/combination packs follow the most stringent item they contain.

Reclassification rules

Movement to a less stringent class proceeds stepwise. FDA may up-classify without a company request where safety evidence warrants it, considering international classifications, post-marketing safety data, and the risk of inappropriate use without supervision. Following any reclassification, Market Authorization Holders must file a post-approval change (PAC) so labels and records reflect the new class; a new Certificate of Product Registration (CPR) is issued. Stockpiling in anticipation of changes is prohibited.

Active-ingredient master list

FDA will publish and update a list of active ingredients with their assigned classes. Where an active spans multiple classes, the applicable class is distinguished by dosage strength, dosage form, indication, and related criteria. Updates occur annually or when reclassification decisions are finalized.

Labelling, storage, and advertising

Pharmacist-only products must display “PHARMACIST-ONLY” prominently on the principal display panel. All non-prescription products require a Patient Information Leaflet (PIL); if no PIL is provided, equivalent information must appear on the inner panel of the outer carton when dispensed with such packaging.

Placement rules mirror access tiers: prescription and pharmacist-only medicines are stored out of direct public reach (e.g., behind the counter), while general-sales items are displayed in a segregated section. Only non-prescription medicines may be advertised to the public; prescription products are limited to professional channels.

Transition and enforcement

For products affected by reclassification, PAC submissions follow staged timelines, and a one-year manufacturing-level exhaustion period applies to labelling updates after approval. Stickering is permitted when moving to a more stringent class, subject to FDA approval. Non-compliance can result in disapproval, suspension or cancellation of registrations, findings of misbranding/adulteration, and penalties under the Consumer Act for stockpiling.

On 13 October 2025, the Philippine Department of Agriculture (DA) notified the World Trade Orgainzation (WTO) of a comprehensive draft Department Circular that overhauls the country’s import regime for a broad range of agricultural and fishery commodities, animal feeds, meat, live animals, select laboratory biologics, fertilizers, pesticides, and other agricultural chemicals.

The proposed measure unifies permitting, border inspection, transport, storage, testing, and disposal rules under a single instrument, aligning procedures with Codex Alimentarius Commission, the World Organisation for Animal Health (WOAH), and the International Plant Protection Convention (IPPC) standards. Written comments may be submitted until 12 December 2025. The regulation is expected to be adopted by December 2025 and take effect 15 days after publication.

Scope and Policy Frame

The draft Circular applies to commodities classified under HS headings 01–05, 06–15, 16, 23, 30.02/30.04 (specified laboratory samples), 31, 38 (including biopesticides), and 03 (fish and aquatic products). It explicitly includes wood packaging under the International Standards for Phytosanitary Measures (ISPM) No. 15, genetically modified (GM) plants/events where applicable, and “goods referred to DA” that are suspected of harboring regulated pests.

Its objectives include food safety, animal health, plant protection, and protection of humans from animal/plant pests and diseases.

Article Structure and Roles

The draft spans preliminary provisions to final clauses, detailing application, review, inspection at port and storage, violations, sanctions, and disposal. Issuing authorities are designated as: 

• Bureau of Plant Industry (BPI) - plants/plant products
• Bureau of Animal Industry (BAI) - live animals, animal products, feeds
• Bureau of Fisheries and Aquatic Resources (BFAR) - fish/fishery products.
• Fertilizer and Pesticide Authority (FPA) - pesticides and agricultural chemicals. 

Coordination with other agencies such as the National Meat Inspection Service (NMIS), Department of Environment and Natural Resources (DENR-CITES), and Food and Drug Administration (FDA) is specified for mixed-jurisdiction goods.

Operational Mechanics

Licensing and Declarations

An SPS Import Clearance (SPSIC): Required prior to loading at origin. This sanitary and phytosanitary (SPS) clearance confirms that imported goods comply with food safety, animal health, and plant protection standards. It is non-transferable and valid for one shipment per clearance. Applications are submitted electronically via the DA Trade System by registered/licensed importers. The DA targets seven working days for processing. Unacted applications are deemed approved, while incomplete filings are rejected.

For pesticides and agri-chemicals, the Certificate Authorizing Importation (CAIP) is issued by the FPA to licensed handlers with product registration, experimental-use permit (EUP), or a letter of no objection. Unused CAIPs lapse after 60 days.

Timelines & “Must-Ship-Out-By” Controls

Each SPSIC stipulates a Must-Ship-Out-By (MSOB) date, defining the shipment window from issuance:

• 30 days - live, fresh, or chilled fish
• 20 days - fresh fruit and vegetables
• 60–90 days - fertilizers, pesticides, feeds, live animals, and animal products
• 180 days - seeds

Shipment must load on or after SPSIC issuance and on or before the MSOB date. Unused SPSICs automatically expire once the MSOB lapses.

Risk-Based Border Management

• Pre-arrival: Importers submit an e-Request for Inspection (e-RFI) at least 48 hours before arrival.
• Port inspection: Joint document and physical checks (DA Quarantine + BOC), with risk-based escalation to laboratory testing. Shipments failing conditions (e.g., no SPSIC, fake/expired SPSIC, contamination, misdeclaration, mixed tariff goods) face hold, seizure, or refusal.
• Post-port movement: Sealed consignments transfer only to DA-registered storage facilities indicated in the e-RFI; seals may be broken only by DA officers at destination.

Laboratory Testing and Enforcement

Laboratory testing (for contaminants, residues, heavy metals, pathogens; consideration of pre-border verification) occurs at DA central or DA-accredited labs, at importer cost; results are recorded in the DA Trade System.

Non-compliant consignments are subject to seizure, destruction, return to origin, third-country shipment, or donation (with strict food-safety clearance). Public auction is prohibited for agri-fish commodities. Appeals may be filed to the DA Secretary within 10 days.

Digital Administration and Data Integrity

The Circular formalizes the DA Trade System as the back-office platform for SPSIC/e-RFI processing, tagging (e.g., “Used”, “Confiscated”), inter-agency validation (e.g., against BOC’s Inward Foreign Manifest), and audit trails supporting risk-based inspection and enforcement.

Alignment with International Standards

The WTO notification affirms conformance with Codex STAN 193-1995, WOAH Terrestrial/Aquatic Codes, and IPPC (e.g., ISPM 2, ISPM 15), signaling harmonization of risk analysis, certification, inspection, and treatment protocols for traded commodities.

Timeline and Outlook

• Comment deadline: 12 December 2025 (WTO SPS Committee filing G/SPS/N/PHL/533).
• Adoption target: December 2025
• Effectivity: 15 days after publication in the Official Gazette or a newspaper of general circulation and filing with the UP Law Center’s Office of the National Administrative Register (ONAR).

If adopted as notified, importers and brokers should prepare for strict MSOB controls, mandatory e-RFI pre-arrival filings, seal-integrity requirements, and expanded risk-based inspections backed by integrated DA–BOC data checks. Pesticide handlers must ensure FPA licensing and product registration/EUP alignment. Non-compliance will more quickly trigger confiscation/return and no-auction disposition pathways.