Philippines Pharmaceutical Licensing

AO No. 2024-0015 covers pharmaceutical manufacturers (including packers/repackers), traders, distributors acting as importers/exporters/wholesalers, and pharmaceutical outlets. The scope of pharmaceuticals includes drugs, medicines, biological products and APIs, among others. The proposed project should be broken down by activity—manufacturing, packing, importing, exporting, wholesaling, retailing, online sales, warehousing and product registration—rather than applying for a generic “drugstore licence”.

Annex B accepts the relevant registration documents of sole proprietorships, corporations, partnerships, cooperatives and certain government entities. This reflects the evidentiary route for an application; it is not a recommendation in this record on corporate form, minimum capital or foreign ownership percentage, nor a complete determination of market-entry requirements. Such corporate and investment matters must be verified separately.

— Establishment LTO: for premises and authorised activities.

— Individual pharmacist qualifications and QP: separate from the business LTO.

— CPR: product marketing authorisation; it cannot be replaced by an LTO.

— Local business formalities, ordinary import/export customs clearance and dangerous-drug permits: assess separately.

Republic Act No. 9711 defines an LTO as an establishment authorisation required before engaging in activities such as manufacturing, importing, exporting, selling, wholesaling/distribution, and defines product registration as a separate application and approval. FDA AO No. 2024-0015 is the direct rule currently governing initial LTO applications, renewals and amendments.

Federal/local responsibilities must be distinguished: the FDA is responsible for pharmaceutical LTOs and CPRs; Annex B recognises an LGU Mayor’s Permit or Barangay Certificate as proof of address when the addresses do not match. FDA materials do not replace confirmation by the LGU where the premises are located that the actual business and premises comply.

— FDA: LTOs, inspections and product marketing authorisations.

— FDA eServices: online portal for LTO and product services.

— LGU: local business/address matters, to be confirmed for the specific location.

— DDB/PDEA: dangerous drugs and controlled substances are regulated separately.

Drugstores, pharmacies, boticas and non-prescription drug retail outlets are pharmaceutical outlets. Only a pharmaceutical outlet licensed or authorised by the FDA may compound, sell, offer for sale or dispense drugs to the public. Retail outlets must also hold a valid LTO for online ordering/sales.

Pharmacist requirements depend on the products sold and their classification. Category A outlets selling prescription drugs or pharmacist-only OTC medicines require a pharmacist to be physically present while the outlet is open. Category B applies only to statutorily listed non-prescription and similar circumstances, and may not sell prescription drugs or pharmacist-only OTC medicines.

— Category A: prescription drugs, pharmacist-only OTC medicines, etc.; direct, immediate supervision.

— Category B: applies only to specified circumstances involving ordinary OTC medicines/household remedies, etc.

— If medical devices are also sold: obtain a separate medical-device retail LTO.

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Apply for a pharmaceutical distribution LTO based on the actual activities of importing, exporting and/or wholesaling. The AO defines a distributor-importer as an entity that imports raw materials, APIs or finished products and wholesales them to locally FDA-licensed establishments; a distributor-wholesaler obtains the above items from locally FDA-licensed establishments for domestic wholesale.

Distribution activities must comply with applicable GxP, including GDSP. The FDA may inspect warehouses, vehicles, products, containers, labels and related records. Pre-licensing inspection applies to initial applications or applicable major variations, and risk-based routine inspections may continue throughout the licence period.

— List suppliers/customers, addresses and local or imported product categories in the application.

Changes to supplier/customer lists are minor variations/notification matters.

The scope of an import/export LTO is not equivalent to per-shipment ordinary customs clearance or a dangerous-drug permit.

A manufacturer LTO covers operations involving the preparation, processing, formulation, filling, packaging, repackaging and labelling of pharmaceuticals; manufacturers, packers and repackers are all included. In addition to the general eApplication materials, a manufacturing application must submit a Site Master File. The SMF of a pharmaceutical manufacturer must comply with PIC/S PE 008-04 and its amendments.

The FDA requires compliance with applicable GMP, GDSP and other GxP standards for the activities authorised. Pre-licensing inspections of manufacturers remain in place; the actual relocation of a manufacturing plant is a major variation. Contract manufacturing, packaging and repackaging are permitted, but the FDA must be notified and authorisation obtained.

— LTO: authorisation for a manufacturing site/activity.

— SMF: a document containing information on the manufacturing site, quality, production and quality control.

— CPR: product marketing authorisation, which must be applied for and maintained separately.

A company LTO does not replace an individual's professional qualifications. The AO requires every covered establishment to have at least one QP. The QP should be a regular/full-time employee with relevant technical competence based on professional qualifications, training or experience, and is responsible for application documents, inspection communications and ongoing compliance. Drug establishments must also, as applicable to their activities, be supervised by a registered and licensed pharmacist.

Adding or replacing a pharmacist is a minor variation to the LTO. Annex D lists the application form, fees and valid PRC ID. If the new pharmacist was previously associated with another establishment, proof of termination of employment/resignation is generally also required, along with a list for Category A/B submissions of all their outlets, addresses, geographical locations, shifts and LTO numbers.

— QP: the person responsible for an establishment's ongoing compliance; this is not equivalent to the duties of every category of pharmacist.

— Registered and licensed pharmacist: supervision requirements for Category A/applicable drug activities.

— PRC identification: one of the documents for a pharmacist change to an LTO; it is not a business authorisation.

The FDA may enter and inspect facilities, factories, warehouses and vehicles used for regulated activities at reasonable times. Even if an establishment uses a virtual office, it must maintain a physical site where the licensed activities actually take place; the LTO and submitted documents must state that physical address, not the virtual office address.

If the business registration address differs from the business address, Annex B requires submission of a Business/Mayor’s Permit or Barangay Certificate stating the complete business address. If the building is not owned by the applicant, the lease must be presented during inspection. This provision should not be interpreted to mean that all LGUs nationwide have uniformly approved any pharmacy use.

— Retail: a controlled dispensing area, orderly layout and appropriate storage.

— Wholesale: warehouses, vehicles, labels and records may be inspected by the FDA.

— Manufacturing: SMF, GMP and pre-licensing inspection.

Initial applications, renewals and variations are submitted through FDA eServices. An initial application includes the eApplication and Declaration and Undertaking, QP information, applicable pharmacist outlet list, entity registration and proof of activities, applicable Risk Management Plan, manufacturing SMF, supplier/customer list, contracts and fees. The listed documents must be available for verification during inspection or throughout the LTO validity period.

The process consists of online submission, pre-assessment, payment, inspection and substantive evaluation. Passing pre-assessment does not mean approval; after the applicant pays the pre-assessment and application fees, the FDA evaluates the application against documentary and technical standards. Approval of an initial application, major variation or routine renewal is subject to a satisfactory applicable inspection.

— The official email address is the channel for online communications and submission of additional documents.

— The pre-assessment payment notice and application payment notice are each valid for 10 working days.

— Payment, inspection scheduling, CAPA and the evaluation period may affect the actual timeframe.

Under the AO, fees for LTOs and CPR/CPNs are calculated by multiplying the annual rate by the corresponding number of validity years; the actual amount payable for an application, pre-assessment or variation is as stated in the Order of Payment issued by the FDA. This review did not verify current numerical fees for drug LTOs by company size, activity or additional services from readable official materials, so no amounts are stated.

The initial LTO is valid for 3 years for micro/small enterprises and 6 years for medium/large enterprises; renewal LTOs are valid for 6 years and 12 years, respectively. Approved major or minor variations follow only the remaining validity period of the original LTO and do not restart a full term.

— Automatic or routine renewal: both must be submitted through eServices within 90 calendar days before the LTO expiry date.

— For renewal after expiry, a renewal fee at twice the normal rate and a surcharge of 10% per month (or part of a month) apply, for a maximum of 120 days; after that, the initial application procedure applies.

— Failure to pay by the deadline in the payment notice will result in the application being automatically cancelled or not approved.

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Throughout the LTO validity period, the information required under Annex B remains an ongoing requirement; non-compliance may constitute a deficiency or grounds for regulatory action. Establishments must maintain applicable standards such as GMP/GDSP according to their activities and cooperate with FDA routine, monitoring, investigative or other inspections. The frequency of routine inspections is determined by risk assessment and the rating from the previous inspection.

If a renewal application for ongoing activities is submitted in a timely and complete manner, the existing LTO does not expire before the FDA makes a decision. Automatic renewal applies only when its applicable conditions are met, such as submission and payment before expiry and a declaration that the establishment has had no changes; exceptions are set out separately in AO Annex E.

— Reports may show incidents in which a product caused a serious adverse effect, illness, injury or death.

— Promptly recall, withdraw from the market or seize products deemed unsafe/harmful by the FDA, or stop the relevant activities.

— Retain products, containers, labels, equipment and records required for inspection, and implement CAPA.

Changes to any authorised activity or licence information must be submitted to the FDA as a major or minor variation. While a renewal application is pending, a variation generally cannot also be applied for or approved, and vice versa. Relocation of a manufacturing/packaging/repackaging facility is a major variation; a physical relocation of a drug retail outlet is also classified as a major variation.

Annex D classifies a change in establishment ownership as a minor variation and requires an application form, fees, registration documents and deeds of the new owner, and evidence of the ownership transfer, such as a transfer agreement, MOA or eligibility declaration. Changes of pharmacist, distribution activities, office address, and additions or deletions of suppliers/products also have their own variation documents.

— Major variations: the initial procedure, inspection and evaluation apply; the fee for relocating a manufacturing facility is equivalent to the initial application fee.

— Minor variations: changes such as ownership, pharmacist, suppliers/products, etc., still require an application/notification.

— CPR product information and LTO establishment information are separate variation tracks.

LTO and CPR must be kept strictly separate. AO expressly states that an establishment must first hold a valid LTO before it may apply for CPR/CPN and other authorisations; RA9711 prohibits dealing in health products that require registration but are not registered. The CPR status and authorised scope of each drug and applicable product category intended for sale/import/manufacture must be checked individually.

Cross-border trade also does not involve a single permit: a distributor LTO may include importer/exporter activities, but the FDA page currently available for the import/export of “finished drug products and raw materials” is still marked as a draft for comments and cannot be treated as the current ordinary-drug customs procedure. Imports and exports of dangerous drugs/controlled substances separately require the applicable PDEA general permit and a permit for each transaction.

— LTO: authorisation for establishment/premises activities.

— CPR: product marketing authorisation.

— Import/export: confirm against the scope of the distribution LTO and the applicable customs procedures.

— Dangerous drugs: separate DDB/PDEA authorisations apply; these are not granted automatically by an LTO/CPR.