Importing injectable products into the Philippines: Food and Drug Administration (FDA) License to Operate (LTO) and Certificate of Product Registration (CPR) for foreign manufacturers and local distributors

In short: the Philippines splits the approval into two documents held by two kinds of party. The License to Operate (LTO) belongs to an establishment and the Certificate of Product Registration (CPR) belongs to a product. Only an establishment that already holds a valid LTO may apply for a CPR, so a foreign manufacturer without a local establishment reaches the registration process through a local LTO holder that files the application with the manufacturer's dossier.

This article is for foreign manufacturers, and for local importers and distributors weighing a registration partnership. It explains what each document covers, who can hold it and what a manufacturer supplies. We write License to Operate (LTO) and Certificate of Product Registration (CPR) in full where they first appear, because both abbreviations have other meanings in the Philippines: LTO is also the name of the Land Transportation Office, and CPR is also a common medical abbreviation.

It summarizes the statute, the implementing rules and the service descriptions published by the Food and Drug Administration (FDA) Philippines that we could read directly, and it marks every point where we rely on a secondary description. FDA web pages for advisories and circulars could not be retrieved by our tools, so those were not read in full. Nothing here is legal advice. The current orders, forms and fees should be confirmed with the FDA before any filing.

Two documents, held by different parties

The legal base is Republic Act (RA) No. 3720, as amended by RA 9711, the Food and Drug Administration Act of 2009. Section 10 of RA 9711 rewrites the list of prohibited acts. It forbids any natural or juridical person to manufacture, import, export, sell, offer for sale, distribute, transfer or retail a drug without the license to operate that the Act requires (Section 11(k) as amended). A separate prohibition covers health products that require registration and are not registered (Section 11(a) and (j) as amended). The Act defines licensing as the approval of an establishment before it engages in these activities, and registration as the approval of a health product before it is marketed.

The implementing rules and regulations (IRR), issued as Department of Health Department Circular No. 2011-0101, put the split in one place. Book II, Article I, Section 3 states that an LTO is prima facie evidence of the licensee's authority to carry out the activities it names, and that only establishments with a valid LTO from the FDA may apply for registration. A CPR is in the same way prima facie evidence of the registrant's authority over that product. The two documents therefore answer different questions, and they are held by different kinds of party.

What the License to Operate covers

The FDA publishes citizen's charter service sheets that describe each application step by step. The sheet for the initial LTO of drug traders, drug distributors (importer, exporter, wholesaler), drugstores and similar establishments is handled by the Center for Drug Regulation and Research and cites Administrative Order (AO) No. 2020-0017. The applicant files through the FDA eServices portal. The e-application form names a qualified person by self-declaration and carries a location plan with GPS coordinates. The upload list asks for proof of business registration, from the Department of Trade and Industry for a sole proprietorship or from the Securities and Exchange Commission for a corporation. The sheet refers separately to an inspection agenda and lists seven working days for the review steps it covers, so planning should allow more.

Every item on that list assumes a business that exists in the Philippines. We found no FDA text that lets a foreign manufacturer hold the license from abroad. Consultancy sources describe two routes: the manufacturer sets up a local entity, or it works with an existing LTO holder. Those sources are commercial and disagree on details.

Two cautions apply. First, secondary sources report that AO 2020-0017 was replaced by AO 2024-0015 with effect from January 2025, with different validity periods and fees. We could not read the order, so this article gives no validity period and no fee. Second, an earlier FDA circular, Circular No. 2014-026 of November 21, 2014, shows what a pre-opening inspection looked at for a drug distributor: the pharmacist in charge, the quality management system, distributorship agreements, foreign GMP certificates, and good distribution and storage practices, including cold-chain management. Later orders may have changed the detail, but a local partner will be asked about the same subjects.

What the Certificate of Product Registration covers

An FDA requirements sheet for drug products states that the applicant shall be a holder of a valid License to Operate, and it attributes the rule to AO 2020-0045 and FDA Circular No. 2022-004. This matches Section 3 of the IRR described above. The registrant is therefore never the foreign manufacturer acting alone. It is an LTO holder whose name appears on the certificate.

The FDA's service description for the initial registration of prescription generic drugs gives the clearest picture of the dossier. It asks for the ASEAN Common Technical Dossier in two parts: administrative data and product information, then quality data on the drug substance and the drug product. For an imported product, the certifications are the license of the pharmaceutical industry or importer, a Certificate of Pharmaceutical Product (CPP) issued by the competent authority of the country of origin in the current World Health Organization format, and a foreign GMP clearance. A site master file, labeling, a package insert and a summary of product characteristics complete the first part. A representative unit of the product with its certificate of analysis is requested when the evaluator asks for it.

The same sheet states that the applicant may ask for a registration valid for two years or for five years. For a product with a proposed brand name, the evaluation includes a separate brand name clearance. The stage-by-stage table in the sheet adds up to 120 working days of FDA processing, and a notice of deficiencies, which asks the applicant for missing or corrected documents, extends the real calendar time.

That sheet covers prescription generic drugs. Which category and which data requirements apply to any given product depends on the product itself, and we have not assessed this for any product.

Where a foreign manufacturer fits

Because the CPR applicant must hold an LTO, a manufacturer outside the country and an LTO holder inside it divide the work. The manufacturer owns the technical content and the evidence from its own site. The LTO holder owns the filing, the correspondence with the FDA and the licensed activities of importing, storing and distributing. Consultancies call a local LTO holder carrying the registration of a foreign product "CPR housing", a commercial label and not an FDA term.

EFBA is a manufacturer of IV vitamin and nutrient formulations. IVIXIR is not registered; it is not promoted in the Philippines. EFBA supplies manufacturer documentation to a licensed local company that holds the license and files the application. EFBA does not file applications and does not hold any Philippine license.

Registration status and promotion

Section 10 of RA 9711 also prohibits the promotion, advertising or sponsorship of a health product that requires registration and is not registered. The IRR repeat the point in Book II, Article V, where Section 2(a) says that a health product which has not been registered or authorized shall not be advertised or promoted. We found no exception based on the audience in either text. Partners should read these provisions with their own counsel.

A practical order of work

• Check the partner's license. Confirm that the company holds an LTO for the right activity, and confirm it with the FDA and not only from a copy.
• Agree whose name the product is registered in. The CPR names the registrant, and that party carries the product's regulatory obligations afterwards.
• Assign document ownership. Settle in writing who prepares the dossier, who holds the GMP and CPP evidence and who writes the local label.
• Plan for the review. Check the current order for the product's category, and allow for pre-assessment, queuing, deficiency notices and, for a brand name, its separate clearance.
• Discuss supply last. Arrangements for moving product belong after registration and need the license the law requires.

What we could and could not read

We read RA 9711 as published by the Lawphil project, the IRR in the copy held by the World Intellectual Property Organization (the scan is partly garbled), three FDA service and requirements sheets uploaded in 2023, and FDA Circular No. 2014-026 as reproduced by a legal database. We did not read AO 2020-0017, AO 2020-0045, Circular No. 2022-004 or AO 2024-0015; we know them only through the FDA's own citations or secondary reports. The FDA remains the authority on every point.