The FDA Philippines (Formely the Bureau of Food and Drugs) was created under the Philippines Department

of Health as the
regulatory and enforcement organization for all food, drug, cosmetic, meadical equipment, and related products.

If you are looking to import, retail, wholesale, distribute, manufacture, or export food, pharmaceuticals, food, or health and beauty
products most likely will need to register with BFAD for your License to Operate LTO and register any products you wish to work
with. An LTO must be secured before you are able to do any product registration with BFAD.

Each product that you wish to work with must undergo a separate product registration process. Depending on the classification,
food, food supplement, drug, or cosmetic, there is a vastly different registration requirement and processing time.

Your business might require you additional permits and licenses to operate. Businesses that involves manufacture, packaging, re-
packaging, local distribution, import, export, and retail of processed foods, drugs, cosmetics, medical devices, hazardous
substances and chemicals, are required to secure a License to Operate(LTO) from the Philippine Food and Drug Administration,
more commonly known as Bureau of Food and Drugs (BFAD). Depending on the number of your activities and the types of goods
involved, you might be required to have more than 1 License to Operate.

The classification of the License to Operate you need will depend on the classification of products that you will be marketing or
manufacture. And the requirements to acquire these Licenses to Operate varies depending on the products and activity involved,
while some of these requirements do not change.

Your business’ activities are limited by the License/s to Operate you have. Like, a License to Operate as Distributor of Food cannot
be used for distributorship of drugs. And License to Operate as Exporter does not cover the activity to import. In a case where you
import raw materials, manufacture it into goods, and export it, you will be required to have 3 licenses to operate because your
business is involve in 3 different activities.

Acquiring an LTO may take a period of 1 to 2 months, depending on availability of documents and results of your establishment
inspection by the BFAD-FDA officer. This processing period is more realistic than the suggested processing period posted in
government websites. Having someone knowledgeable about the preparation of technical requirements and processes for the
application of LTO will hasten the application process.

Only after acquiring a valid License to Operate you can start registering your products to the Philippine Food and Drug
Administration.

Requirements for License to Operate (LTO)

 Accomplished Petition Form/Joint Affidavit of Undertaking Duly Notarized.
 List of Products to be distributed identified by generic names and brand names intended for use.

 Copies of Pharmacist Board Registration Certificate, PRC_ID, valid PTR, ID picture, Duties and Responsibilities.

 Certificate of Attendance of Owner/Pharmacist to a BFAD seminar on Licensing of Drug Establishments and Outlets in the
Philippines.

 Locational Plan and Floor Plan (Office and Storage Room) with dimensions.

 If a corporation, Certificate of Registration with SEC and Articles of Incorporation/Partnership.

  If single proprietorship, a Certificate of Business Name Registration with Bureau of Trade Regulation and Consumer
Protection (BTRCP)

 Contract of Lease for the space to be occupied.

If Importer
 A duly authenticated (by the Territorial Philippine Consulate), Foreign Agency Agreement FAA from each supplier.
 Certificate of Registration of manufacturer and its conformity with Good Manufacturing Practices From Health Authority
authenticated by Philippine Consulate.

If Wholesaler
 A Valid current contract with BFAD licensed supplier/manufacturer
 A certificate that the products supplied are registered with BFAD

 Copy of LTO from supplier/manufacturer

If Exporter
 A Valid current contract with BFAD licensed supplier/manufacturer
 A certificate that the product supplied are registered with BFAD

 Copy of LTO from supplier/manufacturer

The Following Must also be Presented Upon Application for LTO

 Reference materials:
 Philippine National Drug Formula

 - R.A. 3720, Food, Drugs, Devices & Cosmetic Act

 - R.A. 6675, Generics Act of 1988 and relevant implementing rules and regulations

 - R.A. 5921, Pharmacy Law as amended and relevant implementing rules and regulations.

 Any one of the following reference books:

 - United State Pharmacopoeia/National Formulary (USP/NF) latest edition

 Remington’s Pharmaceutical Sciences (latest edition)

 - Goodman & Gilman Pharmacological Basis of Therapeutics (latest edition)

 Batch Distribution Record Book

Procedure for Securing LTO

 Gather application and all requirements and submit to BFAD registration department.
 Interview with Food and Drug Registration Office FDRO.

 Licensing Department will review requirements and application to make sure complete.

 Receive Order for Payment to FDRO and receive completed application.

 Physical inspection of office and facility. Submit report to licensing section of BFAD.

 Director Approval of LTO.

  Release of documents to applicant

Total Process Time For the Registration of LTO is 2-3 weeks but can take up to 1-2 months for processing

Requirements for Product Registration with BFAD

 Accomplished application form No.1 and No. 8 Duly Notarized.
 Copy of valid contract between manufacturer and trader/distributor/seller/exporter/importer.

 Copies of valid LTO's for manufacturer/trader/distributor/seller/exporter/importer.

 Unit Dose and Batch Formulation in Metric System.

 Technical specification on all Raw Materials.

 Certificate of Analysis on raw materials and finished product from manufacturer.

 Technical Specification on finished Product.

 Master manufacturing procedure, Production equipment, Sampling and In-process controls, Master packaging procedure.

 Assay on test procedures and data analysis if applicable.

 Stability study in accordance with Philippines national guidelines and ASEAN guidelines.

 Representative sample of packaging and labeling materials for commercial market.

 Copy of ACB approval

 For foreign manufactured products, a copy of the Original Product Registration in the manufacturing country.

Procedure for Product Registration with BFAD

 Submission of application and all requirements to Public Assistance Information and Compliance Section of BFAD for
assessment.
 Accounting and billing department to asses registration fees to be paid at cashier.

 Product services division of BFAD will evaluate all the requirements and prepare endorsement for Certificate of
Registration.

 Director signs Certificate of Registration and Product Registration documents can be picked up from BFAD.

Entire product registration process can be completed in 2-4 weeks* from submission of requirements

*Depending on type of Product: Cosmetic 2-4 weeks, Food 1-2 months, Pharmaceutical 8 months - 1 year

After acquiring a valid License to Operate, you may start the registration of your products to the Philippine FDA. The products to be
marketed or to be manufactured may be classified as one of the following:
FOODS

Category I
Category II
Food Supplement
DRUGS
Over-the-counter (OTC) Drug
Prescription Drug
Regulated Drug
Traditional Medicine
MEDICAL DEVICES
COSMETICS
HAZARDOUS SUBSTANCE

Furthermore, products are also classified according to origin:

Imported
Locally Manufactured

Based on the classification of your product, you will be required to submit technical requirements, certificates of analysis, stability
testing, as well as proposed product labels, agreement contracts with parties involved in your operations; like toll manufacturers and
suppliers of raw materials. Food and Drug Administration may require additional supporting documents regarding the product
applying for CPR.

PROCESSING A PRODUCT REGISTRATION

Product registration starts with the assessment and evaluation of the documents and technical requirements of your product to the
Public Assistance Information & Compliance Section (PAICS) or to the Product Services Division (PSD), depending on the
classification of the product applied for.

After the preliminary evaluation of the technical documents, the PAICS or the PSD will issue an assessment slip, wherein the
amount to be paid for the application is also indicated. This assessment slip will be presented to the accounting division. You will be
given and Order of Payment and will be requested to pay the amount indicated to the Cashier.

After the payment, the applicant will proceed to the PAICS for the submission of requirements. The applicant must have a copy of all
the documents submitted filed in a folder that will serve as a receiving copy. Keep also in mind that documents submitted in
photocopy should be supported with the original copy upon request of the evaluating officer. Upon submitting the documents, the
applicant will be given a Routing Slip Number (RSN). The RSN will be written on the receiving copy, the RSN is used to verify the
status of the application, to follow-up and inquire about the updates of the application. A follow-up can only be made 3 months after
the application for the Certificate of Product Registration has been filed. Also keep your RSN always on hand; this is the only
reference number that could trace the status of your application.

On initial follow-up, you may be given a Certificate of Product Registration (CPR), a Letter of Denial (LOD) or a Notice of Deficiency
(NOD). There are very few cases that FDA denies an application, or issues a CPR right away. Usually, upon initial follow-up, the
applicant receives an NOD. The reason for this is because the one that conducted the preliminary assessment of the requirements
during the receiving is different from the one who will conduct the thorough evaluation of the technical requirements. It’s up to the
evaluating officer’s discretion to notify deficiencies, approve or deny the product registration.
If the application has been approved, it will be forwarded to the Chief of the Product Services Division for signatory, then to the
Office of the Director also for signatory. On the event that the Office of the Director finds irregularities or deficiencies on your product
registration, the Office of the Director may again deny your application, or issue a Notice of Deficiency.

NOTICE OF DEFICIENCY

If an applicant receives a notice of deficiency, all he has to do is to comply the requested documents by the Philippine FDA.
Compliance should be made within thirty (30) days after receiving the notice of deficiency. If the applicant fails to comply within the
said thirty (30) days, the application will be considered as an initial registration, and start the process all over again.

CERTIFICATE OF PRODUCT REGISTRATION

A Certificate of Product Registration is the certificate issued by the Bureau of Food and Drugs/ Philippine FDA (Food and Drug
Administration) for the purpose of marketing and free distribution of a product after evaluation and of its safety, efficacy and quality.

Only after a CPR has been secured, the Applicant Company or individual can proceed with product marketing, selling and
distribution, considering that these activities are limited by their License to Operate.

Also remember that CPR’s are not stand-alone certificates, each CPR is owned by a particular company/proprietor having a duly
registered LTO.