FDA MEMORANDUM ON CIRCULAR ON QPIRA

1. Regulatory guidelines applicable in the licensing of drug establishments in the

Philippines.

IV. GENERAL GUIDELINES

A. The terms used in this AO shall have the meaning as defined in RA 9711 and its IRR, and
related laws and regulation.
B. All establishments covered in this AO shall first secure the appropriate LTO or authorization
from FDA prior to engaging in the manufacture, importation, exportation, sale, offering for sale,
distribution, transfer, promotion, advertisement and for sponsorship of any activity that involves
health product.
C. All licensed manufacturers are granted an Initial LTO based on the minimum requirements set
by FDA in order to operate a manufacturing plant. A Certificate of GMP Compliance shall only
be issued upon demonstration of satisfactory compliance to GMP and effective up to the validity
of the current LTO. Thereafter, the Certificate of GMP Compliance shall be issued each time the
LTO is renewed.
D. All covered establishments must continuously comply with the existing requirements,
regulations and standards, otherwise they may be ordered closed or their licenses be suspended
or revoked motu proprio, or upon petition by any affected person. A violation with any of the
terms and conditions of the LTO may result in the suspension, revocation or cancellation of the
LTO, or disapproval of its application for renewal.
E. All covered establishments shall be under the supervision of a qualified person(s) as required
by pertinent rules and regulations (refer to Annex A).
F. The FDA shall have the authority to enter any covered establishment for (1) inspection and/or
for (2) verification of documents submitted to FDA in support of its application for license.
G. The responsibility of ensuring the safety, quality, and when applicable, the efficacy and/or
purity of health products, shall rest upon all the establishments or persons involved in the
production, sale, handling, packing, transport, distribution, trading and storage thereof.

V. SPECIFIC GUIDELINES

A. In case the health product has been banned or withdrawn for health and safety reasons in the
country of origin, the importer shall immediately undertake the necessary measures in banning
from the public its sale, distribution or donation, or its immediate recall, withdrawal or seizure
from the market.
B. Establishments engaged in health product that is declared by FDA to be injurious, unsafe or
dangerous are required to immediately recall, withdraw, or seize the product, or ban its sale,
distribution or donation to the public.
C. For drug establishments:

1. All drug establishments engaged with vaccines, biologics and other temperature—sensitive
drug products shall comply with the cold chain management requirements.
2. All drugstores, whether privately owned or government-owned, shall be under the supervision
of a registered pharmacist when operating or open for business, unless otherwise allowed by
other pertinent laws or regulations.
3. All FDA-required information, education and communication campaign material shall be
displayed in the establishment’s conspicuous area.

D. All approved LTO applications shall be sent through courier directly to the establishment’s
owner, president, CEO, general manager or equivalent responsible officer as indicated in the
application form.

Activity: LTO licensing application

2. Regulatory guidelines applicable in the product registration in the Philippines.

Activity: CPR Application Processes

REQUIREMENTS FOR FDA REGISTRATION IN THE PHILIPPINES

April 03, 2018

The Philippine Food and Drug Administration (FDA) is the national health product regulatory
agency created by Republic Act (RA3720), as amended by Executive Order No. 175 and RA
9711. It was created under the Department of Health to license, monitor, and regulate the flow of
food, drugs, cosmetics, medical devices, and household hazardous waste in the Philippines.

Business entities must secure both a License To Operate (LTO) and a Certificate of Product
Registration (CPR) from the FDA Philippines before it can engage in the manufacture,
importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertisement
and/or sponsorship of the following products in the Philippines:

1. Drugs;
2. Pharmaceuticals;
3. Medical devices;
4. Cosmetics;
5. Processed Food;
6. Toys;
7. Child care articles;
8. Veterinary products; and
9. Household/urban pesticides.

The following are the requirements for application of a License to Operate (LTO):
For Initial Application

 Accomplished Application Form with Declaration and Undertaking

 Proof of Business Name Registration
 Site Master File (for manufacturers of drugs, devices and cosmetics)
 Risk Management Plan
 Payment of the appropriate filing fee

For Renewal Application

 Accomplished Application Form with Declaration and Undertaking

 Payment of the appropriate filing fee

Meanwhile, the following are the requirements for securing the Certificate of Product
Registration (CPR):

For Initial Application

 Integrated Application Form

 Proof of payment of fees
 Clear and complete loose labels or artworks
 Pictures of the product
 For food supplement, a sample in actual commercial presentation
 As applicable, justification of label claims (i.e. nutritional facts, Halal logo, nutritional
and health claims)
For a company to be able to import, distribute, market, advertise or manufacture their products
here in the Philippines, they must first secure a License to Operate (LTO) as
Importer/Distributor/Wholesaler, for products imported from different countries, or as
Manufacturer, for locally manufactured products. After obtaining an LTO companies may then
proceed to apply for a Certificate of Product Registration (CPR), which states that the product
has been evaluated and officially registered with the Philippine FDA.

Establishments under industries requiring a License to Operate as manufacturer, importer,

distributor, wholesaler, or exporter:

 Food
 Drugs
 Cosmetics
 Household Hazards
 Veterinary Products
 Medical Devices (to be submitted to the Department Of Health – Center for Device,
Regulation, Radiation Health and Research)
Requirements:
 Accomplished and duly notarized Petition Form and Joint Affidavit of Undertaking;
 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, and
Duties and Responsibilities;
 Certificate of Attendance of owner or pharmacist to an FDA seminar on Licensing of Drug
Establishments;
 Certificate of Registration with SEC and Articles of Incorporation/Partnership (for
corporations or partnerships);
 Certificate of Business Name Registration with DTI (for single proprietorships);
 Locational plan and floor plan (office and storage room) with dimensions; and
 Contract of lease for the space to be occupied.
If Importer
 Foreign Agency Agreement (FAA) from each supplier, duly authenticated by the Territorial
Philippine Consulate
 Certificate of Registration of manufacturer and its conformity with the Good Manufacturing
Practices From Health Authority authenticated by the Philippine Consulate
If Wholesaler
 Valid current contract with FDA licensed supplier/manufacturer
 Certificate of product registration from FDA
 Copy of LTO from supplier/manufacturer
If Exporter
 Valid current contract with FDA licensed supplier/manufacturer
 Certificate of product registration from FDA
 Copy of LTO from supplier/manufacturer
Requirements for verification during inspection:
 Reference materials:
 o Philippine National Drug Formulary (latest edition)
o R.A. 3720: Foods, Drugs, Devices & Cosmetics Act
o R.A. 6675: Generics Act of 1988 and Relevant Implementing Rules and Regulations
o R.A. 5921: Pharmacy Law as amended and Relevant Implementing Rules and
Regulations
o Latest edition of United State Pharmacopoeia/National Formulary (USP/NF), or
Remington’s Pharmaceutical Sciences, or Goodman & Gilman’s The Pharmacological
Basis of Therapeutics
 Batch Distribution Record Book
Procedure:
1. Submit application requirements to FDA;
2. Proceed with interview with the Food and Drug Registration Office (FDRO);
3. Review of completion of requirements and application by the Licensing Department;
4. Receive Order for Payment and complete application;
5. Request for schedule of inspection;
6. Physical inspection of office and facility by the FDRO;
7. Approval of the LTO by the Director; and
8. Release of documents to applicant.