Republic of the Philippines

Department of Health

FOOD AND DRUG ADMINISTRATION

Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751

Website: www.fda.gov.ph Email: info@fda.gov.ph

Draft as of 1 November

Administrative Order

No. _____________

SUBJECT: Amendment to Administrative Order No. 2016-0003 on the Guidelines

on the Unified Licensing Requirements and Procedures of the Food and

Drug Administration

I. RATIONALE

The 1987 Philippine Constitution mandates the establishment of an effective food and

drug regulatory system that is responsive to the country’s health needs and problems.

On August 18, 2009, Republic Act No. 9711, otherwise known as the Food and Drug

Administration Act of 2009, amended certain section of Republic Act No. 3720, series of 1963

(as amended), otherwise known as the Food, Drugs and Devices, and Cosmetic Act, mandated

the FDA to issue License to Operate (LTO) to all establishments, namely manufacturers,

traders, and distributors (importers, exporters and wholesalers), among others, engaged in

business and operations involving health products and to issue product market authorization on

all health products prior to manufacture, importation, exportation, sale, offering for sale,

distribution, transfer, non-consumer use, promotion, advertising, or sponsorship. For the

protection of public health and welfare, health products that are adulterated, unregistered or

misbranded should not be used, consumed or offered for sale.

Health products as defined by Republic No. 9711, otherwise known as the Food and

Drug Administration Act (FDA) Act of 2009, includes processed food, food supplements, food

additives and ingredients, drugs or medicines, cosmetics, medical and health related devices,

including diagnostic kits and reagents, radiation emitting devices or equipment, household

hazardous substances, including urban pesticides, cigarettes, toys and childcare articles, among

other products as determined by the DOH-FDA for the protection of public health and safety.

This Administrative Order is an amendment to Administrative Order No. 2016-0003 on

the Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug

Administration. This issuance is aligned with the Universal Healthcare Law and the Department

of Health (DOH) F1+ Strategic Goals which are geared towards better health for all Filipinos

and more responsive health systems by developing innovative regulatory mechanisms for

equitable distribution of quality and affordable health goods and services.

This issuance is part of the FDA’s policy and effort to re-engineer and streamline its

services, and automate its system to make it easier to put up or renew businesses in the

Philippines and to spare people of intolerable queuing time or unnecessary waiting time. It is

compliant with the requirements of Republic Act No. 11032, otherwise known as the Ease of

Doing Business (EODB) and Efficient Government Service Delivery (EGSD) Act of 2018,

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which was signed into law on May 28, 2019, and the issuance of the Implementing Rules and

Regulations on July 17, 2019.

II. OBJECTIVES

The objective for issuing this Administrative Order is as follows:

1. To amend and update Administrative Order No. 2016-0003 on the Guidelines on the

Unified Licensing Requirements and Procedures of the Food and Drug Administration;

2. To provide simplified guidelines on the License to Operate requirements and process of

initial and renewal of application; and

3. To comply with the provisions of RA 11032 to re-engineer and streamline its services and

automate its system and with requirement to process all applications within the maximum

prescribed processing time depending on the complexity of the transaction.

III. SCOPE AND COVERAGE

This Administrative Order shall be implemented by the Center for Cosmetics Regulation

and Research (CCRR), Center for Drug Regulation and Research (CDRR), Center for Food

Regulation and Research (CFRR) and Center for Device Regulation, Radiation Health and

Research (CDRRHR) and the Common Service Laboratories, supported by the Field

Regulation Operations Office (FROO), FDA Action Center (FDAC), Policy and Planning

Service (PPS), Legal Support Service Center (LSSC) and Administrative and Finance Service

(AFS).

The scope of health products shall include, but not limited them to the following:

a. Under the CCRR, all cosmetic products, household/urban hazardous substances, including

urban pesticides, and toys and child care articles;

b. Under the CDRR, all drugs, including vaccines, biologics, veterinary medicines and animal

health products, medical oxygen, traditional medicine, herbal medicines and health

supplements;

c. Under the CDRRHR, all medical devices, radiation-emitting devices, in-vitro diagnostic

device and reagents; refurbished medical devices; equipment or devices used for treating

sharps, pathological and infectious waste, water treatment devices/systems; and other

health-related devices; and

d. Under the CFRR, all processed food products, food supplements, raw materials, ingredients and additives for food.

Further inclusion of health products from the list shall be guided by RA 9711 on the

definition of health products.

The following establishments, whether public or private, shall be covered by this Order:

a. Manufacturers, including repackers (food) and refurbisher (medical device),

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b. Traders,

c. Distributors as importers, exporters, and/or wholesalers,

d. Drug outlets, such as drugstores, pharmacies (community, hospital or institutional), or

boticas, and retail outlets for non-prescription drugs (RONPD),

e. Retailer of medical devices

The following FDA issuances on licensing are still in effect: a) RA 8172 (ASIN Law) for

licensing of salt manufacturers and distributors; b) Administrative Order No. 18-A s. 1993 for

licensing bottled water manufacturers and distributors; c) Administrative Order No. 2014-0034

and FDA Circular No. 2014-003 for licensing clinical trials sponsors and contract research

organizations (CROs); and d) the issuances covering radiation facilities, among others.

The following shall not be covered by this Order: clinical research organizations and

clinical trial principal investigator, operators or applicators of household or urban pesticides;

organizers of national and international trade fairs and exhibits; donors, organizations or

persons involved in donations, medical missions and other humanitarian activities; importers

of collector’s items; and groceries and supermarkets, wet markets, slaughterhouses or abattoirs,

dressing plants, fish ports, wet markets, supermarkets, school canteens, restaurants, catering

establishments, fast foods, restaurants, kiosks, caterers, chandlers, convenience stores, and the

likes.

III. DEFINITION OF TERMS

For the purpose of implementing these Order, the terms used shall have the meaning as

defined in RA 9711, its IRR, and related laws and regulations. However, the following terms

are hereby defined for greater clarity:

1. Initial Application or Original Application refers to the License to Operate (LTO) applied

to FDA prior to engaging in the business or operation involving the manufacture,

importation, exportation, sale, offer for sale, distribution, transfer, and where applicable

the use, testing, promotion, advertisement, and/or sponsorship of health products.

2. Authorized Person refers to the owner, President, Chief Executive Officers (CEO) or its

equivalent, or any organic or full-time employee representing the establishment in an

authorized or official capacity. Online transaction shall not be entrusted to a person who is

not the duly authorized person since log in names and passwords should be owned by the

company or the applicant. For emphasis, consultants and liaison officers who work part-

time or work on a per product basis shall not be considered duly authorized person. A duly

authorized person may also be the Qualified Person of the establishment as defined in this

issuance.

3. Qualified Person refers to an organic or full-time employee of the establishment who possess technical competence related to the establishment’s activities and health products

by virtue of his profession, training or experience. A qualified person has the responsibility

to comply with the technical requirements of the FDA or discuss or clarify matters with

the FDA when submitting technical requirements or engage the FDA officials when

conducting inspection or post-market surveillance activities. The qualified person may

also be the duly Authorized Person of the establishment.

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4. Qualified Person in Industry Regulatory Affairs (QPIRA) is a person who has completed

a training on licensing of establishments and registration of health products, conducted by

the FDA Academy of the Policy and Planning Service in collaboration with the four FDA

Centers. Attendance and completion of QPIRA training is not a qualification in any way

that entitles a person the exclusive right or privilege to transact business with the FDA. All

FDA clients, regardless if he or she completed QPIRA training or not, shall be entertained

by the FDA.

5. Refurbished medical device refers to the medical device of which the whole or any part

thereof has been substantially rebuilt, whether or not using parts from one or more used

medical devices of that same kind, so as to create a medical device that can be used for the

purpose originally intended by the product owner of the original medical device, and which

may have had the following work carried out on it: a.) stripping into component parts or

subassemblies; b.) checking their suitability for reuse; c.) replacement of components/sub-

assemblies not suitable for reuse; d.) assembly of the reclaimed and/or replacement

components/sub-assemblies; e.) testing of the assembled device against either original or

revised release criteria; or f.) identifying an assembled medical device as a refurbished

medical device. (AMDD, 2015)

6. Site Master File refers to the specific information about the quality assurance the

production and/or quality control of manufacturing operations carried out at the named site

and any closely integrated operations at adjacent and nearby buildings. If only part of an

operation is carried out on the site, a Site Master File need only describe those operations,

e.g. analysis, packaging, etc. The Site Master File may take another name or term when

applied to other health products regulated by the FDA, such as food and food products. For

the purpose of documentary requirement for pre-licensing inspection, the Site Master File

shall suffice.

7. Risk Management Plan refers to the document that contains the details on how to identify,

characterize, prevent or minimize the risk relating to the products that the establishment is

engaged in. It shall include post-market surveillance activities and interventions to manage

identified risks.

IV. GUIDELINES

1. All establishments, whether public or private entity, engaged in business or operation on

health products shall first secure a License to Operate (LTO) issued by the FDA and

product market authorizations, i.e. Certificate of Product Registration (CPR), Certificate

of Product Notification (CPN), before engaging in the manufacture, importation,

exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion,

advertising, or sponsorship activities.

2. All provisions of RA 11032, the EODB and EGDS Act, and its Implementing Rules and

Regulations shall apply in implementing this Order. Among others, the FDA shall

establish an online LTO application in its website (www.fda.gov.ph) with tracking of

application and issue guidelines on how to use the online e-LTO system. The FDA shall

set up a system wherein the LTO may be printed by the applicants themselves in the

convenience of their offices or homes. Otherwise, the LTOs shall be sent through courier

directly to the address of the owner, president, CEO, general manager or duly authorized

person or officer as indicated in the application form.

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3. Filling-out of application forms shall be done only by duly Authorized Persons, as defined

in this Order. It is the responsibility of the owner or CEO, or its equivalent, to secure the

online log in name and password to its authorized representative.

4. All establishments shall have a Qualified Person as defined in this issuance.

5. All establishments, except manufacturing plant or facilities, shall not require pre-licensing

inspection before approval of the LTO. Inspection shall be done pos-licensing approval.

6. All manufacturers, manufacturing plants and facilities applying for LTO as Manufacturer

shall undergo pre-licensing inspection by the FROO, which shall be done simultaneously

with the document review done by the Centers. The FROO shall forward the Certificate

of Compliance (COC) to the concerned Center for issuance of the LTO.

7. The FDA shall have the authority to enter any FDA-licensed establishments during

operating hours to conduct routine or spot check inspections. It is the responsibility of the

licensed establishments to immediately recall, withdraw or remove health products from

the market that is banned or declared injurious, unsafe or dangerous by the FDA or products

or batches of product that have been found to pose imminent danger to public health or

consumer safety.

8. All establishments shall provide the appropriate storage condition to maintain the safety

and quality of health products. All drug establishments engaged in vaccines, biologics and

other temperature-sensitive drug products shall comply with the cold chain management

requirements.

9. For drug establishments, including drug outlets, whether private or public, these shall be

under the supervision of a registered pharmacist during operating or business hours, unless

allowed by other pertinent law or regulation.

10. The schedule of fees and charges for licensing and inspection shall be covered by the most

recent DOH-FDA issuance.

V. LTO APPLICATION AND RENEWAL PROCESS

1. Initial LTO

A. Requirements

1) Accomplished e-Application Form (e-Portal).

The following information or documents, among others, shall be required when

accomplishing the e-Application Form which can be accessed through the FDA e-Portal

(www.fda.gov.ph). Among other information, the applicant shall provide information

a location plan and global positioning system (GPS) and the name of the Qualified

Person, depending on the type of health product establishment as specified in Annex A.

The Declaration and Oath of Undertaking shall be replaced by Self-Declaration for

simplification of requirements.

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2) Proof of Business Name Registration

Any one of the following shall be submitted as proof of business name registration:

a. For single proprietorship, the Certificate of Business Registration issued by the

Department of Trade and Industry (DTI);

b. For Corporation, Partnership and other Juridical Person, the Certificate of

Registration issued by the Securities and Exchange Commission (SEC) and Articles

of Incorporation;

c. For Cooperative, the Certificate of Registration issued by the Cooperative

Authority and Articles of Cooperation; or

d. For Government-Owned or Controlled Corporation, the law creating the

establishment, if with original charter, or its Certificate of Registration issued by the

Securities and Exchange Commission (SEC) and Articles of Incorporation, if without

original charter.

When the business or establishment address is different from the business name

registration address, the applicant shall submit a copy of the Business Permit (e.g.

Mayor’s Permit).

3) Proof of Payment.

Payment to the FDA cashier and other modes of payments through the bank or other

payment centers shall be established by the FDA.

4). Additional Requirements for Applications of LTO as Manufacturer

a. A Certificate of Compliance (COC) on inspection is a required document issued by

the FDA to a health product manufacturer before applying for a LTO as Manufacturer.

The application for LTO as manufacturer shall not be accepted without the COC issued

by the FDA.

i. The application for LTO as Manufacturer shall not be accepted without the

COC issued by the FDA.

ii. The COC shall be issued to the applicant manufacturer after complying with

Good Manufacturing Practice (GMP) requirements or for meeting the

minimum requirements on hygiene and sanitation depending on the type of

establishment, whether large or MSMEs, or the acceptable level of protection

for the consumers.

iii. The FDA Field Regulatory Operations Office (FROO) shall issue a separate

FDA Circular on the application process requirements for the application for a

COC using the same online system for e-LTO. The FDA-FROO shall schedule

and conduct the pre-licensing inspection, and issued the COC approval or

disapproval within the ARTA maximum prescribed processing time. iv. The information and documentary requirements to be attached to the

application shall be limited to the manufacturing activities and health products

to be produced by the manufacturing plant or facilities.

b. The Risk Management Plan (RMP) shall be required for all drug, cosmetics and

medical device manufacturers, traders and distributors (importer, exporter and/or

wholesaler). The CFRR requires it only for medium and large food manufacturers.

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The Site Master File (SMF) shall be required for applicants applying for LTO as

manufacturers of drugs (CDRR), cosmetic manufacturers (CCRR) and medical device

manufacturers (CDRRHR). The CFRR requires it only for large and medium food

manufacturers (CFRR). This documentary requirement and any documents pertaining to it as

required by the concerned Center shall be asked from the applicant or qualified person for

verification or validation by the inspector during the actual inspection only.

B. Processing of LTO Application

1. The processing time from submission of application to release of the LTO shall be in

strict compliance with the ARTA-approved FDA Citizens Charter.

2. Online application and processing of LTO shall be instituted by the FDA. Filing of

initial, and renewal, of LTO shall be done online through the e-Portal of the FDA

(www.fda.gov.ph).

3. The application is considered filed with the FDA when the applicants have received an

Acknowledgement Receipt as required by RA 11032. The Acknowledgement Receipt

shall contain the unique identification number of the application, agency logo, name of

the FDA employee who received the application, the date and time of application,

payment, and the statement of completeness of the documents submitted.

4. The evaluator shall assess the veracity of the application and documentary requirements.

Falsified, withholding any data or information, or misrepresented documents or material

facts shall be ground for disapproval. Approval or disapproval of applications shall be

according to the provision of the IRR of RA 11032.

5. The status of the application may be viewed by the application online or through the

doc tracking system.

6. The FDA shall establish an electronic system by which the applicant or authorized

representative can print the LTO in the convenience of their office or home.

2. Renewal of LTO

A. Requirements

The requirements for renewal of LTO are as follows:

1) Accomplished e-Application Form with Declaration and Undertaking and

2) Payment

B. Process

1. Automatic renewal as provided by RA 11032, specifically Rule VIII. Section 1. On

When Shall Automatic Approval of an Original Application or Request be Granted,

shall apply in this process.

2. Application for renewal shall be done 3 months prior to the expiration of the LTO.

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3. No variation in LTO (see Variation in LTO below) shall be done during the renewal of

the LTO.

4. Processing of application shall be within the ARTA-approved FDA Citizens Charter.

5. Approved LTOs shall be printed by the applicant or sent by courier by the FDA.

3. Variations in LTO

Variations in the LTO and critical changes in circumstances of the establishments that

may have impact the safety and quality of the health products require FDA approval.

A. Requirements

The requirements for application for variations in LTO shall be as follows:

1. The documentary requirements depending on the variation or circumstances of the

establishment or the product are shown in Annex B.

2. Payment

B. Process

1. Application for variation shall be done online application for variation in the LTO.

2. The maximum prescribed processing time shall be according to the provision of the

EODB Act.

3. Processing of application shall be within the ARTA-approved FDA Citizens Charter.

4. Approved LTOs shall be printed by the applicant or sent by courier by the FDA.

VI. VALIDITY AND FEES

The validity of LTOs and the applicable fees and other charges shall be covered by the

latest FDA issuance.

VII. CANCELLATION OF LICENSE TO OPERATE

The owner or authorized person may apply for voluntary cancellation of its existing

license by filing a formal notification with the FDA.

The FDA may conduct verification of the voluntary closure of the establishment or

voluntary cancellation of the LTO. The FDA may impose penalty for the cancellation of license.

When the license is cancelled either automatically or voluntarily, the FDA shall retain

jurisdiction over violations committed by the establishments while it was in operation.

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VIII. REPEALING CLAUSE

All issuances, or parts thereof, pertaining to LTO applications covered by this

Administrative Order are hereby repealed.

IX. SEPARABILITY CLAUSE

If any portion or provision of this Order is declared invalid or unenforceable or

unconstitutional, the validity or enforceability of the remaining portions or provisions shall be

affected, and this Order shall be construed as if it did not contain the particular invalid or

unenforceable or unconstitutional portion or provision.

X. MANDATORY REVIEW

This Administrative Order shall be reviewed by the FDA after three (3) years of

implementation.

XI. EFFECTIVITY

This Administrative Order shall take effect 30 days following its publication in two

newspapers of national circulation and submission to the University of the Philippines Law

Center.

FRANCISCO T. DUQUE III, MD

Secretary of Health

ANNEX A

Qualified Person Qualification and Credential Requirements

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Type of

Establishment

Qualified Person Credentials Required

Drug Manufacturer, Trader and Distributor

(wholesaler, importer,

exporter), and drug

outlet, RONPD

Registered Pharmacists Professional Regulatory

Commission (PRC) Identification

Card (ID)

Food Manufacturer, Trader and Distributor

(wholesaler, importer,

exporter)

Company Regulatory

Officer and Food Safety

Compliance Officer

Certificate of Attendance on

seminar on food safety, GMP or

HACCP given by the academe, WHO, FAO, NGOs, cooperative,

food industry organizations,

professional organizations, or the

FDA Academy

Medical devices,

radiation-emitting

devices,

in-vitro diagnostic device and reagents;

refurbished medical devices;

equipment or devices used for treating

sharps, pathological

and infectious waste,

water treatment

devices/systems; and

other health-related devices

Manufacturer, Trader

and Distributor

(wholesaler, importer,

exporter)

Registered professional or

graduates in the field of

allied health profession:

Pharmacy, Engineering

(includes the following

course but not limited to EE,

ECE, ME, CoE, CHE, SE),

Nursing, Medical

Technology, Dentistry,

Radiologic Technology,

Medicine, Computer

Science, Chemistry,

Physical Therapy and other

allied science courses

relevant to the device to be

distributed, imported or

manufactured.

a. PRC ID for professions with

Board/Licensure Exam or

Diploma for profession without

Board/Licensure Exam

b. Certificate of Attendance to

seminars, training, learning and

development activities on

medical device safety, quality

and use given by the academe,

industry, organization,

professional organization,

National Regulatory

Authorities, international

organization, like the WHO and

ISO

Cosmetic establishments,

manufacturer, trader

and distributor

(wholesaler, importer,

exporter)

Registered Pharmacists and

other related or allied health professionals

a. PRC ID

b. Certificate of Attendance to seminars, training, learning and

development activities on

cosmetic safety, quality and use

given by the academe, industry

organization, professional

organization, National

Regulatory Authorities,

international organization, like

the WHO and ISO, including

seminar conducted by the FDA

Academy for QPIRA

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When applicable or requested by the Center,

other Qualified Persons may asked to be included when filling up the Application Form

Drug Manufacturer

a. Production Manager/head

b. Quality Assurance Manager/head

c. Quality Control Manager/head

d. Authorized person for batch release

e. Pharmacovigilance officer

Food Manufacturer

a. Production Manager/head

b. Quality Assurance Manager/head

c. Quality Control Manager/head

d. Food Safety Officer

e. Any designated senior technical personnel

Medical Device Manufacturer

a. Production Manager/head

b. Quality Assurance Manager/head

c. Quality Control Manager/head

Cosmetic Establishment

a. Production Manager/head

b. Quality Control and/or Assurance Manager/head

ANNEX B

List of Requirements for Specific Variation in the LTO

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Transfer of Location of Manufacturing Plant and Drug Retailers

1. Document Requirement:

1. Business permit reflecting the new address

2. Updated Site Master File

Expansion of Manufacturer and/or Additional Product Line; or Change of

Manufacturing Activity

Document Requirement: Updated Site Master File

Transfer/Addition of Warehouse; or Transfer of Location Offices

1. Document Requirement: Business permit reflecting new warehouse

Change of Distributor Activity

1. Document Requirement: Contract Agreements showing change in activity

Additional Drugstore Activity

Documentary Requirement:

Additional Credentials of Pharmacist, where applicable

Other documents related or specific to the additional activity

Change of Ownership

1. Documentary Requirement: Any proof on the transfer of ownership such as any

of the following: Deed of sale or assignment or transfer of rights/ownership,

Memorandum of Agreement, or notarized Affidavit of the owner, proprietor,

Chairman or CEO of the establishment validating the transfer

Change of Business Name; or Zonal Change in Address

1. Documentary Requirement: Proof of reflecting the new name (business

registration) or zonal change

Change of Qualified Personnel

1. Documentary Registration: Name of new qualified person, with credentials

when applicable