CITIZEN’S CHARTER Citizen's Cha… · Article I of Book II of the RA 9711 Implementing Rules and Regulations, and Other Purposes CHECKLIST OF REQUIREMENTS WHERE TO SECURE 1)Basic

FOOD AND DRUG ADMINISTRATION

Department of Health

CITIZEN’S CHARTER

2020 (1st Edition)

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Profile

I. Mandate:

To protect the general public by ensuring the safety, efficacy, and quality of health products.

II. Vision:

To be an internationally recognized center of excellence in health product regulation by 2026.

III. Mission:

To guarantee the safety, quality, purity, efficacy of health products in order to protect and promote the right to health of the general public.

IV. Service Pledge:

Ensure the safety, efficacy, quality, and purity of health products by fostering integrity, transparency, and excellence-based standards and policies, in a healthy and safe work environment.

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CENTER FOR COSMETIC REGULATION AND RESEARCH External Services

List of Health Products Covered

A. Cosmetics

B. Household/Urban Hazardous Substances

C. Household/Urban Pesticides

D. Toys and Childcare Articles

List of Services External Services

Issuance of User Account to Access FDA E-Services/ Provision of Appointment Schedule and Document Tracking Number (DTN) / Receiving of Application for License to Operate Lodge at The E-Services and Other Authorizations / Receiving of Letters and Other Documents in Relation to Clients Application ........................................5

Issuance of Official Receipts and Posting of Payment .........................................................6

License to Operate of Establishment

I. License to Operate – Initial Application for Manufacturers of Cosmetics, Household Urban Hazardous Substances (HUHS), Toys and Child Care Articles (TCCAS), and Household Urban Pesticides (HUPS) ....................................................8

II. License to Operate – Initial Application for Traders, Distributors (Importer, Exporter, Wholesaler) of Cosmetics, Household Urban Hazardous Substances (Huhs), Toys and Child Care Articles (TCCAS) and Household Urban Pesticides (HUPS) ...........................................................................................................12

III. License to Operate – Renewal Application ...................................................................16

IV. License to operate – Variation Application ...................................................................20

Certificate of Product Registration/Notification

1. Cosmetic and Toys and Childcare Articles (TCCA) Notification, User Account, and Password ............................................................................................................................24

A. Initial Application ........................................................................................24 B. Renewal Application ..................................................................................25

C. Change in Credentials Application ..........................................................26

2. Cosmetic Product Notification ...........................................................................................26 3. Toys and Childcare Articles Product Notification ...............................................................28

4. Certificate of Product Registration (CPR) for Household Urban Pesticides (HUP) ...........29

A. Initial Application of Active Ingredient .....................................................29 B. Initial Application of Formulated Product ................................................31

C. Renewal Application of Product Registration .........................................34

D. Variation Application of Product Registration .........................................35

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5. Certificate of Product Registration (CPR) for Household Urban Pesticides (HUP) Off-Label Use / Public Health Emergency Exemption Permit .....................................38

6. Bureau of Custom (BOC) Clearance ...................................................................................39

7. Certificate of Free Sale (CFS)..............................................................................................41

8. Good Manufacturing Practice (GMP) Certificate ................................................................42

9. Sales and Promotion Permit .................................................................................................44

A. INITIAL APPLICATION .............................................................................44 B. AMENDMENT APPLICATION .................................................................46

FIELD REGULATORY OPERATIONS OFFICER INSPECTION AGENDA

A. SIMPLE Bureau of Customs – For Donation ..............................................................48

Bureau of Customs – For Personal Use ......................................................48

B. COMPLEX INSPECTION AGENDA – COSMETICS & HOUSEHOLD URBAN

PESTICIDES DISTRIBUTOR ..........................................................................49

C. HIGHLY TECHNICAL INSPECTION AGENDA – TOYS AND CHILDCARE ARTICLES

MANUFACTURER ..........................................................................................50

INSPECTION AGENDA – COSMETICS & HOUSEHOLD URBAN

PESTICIDES DISTRIBUTOR ..........................................................................51

INSPECTION AGENDA – DRUG, MEDICAL DEVICE and COSMETIC

REPACKER/ PACKER .....................................................................................52

FDAC .........................................................................................................................................54 FEEDBACK AND COMPLAINT MECHANISM ..................................................................59

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ISSUANCE OF USER ACCOUNT TO ACCESS FDA E-SERVICES/ PROVISION OF APPOINTMENT SCHEDULE AND DOCUMENT TRACKING NUMBER (DTN) / RECEIVING OF APPLICATION FOR LICENSE TO OPERATE LODGE AT THE E-SERVICES AND OTHER AUTHORIZATIONS / RECEIVING OF LETTERS AND OTHER DOCUMENTS IN RELATION TO CLIENTS APPLICATION

Center/Office : Food and Drug Action Center Classification : Simple Type of Transaction : G2B-Government to Business Who May Avail : All Manufacturers, Traders, Distributors (Importer, Exporter,

Wholesaler) of Food, Drugs, Cosmetics, Household Urban Hazardous Substances (HUHS), Toys and Child Care Articles (TCCAs), Household Urban Pesticides (HUPs) and Medical Devices

Fees to be Paid : AO 50 s.2001

CLIENT STEPS AGENCY ACTION PROCESSING TIME

PERSON RESPONSIBLE

1) USER ACCOUNT Sends email request to [email protected] for e-LTO user account following FDA Circular 2016-004 ● Accesses the FDA e-portal ● Logs in using FDA-issued

user account ● Accomplish application for

License to Operate ● Uploads documentary

requirements in PDF format

● Prints Order of Payment generated

Completes application process by clicking he “NEXT STEP” and “CONTINUE”buttons

1) FDAC checks email request and sends username and password to the client. Creates user account for client

1-2 working days

FDA Action Center (FDAC)

2) SCHEDULE/ APPOINTMENT Sends email request to [email protected] for schedule

2) FDAC checks email request and sends DTN for drug registrations and other authorizations to the client

1-2 working days

FDA Action Center (FDAC)

3) Pays the required fee through any of the following:

FDA Cashier at FDAC Starmall Alabang

BancNet Online**Landbank Branchesusing the Online Collection Payment Slip**

3) Receives payment and issues Official Receipt.

Posts payment

1 working day FDA Cashier

System routes application to appropriate Center/Office ● Application from

Manufacturer is routed to

mailto:[email protected]

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concerned Field Regulatory Office for review and inspection

Applications from Distributor, Retail Outlets, CRO/Sponsors are forwarded to appropriate Center for review

4) CLIENT WITH SCHEDULE TO APPEAR Gets queueing number for counter 3 and submits documents with soft copies for registration, CAPA, compliances, and other authorizations. Client may also submit documents at FDA Ali Mall Cubao: Received documents are transmitted to FDAC Alabang every Tuesday and Friday and as deemed necessary.

4) FDAC issues Acknowledgement Receipt with DTN, prepares transmittal and endorses received applications to the concerned Center/ Office.

▪ Staff copies files from client’s USB and stores the files in FDAC’s external hard drive. “USB is returned to client.”

Processing Time is 3 Minutes. Transmission of documents is Before 12 noon of the next working day

Head and Information Officer II at Public Assistance and Complaints’ Desk (PACD)

5) WALK-IN CLIENT Gets queueing number for counter 2 and submits letters and other documents, as deemed necessary, in relation to their application. At FDA Ali Mall Cubao: Received documents are transmitted to FDAC Alabang every Tuesday and Friday and Whenever deemed necessary.

5) FDAC issues Acknowledgement Receipt with DTN, prepares transmittal and endorses received documents to the concerned Office/ Center

Processing Time is 3 MINUTES. Transmission of documents is Before 12 noon of the next working day.

Head and Information Officer II at Letters Section

ISSUANCE OF OFFICIAL RECEIPTS AND POSTING OF PAYMENT

Center/Office : AFS – Cashier

Classification : Complex

Type of Transaction : G2B – Government to Businesses, G2G – Government to Government

Who May Avail : All Manufacturers, Traders, Distributors (Importers, Wholesalers, Exporters) of Food, Drugs, Cosmetics, Toys and Child Care Notification, Household Urban Pesticides (HUSP), Medical Devices and Drugstores/Retail Outlets for Non-Prescriptions Drugs

Fees to be Paid : AO 50 s. 2001

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1. Order of Payment Form E-Services

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2. Integrated Application Form/Document Tracking No.

FDAC Center/Regional Offices

3. Manual Assessment Form FDAC Center/Regional Offices

4. Corresponding cash/check for payment

Applicant

CLIENT STEPS AGENCY ACTION PROCESSING

TIME PERSON

RESPONSIBLE

Collection of Payment

1) Applicants with Order of Payment, Assessment form and DTN scheduled for the day will be accommodated by the FDA Cashier

Applicant

2) Get a number from the Guard on Duty on a first come first served basis.

1) Priority number will be given to Senior Citizens, Persons’with Disability and Pregnant Women.

Applicant

3) Wait for your number to be called. Otherwise the next client will be served. Clients who have waived their turn must secure another number and wait for their turn.

2) Maximum of five (5) applications per transaction per client. In excess of 5 applications, clients must secure for another number to be called before he/she can pay the remaining applications.

4) Client submit/present the Order of payment/DTN to FDAC Cashier (2 copies)

3) Receives and verifies the copy of the DTN/IAOPF downloaded by the client or as filled up by the client/s as reference for acceptance of payment

1 minute FDAC SCO

4) Encodes the details of payment and Prints the pre-numbered or and affix signature above the name of the SCO and CO (Name is currently pre-encoded in the OR)

3-5 minutes FDAC SCO

5) Payment in Cash/ Check/Combination of Cash and Check

5) Release the original Official Receipt and the DTN/ IAOPF with stamped “PAID” in the Client’s copy.

1 minute FDAC SCO

6) Attached copy of the DTN/IAOPF and file the duplicate and triplicate copy of Official Receipt

1 minute FDAC SCO

Posting of Payment

Verified payment through Over-the-counter report of collection and for Online

1 minute per application

Cashier Staff

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Bancnet and LBP OnColl payment through Bank reports

Log in to FDA Information System for DTN Posting or in FDA E Portal System for EPS Posting

1-2 minutes per application

Cashier Staff

Note:

Over-the-Counter payment Within 2 working days

Online Bancnet Payments Within 2-3 working days

LBP OnColl Payments Within 3-5 working days

TOTAL: 2-5 working days

Disclosure Statement: Standard Processing Time is reckoned from the time the complete properly filled up documents are received by the Special Collecting Officer until the transaction of the customer is completed. Processing Time does not include waiting time that may vary depending on the number of customers availing the FDA services or systems maintenance

LICENSE TO OPERATE OF ESTABLISHMENT

I. LICENSE TO OPERATE – INITIAL APPLICATION FOR MANUFACTURERS OF COSMETICS, HOUSEHOLD URBAN HAZARDOUS SUBSTANCES (HUHS), TOYS AND CHILD CARE ARTICLES (TCCAS), AND HOUSEHOLD URBAN PESTICIDES (HUPS)

Center/Office : Center for Cosmetics Regulation and Research (CCRR)

Classification : Highly Technical

Type of Transaction : G2B - Government to Business

Who May Avail : All Manufacturers Cosmetics, Household Urban Hazardous Substances (HUHS), Toys and Child Care Articles (TCCAs), and Household Urban Pesticides (HUPs)

Fees to be Paid : Cosmetics Manufacturer: 20 Million and below - Php 5,000 +1 % LRF over 20 Million but below 50 Million - Php 10,000 + 1 % LRF 50 Million and above - Php 15,000 + 1 % LRF Household Hazardous Substance Manufacturer: 1 Million and below - Php 1,000 + 1 % LRF over 1 Million but below 5 Million - Php 2,000 + 1 % LRF 5 Million but below 10 Million - Php 3,000 + 1 % LRF 10 Million but below 20 Million - Php 5,000 + 1 % LRF` 20 Million but below 50 Million - Php 10,000 + 1 % LRF 50 Million and above - Php 15,000 + 1 % LRF Administrative Order 50 s. 2001* Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs FDA Circular No. 2011-003

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Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further Amended by PD 1856


1)Basic Requirements based on the Administrative Order No. 2020-0017: ● Accomplished e-Application Form as

prescribed by FDA regulations..

● Location plan and Global Positioning

System (GPS) coordinates to be filled in

the eApplication Form

● Name of the Qualified Person (refer to

Annex A of AO 2020-0017) depending

on the type of health product

establishment (refer to Annex B of AO

2020-0017)

● Self-Declaration in the e-Application

Form

FDA e-Portal (www.fda.gov.ph) Applicant/Qualified person Applicant/Qualified person

2) Proof of Business Registration Any one of the following shall be submitted as proof of business name registration (in pdf): ● For single proprietorship, the Certificate

of Business Registration issued by the

Department of Trade and Industry (DTI)

(1 Scanned copy PDF)

● For Corporation, Partnership and other

Juridical Person, the Certificate of

Registration issued by the Securities and

Exchange Commission (SEC) and

Articles of Incorporation (1 Scanned

copy PDF)

● For Cooperative, the Certificate of

Registration issued by the Cooperative

Authority and Articles of Cooperation (1

Scanned copy PDF)

● 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

(1 Scanned copy PDF)

Applicant/Qualified person

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When a 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 income (Latest Audited Financial Statement with Balance Sheet)


4) Proof of payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

FDA Cashier/Other FDA Authorized Payment Portals or Banks

5) Additional Requirements for Applications of LTO as Manufacturer of all health products Risk Management Plan (RMP) (Checking

upon Inspection)

This is required for, cosmetics, HUHS, including household/urban pesticides (HUP) and toys and childcare articles (TCCA), manufacturers, Site Master File (SMF) (Checking upon Inspection) This is required for, cosmetics, HUHS, including household/urban pesticides (HUP) and toys and childcare articles (TCCA), manufacturers

Applicant/Qualified person Applicant/Qualified person

CLIENT STEPS AGENCY ACTION FEES TO BE PAID

PROCESSING TIME

PERSON RESPONSIBLE

1) The qualified person self- registers in the e-portal (http://eportal.fda.gov.ph) and uploads required documentary requirements for e-LTO application

1) Assess the completeness of the application. If complete, Order of Payment will be generated and will be given to the client thru the ePortal and Email notification. If incomplete, the application will not be received and will be returned to the client. Notice of Deficiency will be given to the client thru ePortal and Email notification.

None 0 1) Authorized Representative of the Applicant Company 2) FDA Evaluator (Center/Licensing and Registration Division)

2) The applicant company None 0 Authorized

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receives the system-generated Order of Payment thru the ePortal and Email notification.

Representative of the Applicant Company

3) The applicant company pays the assessed fee as per the system generated Order of Payment Form through FDAC Cashier or any other means prescribed by FDA (e.g. BANCNET, LANDBANK ONCOLL). Timeline of posting for each mode of payment: 1. Over the counter (FDA Cashier) – the payment will be posted after 2 days 2. Bank payment

Payment - the payment will be posted after 5 days

- the payment will be posted after 2 days

2) FDA Cashier receives the payment for FDAC Cashier payments. Received notification of payment for bank payments;

Cosmetics Manufacturer:

20 Million and below - Php 5,000 + 1 % LRF over 20 Million but below 50 Million - Php 10,000 + 1 % LRF 50 Million and above - Php 15,000 + 1 % LRF Household Hazardous Substance Manufacturer:

1 Million and below - Php 1,000+ 1 % LRF over 1 Million but below 5 Million - Php 2,000+ 1% LRF 5 Million but below 10 Million - Php 3,000+ 1 % LRF 10 Million but below 20 Million - Php 5,000+ 1 % LRF 20 Million but below 50 Million - Php 10,000+ 1 % LRF 50 Million and above - Php 15,000+ 1% LRF

0 FDA Cashier Administrative and Finance Service (AFS)/General Services Division (GSD)/Cashier Section

3) Post payment in ePortal for confirmed payments. This will prompt automatic decking of application to respective Center

None 1 working day

FDA Cashier Administrative and Finance Service (AFS)/General Services Division (GSD)/Cashier Section

4) Receive application and sort per product category

None 1 working day

Administrative Officer (Field Regulatory Operations Office)

5) Inspect 10 working Regional

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manufacturing facility days

Field Officer/ Inspector

6) Endorse COC/RL to Center

None 1 working day

Regional Field Officer/Licensing Officer

7) Evaluation of correctness of submitted documentary requirements. Recommend pre-license inspection of the establishment.

None 2 working days

FDA Evaluator (Center/Licensing and Registration Division)

8) Checking and quality assurance of the documents provided and compliance

None 2 working days

Technical Officer of specific Center of jurisdiction

9) Approval of LTO If application is disapproved, the applicant will be notified through email and will receive the Letter of Denial

None 1 working day

Center Director of jurisdiction

4) The applicant company receives notification and link of LTO for printing

Authorized Representative of the Applicant Company

TOTAL: 20 working days

II. LICENSE TO OPERATE – INITIAL APPLICATION FOR TRADERS, DISTRIBUTORS (IMPORTER, EXPORTER, WHOLESALER) OF COSMETICS, HOUSEHOLD URBAN HAZARDOUS SUBSTANCES (HUHS), TOYS AND CHILD CARE ARTICLES (TCCAS) AND HOUSEHOLD URBAN PESTICIDES (HUPS)

Center/Division : Center for Cosmetic Regulation and Research (CCRR)


Type of Transaction : G2B – Government to Business

Who May Avail : All Traders, Distributors (Importer, Exporter, Wholesaler) Cosmetics, Household Urban Hazardous Substances (HUHS), Toys and Child Care Articles (TCCAs) and Household Urban Pesticides (HUPs)

Fees to be Paid : Cosmetics Distributors: Importer, Exporter, Wholesaler- Php 3,000+ 1 % LRF Cosmetics Trader: 20 Million and below -Php 3,000+ 1 % LRF over 20 Million but below 50 Million- Php 5,000+ 1% LRF

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50 Million and above - Php 7,000+ 1 % LRF Household Hazardous Substances: Importer, Exporter, Wholesaler- Php 3,000+ 1 % LRF Note: The fees charged for the manufacturers and traders of products regulated by BFAD are based Administrative Order 50 s. 2001* Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs FDA Circular No. 2011-003 Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further Amended by PD 1856


1)Basic Requirements based on the Administrative Order No. 2016-0003 and its amendments:

● Accomplished e-Application Form as prescribed by FDA

regulations.

● Location plan and Global Positioning System (GPS) to be filled

in the eApplication Form

● Name of the Qualified Person (refer to Annex A of AO 2016-

0003 and its amendments)

● Self-Declaration in the e-Application Form

FDA e-Portal (www.fda.gov.ph) Applicant Applicant Applicant

2) Proof of Business Registration Any one of the following shall be submitted as proof of business name registration: ● For single proprietorship, the Certificate of Business Registration

issued by the Department of Trade and Industry (DTI) (1 Scanned

copy PDF)

● For Corporation, Partnership and other Juridical Person, the

Certificate of Registration issued by the Securities and Exchange

Commission (SEC) and Articles of Incorporation (1 Scanned copy

PDF)

● For Cooperative, the Certificate of Registration issued by the

Cooperative Authority and Articles of Cooperation (1 Scanned

copy PDF)

● 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 include Mayor’s Permit or Barangay Clearance

provision (1 Scanned copy PDF)

A copy of Business permit (i.e. Mayor’s Permit or Barangay Clearance provision) will be submitted for business or establishment address with

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different business name registration address.



4) Risk Management Plan (RMP) This is required for, cosmetics, HUHS, including household/urban pesticides (HUP) and toys and childcare articles (TCCA), Distributors /Traders



PROCESSING TIME

PERSON RESPONSIBLE

1) The qualified person self- registers in the e-portal (http://eportal.fda.gov.ph) and uploads required documentary requirements for e-LTO application

1) Assess the completeness of the application.

If complete, Order of Payment will be generated and will be given to the client thru the ePortal and Email notification.

If incomplete, the application will not be received and will be returned to the client. Notice of deficiency will be given to the client through ePortal and Email notification.

None 0 1) Authorized Representative of the Applicant

Company 2) FDA

Evaluator (Center/Licensing and Registration Division)

2) The applicant company receives the system-generated Order of Payment thru the ePortal and Email notification.

None 0 Authorized Representative of the Applicant Company

3) The applicant company pays the assessed fee as per the system generated Order of Payment Form through FDAC Cashier or any other means prescribed by FDA (e.g. BANCNET,

2) FDA Cashier receives the payment for FDAC Cashier payments

Received notification of payment for bank payments;

Cosmetics Distributors: Importer, Exporter, Wholesaler- Php 3,000 + 1 % LRF Cosmetics Trader: 20 Million and below -Php

FDA Cashier Administrative and Finance Service (AFS)/General Services Division (GSD)/Cashier Section

http://eportal.fda.gov.ph/

http://eportal.fda.gov.ph/

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LANDBANK ONCOLL).

Timeline of posting for each mode of payment: 1. Over the counter (FDA Cashier) – the payment will be posted after 2 days 2. Bank payment

Payment the payment will be posted after 5 days

– the payment will be posted after 2 days

3,000 + 1 % LRF over 20 Million but below 50 Million- Php 5,000+ 1 % LRF 50 Million and above - Php 7,000+ 1 % LRF Household Hazardous Substances: Importer, Exporter, Wholesaler- Php 3,000 + 1 % LRF Note: The fees charged for the manufacturers and traders of products regulated by BFAD are based

3) Post payment in eServices for confirmed payments. This will prompt automatic decking of application to respective Center (CDRR, CFRR CDRRHR, CCRR)

None 1 working day FDA Cashier Administrative and Finance Service (AFS)/General Services Division (GSD)/Cashier Section


None 1 working day

Administrative Officer (Center of jurisdiction)


None 12 working days

Technical Officer of specific Center of jurisdiction

7) Approval of LTO If application is disapproved, the

None 1 working day Center Director of jurisdiction

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applicant will be notified through email and will receive the Letter of Denial




III. LICENSE TO OPERATE – RENEWAL APPLICATION

Center/Office : Center for Cosmetics Regulation and Research (CCRR)



Who May Avail : All Manufacturers, Traders, Distributors (Importer, Exporter, Wholesaler) Cosmetics, Household Urban Hazardous Substances (HUHS), Toys and Child Care Articles (TCCAs) and Household Urban Pesticides (HUPs)

Fees to be Paid : Cosmetics Distributors: Importer, Exporter, Wholesaler Php 6,000 + 1 % LRF Cosmetics Manufacturer: 20 Million and below - Php 10,000 + 1 % LRF over 20 Million but below 50 Million - Php 20,000 + 1 % LRF 50 Million and above - Php 15,000 + 1 % LRF Cosmetics Trader: 20 Million and below - Php 6,000 + 1 % LRF over 20 Million but below 50 Million - Php 10,000 + 1 % LRF 50 Million and above - Php14,000 + 1 % LRF Household Hazardous Substances: Importer, Exporter, Wholesaler - Php 6,000 + 1 % LRF Household Hazardous Substance Manufacturer: 1 Million and below - Php 2,000 + 10 % LRF over 1 Million but below 5 Million - Php 4,000 + 1 % LRF 5 Million but below 10 Million - Php 6,000 + 1 % LRF 10 Million but below 20 Million - Php 10,000 + 1 % LRF 20 Million but below 50 Million - Php 20,000 + 1% LRF 50 Million and above - Php 30,000 + 1% LRF Administrative Order 50 s. 2001* Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs FDA Circular No. 2011-003 Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further Amended by PD 1856 FDA Circular No. 2011-004 Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering License of

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Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section 3, Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing Rules and Regulations, and Other Purposes


1)Basic Requirements based on the Administrative Order No. 2020-0017:

● Accomplished e-Application Form as

prescribed by FDA regulations..

● Declaration and Undertaking

FDA e-Portal (www.fda.gov.ph) Applicant




PROCESSING TIME

PERSON RESPONSIBLE

1) The qualified person applies for Renewal based on the Administrative Order No. 2016-0003 and its amendments in the e-portal via [email protected] and uploads required documentary requirements for e-LTO variation application

1) Assess the completeness of the application. If complete, Order of Payment will be generated and will be given to the client through the ePortal and Email notification. If incomplete, the application will not be received and will be returned to the client. Notice of Deficiency will be given to the client through ePortal and Email notification.

None 0

1) Authorized Representative Representative of the Applicant Company 2) FDA Evaluator (Center/Licensing and Registration Division)

2) The applicant company receives the system-generated Order of Payment through the ePortal and Email notification.


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3) The applicant company pays the assessed fee as per the system generated Order of Payment Form through FDAC Cashier or any other means prescribed by FDA (e.g. BANCNET, LANDBANK ONCOLL).


Payment – the payment will be posted after 5 days


2) FDA Cashier receives the payment for FDAC Cashier payments

Received notification of payment for bank payments.

Cosmetics Distributors:

Importer, Exporter, Wholesaler Php 6,000 + 1 % LRF Cosmetics Manufacturer:

20 Million and below - Php 10,000+ 1 % LRF` over 20 Million but below 50 Million - Php 20,000+ 1 % LRF 50 Million and above - Php 15,000 + 1 % LRF Cosmetics Trader:

20 Million and below - Php 6,000+ 1 % LRF over 20 Million but below 50 Million - Php 10,000 + 1 % LRF 50 Million and above - Php14,000 + 1 % LRF Household Hazardous Substances:

Importer, Exporter, Wholesaler - Php 6,000 + 1 % LRF Household Hazardous Substance Manufacturer:

1 Million and below - Php 2,000+ 1 % LRF over 1 Million but below 5 Million - Php 4,000+ 1 % LRF 5 Million but below 10 Million - Php 6,000 + 1 % LRF 10 Million but below 20 Million

0 FDA Cashier Administrative and Finance Service (AFS/General Services Division (GSD)/Cashier Section

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- Php 10,000 + 1 % LRF 20 Million but below 50 Million - Php 20,000 + 1% LRF 50 Million and above - Php 30,000 + 1 % LRF

3) Post payment in ePortal for confirmed payments. This will prompt automatic decking of application to respective Center

None 1 working day FDA Cashier Administrative and Finance Service (AFS/General Services Division (GSD)/Cashier Section


None 1 working day FDA Evaluator (Center/ Licensing and Registration Division)

5) Evaluation of correctness of submitted documentary requirements.

None 2 working days FDA Evaluator (Center/Licensing and Registration Division)



7) Approval of LTO

If application is disapproved, the applicant will be notified through email and will receive the Letter of Denial

None 1 working day Center Director




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IV. LICENSE TO OPERATE – VARIATION APPLICATION

Center/Office : Center for Cosmetic Regulation and Research (CCRR)



Who May Avail : All Manufacturers, Traders, Distributors (Importer, Exporter, Wholesaler) of Cosmetics, Household Urban Hazardous Substances (HUHS), Toys and Child Care Articles (TCCAs), Household Urban Pesticides (HUPs) s

Fees to be Paid : Amendment of LTO or Re-issuance (if lost) – Php 500+ 1 % LRF Administrative Order 50 s. 2001* Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs FDA Circular No. 2011-003 Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further Amended by PD 1856


1)List of Requirements for Specific Variation based on the Amendment of Administrative Order No. 2020-0017: A. Transfer of Location of Manufacturing Plant and Drug Retailers Documentary Requirement:

1. Business permit reflecting the new

address

2. Updated Site Master File to be

presented upon inspection

B. Expansion of Manufacturer and/or Additional Product Line; or Change of Manufacturing Activity Documentary Requirement:

1. Updated Site Master File to be

presented upon inspection

C. Transfer of Location Offices Documentary Requirement:

1. Business permit reflecting new location

of office


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D. Transfer of Location of Drug Retailers

Documentary Requirement: 1. Business permit reflecting new

address

E. Change of Distributor Activity

Documentary Requirement:

1. Contract Agreements showing change

in activity

F. Transfer or Addition of Warehouse Documentary Requirement:

1. Business permit reflecting new

warehouse

G. Additional Drugstore Activities Documentary Requirement:

1. Additional Credentials of Pharmacist,

as applicable

2. Other documents related or specific to

the additional activity (see Annex C of

AO 2020-0017)

H. Expansion of Office Establishment Documentary Requirement:

1. Expansion floor plan

I. Change of Ownership


1. Business name registration reflecting

new ownership

2. Any proof on the transfer of ownership

(see Annex C of AO 2020-0017)

J. Change of Business Name; Documentary Requirement:

1. Business permit reflecting the new

name

J. Zonal Change in Address


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1. Certificate of Zonal Address

K. Change of Qualified Person Documentary Requirement:

1. Name of new qualified person, with

credentials when applicable

2. Applicable requirements as specified in

Annex B of AO 2020-0017

M. Change of Authorized Person


1. Name of new qualified person

2. Updated contact details




PROCESSING TIME

PERSON RESPONSIBLE

1) The qualified person applies for specific variation as based on the Amendment of Administrative Order No.2020-0017 in the e-portal via [email protected] and uploads required documentary requirements for e-LTO variation application

1) Assess the completeness of the application.

If complete, Order of Payment will be generated and will be given to the client through the ePortal and Email notification. If incomplete, the application will not be received and will be returned to the client. Notice of deficiency will be given to the client through ePortal and Email notification.

None 0

1)Authorized Representative of the Applicant Company

2) FDA Evaluator

(Center/Licensing and Registration Division)

2) The applicant company receives the system-generated Order of Payment through thee


23

Portal and Email notification.

3) The applicant company pays the assessed fee as per the system generated Order of Payment Form through FDAC Cashier or any other means prescribed by FDA (e.g. BANCNET, LANDBANK ONCOLL).


OnColl Payment – the payment will be posted after 5 days


2) FDA Cashier receives the payment for FDAC Cashier payments Received notification of payment for bank payments.

Amendment of LTO or Re-issuance (if lost) – Php 500

0 FDA Cashier Administrative and Finance Service (AFS/General Services Division (GSD)/Cashier Section

3) Post payment in ePortal or confirmed payments. This will prompt automatic decking of application to respective Center

None 1 working day

FDA Cashier Administrative and Finance Service (AFS/General Services Division (GSD)/Cashier Section


None 1 working day FDA Evaluator (Center/Licensing and Registration Division)

5) Evaluation of correctness of submitted documentary requirements.


24

6) Checking and quality assurance of the documents provided and compliance.

None 2 working days

FDA Evaluator (Center/Licensing and Registration Division)

7) Approval of Variation

If application is disapproved, the applicant will be notified through email and will receive the Letter of Denial

None 1 working day Center Director of jurisdiction

4) The applicant company receives notification and link of LTO with appropriate amendment for printing



Note:

1. The fees charged for manufacturers and traders of products regulated by BFAD are based on the capital invested.

2. Renewal of LTO shall be on the anniversary of its issuance and shall be valid for two years.

Certificate of Product Registration/Notification

1. Cosmetic and Toys and Childcare Articles (TCCA) Notification, User Account, and Password

Issued to licensed establishments that will apply for product notification.

Center/Division : Center for Cosmetic Regulation and Research

Classification : Simple

Type of Transaction : G2B – Government to Business Entity

Who May Avail : Licensed Cosmetic and TCCA establishments (Distributor, Trader, Manufacturer)

Fees to be Paid : None

A. INITIAL APPLICATION


1. Valid LTO FDA-CCRR

2. QPIRA ID (for Cosmetics or TCCA) or Notarized authorization letter (Annex A of FMC 2015-010)

FDA Academy or FDA Memorandum Circular 2015-010

25


PROCESSING TIME

PERSON RESPONSIBLE

1. Applicant e-mails the request following the format stated in FMC 2015-010 to [email protected]

None Applicant

2. Verification of information sent

1. Data Controller verifies the information if correct and complete

None 1 Working Day

Information Technology

Officer CCRR

3. Creation of username and password

2. Data Controller creates user name and password

None 30 Minutes

4. Sending of username and password to applicant

3. Data Controller sends the username and password to applicant

None 30 Minutes

TOTAL: 1 Working Day, 1 Hour

B. RENEWAL APPLICATION

CHECKLISTOF REQUIREMENTS WHERE TO SECURE


2. Letter of Request (Annex C of FMC2015-010) FDA Memorandum Circular 2015-010

3. QPIRA ID (for Cosmetics or TCCA) or Notarized authorization letter (Annex A of FMC2015-010)



PROCESSING TIME

PERSON RESPONSIBLE

1. Applicant e-mails the request following the format stated in FMC 2015-010 to [email protected]

None Applicant



None 1 Working Day Information Technology Officer CCRR


2. Data Controller reactivates the username and password and send it to applicant

None 30 Minutes Information Technology Officer CCRR

TOTAL: 1 Working Day, 30 Minutes





26

C. CHANGE IN CREDENTIALS APPLICATION


1. Letter of request Applicant

2. QPIRA ID (for Cosmetics or TCCA) or Notarized authorization letter (Annex A of FMC 2015-010)


CLIENTSTEPS AGENCY ACTION FEES TOBE PAID

PROCESSING TIME

PERSON RESPONSIBLE

1. Applicant e-mails the request following the format stated in FMC 2015-010 [email protected]

None Applicant



None 1 Working Day Information Technology Officer CCRR


2. Data Controller sends the username and password to applicant

None 30 Minutes

Information Technology Officer CCRR

TOTAL:

1 Working Day, 30 Minutes

2. Cosmetic Product Notification

Issued to licensed establishments that will place a cosmetic product in the market.

Center/Office : Center for Cosmetics Regulation and Research



Who May Avail : Licensed Cosmetic Establishments (Distributor, Trader, Manufacturer)

Fees to be Paid : Php 500.00 +1% LRF not less than Php 10.00 for 1-year validity Additional Php 100.00 per variant


1. Cosmetic e-portal user account CCRR




27

3. Substantiation (for further clarifications)

3.1. Artwork of the Product labeling

3.2. Instructions for use

3.3. Mechanism of action of the product

3.4. Certificate of Origin of the ingredient

3.5. Safety Data Sheet

3.6. Certificate of Analysis

Source / Applicant


PROCESSING TIME

PERSON RESPONSIBLE

1. Applicant request for e-portal username and password

None Applicant

2. Applicant accomplish the application form and declaration in the e-portal

None Applicant

3. Applicant generates order of payment and pays the fee through Landbank Branch or FDA Cashier

Php 510.00 Additional Php 100.00 per variant

30 Minutes FDA Cashier personnel or Landbank Personnel

1. Payment will be posted after bank clearing

None 5 Working Days

FDA Cashier Personnel

2. Evaluator checks the correctness of the application

*Substantiation may be asked if there will be further clarification

None 12 Working

Days

Food Drug Regulation Officer CCRR

3. CCRR Director will give the final decision on the application

None 30 Minutes Director IV CCRR

4. Acknowledgement or disapproval will be forwarded to applicants e-portal account

None Applicant

TOTAL: 510.00 Additional Php 100.00 per variant

18 Working Days

28

3. Toys and Childcare Articles Product Notification

Issued to licensed establishments that will place a toy or childcare article product in the market.

Center/Division : Center for Cosmetics Regulation and Research



Who May Avail : Licensed Toys and Childcare Articles Establishments (Distributor, Manufacturer) Fees to be Paid : Php 100.00 +1% LRF not less than Php 10.00 (maximum of five (5) SKUs)


1. TCCA e-portal user account CCRR


3. Laboratory Test Report

3.1. For toys intended for children below14 y/o

3.1.1. Parts 1 to 3 of the PNS/ISO 8124 and reports for phthalate testing if the toy product contains PVC

3.2. For swings, slides, and similar activity toys 3.1.2. Parts 1 to 4 of the PNS/ISO 8124 and

reports for phthalate testing if the toy product contains PVC

3.3. For Childcare Articles 3.1.3. Laboratory reports f or migration of

elements (Antimony, Arsenic, Barium, Cadmium, Chromium, Lead, Mercury, Selenium) and phthalate testing

Supplier

4. Labeling and Packaging including other informative materials

- Shall be submitted during the application or with thirty (30) days of the acknowledgement of the application

Applicant


PROCESSING TIME

PERSON RESPONSIBLE

1. Applicant request for e-portal username and password

None

Applicant

2. Applicant accomplish the application form and declaration in the e-portal

None

Applicant

3. Applicant generates order of payment and pays the fee through Landbank Branch or FDA Cashier

PHP110.00

30 Minutes

FDA Cashier personnel or Landbank Personnel

1. Payment will be posted after bank clearing

None 5 Working

Days

FDA Cashier Personnel

2. Evaluator checks the None 12 Working Food Drug

29

correctness of the application

Days Regulation Officer CCRR

3. CCRR Director will give the final decision on the application

None 30 Minutes

Director IV CCRR

4. Acknowledgement or disapproval will be forwarded to applicants e-portal account

None

Applicant

TOTAL: PHP110.00 18 Working Days

4. Certificate of Product Registration (CPR) for Household Urban Pesticides (HUP)

Issued to licensed establishments that are engaged in the manufacture, importation, exportation, sale, and offer for sale, distribution, donation, transfer, testing, promotion, advertising, or sponsorship of household pesticide products and/or active ingredient/s. But will not cover genetically-modified/engineered household pesticide products.

Center/Division : Center for Cosmetics Regulation and Research



Who May Avail : Licensed HUP Establishments (Distributor, Trader, Manufacturer)

Fees to be Paid : Based on years of validity applied for +1% LRF *years of validity

2 year validity – Php 1,000



5 year validity – Php 2,500 For Variation Application Php 500.00 +1% LRF not less than Php 10.00

A. INITIAL APPLICATION OF ACTIVE INGREDIENT


1. Integrated application form FDA website (https://ww2.fda.gov.ph/industry-corner/downloadables) (kindly specify the site address) 2. Valid LTO FDA-CCRR

3. Copy of official receipt FDA cashier

Refer to AO 2019-0008 Annex A for Specific Data of the following requirements:

4. Chemical Identity Manufacturer or any 3rd party laboratory

5. Physical properties of the Active Ingredient

6. Product Specifications

7. Certificate of Analysis

https://ww2.fda.gov.ph/industry-corner/downloadables


30

9. Any of the following proof of Manufacturer’s compliance to Good Manufacturing Practice (GMP)

9.1. Certificate of Free Sale (CFS) issued by the National Regulatory Authority of country of origin

9.2.Certificate of Good Manufacturing Practice (GMP) based on international manufacturing Standards

9.3. Manufacturing license

9.4. ISO Certificate related to manufacturing

Manufacturer

10. Submission of actual sample and reference standard

Applicant or Supplier/Manufacturer

11. Toxicity Study

11.1. Acute

11.2. Corrosion / Irritation

11.3. Allergy / Sensitization

11.4. Sub-chronic

11.5. Reproduction effects

11.6. Teratogenicity

11.7. Neurotoxicity

11.8. Mutagenicity

11.9. Carcinogenicity and chronic (long term) toxicity studies in rats

Toxicity testing laboratory

12. Human Exposure and Safety

12.1. Medical Data / Poisoning symptoms /Antidote

12.2. Personal protective equipment

12.3. Other precautions

Manufacturer or Supplier

13. Environmental Fate and Effects

14. Labeling / Packaging

CLIENT STEPS AGENCY ACTION FEES TO BE PAID PROCESSING TIME

PERSON RESPONSIBLE

1. Applicant requests for a schedule of submission of requirements

None FDAC personnel

2. Pre-assessment of documents

1. Checking of completeness of documents

None 1 hour / application


3. Applicant pays the fee

2 Year validity –Php 1,000 3 Year validity – 4 Php 1,500 5 Year validity –Php 2,000

6 Year validity –Php 2,500 For Variation Application

Php 500.00 +1%

30 Minutes FDA Cashier personnel

8. Safety Data Sheet

31

LRF not Less than Php 10.00

4. Applicant submits requirements (electronic copy)

2. Receives complete requirements

None 30 Minutes FDAC officer of the day

None FDAC personnel

3. Data Controller receives the application and update the database

None 30 Minutes Administrative Assistant VI CCRR

4. Evaluator checks the correctness of documents

None 10 Working Days


5. Consultant reviews bio-efficacy study and/or toxicity study

None 8 Working Days


6. Evaluator review and prepares recommendation of consultant

None 2 Working Days


7. Checks if the recommendation is appropriate

None 30 Minutes Food Drug Regulation Officer CCRR

8. CCRR Director signs the final authorization


9. Data Controller updates the database and forwards the final authorization to records section


10. Releasing None AFS-Releasing personnel

TOTAL: 20 Working Days, 2 Hours

B. INITIAL APPLICATION OF FORMULATED PRODUCT

CHECKLISTOF REQUIREMENTS WHERE TO SECURE 1. Integrated application form FDA website

(https://ww2.fda.gov.ph/industry-corner/downloadables)



Refer to AO 2019-0008 Annex B for Specific Data of the following requirements:

4. Product Identity Manufacturer

5. Quantitative and Qualitative Composition of product



32

6. Technical Specifications of the formulated product Manufacturer

7. Product Specifications– Tolerance for the Active Ingredient

8. Certificate of Analysis Manufacturer or any 3rd party laboratory 9. Test procedures/methods conducted on the formulated product

10. Safety Data Sheet of the formulated product Manufacturer

11. Any of the following proof of Manufacturer’s compliance to Good Manufacturing Practices (GMP)

11.1. Certificate of Free Sale (CFS) issued by the National Regulatory Authority of country of origin

11.2. Certificate of Good Manufacturing Practice (GMP) based on international manufacturing Standards

11.3. Manufacturing license

11.4. ISO Certificate related to manufacturing

12. Substantiation to support special product claims Applicant or Manufacturer

13. Product Stewardship Program Applicant

14. Submission of actual sample and reference standard Applicant or Supplier/Manufacturer

15. Toxicity Study

15.1. Acute

15.2. Corrosion / Irritation

15.3. Allergy / Sensitization

15.4. Sub-chronic

15.5. Reproduction effects

15.6. Teratogenicity

15.7. Neurotoxicity

15.8. Mutagenicity

15.9. Carcinogenicity and chronic (long term) toxicity studies in rats

Toxicity testing laboratory

16. Bio-efficacy Data 3rd party testing laboratory

17. Human Exposure and Safety

17.1. Operators exposure data

17.2. Bystanders exposure data

17.3. Medical data / Poisoning symptoms /Antidote

17.4. Permissible exposure level

17.5. Personal protective equipment

17.6. Other precautions

Manufacturer or Supplier

18. Environmental Fate and Effects

19. Labeling / Packaging


PROCESSING TIME

PERSON RESPONSIBLE


None FDAC personnel

2. 1. Checking of completeness of documents



33

3. Applicant pays the fee 2 Year validity –Php1,000 3 Year validity –Php1,500 4 Year validity –Php2,000 5 Year validity –Php2,500 For Variation Application

Php 500.00 +1%LRF not less than Php 10.00





None FDAC personnel







None 8 Working Days



None 2 Working Days









TOTAL: 20 Working Days

34

C. RENEWAL APPLICATION OF PRODUCT REGISTRATION

CHECKLIST OF REQUIREMENTS WHERE TO SECURE 1. Integrated application form FDA website (https://ww2.fda.gov.ph/industry-corner/downloadables) 2. Post-market surveillance monitoring report Applicant

3. An attached legible, comprehensive and indelible specimen of all labeling materials per pack size (including outer, immediate, package inserts, if any) in English and/or Filipino language with local dialects as applicable

4. Copy of official receipt FDA Cashier


PROCESSING TIME

PERSON RESPONSIBLE


None FDAC personnel




2. Applicant pays the fee 2 Year validity –Php1,000 3 Year validity –Php1,500

4 Year validity –Php2,000 5year validity –Php2,500

For Variation Application Php 500.00 +1%LRF

not less than Ph 10.00





None FDAC personnel




None 20 working days




35









D. VARIATION APPLICATION OF PRODUCT REGISTRATION


1. Integrated application form FDA website (https://ww2.fda.gov.ph/industry-corner/downloadables)

2. Letter of Request Applicant

3. Valid LTO

4. Original copy of valid CPR


Specific Requirements: Major Variation

1. Change in product name (brand name/variant name)

a. Notarized affidavit/declaration of no change in the formulation

b. Extension of use or claim and new bio-efficacy study, if there is request to include additional target pests

c. Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable

Applicant 3rd party testing laboratory Applicant

2. Change in Rate, Timing or Frequency of application or method of application

a. Extension of use or claim and new bio-efficacy study, if there is request to include additional target pests

b. Study or studies that shall justify request for change in rate, timing or frequency of application, or method of application

c. Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialect as applicable

3rd party testing laboratory 3rd party testing laboratory Applicant



36

3. Change in label claim/ Request for additional target pests

a. Extension of use or claim and new bio-efficacy study, if there is request to include additional target pests

b. Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable

3rd party testing laboratory Applicant

4. Change in GHS category / hazard class

a. Copy of Safety Data Sheet

b. Copy of complete toxicity studies, if request is for change in hazard class


Manufacturer

Toxicity testing laboratory Applicant

Specific Requirements: Minor Variation

1. Change in business name of the manufacturer or distributor

a. Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable

Applicant

2. Change in product ownership

a. Copy of termination contract / Deed of Assignment

b. Copy of the agreement of the new MAH and manufacturer


Applicant Applicant Applicant

3. Change of address of the distributor of the product

a. Any valid document showing proof of transfer


Applicant

4. Addition or deletion of packaging of the product

a. Notarized affidavit/declaration of no change in the formulation


Applicant Applicant

37

CLIENT STEPS AGENCY ACTION FEES TO BE PAID PROCESSING TIME

PERSON RESPONSIBLE


None FDAC personnel

2. Pre assessment of documents





2 Year validity –Php1,000 3 Year validity –Php1,500 4 Year validity –Php2,000 5 Year validity –Php2,500 For Variation Application

Php 500.00 +1%LRF not less than Php10.00





None FDAC personnel














38

5. Certificate of Product Registration (CPR) for Household Urban Pesticides (HUP) Off-Label Use / Public Health Emergency Exemption Permit

May be applied for use by an unregistered household pesticide product or by a registered household pesticide product with use different from what has been approved by the FDA during emergency conditions as declared by the DOH or the respective Local Government Unit (LGU) such as pest outbreaks or disease/ epidemic.

Center/Office/Division : Center for Cosmetics Regulation and Research



Who May Avail : Licensed HUP Establishments (Distributor, Trader, Manufacturer)

Fees to be Paid : Php 500.00 +1% LRF not less than Php 10.00


1. Letter of Request Applicant

2. Information required for the public health exemption

3. Description of the HUP product

4. Description of the proposed use

5. Alternate methods of control

6. Bio-efficacy study 3rd party testing laboratory

7. Toxicity study Toxicity testing laboratory

8. Description of the proposed enforcement program Applicant


CLIENTSTEPS AGENCY ACTION FEES TO BE PAID

PROCESSING TIME

PERSON RESPONSIBLE


None FDAC personnel





3. Applicant pays the fee PHP 510.00 30 Minutes FDA Cashier personnel




None FDAC personnel



39





None 8 Working Days



None 2 Working Days








5. Releasing None AFS-Releasing personnel TOTAL: 510.00 20 Working

Days, 3 Hours

6. Bureau of Custom (BOC) Clearance

Issued to licensed establishments that will import products that are not yet notified but will be used for testing, research and development, clinical trial, exhibition, and so forth.




Who May Avail : Licensed Cosmetic, HUHS, HUP, TCCA, *ENDS/ENNDS Establishments with activity as importer of finished products(Distributor, Trader, Manufacturer) Fees to be Paid : Php 500.00 +1% LRF not less than Php 10.00


1. Letter of intent stating the purpose of importation Applicant

2. Airway Bill or Bill of Lading Designated courier

3. Packing List Applicant

4. Proforma Invoice Applicant

5. For Exhibition Applicant

5.1. Notarized affidavit of undertaking

5.2. Product Information (brochure, leaflet, label)

6. For clinical trial/research

6.1. Copy of protocol

Applicant

40

7. For Donation

7.1. Letter of endorsement from DOH-BIHC

7.2. Deed of donation

DOH-BIHC Applicant

8. Copy of valid LTO FDA-CCRR (kindly specify the releasing office)



PROCESSING TIME

PERSON RESPONSIBLE

1. Applicant submits the requirements to Letters Section of FDAC

None Applicant





PHP 510.00 30 Minutes FDA Cashier personnel

4. Applicant submits requirements (hardcopy)



5. Application is forwarded to CCRR

None FDAC personnel

6. Application is received by CCRR Data Controller and forwarded to CCRR Evaluator



7. Evaluation of application


None 2 Working Days Food Drug Regulation Officer CCRR

8. Checking of recommendation



9. Signing of recommendation (may be approved or disapproved)



10. Authorization is forwarded to Records Section for releasing

7. Data controller updates the database and forwards the authorization to records section



TOTAL: 510.00 2 Working Days, 3 Hours, 30

Minutes

41

7. Certificate of Free Sale (CFS)

Issued to licensed establishments that will export their products to other countries.




Who May Avail : Licensed Cosmetic, HUHS, HUP, TCCA, *ENDS/ENNDS Establishments with activity as exporter of finished products (Distributor, Trader, Manufacturer)

Fees to be Paid : *Php 500.00 per product per country (except for U.S.A. or U.A.E. which is computed per state or emirate) +1%LRFnot less than Php 10.00


1. Integrated application form FDA website https://ww2.fda.gohv.ph/industry-corner/downloadables 2. Letter of intent stating the country where the product

will be exported Applicant

3. Valid LTO with activity as exporter FDA-CCRR

4. Copy of valid product registration/notification FDA-CCRR



PROCESSING TIME

PERSON RESPONSIBLE


None FDAC personnel




3. Applicant pays the fee *Php 500.00 per product per country (except for U.S.A. or U.A.E .which is computed per state or emirate) +1%LRFnot less than Php 10.00


42




None FDAC personnel




None 2 Working Days









TOTAL: 2 Working Days, 3 Hours,

30 Minutes

8. Good Manufacturing Practice (GMP) Certificate

Issued to licensed cosmetic manufacturers that are at least one year operational.

Center/Office/Division : Center for Cosmetic Regulation and Research



Who May Avail : Licensed Cosmetic Manufacturer

Fees to be Paid : Php 1,000.00 +1% LRF(validity of2 years)


1. Letter of intent Applicant

2. Copy of Valid LTO as Cosmetic Manufacturer FDA-CCRR


CLIENT STEPS AGENCY ACTION FEES TO BE

PAID PROCESSING

TIME PERSON

RESPONSIBLE

1. Applicant submits the requirements to Letters Section in FDAC

None Applicant

43




3. Applicant pays the fee through Landbank Branch or FDA Cashier

PHP1,010.00


4. Applicant submits requirements (hardcopy)




None FDAC personnel





4. Evaluator checks the correctness of documents.

*Proceed to no.9 if inspection is not required

None 5 Working Days


7.1. Application is referred to FROO for inspection, if required

5. Data Controller updates the database and forwards the application to FROO

None Administrative Assistant VI CCRR

7.2. CCRR receives Inspection Report or Recommendation Letter from FROO

6. Data Controller receives the report and update the database then forwards to CCRR Evaluator

None Administrative Assistant VI CCRR


7. Evaluator checks the correctness of documents.

None 5 Working Days


9. Checking of recommendation










TOTAL: 1,010.00 5 Working Days,

3 Hours, 30 Minutes

44

9. Sales and Promotion Permit

Issued to licensed establishments that intends to have broad consumer participation which contain promises of gain such as prizes, in cash or in kind, as reward for the purchase of a product, security, service, or winning in a contest, game, tournament and other similar competitions which involve determination of winner/s and which utilize mass media or other widespread means of information.

Center/Office/Division : Center for Cosmetic Regulation and Research



Who May Avail : Licensed Cosmetic, HUHS, HUP, TCCA Establishments (Distributor, Trader, Manufacturer) or advertising agency representing the former Fees to be Paid : Initial application *Based on the following promo size +1%LRF: 1. Php 300,000 and below – Php 1,000 2. Php 300,001 to Php 500,000 – Php 2,000

3. Php 500,001 to Php 1million – Php 3,000

4. Above Php 1 million –Php 5,000 Amendment application Php 300.00 +1% LRF not less than Php 10.00

A. INITIAL APPLICATION


1. Integrated application form FDA website https://ww2.fda.gov.ph/industry-corner/downloadables

2. Information Sheet and Mechanics of the sales promotion FDA website https://ww2.fda.gov.ph/industry-corner/downloadables

3. Copy of Valid LTO FDA-CCRR


5. Copy of lay-out of any promo materials Applicant


CLIENT STEPS AGENCY ACTION FEES TO BE PAID PROCESSINGTIME PERSON

RESPONSIBLE


None FDAC personnel




45


Initial application *Based on the following promo size +1%LRF: 1.Php 300,000 and below–Php 1,000 2. Php 300,001 toPhp500,000 – Php 2,000 3. Php 500,001 toPhp1million – Php 3,000 4. Above Php 1million – Php 5,000


4. Applicant submits requirements (electronic copies)




None FDAC personnel






None 5 Working Days Administrative Assistant VI CCRR

8.Checking of recommendation









46


TOTAL: 5 Working Days, 3 Hours, 30

Minutes

B. AMENDMENT APPLICATION


1. Integrated application form FDA website (https://ww2.fda.gov.ph/industry-corner/downloadables) (kindly indicate the site address)

2. Letter of intent stating the type of amendment Applicant

3. Copy of previously approved promo permit Applicant

4. Copy of Valid LTO FDA-CCRR


6. Copy of lay-out of any promo materials Applicant


CLIENT STEPS AGENCY ACTION FEES TO BE

PAID PROCESSINGTI

ME PERSON RESPONSIBLE


None FDAC personnel





PHP 310.00 30 Minutes FDA Cashier personnel or Landbank Personnel

4. Applicant submits requirements (electronic copies)



None FDAC personnel




None 5 Working Days

Administrative Assistant VI CCRR





47



7. Data Controller updates the database and forwards the final authorization to Records Section


5 Releasing None AFS-Releasing personnel

TOTAL: PHP310.00 5 Working Days, 3 Hours,

30 Minutes

48

FIELD REGULATORY OPERATIONS OFFICER INSPECTION AGENDA

A. SIMPLE

Bureau of Customs – For Donation

Certification Classification1

Type of Transaction2

Processing Time3

List of Requirements

Inspection Report with recommendation for release (Upon validation /inspection of the products)

Simple Government-to-Business

(G2B)

3 d Upon receipt of request for inspection from the consignee

FDA Clearance issued by Centers

Legend: 1 Classify if Simple, Complex, or Highly Technical Transaction 2 Classify if Government-to- Citizens (G2C), Government-to-Business (G2B), and Government-to-Government (G2G) 3 Based on Current Citizen’s Charter Timeline Bureau of Customs – For Personal Use

Certification Classification1

Type of Transaction2

Processing Time3

List of Requirements

E-mail Reply (citing Joint Circular No.1)

Simple Government-to-Business

(G2B)

1 day Upon receipt of request for inspection from the consignee

E-mail Request

Legend: 1 Classify if Simple, Complex, or Highly Technical Transaction 2 Classify if Government-to- Citizens (G2C), Government-to-Business (G2B), and Government-to-Government (G2G) 3 Based on Current Citizen’s Charter Timeline

49

B. COMPLEX

Inspection Activity

I. Opening Meeting Introductions Inspection scope Attendance record

II. Document Review

2.1 Organization, Management & Personnel

Organizational Chart Job Description / Duties and responsibilities of personnel involved in supply chain Training Plan Training Records and/or Competency evaluation of personnel

2.2 QMS & Documentation License to Operate Proof of Business Registration (DTI / SEC and Business / Mayor’s Permit) Standard Operating Procedures Records

- Distribution Records - Importation documents - Receipts from suppliers - Receipts issued to customers - Product complaints - Product recall - Summary list with status of notification - Recorded temperature and relative humidity (RH) monitoring data (where

applicable) - Calibration records of temperature/RH monitors (where applicable) - Stock Reconciliation/ Inventory

2.3 Contract activities Distribution agreements with suppliers ( quality agreements)

- FDA Licenses (for local suppliers) / GMP Certificates or other equivalent document (for foreign suppliers)

Agreement with third party (TP) logistics or carrier (when applicable) III. Walk-through Inspection

3.1 Warehouse facilities

Adequate/ sufficient and labeled or identified areas for products: Commercial stocks/Rejects /Returns/Recalled Facilities & equipment (PPEs for HUPs)

- Storage conditions (must be in compliance with the recommendations of manufacturer or instructions on the label)

- Temperature monitors Sanitation /Pest Control Records Stock Rotation ((first expiry/first out (FEFO) system must be observed)

3.2 Products Labeling compliance Status of Notification/ Product registration


PESTICIDES DISTRIBUTOR

50

Sample collection (as necessary) 3.3 Other Requirements

Product Information File for Cosmetic Products - Part I Administrative Documents & product Summary - Part II Quality Data of Raw Materials - Part III Quality Data of Finished Product - Part IV Safety & Efficacy Data

IV. Report Writing Consolidation and discussion of findings

V. Exit Meeting Attendance record Presentation/ discussion of findings Signing of Inspection Report

C. HIGHLY TECHNICAL

Inspection Activity

OPENING MEETING

Presentation of Inspection / Audit Plan Presentation of Floor Plan and Plant Lay-Out Scope of Inspection

PLANT INSPECTION

Premises & Equipment o Production areas o Sampling Area o Packaging o Maintenance of facilities o Cleaning of equipment o Maintenance/Calibration of Equipment o Pest Control o Waste Disposal

Warehouse

o Raw Materials o Packaging Materials o Finished Goods

DOCUMENTATION REVIEW

Duly Accomplished Integrated Application Form DTI / SEC Registration Business Permit / Mayor’s Permit Contract of Lease of Office or Proof of Ownership (TCT) or Certificate of Occupancy Contract of Lease of Warehouse or Proof of Ownership (TCT) or Certificate of

Occupancy Training Certificates Internal Audit 201 File of Technical Person / Authorized Person

INSPECTION AGENDA – TOYS AND CHILDCARE ARTICLES

MANUFACTURER

51

Standard Operating Procedures (if applicable) Certificate of Analysis of Finished Goods (Third Party) Disposal Plan Recall Plan Incoming Delivery Receipts and Distribution Records

REPORT WRITING EXIT MEETING

Inspection Activity

I. Opening Meeting Introductions Inspection scope Attendance record

II. Document Review

2.4 Organization, Management & Personnel

Organizational Chart Job Description / Duties and responsibilities of personnel involved in supply chain Training Plan Training Records and/or Competency evaluation of personnel

2.5 QMS & Documentation License to Operate Proof of Business Registration (DTI / SEC and Business / Mayor’s Permit) Standard Operating Procedures Records

- Distribution Records - Importation documents - Receipts from suppliers - Receipts issued to customers - Product complaints - Product recall - Summary list with status of notification - Recorded temperature and relative humidity (RH) monitoring data (where

applicable) - Calibration records of temperature/RH monitors (where applicable) - Stock Reconciliation/ Inventory

2.6 Contract activities Distribution agreements with suppliers (quality agreements)

- FDA Licenses (for local suppliers) / GMP Certificates or other equivalent document (for foreign suppliers)

Agreement with third party (TP) logistics or carrier (when applicable) III. Walk-through Inspection

3.4 Warehouse facilities

Adequate/ sufficient and labeled or identified areas for products: Commercial stocks/Rejects /Returns/Recalled


PESTICIDES DISTRIBUTOR

52

Facilities & equipment (PPEs for HUPs) - Storage conditions (must be in compliance with the recommendations

of manufacturer or instructions on the label) - Temperature monitors

Sanitation /Pest Control Records Stock Rotation ((first expiry/first out (FEFO) system must be observed)

3.5 Products Labeling compliance Status of Notification/ Product registration Sample collection (as necessary)

3.6 Other Requirements Product Information File for Cosmetic Products

- Part I Administrative Documents & product Summary - Part II Quality Data of Raw Materials - Part III Quality Data of Finished Product - Part IV Safety & Efficacy Data

VI. Report Writing Consolidation and discussion of findings

VII. Exit Meeting Attendance record Presentation/ discussion of findings Signing of Inspection Report

Inspection Activity

Opening Meeting Introduction from FDA Lead Inspector Discussion of Scope, Inspection Plan and GMP Standard Timetable Attendance Sheet Company Introduction and Overview

Design and Lay-out Review prior to Site Inspection (Warehouse, Repacking/Packing Area)

Site Inspection Warehouse (Starting Materials and Finished Goods)

Receipt Sampling Storage area (quarantine, approved, reject, cool room) Storage condition (temperature, humidity) Approval for use / release prior to repacking or packing Dispatch

Repacking / Packing Facility

Building Maintenance and Structure Gowning Areas / Changing Rooms Repacking/Packing Area Storage condition (temperature, humidity) Line Clearance In-process controls Cross contamination prevention measures Equipment (status: cleaning, maintenance, calibration)

INSPECTION AGENDA – DRUG, MEDICAL DEVICE and COSMETIC

REPACKER/ PACKER

53

Control of labels and pre-printed packaging materials Coding Storage of finished goods Retention Sample

Utilities and Engineering Services (if applicable) Air Handling Units

Design and Structure Operation and Maintenance Monitoring

Pest Control and Waste Disposal

Documentation

Pharmaceutical Quality System Quality Risk Management Change Control Deviation CAPA Supplier Qualification Batch Release Procedure

Personnel Organizational Chart Job Description

Training and Assessment Personnel Hygiene Health Examination

Batch Packaging Records Review Packaging Specifications

Other Relevant Documents

Standard Operating Procedures Receiving and Dispatch Cleaning and Sanitization of Premise and Equipment Storage conditions to each category of materials Quality Control check Reprocessing / Reworking Handling of excess packaging materials Out-of-Specifications

Product Complaint and Recall Outsourced Activities Self-Inspection Report Writing

Discussion of audit findings

54

1. Issuance of Electronic Portal (E-Portal) User Account

2. Issuance of Appointment Schedule and Document Tracking Number

Center/Office/Division

: FDAC Account Section



Who may Avail

: Manufacturer, Traders, Distributors, Importers, Exporters, Wholesalers, Drug Outlets, and other Establishment and Facilities of health products, as determined by Food and Drug Administration

Fees to be paid : No required payment


1. Accomplished Integrated Application Form

(IAF) (pdf format) 2. Signed and Notarized Petition (pdf format)

Food and Drug Administration Philippines

Website


: FDAC Account Section



Who may Avail

: Manufacturer, Traders, Distributors, Importers, Exporters, Wholesalers, Drug Outlets, and other Establishment and Facilities of health products, as determined by Food and Drug Administration

Fees to be paid : No required payment


1. Signed and notarized Authorization

Letter (Annex B - FDA Circular No. 2016-004) (pdf format)

Food and Drug Administration Philippines Website

FDA Circular No. 2016-004

“Procedure on the Use of the New Application Form for License to Operate

(LTO) thru the Food and Drug Administration (FDA) Electronic Portal”

CLIENT STEPS AGENCY ACTION Fees to be Paid

PROCESSING TIME

PERSON RESPONSIBLE

1. Sends an email request to [email protected]

1.Checks the received e-mail as to completeness and appropriateness of the request

None 15 Minutes

FDAC Staff Information

Officer II

2. Receives username and password

2. Issues user account (username and password) to client

None Next Working

Day

FDAC Staff Information

Officer II

TOTAL: None 2 Working Days

55

FDA Circular No. 2014-003 “Filling and Receiving of Registration,

Licensing and Other Application using the Integrated Application Form”

CLIENT STEPS AGENCY ACTION Fees to be Paid

PROCESSING TIME

PERSON RESPONSIBLE

1. Send application e-mail to [email protected]

1.Checks the received e-mail as to completeness and appropriateness of the request

None 15 Minutes FDAC Staff

Information Officer II

2. Receives Document Tracking Log and Appointment Schedule

2.Issues appointment schedule and Document Tracking Log (DTL) to the client’s e-mail

None

Next Working Day

FDAC Staff Information Officer

II

TOTAL: None 2 Working

Days

3. Filling of Complaint (Walk-in)

Filing of complaint through personal appearance at the Food and Drug Action Center (FDAC)


: FDAC CSAT/E-Report Section


Type of Transaction : G2G - Government to Business, G2C - Citizen, or G2G - Government

Who may Avail : All

Fees to be paid : None


Written letter addressed to Director General of Food and Drug Administration (FDA)

Full name Address Contact details Details of the acts complained of Name of center/office of person(s)

charged, if applicable Evidence of such violation, if applicable

Food and Drug Action Center


56

CLIENT STEPS AGENCY ACTION

Fees to be paid

PROCESSING TIME

PERSON RESPONSIBLE

1. Submits a written letter addressed to the Director General of the Food and Drug Administration (FDA) to E-Report Section of the Food and Drug Action Center (FDAC) Address: 3rd Flr. Starmall Alabang, Muntinlupa

1. Receives the written letter and encodes the details in the FDA Inventory System and generates Document Tracking Number (DTN)

None 5 Minutes

FDAC E-Report Staff (Administrative Assistant III)

2. Receives an acknowledgement receipt.

2. Encodes the DTN and details of the E-Report Database for tracking and monitoring. 3. Prints the acknowledgement receipt

None 5 Minutes

4. Endorses the received document/s to the concerned center/office

None Day 1

TOTAL: None 1 Working Day,

10 Minutes

4. Filling of Complaint (Online)

Filling of complaint through e-mail, [email protected]


: FDAC CSAT/E-Report Section


Type of Transaction : G2B - Government to Business, G2C - Citizen, or G2G - Government

Who may Avail : All



For complaint or feedback via e-mail, kindly include the following information if applicable:

Full name: Address:

Food and Drug Action Center


57

Contact details: Details of the complaint/feedback Person(s) in-charged Evidence of such violation

CLIENT STEPS AGENCY ACTION

Fees to be paid

PROCESSING TIME

PERSON RESPONSIBLE

1. Send complaint via e-mail with the detailed information to the Food and Drug Action Center (FDAC) E-mail: [email protected] [email protected]

1. Checks the received document along with other attached documents if available.

None

5 Minutes

FDAC E-Report Staff (Administrative Assistant III)

2. Encodes the complaint details and generates Document Tracking Number (DTN) in the FDA Inventory System

None

3. Encodes the DTN and compliant details in the E-Report Database for tracking and monitoring.

None

2. Receives acknowledgement receipt and DTN

4. Send an acknowledgement receipt including DTN

None 5 Minutes

5. Endorse the received document/s to the concerned center/office through e-mail

None Day 1

TOTAL: None 1 Working Day, 10 Minutes

5. Receiving of Application(s) and Other Documents of FDAC - Public Assistance and Complaint Desk (PACD) and Letter Section


: FDAC PACD and Letter Section



Who may Avail : Manufacturer, Traders, Distributors, Importers, Exporters, Wholesalers, Drug Outlets, and other Establishment and


58

Facilities of health products, as determined by Food and Drug Administration

Fees to be paid : Administrative Order No. 50 s. 2001 “Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs”


1. Issued Document Tracking Log (Scheduled Client)

2. Soft copies (PDF File format) of the documents based on the application requirements

???

CLIENT STEPS AGENCY ACTION Fees to be paid

PROCESSING TIME

PERSON RESPONSIBLE

1. Submits application and other documents to PACD or Letter Section

1. Checks the application and other documents if the payment has been made

AO No. 50 s. 2001

5 Minutes FDAC


2. Receives acknowledgement receipt

2. Checks the received application/s and other documents. 3. Stamp the client’s Document Tracking Log as an acknowledgement receipt of the document/s

None

3 minutes FDAC


4. Routes the received application and/or other document to the concerned center/office

None Next

Working Day (Before 12nn)

FDAC Courier Information

Officer II


Day, 8 minutes

6. Assistance to Phone Callers


: FDAC Phone Operator Section



Who may Avail : All



None

None

59


PROCESSING TIME

PERSON RESPONSIBLE

Calls the FDAC designated landline numbers 8-8211177 8-8211176 8-8211159 8-8211220 8-8211162

1. Answer phone calls and identify the client’s concern

2. Acts on client’s concern 3. Highly technical concerns are advise to send an e-mail to the designated center/office e-mail address

None

10 Minutes Depending on the complexity

of the issue

FDAC Phone Operators


TOTAL: None 10 Minutes

7. Customer Satisfaction Survey (CSS) Form

Center/Office/Division : FDAC CSAT/E-Report Section



Who may Avail : All



CSS Form

Food and Drug Action Center (FDAC)


PROCESSING TIME

PERSON RESPONSIBLE

1. Fill-out the CSS form and drops it at the designated suggestion box

1. Consolidates all filled-out CSS forms at the end of the month

None 3 Minutes FDAC

E-Report Staff (Administrative Assistant III) 2. Routes the

consolidated forms to the concerned center/office

None Day 1


day, 3 Minutes

FEEDBACK AND COMPLAINT MECHANISM

How to send feedback

Answer the Customer Satisfaction Survey form in the receiving area and drop it in the suggestion box Food and Drug Action Center (FDAC)

60

Contact info: (8)821-1177, (8)8211176, (8)8211159, (8)8211220, (8)8211162

How feedback are processed

The admin verifies the nature of feedback after a month. The same will be referred to the office concerned. Upon receiving the response of the concerned center/office, the client will be informed via e-mail. For follow-up, the contact information are as follows: 8)821-1177, (8)8211176, (8)8211159, (8)8211220, (8)8211162 For queries, the contact information are as follows: 8)821-1177, (8)8211176, (8)8211159, (8)8211220, (8)8211162 [email protected]

How to file a complaint

To file a complaint against the Food and Drug Administration (FDA) or product under jurisdiction of FDA, provide the following details via e-mail or walk-in

Full name and contact information of the complainant

Narrative of the complaint Evidence, if applicable Name of the person being

complained, if applicable Send all complaints against the FDA or product to [email protected] or through walk-in at Food and Drug Action Center (FDAC)

How complaints are processed

All complaints received will be monitored by the E-Report Section at the Food and Drug Action Center (FDAC) The FDAC shall coordinate with the concerned Center or Office to answer the complaint and shall investigate, if necessary. The E-Report Section or concerned Center or Office shall give the feedback to the client/complainant via e-mail or letter.
