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(BFAD) CITIZEN'S CHARTER - fda.gov.ph

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BUREAU OF FOOD AND DRUGS (<strong>BFAD</strong>) CITIZEN’S <strong>CHARTER</strong><br />

CCT Team Leader - Prof. Leticia-Barbara B. Gutierrez<br />

Director<br />

CCT Deputy Team Leader - Atty. Emilio L. Polig<br />

OIC, Deputy Director<br />

CCT Members - Jesusa Joyce N. Cirunay<br />

Chief, Product Services Division<br />

Atty. Emilio L. Polig<br />

Chief, Legal, Information and Compliance Dvision<br />

Ma. Lourdes S. Santiago<br />

OIC, Laboratory Services Division<br />

Virginia Francia C. Laboy<br />

OIC, Policy, Planning and Advocacy Division<br />

Nemia T. Getes<br />

OIC, Regulation Division I<br />

Rhoda Laine D. Manaloto<br />

OIC, Regulation Division II<br />

Ma. Victoria F. Calzado<br />

OIC, Administrative Division<br />

Sub CCT Members - Marivic E. Paulino<br />

Helena Alcaraz<br />

Grace L. Medina<br />

Florita M. Moraleja<br />

Asuncion Bonaobra<br />

Merlita Pedron<br />

Nilanda Ambrosio<br />

Cynthia Lim<br />

Tomasa Gutierrez<br />

Ma. Rosario DC. Dalangin<br />

Minerva Cauyan<br />

Evangeline S. Manalo<br />

Cristina dela Cruz<br />

Albina Mendoza<br />

Emelita C. Romano<br />

Damaso P. Velasco


Product Services Division<br />

Food Section<br />

Frontline Service: Issuance of Certificate of Product Registration (CPR)<br />

Clients: All Food Manufacturers/Distributors, Importers/Wholesalers/Exporters<br />

Schedule of Availability of Service: Evaluation of Technical Documents (Monday-Friday 7:00<br />

Am-5:30 PM)<br />

Application (Mondays only 8:00am – 3:00 pm)<br />

Fees: Category I- Initial-PhP 400-1000.00<br />

- Renewal-PhP 1000.00 + 500 surcharge (if applicable)<br />

Category II-Initial-PhP 500-1250.00<br />

- Renewal-PhP 1250 + 625 surcharge (if applicable)<br />

How to avail of the service:<br />

No. STEPS in PROCESSING<br />

APPLICATIONS FOR<br />

REGISTRATION<br />

1 *Go to PAICS-Rm. 101. Log in<br />

the Record Sheet provided for<br />

clients. Get a number and<br />

wait for the number to be<br />

called.<br />

* Submit complete<br />

requirements together with<br />

accomplished Assessment Slip<br />

2 *Go to Accounting Section<br />

and submit assessment slip<br />

3 Go to Cashier and submit<br />

Order of payment with the<br />

assessment slip for payment<br />

of registration fee<br />

4 Go to PAICS<br />

And submit the complete set<br />

of documents and proof of<br />

payment<br />

AGENCY/<br />

ACTION<br />

*Pre-assess the application<br />

documents.<br />

*Sign assessment Slip If the<br />

documents are not yet<br />

complete, notify client of the<br />

deficient documents.<br />

*Receive Assessment slip,<br />

prepares and issues Order of<br />

Payment<br />

*Receive payment for<br />

registration and issues<br />

Official Receipt<br />

*Receive complete set of<br />

documents from the client.<br />

Assign a Routine Slip<br />

Number per product<br />

application. Mark the<br />

receiving copy with RSN and<br />

affix signature and date of<br />

receipt.<br />

5 * Encoding of received<br />

applications<br />

*Endorse all documents and<br />

samples to PSD-Food<br />

Section.<br />

6 * Tagging and Sorting of<br />

applications from PAICS<br />

*Segregate applications for<br />

re-applications and<br />

automatic renewal.<br />

*Forward all re-applications<br />

and automatic renewal to<br />

designated evaluators for<br />

immediate processing.<br />

2<br />

OFFICE/<br />

PERSON<br />

RESPONSIBLE<br />

FDRO II/III, ND<br />

III<br />

LOCATION<br />

OF OFFICE<br />

Rm. 101<br />

DURATION<br />

OF<br />

ACTIVITY<br />

20 minutes<br />

(within Day<br />

1)<br />

Accounting<br />

Section -<br />

Rm. 113 10 minutes<br />

Administrative<br />

(within Day<br />

Division<br />

1)<br />

Cashier Section Rm112 10 minutes<br />

(within Day<br />

1)<br />

PAICS Clerk Rm. 101 15 minutes<br />

(within Day<br />

1)<br />

PAICS Clerk Rm 101 30 minutes<br />

PSD-Food<br />

Clerk/Typist<br />

PSD Annex<br />

Building-<br />

PSD Food<br />

(within Day<br />

2)<br />

20 minutes<br />

(within Day<br />

3)


7 *Filing of applications<br />

awaiting evaluation<br />

chronologically using the<br />

RSN.<br />

8 *Decking of documents for<br />

evaluation<br />

*Assign applications to<br />

designated evaluators using<br />

the first-in-first out system.<br />

9 *Forwarding of decked<br />

applications<br />

to each evaluator<br />

10 *Evaluation of Documents<br />

using the first-in-first out<br />

system.<br />

11 *Review of Evaluation and<br />

recommendation of<br />

evaluator. Assign the food<br />

registration number (if<br />

approved)<br />

12 *Type Certificate of Product<br />

Registration (CPR) or Letter<br />

of Denial if dissapproved<br />

13 *Review and initial the typed<br />

CPR/Letter of Denial<br />

14 *Separate typed CPR/LOD<br />

from the documents<br />

15 *Review and initial typed<br />

CPR/LOD<br />

16 *Encode typed LOD/CPR in<br />

PSD Database<br />

17 *Sign typed LOD/CPR<br />

*Encode CPR at the Office of<br />

the Director (OD)Database<br />

3<br />

PSD-Food Clerk PSD-Food<br />

Storage<br />

Room.<br />

PSD-Food<br />

Supervisor<br />

PSD-Food<br />

Clerk/Typist<br />

PSD-Food<br />

Evaluators<br />

(FDRO II/III/ND<br />

III)<br />

PSD Food<br />

Supervisor<br />

-PSD Food Typist<br />

for CPR<br />

-FDRO II/III/ND<br />

III<br />

-PSD Food<br />

Supervisor<br />

Annex Bldg.<br />

PSD-Food<br />

Annex Bldg.<br />

PSD-<br />

Annex Bldg.<br />

PSD-Food<br />

Annex Bldg.<br />

PSD-Food<br />

Annex Bldg.<br />

PSD-Food<br />

Annex Bldg.<br />

PSD-Food<br />

PSD Food Clerk Annex Bldg.<br />

PSD-Food<br />

PSD Chief Annex Bldg.<br />

Office of the<br />

Chief<br />

PSD Food Clerk Annex Bldg.<br />

PSD-Food<br />

-<strong>BFAD</strong> Director<br />

-OD Clerk<br />

Office of the<br />

Director<br />

2 months<br />

(queuing<br />

time prior to<br />

evaluation)<br />

(Day 4 to<br />

Day 61)<br />

30 minutes<br />

(within Day<br />

62)<br />

45 minutes<br />

(within Day<br />

62)<br />

2 hours<br />

(within Day<br />

63)<br />

20 minutes<br />

(within Day<br />

64)<br />

15 minutes<br />

(within Day<br />

65)<br />

10 minutes<br />

(within Day<br />

65)<br />

30 minutes<br />

(within Day<br />

65)<br />

10 minutes<br />

(within Day<br />

65)<br />

10 minutes<br />

(within Day<br />

66)<br />

10 minutes<br />

-three weeks<br />

18 Scan and encode the CPR Administrative Rm.112<br />

(Day 62 to<br />

83)<br />

10 minutes<br />

Clerk<br />

(within Day<br />

-PPAD Clerk Rm.110 83)<br />

19 * Receive the CPR/LOD and *Release CPR or Letter of -Releasing Clerk Rm. 100 10 minutes<br />

affix his/her signature on the Denial<br />

stamp pad mark.<br />

(within Day<br />

83)<br />

Total Time Spent: 2 months and 3 weeks ���� 59 working days


Drug Section<br />

Duration : 12 months (Calendar days)<br />

Flowchart for Drug Product Application – Initial Registration<br />

No. CLIENT/APPLICANT<br />

AGENCY ACTIVITIES PERSON LOCATION<br />

ACTION<br />

RESPONSIBLE OFFICE<br />

1 Download checklist of<br />

Client & Coop Website &<br />

requirements for product<br />

Staff<br />

<strong>BFAD</strong><br />

registration from the <strong>BFAD</strong><br />

website (www.bfad.<strong>gov</strong>.<strong>ph</strong>) or<br />

<strong>ph</strong>otocopy the same at the<br />

<strong>BFAD</strong> COOP Canteen (with<br />

fee)<br />

canteen<br />

2 Get number to the guard on- Issuance of priority number Guard PSD (Annex<br />

duty for filing of drug product<br />

evaluation. Wait for the<br />

number to be called<br />

bldg.)<br />

3 Submit product application to<br />

the evaluator on duty for<br />

assessment<br />

*For walk-in clients 1-3 steps<br />

will no longer be applicable<br />

4 Go to Accounting Section for<br />

validation of payment and pay<br />

the required fee<br />

5 Receiving & assigning Routine<br />

Slip Number (RSN) #<br />

Encoding of application for<br />

product registration<br />

6 Follow-up after 90 days<br />

proceed to the Releasing<br />

Window and check if<br />

NOD/CPR/LOD is available<br />

7 Proceed to PSD and submit<br />

compliances to NOD/re- apply<br />

for LOD<br />

8 Proceed to PAICS and submit<br />

the documents<br />

9 Proceed to releasing window<br />

and present ID/ authorization<br />

letter<br />

Pre-assess the product<br />

application & indicate the<br />

amount to be paid on the<br />

assessment slip<br />

Validation of order of<br />

payment & acceptance of<br />

payment<br />

Received /assigned RSN No.<br />

Encode the product<br />

application<br />

Check and release the Letter<br />

of Denial, Notice of<br />

Defficiency, Certificate of<br />

Product Registration (if<br />

available)<br />

Check the submitted<br />

compliance and return the<br />

documents to client for<br />

submission to PAICS. Advise<br />

client to follow-up after 60<br />

days<br />

Receive the documents<br />

encode and assign RSN.<br />

Forward the compliances to<br />

PSD for final evaluation<br />

Check and release the CPR/<br />

LOD<br />

4<br />

Evaluator<br />

(FDROs)<br />

Accounting<br />

Clerk/Cashier<br />

Clerk<br />

PSD (Annex<br />

bldg.)<br />

Accounting<br />

(Rm. 113) &<br />

Cashier<br />

Section<br />

(Rm.112)<br />

Clerk PAICS (Rm.<br />

101)<br />

Releasing<br />

Personnel<br />

Releasing<br />

Window<br />

Evaluator PSD (Annex<br />

bldg.)<br />

PAICS Personnel PAICS (Rm.<br />

101)<br />

Releasing<br />

Personnel<br />

Releasing<br />

Window<br />

DURATION<br />

OF ACTION<br />

2 hours<br />

(Depending<br />

on the<br />

number of<br />

applicants)<br />

30 minutes<br />

10 minutes<br />

15 minutes<br />

90 Days<br />

(follow-up)<br />

90 days for<br />

compliance<br />

15 minutes<br />

(checking)<br />

7 months<br />

(queuing<br />

time prior to<br />

evaluation)<br />

30 minutes<br />

(checking)<br />

60 days<br />

(follow-up)<br />

30 minutes<br />

10 minutes


Cosmetic and Household Hazardous Substances/Pesticides Section<br />

Maximum Duration of Activity : 6 months HHS Pesticides : 12 months<br />

No. CLIENT/APPLICANT<br />

ACTION<br />

1 Download checklist of<br />

requirements for product<br />

registration from the <strong>BFAD</strong><br />

website (www.bfad.<strong>gov</strong>.<strong>ph</strong>) or<br />

<strong>ph</strong>otocopy the same at the<br />

<strong>BFAD</strong> COOP Canteen (with<br />

fee)<br />

2 Get number to the guard onduty<br />

for filing of drug product<br />

evaluation. Wait for the<br />

number to be called<br />

3 Submit product application to<br />

the evaluator on duty for<br />

assessment<br />

4 Proceed to Accounting Section<br />

for validation of payment and<br />

pay the required fee<br />

5 Receiving & assigning RSN #<br />

Encoding of application for<br />

product registration<br />

6 Follow-up after 90 days<br />

proceed to the Releasing<br />

Window and check if<br />

NOD/CPR/LOD is available<br />

7 Proceed to PAICS for<br />

submission of compliance to<br />

NOD’s<br />

9 Proceed to releasing window<br />

and present ID/ authorization<br />

letter<br />

FLOWCHART FOR THE REGISTRATION OF<br />

HOUSEHOLD HAZARDOUS SUBSTANCES/ HOUSEHOLD PESTICIDES<br />

AGENCY ACTIVITIES PERSON<br />

RESPONSIBLE<br />

Client & Coop<br />

Staff<br />

5<br />

LOCATIO<br />

N OFFICE<br />

Website &<br />

<strong>BFAD</strong><br />

canteen<br />

Issuance of priority number Guard PSD<br />

(Annex<br />

bldg.)<br />

Pre-assess the product<br />

application & indicate the<br />

amount to be paid on the<br />

assessment slip<br />

Validation of order of<br />

payment & acceptance of<br />

payment<br />

Received /assigned RSN No.<br />

Encode the product<br />

application<br />

Check and release LOD,<br />

NOD, CPR (if available)<br />

Check and receive<br />

compliance then forward to<br />

PSD<br />

Check and release the CPR/<br />

LOD<br />

Evaluator<br />

(FDROs)<br />

Accounting<br />

Clerks/Cashier<br />

Clerks<br />

PSD<br />

(Annex<br />

bldg.)<br />

Accounting<br />

(Rm. 113)<br />

& Cashier<br />

Section<br />

(Rm.112)<br />

Clerks PAICS (Rm.<br />

101)<br />

Releasing<br />

Personnel<br />

Releasing<br />

Window<br />

DURATION<br />

OF ACTION<br />

5 mins.<br />

within<br />

day 1<br />

10 mins<br />

within day 1<br />

10 mins.<br />

10 mins.<br />

Within day 1<br />

10 mins<br />

within day 1<br />

- 4<br />

5 mins<br />

Day 5<br />

(3 months<br />

queuing time<br />

prior to<br />

evaluation)<br />

FDRO PAICS W/in Day 6<br />

depending on<br />

the number<br />

of<br />

compliances<br />

to NOD’s<br />

Releasing<br />

Personnel<br />

Releasing<br />

Window<br />

5 mins.<br />

Day 7


Regulation Division I<br />

Frontline Service : Issuance of License to Operate (Initial)<br />

Clients : Drug Retail Outlet & Distributor Importer/Wholesaler/ Exporter of<br />

Processed Food, Drug, Cosmetics, Household Hazardous Substance<br />

Establishments<br />

Requirements : Refer to Checklist of Requirements<br />

Schedule of Availability of Service:<br />

Inquiries on the application for LTO Mon-Fri 7am – 3:30pm<br />

Submission of documents Mon-Thurs 7am – 3:30pm<br />

Fees : Refer to Checklist of Requirement<br />

(A.O.50 s. 2001- Revised Schedule of Fees)<br />

Duration of Activity : 17 working days (if compliant)<br />

How to Avail of the Service:<br />

No. STEP<br />

APPLICANT/CLIENT<br />

1 � Go to RDI<br />

Log in at the record book<br />

provided for clients, get a<br />

priority number and wait for<br />

the number to be called.<br />

� Submit the<br />

application at Licensing<br />

Section.<br />

2 � Go to<br />

Accounting Section for<br />

assessment and payment of<br />

required fees<br />

� Return the<br />

assessment slip and official<br />

receipt to RD1 Licensing<br />

Section.<br />

3 � Be ready for<br />

inspection at anytime within 5<br />

working days<br />

Note: For deficiencies noted<br />

during inspection<br />

� Submit / Show<br />

compliance within 30 working<br />

days<br />

4 � Wait for 10<br />

working days to complete the<br />

process of issuance of your<br />

License.<br />

AGENCY<br />

ACTION<br />

Receive the documents<br />

Refer client to assigned<br />

evaluators of food/ drug/<br />

cosmetic & household<br />

hazardous substance<br />

Evaluate the application<br />

documents<br />

Prepare assessment slip<br />

Issue Order of Payment<br />

Issue Official Receipt<br />

Attach the assessment slip<br />

to application documents<br />

Advise client that inspection<br />

will be conducted within 5<br />

working days. Likewise, to<br />

have original copy of the<br />

documents available during<br />

inspection.<br />

Inspection of office and or<br />

warehouse / storage room<br />

as per approved Standard<br />

Operating Procedure (SOP).<br />

Check compliance<br />

documents<br />

Prepare company record<br />

files and the License to<br />

Operate<br />

6<br />

PERSON<br />

RESPONSIBLE<br />

FDRO I/II<br />

(officer of the day)<br />

FDRO I/II<br />

(assigned evaluator)<br />

Accounting Clerk<br />

Cashier Clerk<br />

FDRO I / II<br />

(RD1 Licensing<br />

Section)<br />

FDRO II / III<br />

Admin.<br />

Assistants /<br />

FDRO I / II / III<br />

/ IV / V /<br />

LOCATION<br />

OF<br />

OFFICE<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 132 Day 1<br />

10 minutes<br />

Rm. 113<br />

Rm. 112<br />

Rm. 132<br />

Rm. 133<br />

30 minutes<br />

10 minutes<br />

Day 1<br />

15 minute<br />

15 minutes<br />

5 minutes<br />

(Day 2 – 6)<br />

2 hours<br />

(excluding<br />

travel time)<br />

30 minutes<br />

(Day 7–16)<br />

10 working<br />

days


6 � Go to<br />

Releasing Section and present<br />

identification card and / or<br />

authorization letter for<br />

authorized representative<br />

� Receive the<br />

original copy of LTO<br />

Release the original copy of<br />

the License to Operate<br />

(LTO) and ask the client to<br />

sign the duplicate copy<br />

7<br />

Director IV<br />

Person-in-charge<br />

at releasing<br />

section<br />

R. 100 Day 17<br />

15 minutes<br />

Frontline Service : Application for renewal of License to Operate<br />

Clients : Drug Retail Outlet & Distributor Importer/Wholesaler/ Exporter of<br />

Processed Food, Drug, Cosmetics, Household Hazardous Substance<br />

Establishments<br />

Requirements : Accomplished renewal form<br />

Schedule of Availability of Service :<br />

Submission of application for renewal of LTO Mon-Fri: 7am – 3:30pm<br />

Requirements : Refer to Checklist of Requirement<br />

Fees : Retail Drug Outlets – P 1,000.00 per year or P 2,000 per 2 years<br />

Drug Establishments – P 5,000.00 per year or P 10,000.00 per 2 years<br />

Medical Device and Food Establishments– P 4,000.00 or P 8,000 /2 years<br />

Cosmetic and Household Hazardous Substances Establishments –<br />

P3 ,000.00 per year or P 6,000.00 per 2 years<br />

Duration of Activity: Inspection is scheduled within the year<br />

6 working days for the release of revalidated LTO after inspection<br />

How to Avail of the Service:<br />

No. STEP<br />

APPLICANT/CLIENT<br />

1<br />

� Go to RDI<br />

Log in at the record book,<br />

get a priority<br />

number and wait for the<br />

number to be called.<br />

� Submit the<br />

accomplished notarized<br />

renewal application form to<br />

Licensing Section.<br />

2 � Go to<br />

Accounting Section for<br />

assessment and payment of<br />

required fees<br />

� Return<br />

assessment slip and official<br />

receipt to RD1 Licensing<br />

Section.<br />

AGENCY<br />

ACTION<br />

Receive the accomplished<br />

renewal application form<br />

Refer client to assigned<br />

evaluators of food/ drug/<br />

cosmetic & household<br />

hazardous substance<br />

Evaluate the submitted<br />

application<br />

Prepare assessment slip and<br />

update index cards<br />

Issue Order of Payment<br />

Issue Official Receipt<br />

Attached assessment slip to<br />

the submitted application<br />

Advise the client that<br />

inspection will be conducted<br />

by Food Drug Regulation<br />

Officer at anytime within the<br />

year. Section 9 of RA 9485<br />

states that “If a <strong>gov</strong>ernment<br />

office fails to act on an<br />

application for renewal of<br />

PERSON<br />

RESPONSIBLE<br />

FDRO I / II<br />

(officer of the<br />

day)<br />

FDRO I / II<br />

(assigned<br />

evaluator)<br />

Accounting Clerk<br />

Cashier Clerk<br />

FDRO I / II<br />

(RD1 Licensing<br />

Section)<br />

LOCATION<br />

OF<br />

OFFICE<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 132 Day 1<br />

15 minutes<br />

Rm. 113<br />

Rm. 112<br />

Rm. 132<br />

15 minutes<br />

13 minutes<br />

15 minute<br />

15 minutes<br />

5 minutes


3 � Allow the <strong>BFAD</strong><br />

Inspector to enter business<br />

premises to conduct audit<br />

inspection<br />

Note: For deficiencies<br />

noted during inspection<br />

� Submit / Show<br />

compliance within 30 working<br />

days<br />

4 Wait for for the release of<br />

revalidated LTO.<br />

5 � Go to<br />

Releasing Section and<br />

present identification card<br />

and / or authorization letter<br />

for authorized representative<br />

� Receive the<br />

original copy of LTO<br />

license within the prescribed<br />

period, said permit or license<br />

shall automatically be<br />

extended until a decision is<br />

rendered on the application<br />

for renewal.”<br />

Conduct inspection as per<br />

approved Standard<br />

Operating Procedure (SOP)<br />

Check compliance<br />

documents<br />

Endorsement of inspection<br />

report and application for<br />

renewal to Licensing Section<br />

for approval of the Chief of<br />

the Division.<br />

RDI to endorse copy of LTO<br />

to Records Section<br />

Release the original copy of<br />

the License to Operate (LTO)<br />

and ask the client to sign the<br />

duplicate copy<br />

8<br />

FDRO II / III<br />

Rm. 133<br />

3 hours<br />

(excluding<br />

travel time)<br />

30 minutes<br />

FDRO I / II / III Rm. 132 5 working<br />

days.<br />

Person-incharge<br />

at<br />

releasing section<br />

Frontline Service : Issuance of Certificate for Bureau of Custom (BOC) Release<br />

(Certificate for Release of Product from BOC/Antibiotic Importation/<br />

Donation/Medical Mission)<br />

Clients : Distributor Importer/Wholesaler/ Exporter of Processed Food,<br />

Drug, Cosmetics, Household Hazardous Substance Establishments<br />

Requirements : Refer to Checklist of Requirements<br />

Schedule of Availability of Service:<br />

Inquiries on application for certificate: Mon-Fri 7am – 3:30pm<br />

Submission of application documents: Mon-Thurs 7am – 3:30pm<br />

Fees : Refer to Checklist of Requirement<br />

(A.O.50 s. 2001- Revised Schedule of Fees)<br />

Duration of Activity : 8 working days<br />

3 months and 16 days for Certificate of Donation<br />

How to Avail the Service:<br />

No ACTION<br />

APPLICANT/CLIENT<br />

1 � Go to RD1<br />

Log in at the record book,<br />

get a priority<br />

number and wait for<br />

the number to be<br />

called.<br />

� Submit the<br />

Application document to<br />

AGENCY ACTION PERSON<br />

RESPONSIBLE<br />

Receive the<br />

documents<br />

Refer the client to assigned<br />

evaluators of food /drug<br />

/cosmetic & household<br />

hazardous substances<br />

Evaluate documents<br />

Note: In case of deficiency,<br />

FDROI/II<br />

(officer of the day)<br />

FDRO I/II<br />

(assigned evaluator)<br />

R. 100 15 minutes<br />

LOCATION<br />

OF<br />

OFFICE<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 132 Day 1<br />

5 minutes<br />

15 minutes


Licensing Section. note down the findings and<br />

recommendations and return<br />

the documents to client<br />

2 � Go to Accounting<br />

Section for assessment and<br />

payment of required fees<br />

� Return the<br />

assessment slip with official<br />

receipt to RD1 Licensing<br />

Section.<br />

3 � Wait for 6<br />

working days for<br />

completion of the procedure<br />

4 � Go to RD1,<br />

present identification card and<br />

/ or authorization letter for<br />

authorized representative<br />

� Receive the<br />

original copy of certificate<br />

5 � Accompany<br />

<strong>BFAD</strong> Inspector (FDRO II /<br />

III) during the scheduled<br />

inspection of donated<br />

products.<br />

� Sign inspection<br />

report and sample collection<br />

receipts<br />

6 � Wait for the<br />

release of the evaluation for<br />

Accelerated CPR<br />

7 � Go to Releasing<br />

Section, present<br />

identification card and / or<br />

authorization letter for<br />

authorized representative<br />

� Claim the Accelerated<br />

CPR<br />

Prepare assessment slip<br />

Issue Order of Payment<br />

Issue Official Receipt<br />

Attach the assessment slip<br />

to the documents<br />

Advise the applicant to pick<br />

up the certificate after 6<br />

working days.<br />

Release the original copy of<br />

certificate and have the<br />

duplicate copy sign by client<br />

Inform the applicant that an<br />

Officer from Inspection<br />

Section will call within 5<br />

working days to coordinate<br />

collection of samples of<br />

donated products<br />

- Collect samples following<br />

approved Standard<br />

Operating Procedures (SOP)<br />

-Inform the applicant that<br />

each product collected will<br />

undergo laboratory testing<br />

and product evaluation<br />

for Accelerated certificate of<br />

Product Registration (CPR).<br />

Release of the certificate<br />

(Accelerated CPR / Notice of<br />

Deficiencies / Letter of<br />

Denial)<br />

Ask the applicant to sign the<br />

duplicate copy<br />

9<br />

Accounting Clerk<br />

Cashier Clerk<br />

FDRO I/II<br />

(RD1 Licensing<br />

Section)<br />

Admin Assistant<br />

/<br />

FDRO I/II<br />

Rm. 113<br />

Rm. 112<br />

Rm. 132<br />

10 minutes<br />

Day 1<br />

10 minutes<br />

10 minutes<br />

5 minutes<br />

Day 2 - 7<br />

6 days<br />

Rm. 132 Day 8<br />

5 minutes<br />

Day 8 - 13<br />

FDRO II / III Rm. 133 Day 14<br />

4 hours<br />

(including travel<br />

time)<br />

Releasing<br />

Personnel<br />

Rm. 100<br />

Releasing<br />

Window<br />

Day 15 - 105<br />

Day 106<br />

15 minutes


Regulation Division II<br />

Frontline Service: Issuance of License to Operate (Initial)<br />

Clients : All Manufacturers/Traders of Food, Drug, Cosmetic, Medical Device and<br />

Household Hazardous Substances Establishments<br />

Requirements : Refer to Annex A – Checklist of Requirements for Food<br />

Annex B - Checklist of Requirements for Drug/Cosmetic/Medical Device<br />

Annex C – Checklist of Requirements for Household Hazardous Substances<br />

Schedule of Availability of Service: Monday-Friday 8am – 3pm<br />

Fees: Refer to Annex A, B, C (Checklist of Requirements)<br />

How to Avail of the Service: Duration of Process: 29 Days<br />

No. STEP<br />

APPLICANT/CLIENT<br />

1 • Go to RDII. Log in<br />

the record book<br />

provided for clients,<br />

get a number and<br />

wait for your number<br />

to be called.<br />

• Submit the<br />

accomplished<br />

application forms<br />

together with the<br />

documentary and<br />

technical<br />

requirements to the<br />

Licensing Section<br />

2 • Go to Accounting<br />

Section for<br />

verification of fees<br />

then pay to the<br />

Cashier Section (wait<br />

for your name to be<br />

called).<br />

• Return the<br />

Assessment Slip with<br />

OR to Licensing<br />

Section.<br />

3 Wait for 28 working days<br />

(processing time)<br />

AGENCY ACTION OFFICE/<br />

PERSON<br />

RESPONSIBLE<br />

Evaluate and receive<br />

application documents; if<br />

complete, prepare<br />

Assessment Slip; if not,<br />

return to applicant<br />

• Issue Official<br />

Receipt.<br />

• Attach the<br />

Assessment Slip to<br />

the application<br />

documents and<br />

forward to RDII<br />

Receiving Section<br />

for encoding.<br />

• Inspect<br />

establishment<br />

• Prepare report<br />

• Evaluate report<br />

• Prepare LTO/index<br />

card<br />

• Scan LTO &<br />

10<br />

FDRO I/II –<br />

from Licensing<br />

Section (for<br />

documentary<br />

requirements)<br />

FDRO I/II/III<br />

(officer of the<br />

day) – from<br />

Inspection<br />

Section (for<br />

technical<br />

requirements)<br />

-Cashier Clerk<br />

-FDRO I/II<br />

(Licensing<br />

Section)<br />

LOCATION<br />

OF OFFICE<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 130 (day 1)<br />

10 minutes<br />

Rm. 113 –<br />

Accounting<br />

Section<br />

Rm. 112 –<br />

Cashier<br />

Section<br />

Rm 130<br />

20 minutes<br />

30 minutes<br />

(day 1)<br />

20 minutes<br />

(day 2-28)


Note: If the company is not<br />

compliant upon inspection,<br />

owner is given a grace period<br />

of 60 days (Metro Manila) or<br />

90 days (CHD) to comply.<br />

After this grace period,<br />

follow-up inspection will be<br />

conducted.<br />

4 Go to Releasing Unit<br />

Window; present<br />

ID/authorization and<br />

receive the original copy of<br />

License to Operate (LTO)<br />

document<br />

Release the original copy of<br />

LTO to owner or authorized<br />

representative and ask the<br />

client to sign the duplicate<br />

copy of LTO<br />

11<br />

Person-incharge<br />

at the<br />

Releasing Unit<br />

Rm. 100 (day 29)<br />

10 minutes<br />

Frontline Service: Renewal/Revalidation of License to Operate<br />

Clients : All Manufacturers/Traders of Food, Drug, Cosmetic, Medical Device and<br />

Household Hazardous Substances Establishments<br />

Requirements : Letter Request for Renewal<br />

Copy of latest Financial Statement (Balance Sheet) duly notarized/received by<br />

BIR<br />

Original Copy of License to Operate<br />

Schedule of Availability of Service: Monday – Friday, 8am – 3pm<br />

Fees : Based on the Financial Statement; Payment shall be for two (2) years<br />

How to Avail of the Service: Duration of Process: 29 Days<br />

No. STEP<br />

APPLICANT/CLIENT<br />

1 • Go to RDII. Log in<br />

the record book<br />

provided for clients,<br />

get a number and<br />

wait for your number<br />

to be called.<br />

• Present latest letter<br />

request, Financial<br />

Statement & original<br />

LTO<br />

2 • Go to Accounting<br />

Section for<br />

verification of fees<br />

then pay to the<br />

Cashier Section (wait<br />

for your name to be<br />

called).<br />

• Return the<br />

Assessment Slip with<br />

OR to Licensing<br />

Section.<br />

3 Wait for 28 working days<br />

(processing time)<br />

AGENCY ACTION OFFICE/<br />

PERSON<br />

RESPONSIBL<br />

E<br />

• Get & check records<br />

of the<br />

establishment in the<br />

index card & assess<br />

amount to be paid<br />

based on the<br />

Financial Statement<br />

• Prepare Assessment<br />

Slip<br />

• Issue Official<br />

Receipt.<br />

• Record payment on<br />

the index card,<br />

encode in the data<br />

base and forward to<br />

RDII Receiving<br />

Section<br />

• Inspect<br />

establishment<br />

• Prepare report<br />

• Evaluate report<br />

• Prepare LTO/index<br />

card<br />

• Scan LTO &<br />

FDRO I/II –<br />

from Licensing<br />

Section<br />

-Cashier Clerk<br />

-FDRO I/II<br />

(Licensing<br />

Section)<br />

LOCATION<br />

OF OFFICE<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 130 (day 1)<br />

20 minutes<br />

Rm. 113 –<br />

Accounting<br />

Section<br />

Rm. 112 –<br />

Cashier<br />

Section<br />

(day 1)<br />

20 minutes<br />

(days 2-28)


Note: If the company is not<br />

compliant upon inspection,<br />

owner is given a grace period<br />

of 60 days (Metro Manila) or<br />

90 days (CHD) to comply.<br />

After this grace period,<br />

follow-up inspection will be<br />

conducted.<br />

4 For LTO Revalidation:<br />

• Go to RDII. Log in<br />

the record book<br />

provided for clients,<br />

get a number and<br />

wait for your number<br />

to be called.<br />

• Present original LTO<br />

for revalidation<br />

For Re-issuance of LTO<br />

• Go to Releasing Unit<br />

Window; present<br />

ID/authorization<br />

and receive the<br />

original copy of<br />

License to Operate<br />

(LTO)<br />

document<br />

• Revalidate LTO;<br />

update records on<br />

file, index card and<br />

the data base<br />

• Release the original<br />

copy of LTO to<br />

owner or authorized<br />

representative and<br />

ask the client to<br />

sign the duplicate<br />

copy of LTO<br />

12<br />

-FDRO I/II<br />

from<br />

Licensing<br />

Section<br />

-Person-incharge<br />

at the<br />

Releasing<br />

Unit<br />

Rm. 130<br />

Rm 100<br />

Frontline Service: Amendment of License to Operate (Changes in Circumstances)<br />

Change of Business Name/Owner/Address<br />

Clients : All <strong>BFAD</strong> Licensed Manufacturers of Food, Drug, Cosmetic & Medical Device<br />

Establishments<br />

Requirements : Refer to Checklist of Requirement – Annex E<br />

Schedule of Availability of Service: Monday – Friday, 8am – 3pm<br />

Fees : Php 500.00<br />

Note: For Manufacturers – change of address is considered opening/initial application, hence,<br />

client must submit all the documentary and technical requirements.<br />

How to Avail of the Service: Duration of Process: 29 Days<br />

No. STEP<br />

APPLICANT/CLIENT<br />

1 • Go to RDII. Log in<br />

the record book<br />

provided for clients,<br />

get a number and<br />

wait for your<br />

number to be<br />

called.<br />

• Submit the<br />

accomplished<br />

application forms<br />

together with the<br />

documentary and<br />

technical<br />

AGENCY ACTION OFFICE/<br />

PERSON<br />

RESPONSIBLE<br />

Evaluate and receive<br />

application documents; if<br />

complete, prepare<br />

Assessment Slip; if not,<br />

return to applicant<br />

FDRO I/II –<br />

from Licensing<br />

Section<br />

FDRO I/II/III<br />

(officer of the<br />

LOCATION<br />

OF OFFICE<br />

(day 29)<br />

30 minutes<br />

10 minutes<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 130 (day 1)<br />

10 minutes<br />

20 minutes<br />

30 minutes


equirements to the<br />

Licensing Section<br />

2 • Go to Accounting<br />

Section for<br />

verification of fees<br />

then pay to the<br />

Cashier Section<br />

(wait for your name<br />

to be called).<br />

• Return the<br />

Assessment Slip<br />

with OR to<br />

Licensing Section.<br />

3 Wait for 28 working days<br />

(processing time)<br />

Note: If the company is not<br />

compliant upon inspection,<br />

owner is given a grace<br />

period of 60 days (Metro<br />

Manila) or 90 days (CHD) to<br />

comply. After this grace<br />

period, follow-up inspection<br />

will be conducted.<br />

4 Go to Releasing Unit<br />

Window; present<br />

ID/authorization and<br />

receive the original copy of<br />

License to Operate (LTO)<br />

• Issue Official<br />

Receipt.<br />

Attach the Assessment<br />

Slip to the application<br />

documents and forward<br />

to RDII Receiving<br />

Section for encoding.<br />

• Inspect<br />

establishment<br />

• Prepare report<br />

• Evaluate report<br />

• Prepare LTO/index<br />

card<br />

• Scan LTO &<br />

document<br />

Release the original copy of<br />

LTO to owner or authorized<br />

representative and ask the<br />

client to sign the duplicate<br />

copy of LTO<br />

13<br />

day) – from<br />

Inspection<br />

Section<br />

-Cashier Clerk<br />

-FDRO I/II<br />

(Licensing<br />

Section)<br />

Person-incharge<br />

at the<br />

Releasing Unit<br />

Rm. 113 –<br />

Accounting<br />

Section<br />

Rm. 112 –<br />

Cashier<br />

Section<br />

Rm. 130<br />

(day 1)<br />

20 minutes<br />

(day 2-28)<br />

Rm. 100 (day 29)<br />

10 minutes<br />

Frontline Service: Amendment of License to Operate:<br />

Inclusion/Deletion of Additional Product/Source/Toll Manufacturer/Trader<br />

Clients : All <strong>BFAD</strong> Licensed Manufacturers of Food, Drug, Cosmetic & Medical Device<br />

Establishments<br />

Requirements : Refer to Checklist of Requirement – Annex F<br />

Schedule of Availability of Service: Monday – Friday, 8am – 3pm<br />

Fees : Php 500.00<br />

Duration of Process: 6 Days<br />

How to Avail of the Service:<br />

No. STEP<br />

APPLICANT/CLIENT<br />

1 • Go to RDII. Log in<br />

the record book<br />

provided for clients,<br />

get a number and<br />

wait for your<br />

number to be<br />

called.<br />

• Submit the<br />

requirements to the<br />

AGENCY ACTION OFFICE/<br />

PERSON<br />

RESPONSIBLE<br />

Evaluate and receive<br />

documents; prepare<br />

Assessment Slip<br />

FDRO I/II –<br />

from Licensing<br />

Section<br />

LOCATION<br />

OF OFFICE<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 130 (day 1)<br />

30 minutes


Licensing Section<br />

2 • Go to Accounting<br />

Section for<br />

verification of fees<br />

then pay to the<br />

Cashier Section<br />

(wait for your name<br />

to be called).<br />

• Return the<br />

Assessment Slip<br />

with OR to<br />

Licensing Section.<br />

3 Wait for four (4) days<br />

(processing time)<br />

4 • Go to RDII. Log in<br />

the record book<br />

provided for clients,<br />

get a number and<br />

wait for your<br />

number to be<br />

called.<br />

• Receive the original<br />

copy of the<br />

amendment<br />

• Issue Official<br />

Receipt.<br />

• Attach the<br />

Assessment Slip to<br />

the application<br />

documents and<br />

forward to RDII<br />

Receiving Section for<br />

encoding.<br />

Release the original copy of<br />

amendment to owner or<br />

authorized representative<br />

and ask the client to receive<br />

the duplicate copy of<br />

amendment (attachment to<br />

LTO only)<br />

14<br />

-Cashier Clerk<br />

-FDRO I/II<br />

(Licensing<br />

Section)<br />

FDRO I/II –<br />

Licensing<br />

Section<br />

Rm. 113 –<br />

Accounting<br />

Section<br />

Rm. 112 –<br />

Cashier<br />

Section<br />

Rm. 130<br />

(day 1)<br />

20 minutes<br />

(days 2-5)<br />

Rm. 130 (day 6)<br />

20 minutes<br />

Frontline Service: Issuance of Certificate of Good Manufacturing Practice (GMP)<br />

Clients : All <strong>BFAD</strong> Licensed Manufacturers of Food, Drug, Cosmetic & Medical Device<br />

Establishments<br />

Requirements : Letter Request and Copy of Valid LTO<br />

Schedule of Availability of Service: Monday – Friday, 8am – 3pm<br />

Fees : Php 500.00<br />

Duration of Process: 29 Days<br />

How to Avail of the Service:<br />

No. STEP<br />

APPLICANT/CLIENT<br />

• Go to RDII. Log<br />

in the record<br />

book provided for<br />

clients, get a<br />

number and wait<br />

for your number<br />

to be called.<br />

• Submit the letter<br />

request and copy<br />

of valid LTO to<br />

the Licensing<br />

Section<br />

2 • Go to Accounting<br />

Section for<br />

verification of<br />

fees then pay to<br />

the Cashier<br />

AGENCY ACTION OFFICE/<br />

PERSON<br />

RESPONSIBLE<br />

Verify LTO and prepare<br />

Assessment Slip<br />

• Issue Official Receipt.<br />

FDRO I/II<br />

-Cashier Clerk<br />

LOCATION<br />

OF OFFICE<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 130 (day 1)<br />

20 minutes<br />

Rm. 113 –<br />

Accounting<br />

Section<br />

Rm. 112 –<br />

Cashier<br />

(day 1)<br />

20 minutes


Section (wait for<br />

your name to be<br />

called).<br />

• Return the<br />

Assessment Slip<br />

with OR to<br />

Licensing<br />

Section.<br />

3 Wait for 28 working days<br />

(processing time)<br />

Note: If the company is<br />

not compliant upon<br />

inspection, owner is given<br />

a grace period of 60 days<br />

(Metro Manila) or 90 days<br />

(CHD) to comply. After<br />

this grace period, followup<br />

inspection will be<br />

conducted.<br />

4 • Go to Regulation<br />

Division II<br />

• Receive the<br />

original copy of<br />

GMP Certificate<br />

• Attach the Assessment<br />

Slip to the letter<br />

request and forward<br />

to RDII Receiving<br />

Section for encoding.<br />

• Inspect establishment<br />

• Prepare report<br />

• Evaluate report<br />

• Prepare LTO/index<br />

card<br />

• Scan the certificate &<br />

document<br />

Release the original copy of<br />

GMP certificate to owner or<br />

authorized representative and<br />

ask the client to sign the<br />

duplicate copy<br />

15<br />

-FDRO I/II<br />

(Licensing<br />

Section)<br />

FDRO I/II –<br />

Licensing<br />

Section<br />

Section<br />

Rm. 130<br />

(days 2-28)<br />

Rm. 100 (day 29)<br />

10 minutes<br />

Frontline Service: Issuance of Certificate for Release to Bureau of Customs (BOC Certificate)<br />

Clients : All <strong>BFAD</strong> Licensed Manufacturers/Traders of Food, Drug, Cosmetic, Medical<br />

Device and Household Hazardous Substances Establishments<br />

Requirements : Refer to Annex D – Checklist of Requirements for BOC Certificate<br />

Schedule of Availability of Service: Monday – Friday, 8am – 3pm<br />

Fees : Php 300.00<br />

Duration of Process: 6 Days<br />

How to Avail of the Service:<br />

No. STEP<br />

APPLICANT/CLIENT<br />

1 • Go to RDII. Log<br />

in the record<br />

book provided for<br />

clients, get a<br />

number and wait<br />

for your number<br />

to be called.<br />

• Submit the<br />

complete<br />

requirements to<br />

Licensing Section<br />

2 • Go to Accounting<br />

Section for<br />

verification of<br />

fees then pay to<br />

the Cashier<br />

AGENCY ACTION OFFICE/<br />

PERSON<br />

RESPONSIBLE<br />

Evaluate and receive<br />

application documents; if<br />

complete, prepare<br />

Assessment Slip; if not, return<br />

to applicant<br />

• Issue Official Receipt.<br />

FDRO I/II –<br />

Licensing Section<br />

-Cashier Clerk<br />

LOCATIO<br />

N<br />

OF<br />

OFFICE<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 130 (day 1)<br />

15 minutes<br />

- Rm. 113<br />

–<br />

Accounting<br />

Section<br />

(day 1)<br />

20 minutes


•<br />

Section (wait for<br />

your name to be<br />

called).<br />

Return the<br />

Assessment Slip<br />

with OR to<br />

Licensing<br />

Section.<br />

3 Wait for four (4)) days<br />

(processing time)<br />

4 • Go to RDII. Log<br />

in the record<br />

book provided for<br />

clients, get a<br />

number and wait<br />

for your number<br />

to be called.<br />

• Receive the<br />

original copy of<br />

BOC Certificate<br />

• Attach the<br />

Assessment Slip to<br />

the letter request and<br />

forward to RDII<br />

Receiving Section for<br />

encoding.<br />

Release the original copy of<br />

BOC Certificate and ask the<br />

client to sign the duplicate<br />

copy of certificate<br />

16<br />

-FDRO I/II<br />

(Licensing<br />

Section)<br />

FDRO I/II<br />

(Licensing<br />

Section)<br />

- Rm. 113<br />

–<br />

Cashier<br />

Section<br />

-Rm. 130<br />

Frontline Service: Issuance of Import Permit for Penicillin and Its Derivatives<br />

Clients : All <strong>BFAD</strong> Licensed Manufacturers/Traders of Drug Establishments<br />

Requirements : Refer to Annex G – Checklist of Requirements for Import Permit<br />

Schedule of Availability of Service: Monday – Friday, 8am – 3pm<br />

Fees : Php 300.00<br />

Duration of Process: 6 days<br />

How to Avail of the Service:<br />

No. STEP<br />

APPLICANT/CLIENT<br />

1 • Go to RDII. Log<br />

in the record book<br />

provided for<br />

clients, get a<br />

number and wait<br />

for your number<br />

to be called.<br />

• Submit the<br />

complete<br />

requirements to<br />

Licensing Section<br />

2 • Go to Accounting<br />

Section for<br />

verification of fees<br />

then pay to the<br />

Cashier Section<br />

(wait for your<br />

name to be<br />

called).<br />

• Return the<br />

Assessment Slip<br />

with OR to<br />

Licensing Section.<br />

3 Wait for four (4) days<br />

(processing time)<br />

4 • Go to RDII. Log<br />

in the record book<br />

provided for<br />

AGENCY ACTION OFFICE/<br />

PERSON<br />

RESPONSIBLE<br />

Evaluate and receive<br />

application documents; if<br />

complete, prepare<br />

Assessment Slip; if not,<br />

return to applicant<br />

• Issue Official Receipt.<br />

• Attach the<br />

Assessment Slip to<br />

the letter request<br />

and forward to RDII<br />

Receiving Section for<br />

encoding.<br />

Release the original copy of<br />

BOC Certificate and ask the<br />

client to sign the duplicate<br />

FDRO I/II –<br />

Licensing Section<br />

-Cashier Clerk<br />

-FDRO I/II<br />

(Licensing<br />

Section)<br />

FDRO I/II<br />

(Licensing<br />

Section)<br />

(days 2-5)<br />

Rm. 100 (day 6)<br />

10 minutes<br />

LOCATION<br />

OF OFFICE<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 130 (day 1)<br />

15 minutes<br />

- Rm. 113 –<br />

Accounting<br />

Section<br />

- Rm. 113 –<br />

Cashier<br />

Section<br />

-Rm. 130<br />

(day 1)<br />

20 minutes<br />

(days 2-5)<br />

Rm. 100 (day 6)<br />

10 minutes


clients, get a<br />

number and wait<br />

for your number<br />

to be called.<br />

• Receive the<br />

original copy of<br />

Import Permit<br />

copy of certificate<br />

Frontline Service: Hazard Analysis Critical Control Point (HACCP) Certification<br />

Clients : All Licensed Food Manufacturers<br />

Requirements : Valid License To Operate, Letter of Intent and HACCP Documents<br />

Schedule of Availability of Service: Monday-Friday; 8am-5pm<br />

Fees : Php500.00/product<br />

Duration of Process: 29 Days<br />

How to Avail of the Service:<br />

No. STEP<br />

APPLICANT/CLIENT<br />

1 • Go to RDII. Log<br />

in the record book<br />

provided for<br />

clients, get a<br />

number and wait<br />

for your number<br />

to be called.<br />

• Submit the<br />

accomplished<br />

application forms<br />

together with the<br />

documentary and<br />

technical<br />

requirements to<br />

the Licensing<br />

Section<br />

2 • Proceed to<br />

Accounting<br />

Section for<br />

verification of fees<br />

then pay to the<br />

Cashier Section<br />

(wait for your<br />

name to be<br />

called).<br />

• Return the<br />

Assessment Slip<br />

with OR to<br />

Licensing Section.<br />

RD II<br />

3 Wait for 28 working days<br />

(processing time)<br />

Note: If the company is<br />

AGENCY ACTION OFFICE/<br />

PERSON<br />

RESPONSIBLE<br />

Evaluate and receive<br />

application documents; if<br />

complete, prepare<br />

Assessment Slip; if not,<br />

return to applicant<br />

• Issue Official Receipt.<br />

• Attach the<br />

Assessment Slip to<br />

the application<br />

documents<br />

Submit to RDII Receiving<br />

Section for encoding.<br />

• Inspect<br />

establishment<br />

• Prepare report<br />

• Evaluate report<br />

• Prepare HACCP<br />

Certification per<br />

product/index card<br />

• Scan HACCP<br />

Certification &<br />

document<br />

17<br />

FDRO I/II – from<br />

Licensing Section<br />

FDRO I/II/III<br />

(officer of the<br />

day) – from<br />

Inspection<br />

Section<br />

-Cashier Clerk<br />

-FDRO I/II<br />

(Licensing<br />

Section)<br />

LOCATION<br />

OF OFFICE<br />

DURATION<br />

OF<br />

ACTIVITY<br />

Rm. 130 (day 1)<br />

10 minutes<br />

Rm. 113 –<br />

Accounting<br />

Section<br />

Rm. 112 –<br />

Cashier<br />

Section<br />

20 minutes<br />

20 minutes<br />

(day 1)<br />

20 minutes<br />

(day 2-28)


not compliant a grace<br />

period is given to comply,<br />

60 days (Metro Manila)<br />

and 90 days (CHD). After<br />

this grace period, follow<br />

up inspection will be<br />

conducted<br />

4 Go to Releasing Unit<br />

Window; present<br />

ID/authorization and<br />

receive the original copy<br />

of HACCP Certification<br />

Release the original copy of<br />

HACCP Certification to owner<br />

or authorized representative<br />

and have the duplicate copy<br />

received by client<br />

18<br />

Person-in-charge<br />

at the Releasing<br />

Unit<br />

Rm. 100 (day 29)<br />

10 minutes


Laboratory Services Division<br />

Frontline Service : Issuance of Batch Certification (Antibiotics)<br />

Clients : Drug (Antibiotics) Manufacturer, Importer<br />

Requirements : two (2) copies of the application for Batch Certification<br />

Form; <strong>ph</strong>otocopies of valid CPR, valid<br />

LTO/s; Certificate/s of Analysis of Finished Product<br />

and Raw Material/s, Sample for Analysis<br />

Schedule of Availability of Service : Monday to Thursday (8am – 3pm)<br />

Fees : Chemical Method Php 1,800.00/ Microbiological<br />

Method Php 2,800.00<br />

Duration of Activity : one month<br />

How to avail of the service :<br />

No. STEP<br />

APPLICANT/CLIENT<br />

AGENCY ACTION OFFICE/<br />

PERSON<br />

RESPONSIBLE<br />

1. File application Assess/Evaluate the<br />

application<br />

If acceptable:<br />

i. completely fill out the<br />

order of payment in duplicate<br />

copies<br />

ii. Issue order of<br />

payment to the applicant<br />

company<br />

If not acceptable:<br />

i. return the documents<br />

and sample<br />

2. Go to accounting section<br />

and put the assessment<br />

slip on the box provided<br />

by it then pay to the<br />

cashier’s section (wait for<br />

your number to be called)<br />

3. Submit proof of payment<br />

and complete set of<br />

documents<br />

4.<br />

5. Proceed to Releasing Unit<br />

Window; present ID/<br />

authorization and receive<br />

the original copy of Batch<br />

Certification<br />

• Issue order of<br />

payment and Official<br />

Receipt (O.R.)<br />

• Attach the<br />

assessment slip to<br />

the application<br />

documents<br />

• Evaluate and Receive<br />

application<br />

documents and<br />

samples<br />

• Advise client to<br />

return after 20 days<br />

• Process application<br />

and conduct the<br />

appropriate test/s<br />

• Upon completion of<br />

process advise client<br />

to pick up results<br />

• Release the original<br />

Batch Certificate or<br />

Out Of Specifications<br />

Report of Analysis<br />

19<br />

Evaluator<br />

OC-LSD Staff<br />

OC-LSD Staff<br />

Evaluator<br />

Accounting<br />

Clerk/Cashier<br />

OC-LSD staff<br />

OC-LSD staff<br />

OC-LSD staff<br />

OC-LSD staff<br />

Person-incharge<br />

at the<br />

Releasing Unit<br />

LOCATION<br />

OF OFFICE<br />

2/F Main<br />

Bldg. Rm.<br />

223<br />

Accounting<br />

Rm. 113<br />

Cashier<br />

Rm.112<br />

2/F Main<br />

Bldg. Rm.<br />

223<br />

2/F Main<br />

Bldg. Rm.<br />

223<br />

DURATION<br />

OF<br />

ACTIVITY<br />

5 minutes<br />

per sample<br />

submitted<br />

Day 1<br />

3 – 5<br />

minutes per<br />

sample<br />

submitted<br />

Day 1<br />

15 minutes<br />

Day 1<br />

15 minutes<br />

(20 working<br />

days)<br />

Rm 100 10 minutes<br />

(day 21)


Legal Information and Compliance Division<br />

Frontline Service: Issuance of Sales Promo Permits<br />

Clients : <strong>BFAD</strong> Licensed Food, Drug, Cosmetic, Household Hazardous Substances,<br />

Veterinary<br />

& Medical Device Manufacturers, Drugstores, Importers, Distributors, Traders,<br />

Drugstores and Advertising and Promo Agencies<br />

Requirements : Refer to Checklist of Requirements (Per Consumer Act or R.A. 7394)<br />

Schedule of Availability of Service: Monday – Thursday, 8am – 4pm<br />

Fees : Refer to Joint DTI-DOH A.O. 01 s. 2000<br />

How to Avail of the Service<br />

I. SALES PROMO PERMIT APPLICATION<br />

No. STEP<br />

AGENCY ACTION PERSON LOCATION DURATION<br />

APPLICANT/CLIENT<br />

RESPONSIBLE of OFFICE OF ACTION<br />

1 Go to LICD -APM’s Officer Pre-evaluate/assess LICD - APM OD Rm. 107 30 minutes<br />

of the Day (OD) and the submitted documents;<br />

Day 1<br />

submit Application for Prepare assessment slip (2<br />

Sales Promo Permits<br />

copies)<br />

(Note: If documents are<br />

incomplete, return the same<br />

to applicant with a note on<br />

deficiencies)<br />

2 Go to Accounting Section Receive assessment slip and Accounting Rm. 113 10 minutes<br />

for validation of the Prepare order of payment Section –<br />

Day 1<br />

assessment slip<br />

Administrative<br />

Division<br />

3 Submit Order of payment Receive Payment and Cashier Section- Rm. 112 10 minutes<br />

and Pay the<br />

prepare official receipt Administrative (Cashier) Day 1<br />

corresponding fees to the<br />

Cashier Section<br />

Division<br />

4 Return validated<br />

Attach the slip to the LICD – APM OD Rm. 107 2 minutes<br />

assessment slip and get a submitted documents/<br />

Day 1<br />

duplicate copy of the Hand over client’s copy<br />

received/stamped (advise to make the follow up<br />

application<br />

after 3 days)<br />

5 Process application LICD – APM OD Rm. 107 3 days (day<br />

- If with technical matters,<br />

refer to PSD<br />

2 – 4)<br />

6 Follow up application after Advise status of application APM Rm. 107 5 minutes<br />

3 days<br />

OD/Evaluator<br />

Day 4<br />

7 Forward prepared action APM Evaluator Rm. 107 1 hour<br />

(permit or referral) to section<br />

head for review and to affix<br />

initials<br />

Day 4<br />

8 Forward initialed paper to APM Section Rm. 107 2 minutes –<br />

supervisor for further review<br />

and to affix initials<br />

Head<br />

Day 4<br />

9 Review and initial paper. APM Supervisor Rm. 107 10 minutes<br />

Return to APM section head<br />

Day 4-5<br />

10 Forward to the<br />

APM Section Rm. 107 2 minutes<br />

Director/Deputy Director for<br />

review and signature<br />

Head<br />

Day 4-5<br />

20


11 Review and sign Director/Deputy Rm. 218/109 20 minutes<br />

permit/denial<br />

Director<br />

Day 5-10<br />

12 Record signed paper APM OD Rm. 107 5 minutes<br />

Day 10<br />

13 Pick up permit/denial Release permit or denial APM OD Rm. 107 2 minutes<br />

Day 10/11<br />

II. APPLICATION FOR PROMO PERMIT EXTENSION/AMENDMENT<br />

No. STEP<br />

AGENCY ACTION PERSON LOCATION DURATION<br />

APPLICANT/CLIENT<br />

RESPONSIBLE OFFICE OF ACTION<br />

1 Go to LICD -APM’s Officer Pre-evaluate/<br />

LICD - APM OD Rm. 107 30 minutes<br />

of the Day (OD) and<br />

assess<br />

Day 1<br />

submit Application for the submitted documents;<br />

Sales Promo Permits Prepare assessment slip<br />

(Note: If documents are<br />

incomplete, returns the same<br />

to applicant with a note on<br />

deficiencies)<br />

2 Go to Accounting Section Receive assessment slip and Accounting Rm. 113 10 minutes<br />

for validation of the Prepare order of payment Section –<br />

Day 1<br />

assessment slip<br />

Administrative<br />

Division<br />

3 Submit Order of payment Receive Payment and Cashier Section- Rm. 112 10 minutes<br />

and pay the<br />

prepare official receipt Administrative (Cashier) Day 1<br />

corresponding fees to the<br />

Cashier Section<br />

Division<br />

4 Return validated<br />

Attach the slip to the LICD – APM OD Rm. 107 2 minutes<br />

assessment slip and get a submitted documents/<br />

Day 1<br />

duplicate copy of the Hand over client’s copy<br />

received/stamped (advise to make the follow up<br />

application<br />

after 3 days)<br />

5 Process application/request LICD – APM OD Rm. 107 3 days<br />

Day<br />

2 – 4<br />

6 Follow up application after Advises status of request APM Rm. 107 5 minutes<br />

3 days<br />

OD/Evaluator<br />

Day 4<br />

7 Forward prepared action to APM Evaluator Rm. 107 1 hour<br />

section head for review and<br />

to affix initials<br />

Day 4<br />

8 Forward initialed paper to APM Section Rm. 107 2 minutes –<br />

supervisor for further review<br />

and to affix initials<br />

Head<br />

Day 4<br />

9 Review and initial paper. APM Supervisor Rm. 107 10 minutes<br />

Return to APM section head<br />

Day 4-5<br />

10 Forward to the<br />

APM Section Rm. 107 2 minutes<br />

Director/Deputy Director for<br />

review and signature<br />

Head<br />

Day 4-5<br />

11 Review and sign Director/Deputy Rm. 218/109 20 minutes<br />

permit/referral<br />

Director<br />

Day 5-10<br />

12 Record signed paper APM OD Rm. 107 5 minutes<br />

Day 10<br />

13 Pick up approval/denial Release approval or denial APM OD Rm. 107 2 minutes<br />

Day 10/11<br />

RECEIVING OF CONSUMER COMPLAINTS<br />

No. STEP<br />

AGENCY ACTION PERSON LOCATION DURATION<br />

APPLICANT/CLIENT<br />

RESPONSIBLE OF OFFICE OF ACTION<br />

1 Proceed to LICD and file a Ask complainant whether or LICD-Consumer Rm. 107 30 minutes<br />

21


letter-complaint/affidavit<br />

of complaint<br />

2 Advise Complainant to<br />

submit product<br />

complained of (if there is<br />

any) to LSD<br />

not to file the complaint<br />

directly to LGU, DOH-CHD<br />

Offices or other <strong>gov</strong>t.<br />

agencies<br />

If filed at LICD, prepare<br />

indorsement to LGU, DOH-<br />

CHD Offices or over the<br />

complaint, copy furnished the<br />

Complainant<br />

Forward to LICD-Chief for<br />

initial<br />

Forward to OD for signature<br />

of the Director<br />

Release either by registered<br />

mail or personal delivery<br />

Receive complaint sample for<br />

analysis<br />

22<br />

Section<br />

LICD-Person<br />

Assigned<br />

Rm. 107 10 minutes<br />

LICD-Person<br />

Assigned<br />

Rm. 107 2 minutes<br />

LICD Releasing<br />

Clerk<br />

Rm. 109 5 minutes<br />

LICD Releasing<br />

Clerk<br />

Rm. 109 15 minutes<br />

LSD Rm. 223 30 minutes<br />

APPLICATION FOR PROMO PERMIT EXTENSION/AMENDMENT<br />

No. STEP<br />

AGENCY ACTION PERSON LOCATION DURATION<br />

APPLICANT/CLIENT<br />

RESPONSIBLE OFFICE OF ACTION<br />

1 Proceeds to LICD -APM’s<br />

Officer of the Day (OD)<br />

Rm. 107 1 minute<br />

2 Submits Application Pre-evaluates/assesses<br />

the submitted documents;<br />

Prepares assessment slip<br />

(Note: If documents are<br />

incomplete, returns the same<br />

to applicant with a note on<br />

deficiencies)<br />

LICD - APM OD Rm. 107 30 minutes<br />

3 Proceeds to Accounting Prepares order of payment Clerk Rm. 113 10 minutes<br />

Section for validation of<br />

(Accounting<br />

the assessment slip<br />

Section)<br />

4 Pays the corresponding Accepts payment and Clerk Rm. 112 10 minutes<br />

fees<br />

prepares official receipt<br />

(Cashier)<br />

5 Returns validated<br />

Attaches the slip to the LICD – APM OD Rm. 107 2 minutes<br />

assessment slip<br />

submitted documents/<br />

Hands over to the clients<br />

their copy<br />

6 Records the submitted<br />

application<br />

LICD – APM OD Rm. 107 30 minutes<br />

7 Endorses application to<br />

handling evaluator<br />

LICD – APM OD Rm. 107 2 minutes<br />

8 Follows up application Advises status of request APM<br />

Rm. 107 5 minutes<br />

after 3 days<br />

OD/Evaluator<br />

10 Reviews request and types<br />

approval denial<br />

APM Evaluator RM. 107 30 minutes<br />

11 Forwards denial/approval to<br />

section head for review and<br />

subsequent initial<br />

APM Evaluator Rm. 107 2 minutes<br />

12 Reviews and initials prepared APM Section Rm. 107 20 minutes<br />

action<br />

Head<br />

13 Forwards initialed paper to APM Section Rm. 107 2 minutes<br />

Legal Officer II acting as<br />

section’s supervisor for<br />

further review and initial<br />

Head


14 Reviews and initials paper.<br />

Returns to APM section<br />

15 Forwards to the<br />

Director/Deputy Director for<br />

review and signature<br />

16 Reviews and signs<br />

denial/approval<br />

23<br />

APM Supervisor<br />

(Legal Officer<br />

II)<br />

APM Section<br />

Head<br />

Rm. 107 10 minutes<br />

Rm. 107 2 minutes<br />

Directory/<br />

Deputy Director<br />

Rm. 118/109 20 minutes<br />

17 Records signed paper APM OD Rm. 107 5 minutes<br />

18 Picks up approval/denial Releases approval/denial APM OD Rm. 107 2 minutes<br />

19 Files document APM Staff Rm. 107 10 minutes


Administrative Division<br />

Record Section<br />

Frontline Service : Application for Authentication of <strong>BFAD</strong> Documents<br />

Clients : All Food, Drugs, Cosmetics, Medical Devices, Household Hazardous<br />

Substances, Distributors, Traders, Outlets,<br />

Importer/Exporters<br />

Requirements : Application Form and Original Documents<br />

Schedule of Availability of Service : 8:00 am – 5:00 pm<br />

Fees : Regular Lane 50.00 <strong>ph</strong>p/copy Special Lane 100.00 <strong>ph</strong>p/copy<br />

How to Avail of the Service:<br />

No. STEP<br />

APPLICANT/CLIENT<br />

1 Go to the Administrative<br />

Division, Records Section<br />

and get application form<br />

for authentication.<br />

2 Completely and properly<br />

fill-up application form – 1<br />

copy for Express Lane and<br />

2 copies for Regular Lane.<br />

3 Present filled-up<br />

application form together<br />

with the documents to the<br />

Records Officer-In-Charge<br />

for preparation of Order of<br />

Payment.<br />

4 Go to Accounting Section<br />

for the Billing Verification<br />

5 Pay required fee at the<br />

Cashier Section.<br />

6 Return to Records Section.<br />

Submit arranged original<br />

documents in the same<br />

manner as the <strong>ph</strong>otocopies<br />

and put it inside the<br />

envelope/folder separately.<br />

AGENCY<br />

ACTION<br />

Assist the client on how to<br />

fill-out application for<br />

authentication (if necessary)<br />

Check and receive application<br />

for authentication<br />

Pre-assess the<br />

application/documents and<br />

issue order of payment<br />

Prepare/Issue and initial<br />

payment slip<br />

Receive payment and issue<br />

official receipt<br />

Receive documents with<br />

order of payment.<br />

24<br />

PERSON<br />

RESPONSIBLE<br />

Mr. Delfin<br />

Acebedo<br />

Mr. Delfin<br />

Acebedo<br />

Mr. Ricardo<br />

Caraig and Mr.<br />

Jonathan D.<br />

Romagos<br />

LOCATION<br />

OF OFFICE<br />

Admin.<br />

Division –<br />

Records<br />

Section<br />

Admin.<br />

Division –<br />

Records<br />

Section<br />

Admin.<br />

Division –<br />

Records<br />

Section<br />

Accounting Clerk Admin.<br />

Division –<br />

Accounting<br />

Section<br />

Cashier Clerk Admin.<br />

Division –<br />

Cashier<br />

Section<br />

Mr. Ricardo<br />

Caraig and Mr.<br />

Jonathan D.<br />

Romagos<br />

Admin.<br />

Division –<br />

Records<br />

Section<br />

DURATION<br />

OF<br />

ACTIVITY<br />

5 mins.<br />

Day 1<br />

5 mins.<br />

Day 1<br />

3 mins.<br />

Day 1<br />

10 mins.<br />

Day 1<br />

10 mins.<br />

Day 1<br />

5 mins.<br />

Day 1


7 Process request for :<br />

8 Present proof of payment<br />

for:<br />

-The release of<br />

documents (Express<br />

Lane)<br />

-The numbered Claim<br />

copy (Regular Lane)<br />

Express Lane<br />

Regular lane<br />

(Stamp, number, sign and<br />

seal documents for<br />

authentication)<br />

Release authenticated<br />

documents for<br />

Express Lane (maximum of<br />

10 pcs.); release numbered<br />

claim copy for regular lane<br />

9 Present claim number Releases authenticated<br />

documents<br />

25<br />

Mr. Catalino<br />

Sanoy and Mr.<br />

Delfin Acebedo<br />

Ricardo Caraig<br />

and Jonathan<br />

Romagos<br />

Mr. Delfin<br />

Acebedo<br />

Mr. Delfin<br />

Acebedo<br />

Admin.<br />

Division –<br />

Records<br />

Section<br />

Admin.<br />

Division –<br />

Records<br />

Section<br />

Admin.<br />

Division –<br />

Records<br />

Section<br />

* 45 mins.<br />

Day 1 –<br />

Express<br />

Lane<br />

* 2 Days<br />

5 mins.<br />

Day 1<br />

5 mins.<br />

(day 3)<br />

Note: Do not leave the Records Section without the numbered Claim Copy because no document will be released<br />

without it. However, a fee of <strong>ph</strong>p20.00 shall be charged for lost claim copy<br />

Express Lane Time Duration 1 hour and 30 minutes<br />

Regular Lane - 3 days


<strong>BFAD</strong> Performance Pledge<br />

We, the officials and employees of the Bureau of Food and Drugs<br />

pledge and commit to deliver quality public services as promised in this<br />

<strong>BFAD</strong> charter.<br />

Specifically, we will:<br />

Serve with Integrity and Efficiency.<br />

Be prompt and timely.<br />

Display procedures, fees and charges.<br />

Provide adequate and accurate information.<br />

Be consistent in applying rules.<br />

Provide feedback mechanism.<br />

Be polite and courteous.<br />

Demonstrate sensitivity and appropriate behavior and<br />

professionalism.<br />

Wear proper uniform and identification.<br />

Be available during office hours and beyond.<br />

Respond to complaints.<br />

Provide comfortable waiting area.<br />

Treat everyone equally<br />

26


Client Feedback Form<br />

NAME (PANGALAN) _______________________________________________<br />

ADDRESS (TIRAHAN) _____________________________________________<br />

_____________________________________________<br />

PHONE NUMBER (TELEPONO) ______________________________________<br />

E-MAIL ADDRESS _______________________________________________<br />

DIVISION/SECTION (DIBISYON/SEKSIYON) ___________________________<br />

COMPLIMENT OR COMMENT? (PAPURI o KOMENTO?)<br />

_______________________________________________________________<br />

_______________________________________________________________<br />

WHAT IS YOUR COMPLAINT? (ANO PO ANG INYONG REKLAMO?)<br />

_______________________________________________________________<br />

_______________________________________________________________<br />

WHEN DID IT HAPPEN? (KAILAN PO NANGYARI?)<br />

_______________________________________________________________<br />

WHAT WOULD YOU LIKE US TODO? (ANO PO ANG GUSTO NINYONG GAWIN<br />

NAMIN?)<br />

_______________________________________________________________<br />

______________________________________________________________<br />

SIGNATURE (LAGDA) _____________________________________<br />

DATE (PETSA) ___________________________________________<br />

Would you like a written reply? (Nais nyo po ba ng sagot na nakasulat?)<br />

27<br />

Yes (Oo) � No (Hindi)

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