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