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

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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)

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