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

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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

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