FDA CIRCULAR NO. 2010-010, May 24, 2010

[ FDA CIRCULAR NO. 2010-010, May 24, 2010 ]

CUT-OFF TIME FOR RECEIVING OF APPLICATIONS AND PAYMENTS OF FEES IN FDA

For the effective and efficient public service delivery of this Office, applications for Certificate of Product Registration, License to Operate, Laboratory Analysis, Permit, Certification and other related transactions shall be entertained/accepted from 7:00 A.M. to 3:00 P.M. only. No Noon Break Policy will be implemented to accommodate clients during lunchtime.

All divisions concerned will receive applications according to the schedule stated below:

A. Product Services Division/PPAD-PAICS

Monday

-

Food/Food Supplements

Tuesday

-

Drug including Clinical Studies/Protocols(Company Name starting from A-K)

Wednesday

-

Drug including Clinical Studies/Protocols(Company Name starting from L-Z)

Thursday

-

Cosmetics/HHS/Household Pesticides

Friday

-

Cosmetics

Monday – Friday

-

Mailing/Hand carry Permit

B. Regulation Division I

Monday – Thursday

-

Initial/Renewal/Certification

Friday

-

Renewal/Certification

C. Regulation Division II

Monday

-

Food

Tuesday & Wednesday

-

Drug/Medical Device

Thursday

-

Cosmetics/HHS

D. Laboratory Services Division

Monday – Friday

-

Export Clearance/Lot Release Certificate * Government Deliveries and Other Collected Samples

Tuesday – Thursday

-

Batch Notification

* Lot Release Certificate application will be received until 11:00 A.M. only

E. Legal Information and Compliance Division

Monday – Thursday

-

Advertisement and Sales Promo Permit and Certification

Further, acceptance of payments at the Cashier Section for FDA Fees and Charges shall be until 4:00 P.M . only, to provide sufficient time for the preparation of the Report of Collections and Deposits in compliance with the COA requirements.

Priority numbers will be provided in the division concerned. Once the number is called, the client should be present; otherwise, the next client will be served. He/she must secure for another number, if still within cut-off time, and wait again for his/her turn.

Follow-up day will be as follows (8:00 A.M. – 5:00 P.M.)

A. Product Services Division

Thursday

-

Clinical Applications (i.e. Additional Indication, CSP, among others)

B. Legal Information and Compliance Division

Thursday & Friday

-

Advertisement and Sales Promo Permit

Bureau Circular No. 21, s. 2005 is hereby revoked/superseded.

This Circular takes effect on 01 June 2010.

(SGD.) NAZARITA T. TACANDONG, RPh, MPA Acting Director IV