Question & AnswerQ&A (FDA CIRCULAR NO. 2010-010)
Applications for various FDA transactions are accepted from 7:00 A.M. to 3:00 P.M., and payments at the Cashier Section are accepted until 4:00 P.M only.
Monday is designated for Food and Food Supplements applications received by the Product Services Division/PPAD-PAICS.
Cosmetics applications are accepted on Thursdays and Fridays.
The FDA implements a No Noon Break Policy to accommodate clients during lunchtime, meaning applications are accepted continuously from 7:00 A.M. to 3:00 P.M.
If the client is not present when their number is called, the next client will be served. The absent client must secure another number if still within the cut-off time and wait for their turn again.
Regulation Division I handles Initial, Renewal, and Certification transactions Monday through Thursday, and Renewal and Certification on Fridays.
Thursday is the follow-up day for Clinical Applications such as Additional Indications or Clinical Study Protocols.
Lot Release Certificate applications are accepted only until 11:00 A.M.
Bureau Circular No. 21, s. 2005 is revoked or superseded by FDA Circular No. 2010-010.
This Circular took effect on June 1, 2010.