Title
FDA Application and Payment Cut-Off Times
Law
Fda Circular No. 2010-010
Decision Date
May 24, 2010
Effective June 1, 2010, the FDA establishes a structured schedule for receiving applications and payments, operating from 7:00 A.M. to 4:00 P.M. without a noon break, to enhance public service efficiency.
A

Division-Specific Schedule for Application Acceptance

  • Product Services Division/PPAD-PAICS:
    • Monday: Food/Food Supplements
    • Tuesday: Drugs (including Clinical Studies/Protocols) companies A-K
    • Wednesday: Drugs (including Clinical Studies/Protocols) companies L-Z
    • Thursday: Cosmetics, Household Health Supplies (HHS), Household Pesticides
    • Friday: Cosmetics
    • Monday and Friday: Mailing/Hand carry Permit
  • Regulation Division I:
    • Monday to Thursday: Initial, Renewal, Certification
    • Friday: Renewal and Certification only
  • Regulation Division II:
    • Monday: Food
    • Tuesday and Wednesday: Drug and Medical Device
    • Thursday: Cosmetics/HHS
  • Laboratory Services Division:
    • Monday to Friday: Export Clearance and Lot Release Certificate
    • Government deliveries and collected samples on Tuesday to Thursday
    • Lot Release Certificate applications accepted only until 11:00 A.M.
  • Legal Information and Compliance Division:
    • Monday to Thursday: Advertisement and Sales Promotion Permit and Certification

Payment Acceptance Policy

  • Payments for FDA Fees and Charges accepted at Cashier Section only up to 4:00 P.M.
  • Allows enough time for preparation of Report of Collections and Deposits in compliance with Commission on Audit (COA) requirements

Client Handling Procedure

  • Priority numbers distributed in each division
  • Clients must be present when their number is called or the next client will be served
  • Absent clients must obtain a new priority number if within cut-off time and wait their turn again

Designated Follow-up Days

  • Product Services Division: Thursday for Clinical Applications including Additional Indications and Compounded Sterile Preparations (CSP)
  • Legal Information and Compliance Division: Thursday and Friday for Advertisement and Sales Promotion Permit

Repeal and Effectivity

  • FDA Bureau Circular No. 21, s. 2005 is revoked and superseded by this Circular
  • This Circular takes effect on 01 June 2010

Administrative Authority

  • Signed and issued by Nazarita T. Tacandong, Acting Director IV

This Circular serves to promote efficiency and order in the processing of FDA applications and payments, defining specific schedules, payment cut-offs, and client handling to improve service delivery and regulatory compliance.


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