FDA Circular No. 2014-003 dated 11 February 2014

• Filing and Receiving of Registration, Licensing and Other Applications Using the Integrated Application Form

I. RATIONALE

RA 9485 “ Anti Red tape Act of 2007improve efficiency in the delivery of government servicesestablish effective practices to prevent graft and corruption

RA 9485 “ Anti Red tape Act of 2007

• Frontline services shall undergo evaluation and improvement of their transaction systems and procedures to reduce bureaucratic red tape and processing time.

RA 9711 “ Food and Drug Administration Act of 2009”

• Establish and maintain an effective health products and regulatory system

• Prescribe standards, guidelines and regulations

II. OBJECTIVES

• Promote accountability and transparency

• Integrated Application Form be adopted

• Simplify and streamline the requirements for FDA authorization

III. SCOPE•The following authorizations are serve by the Integrated Application Form. 1. License To Operate 2. Certificate of Product Registration (CPR)

III. SCOPE3. Promo and Advertisement Permits4. Certificate of Free Sale5. Export Certificate6. Certificate of Pharmaceutical Products7. Generic Labeling Exemption

III. SCOPE 8. Certificate of Compliance with Good Manufacturing Practice (GMP) 9. Certificate of Compliance with Hazard Analysis and Critical Control Points (HACCP)

IV. GUIDELINES• A. PRINCIPLES 1. The Integrated Application Form is the primary requirement for any authorization issued by FDA.

2. The Integrated Application Form: - electronic file format - publicly accessible - able to be accomplished independent of guidance by an FDA Officer

3. Information and documents submitted will be collected and verified. 4. applicant agrees to be bound to the terms of the petition and declaration forms 5. hardcopies shall no longer be required upon submission

B. REQUIREMENTS1. Complete application documentary requirements stored in a USB device2. Two (2) hardcopies of the Document Tracking Log (DTL) issued by FDA3. Two (2) hardcopies of the accomplished Integrated Application Form (notarized) 4. Original copies of proof of payment 5. One (1) sample in commercial presentation (for CPR application only)

C. PROCEDURES1. Download - www.fda.gov.ph - Integrated Application Form 2. Fill-up Form - appropriate, complete and true information 3. Email - send application to pair@fda.gov.ph

4. Scheduling - within ten (10) working days of receiptof application form through

pair@fda.gov.ph 5. Pay - Land Bank of thePhilippines - FDA Cashier (scheduled to be received for the day)

6. Check - completeness of requirements7. Submission - Application is filed in on schedule. - Only applications scheduled for the day will be accomodated - hard copies will no longer be required at submission