This document outlines guidelines for filing applications using an Integrated Application Form adopted by the Philippines' Food and Drug Administration (FDA) to streamline the application process. The form was created to comply with laws mandating improved efficiency and accountability in government services. It consolidates requirements for various FDA authorizations like licenses and permits onto a single electronic form. Applicants must submit documentary requirements digitally, pay fees, and provide hard copies of certain documents to complete the application process based on a scheduled intake procedure.

1. FDA Circular No. 2014-
003 dated 11 February 2014
• Filing and Receiving of
Registration, Licensing
and Other Applications
Using the Integrated
Application Form

2. I. RATIONALE
RA 9485 “ Anti Red tape Act of
2007
improve efficiency in the
delivery of government
services
establish effective practices
to prevent graft and
corruption

3. 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.

4. RA 9711 “ Food and Drug
Administration Act of 2009”
• Establish and maintain an
effective health products
and regulatory system
• Prescribe standards,
guidelines and regulations

5. II. OBJECTIVES
• Promote accountability and
transparency
• Integrated Application Form
be adopted
• Simplify and streamline the
requirements for FDA
authorization

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

7. III. SCOPE
3. Promo and Advertisement
Permits
4. Certificate of Free Sale
5. Export Certificate
6. Certificate of
Pharmaceutical Products
7. Generic Labeling Exemption

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

9. 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

10. 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

11. B. REQUIREMENTS
1. Complete application documentary
requirements stored in a USB device
2. Two (2) hardcopies of the Document
Tracking Log (DTL) issued by FDA
3. 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)

12. C. PROCEDURES
1. 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

13. 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)

14. 6. Check
- completeness of requirements
7. 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