Objectives
- To promote accountability and transparency through the use of information and communication technologies.
- To adopt and prescribe the Integrated Application Form (IAF) to simplify and streamline FDA authorization application processes.
Scope
- Applies to FDA-regulated products and establishments under the Centers for Drug, Food, and Cosmetic Regulation and Research.
- Covers the following authorizations served by the IAF:
- License to Operate (initial, renewal, compliance, amendments)
- Certificate of Product Registration (initial, renewal, amendments, re-application, Principal CPR, Certificate of Listing)
- Promo and Advertisement Permits
- Certificate of Free Sale
- Export Certificate
- Certificate of Pharmaceutical Product
- Generic Labeling Exemption
- Good Manufacturing Practice (GMP) Compliance Certificate
- HACCP Compliance Certificate
Guidelines - Principles
- The IAF is the primary document requirement for FDA authorizations.
- Satisfies requirements traditionally covered by multiple forms and affidavits.
- Fee assessment is integrated; no separate form needed.
- Completed IAF is mandatory to issue a Document Tracking Log (DTL).
- IAF is an electronic, publicly accessible, self-accomplishable form with four components: Application Form, Petition Form (license), Declaration Forms (drug and non-drug).
- Licensing applications include the Application and Petition Forms; Registration applications include Application and Declaration Forms; other applications only require the Application Form.
- Petition and Declaration Forms require notarization.
- Applicants are bound by the terms of the forms they submit.
- Hardcopies of original authorizations are surrendered when renewing, but hardcopies of supporting documents are submitted only upon request.
- Original documents are presented during onsite audits, though not submitted unless requested.
Guidelines - Requirements
- At submission, applicants must provide:
- Complete documents in preferred file formats (PDF, Word 97-2003, PNG images at least 150 dpi) stored on a USB device.
- Integrated Application Form as filled and signed, notarized if applicable.
- Organized folder structure per application with appropriate file naming.
- Two hardcopies each of the Document Tracking Log and properly notarized Integrated Application Form.
- Original proof of payment (machine-validated OnColl slip or FDA official receipt).
- One commercial presentation representative sample (pharmaceuticals, food supplements, household pesticides) as applicable.
Guidelines - Procedure
- Download the IAF from the FDA website.
- Fill out completely and truthfully.
- Submit application details by email (up to ten applications per email).
- FDA sends Document Tracking Log via email within two working days.
- The DTL contains a unique Routing Slip Number (RSN) for payment, follow-ups, and scheduling.
- Submission schedules set within ten working days; FDA regulates daily submission quotas.
- Payments can be made via Land Bank of the Philippines or FDA Main Office Cashier with specific account details.
- Proof of payment must be presented at the time of document receipt.
- Only scheduled applicants are received; documents transferred electronically from USB.
- Rescheduling of forfeited submissions is allowed only upon compliance with stipulated conditions.
Repealing Clause
- Memorandum Circular No. 2013-0038 is repealed.
- Any inconsistent regulations or provisions are likewise repealed or modified.
Saving Clause
- If any provision is declared invalid or unconstitutional, remaining provisions continue to be effective.
Effective Date
- The Integrated Application Form available for download starting February 17, 2014.
- Only IAF will be accepted for scheduling requests beginning March 3, 2014.
- The Circular took effect on February 17, 2014.