Question & AnswerQ&A (FDA CIRCULAR NO. 2014-003)
The primary purpose is to promote accountability and transparency by simplifying and streamlining the filing and receiving of registration, licensing, and other applications using the Integrated Application Form to improve efficiency in government service delivery in accordance with the Anti-Red Tape Act of 2007.
The circular is based on Republic Act No. 9485 (Anti-Red Tape Act of 2007) and Republic Act No. 9711 (Food and Drug Administration Act of 2009).
It covers FDA-regulated products and establishments under the Centers for Drug Regulation and Research (CDRR), Food Regulation and Research (CFRR), and Cosmetic Regulation and Research (CCRR), including licensing, registration, advertisement permits, product certificates, and certificates related to Good Manufacturing Practices and HACCP.
Authorizations include License to Operate, Certificate of Product Registration, Promo and Advertisement Permits, Certificate of Free Sale, Export Certificate, Certificate of Pharmaceutical Product, Generic Labeling Exemption, Certificate of Compliance with GMP, and Certificate of Compliance with HACCP.
The form consists of four documents: Application Form (Annex I), Petition Form for License Applications (Annex II), Declaration Form for Non-Drug Registration Applications (Annex III), and Declaration Form for Drug Registration Applications (Annex IV).
Only the Petition and Declaration Forms require notarization. Hardcopies of the Integrated Application Form are required in two copies and must be signed and notarized, but other original hardcopies are no longer required except when requested during evaluation or onsite audits.
Fees are assessed within the Integrated Application Form, eliminating the need for separate assessment forms. Payment can be made via Land Bank of the Philippines branches or the FDA Cashier, and proof of payment must be presented upon submission.
Applicants must download and complete the Integrated Application Form, send the application details by email, receive a Document Tracking Log within two working days, schedule submission within ten working days, pay the required fees, and submit documents and samples on the scheduled date at the FDA Central Receiving.
Failure to complete submission requirements, appear on the scheduled date, provide proof of payment, or transfer electronic application documents results in forfeiture of the submission schedule. Forfeited schedules can only be rescheduled by contacting the FDA via email with the original schedule's Routing Slip Number.
It repeals Memorandum Circular number 2013-0038 and modifies or repeals inconsistent regulations or provisions accordingly.