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Republic Act No. 9485, the Anti-Red Tape Act of 2007, was enacted to improve efficiency in the delivery of government services and to establish effective practices aimed at the prevention of graft and corruption in government. Government agencies and offices are mandated to promote transparency with regard to the manner of transacting with the public. Further, these measures shall encompass a program for the adoption of procedures to reduce red tape and expedite transactions in government. Section 5 of the same law states that all offices and agencies which provide frontline services shall undergo evaluation and improvement of their transaction systems and procedures and re-engineer the same if deemed necessary to reduce bureaucratic red tape and processing time.

Section 3 of Republic Act No. 9711, the Food and Drug Administration Act of 2009, has declared it “a policy of the State to adopt, support, establish, institutionalize, improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and designed to:” .... “help establish and maintain an effective health products regulatory system ....”. Section 5 of the same law amending Section 4 of Republic Act No. 3720 provided the FDA with the authority “to prescribe standards, guidelines, and regulations with respect to information, advertisements, and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products as covered in this Act;”.

II. Objectives

With the intention of promoting accountability and transparency through greater use of information and communication technologies, the Integrated Application Form is hereby adopted to simplify and streamline the requirements for FDA authorization, and the application process dependent on the same form is prescribed.

III. Scope

This issuance shall cover FDA-regulated products and establishments under the Center for Drug Regulation and Research (CDRR), Center for Food Regulation and Research (CFRR) and the Center for Cosmetic Regulation and Research (CCRR).

The following authorizations are served by the Integrated Application Form:

IV. Guidelines

A. Principles

1. The Integrated Application Form is the primary documentary requirement for any authorization issued by the FDA.
   
   
   1. The Integrated Application Form satisfies the requirement for any of the following documents required by any Center of the FDA for purposes of licensing, registration, or other authorization: application letter, application form, petition letter, petition form, declaration form, electronic copy affidavit, and the affidavit of undertaking.
   2. The assessment of fees is incorporated into the form and no separate assessment form shall be further required.
   3. A completed Integrated Application Form is required for a Document Tracking Log to be issued by the FDA.
      
      
2. The Integrated Application Form is of an electronic file format, publicly accessible, able to be accomplished independent of guidance by an FDA officer, at a pace and in a facility determined by the applicant;
   
   
   1. The electronic file of the Integrated Application Form is comprised of four documents:
      
      1. Application Form (ANNEX I);
      2. Petition Form for License Applications (ANNEX II);
      3. Declaration Form for Non-Drug Registration Applications (ANNEX III); and
      4. Declaration Form for Drug Registration Applications (ANNEX IV);
         
   2. For licensing application, the Integrated Application Form is a two-page document: the first being the Application Form and the second a Petition Form;
   3. For registration application, the Integrated Application Form is a two page-document: the first being the Application Form and the second a Declaration Form;
   4. or all other applications, the Integrated Application Form is a one-page document comprising of the Application Form.
   5. Only the Petition and Declaration Forms require notarization.
      
      
3. All information and documents submitted to the FDA in satisfaction of any authorization will be collected and verified.
   
   
4. The applicant establishment, represented by the individuals signing the application form, agrees to be bound to the terms of the petition and declaration forms as appropriate.
   
   
5. Hardcopies shall no longer be required upon submission, including original authorization
   
   
   1. All copies of original authorization issued by the FDA shall be surrendered prior to release of a renewed authorization at the Central Releasing;
   2. Hardcopies of the requirements in support of an application shall always be made available and submitted upon request of the Center in the process of evaluation.
   3. Hardcopies of original documents including Certificates of Free Sale are not required to be submitted but must be presented to officers of the FDA during onsite audits.

The following documents are expected to be presented at the point of receiving during the appointed schedule:

1. Complete application documentary requirements in a preferred document format stored in a USB device:
   
   
   1. Include the Integrated Application Form in the format it was accomplished, and a scanned copy of the signed and notarized form as appropriate.
      
      
   2. Store all files relevant to a single application in a single folder labeled with the document tracking number issued by the FDA;
      
      
   3. Each required document comprising a single application must be submitted as an independent file and named as the requirement that it satisfies:
      
      E.g. 1) the PDF of the Certificate of Free Sale is named as ‘Certificate of Free Sale’;
      E.g. 2) the PNG of the floor plan of the ground floor of a facility is named as ‘Floor Plan for the Ground Floor’;
      
      
   4. For multiple applications, each application must have a separate folder;
      
      
   5. Preferred document formats:
      
      
      1. PDF;
      2. Word 97-2003;
      3. PNG for image files;
         
         
   6. Images are preferred to be at least 150 dpi.
      
      
2. Two (2) hardcopies of the Document Tracking Log issued by the FDA
   
   
3. Two (2) hard copies of the accomplished and duly notarized Integrated Application Form signed by the authorized representative and the approving authority of the applicant company.
   
   
4. Original copy(ies) of proof of payment of appropriate fees and charges (machine validated OnColl payment slip or the original copy of the official receipt issued by the FDA Cashier);
   
   
   1. One copy of the Oncoll payment slip will be collected by the Central Receiving for endorsement to Accounting.
      
      
5. One (1) representative sample in commercial presentation for registration application of only the following:
   
   
   1. Pharmaceuticals (contained in a bubble wrap package);
   2. Food supplements; and
   3. Household pesticides only.

C. Procedure

1. Download the Integrated Application Form from the FDA website (www.fda.gov.ph).
   
   
2. Fill-up the Integrated Application Form with appropriate, complete and true information.
   
   
3. Send application email to pair@fda.gov.ph.
   
   
   1. Up to ten (10) application details may be sent in a single email.
   2. Subsequent email communication will be through the email used to submit the application form to FDA, unless other channels are indicated by the applicant.
      
      
4. A Document Tracking Log (Annex V) is sent via email to the applicant within two (2) working days of receipt of application form by FDA.
   
   
   1. A separate Document Tracking Log (DTL) will be issued for every application.
   2. The Routing Slip Number (RSN or Tracking Number) indicated in the DTL is the unique application identifier that will be used in payment, follow-ups and publication.
   3. The schedule of submission of application will be indicated in the DTL.
      
      
5. Scheduling
   
   
   1. Schedule will be set within ten (10) working days of receipt of application form through pair@fda.gov.ph.
   2. Applications will be received daily.
   3. A daily quota on the number of applications scheduled for submission will be set by the FDA.
   4. The FDA reserves the authority to schedule the receipt of applications.
      
      
6. Payment Collection
   
   
   1. Land Bank of the Philippines
      
      
      1. Proceed to any LBP branch for payment;
      2. Fill-out an OnColl Payment Slip (see Annex VI)
         
         

         Table 1 FDA Accounts
         	Center for Cosmetics Regulation and Research	0392-2220-06
         	Center for Device Regulation and Radiation Health Research	0392-2220-30
         	Center for Drug Regulation and Research	0392-2220-14
         	Center for Food Regulation and Research	0392-2220-22

      3. Present the Oncoll Payment Slip to LBP tellers together with the printed application form and document tracking log and the corresponding cash/check payment.
      4. Bank service fee of forty pesos (Php40.00) for every payment transaction made shall be shouldered by the clients.
      5. A validated OnColl Payment Slip and assessment form will be returned by the teller as proof of payment in lieu of the issuance of an Official Receipt.
      6. For verification/ posting of payment receipt, a scanned copy of the validated OnColl Payment Slip should be sent through email to accounting@fda.gov.ph.
         
         
   2. FDA Main Office Cashier
      
      
      1. Proceed to the Cashier for payment;
      2. Present the application form and document tracking log and the corresponding cash/check payment;
      3. An Official Receipt is issued by the Cashier as proof of payment.
      4. Only applicants scheduled to be received for the day will be accommodated by the Cashier, otherwise proceed to any LBP branch for payment.
         
         
7. Receiving

1. Only applicants scheduled for the day will be received;
2. The applicant proceeds to the FDA Central Receiving on the schedule indicated in the Document Tracking Log;
3. The documents identified in Section B. Requirements, Chapter IV. Guidelines of this issuance are submitted;
4. The FDA downloads the electronic copy of the application documents from the USB device of the applicant;
5. The proof of payment is presented;
6. If payment is made through the Land Bank of the Philippines, a machinevalidated copy of the On-Coll Payment Collection Slip is collected;
7. The Central Receiving returns the USB device of the applicant with the updated Document Tracking Log indicating the receipt of the application;

8. Rescheduling after Forfeit of Schedule
   
   
   1. The following conditions shall render the schedule for submission forfeit:
      
      1. Incomplete requirements during submission, including failure to provide proof of payment;
      2. Failure to appear as scheduled;
      3. Failure to complete transfer of electronic application and supporting documents from applicant to FDA;
      4. Other situations that lead to the failure of the completion of the receiving process within schedule.
         
   2. Applicants with forfeited schedules must send to pair@fda.gov.ph the RSN of the original schedule and will be processed for rescheduling.
      
   3. Only forfeited schedules may be rescheduled.

V. Repealing Clause

Memorandum Circular number 2013-0038 is hereby repealed.

Any regulation or provision inconsistent with the terms of this Circular is repealed or modified accordingly.

VI. Saving Clause

If any provision or term of this Circular is declared invalid by any court or tribunal, such declaration shall not affect the remaining provisions of this Circular.

VII. Effective Date

1. The Integrated Application Form will be available for download from www.fda.gov.ph starting 17 February 2014.
2. Only the Integrated Application Form will be accepted for schedule requests starting 3 March 2014.

This Circular shall take effect 17 February 2014.

(SGD) KENNETH Y. HARTIGAN-GO, MD
Director, Food and Drug Administration