Republic of the Philippines me cise FBaw() FOOD AND DRUG ADMINISTRATION 11 February 2014 FDA CIRCULAR No._2014 003 TO: All Establishments Seeking to, or Currently Engaged in the Manufacture, Import, Export, Distribution and Retail of Health Products in the Philippines; the Bureau of Customs, the Department of Trade and Industry, and other agencies requiring documents sued by the Food and Drug Administration FROM Y. HARTIGAN-GO, MD Food and Drug Administration SUBJECT: Filing and Receiving of Registration, Licensing and Other Applications Using the Integrated Application Form I. Rationale 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 lawstates 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: lp 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 I. 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 authori and the application process dependent on the same form is prescribed. Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines es Trunk Line +63 2 857 1900 Fax +63 2 8070751 Website: www.da.gov.ph Email: infra fda.gov.ph voIIL. Scope ee a Republic of the Phil _ oy epee fe FDAD)C FOOD AND DRUG ADMINISTRATION ‘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: » 2 3) 4) 5) 6) D 8) %) License to Operate, including initial, renewal, compliance, and amendments; Certificate of Product Registration, including initial, renewal, amendments, re- application, Principal CPR, and Certificate of Listing of Kdentical Drug Product; Promo and Advertisement Permits; Certificate of Free Sale; Export Certificate: Certificate of Pharmaceutical Product; Generic Labeling Exemption; Certificate of Compliance with Good Manufacturing Practice (GMP); Certificate of Compliance with Hazard Analysis and Critical Control Points (HACCP); IV. Guidelines A. Principles The Integrated Application Form is the primary documentary requirement for any authorization issued by the FDA. a, 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, b. The assessment of fees is incorporated into the form and no separate assessment form shall be further required. c. A completed Integrated Application Form is required for a Document Tracking Log to be issued by the FDA. 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; a. The electronic file of the Integrated Application Form is comprised of four documents: i, Application Form (ANNEX 1) : ii, Petition Form for License Applications (ANNEX II); iii, Declaration Form for Non-Drug Registration Applications (ANNEX IID), and; iv. Declaration Form for Drug Registration Applications (ANNEX IV); Page 2of6Republic of the Philippines aH A) FOOD AND DRUG ADMINISTRATION b. For licensing application, the Integrated Application Form is a two-page document; the first being the Application Form and the second a Petition Form: c. 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. For all other applications, the Integrated Application Form is a one-page document comprising of the Application Form. ¢. Only the Petition and Declaration Forms require notarization. 3. All information and documents submitted to the FDA authorization will be collected and verified. satisfaction of any 4, The applicant establishment, represented by the individuals signing the application form, agrees to be bound to the terms of the petition and declarat forms as appropriate. Hardeopies shall no longer be required upon submission, including original authorization; a. All copies of original authorization issued by the FDA shall be surrendered prior to release of a renewed authorization at the Central Releasing; b. 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. ¢. Hardcopies of original documents including Certificates of Free Sale are not required to be submitted but must be presented to officers of the FDA uring onsite audits. B. Requirements The following documents are expected to be presented at the point of receiving during the appointed schedule: 1. Complete application documentaryrequirements in a preferred document format stored in a USB device: fa, Include the Integrated Application Form in the format it was accomplished, and a scanned copy of the signed and notarized form a appropriate. b. Store all files relevant to a single application in a single folder labeled with the document tracking number issued by the FDA c. 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 “Cenificate of Free Sale’; E.g. 2) the PNG of the floor plan of the ground floor of a facili named as “Floor Plan for the Ground Floor 4. For multiple applications, each application must have a separate folder; ¢. Preferred document formats: Page 3086~- Republic of the Philippines ss 2 Deparment of Health FDALDC FOOD AND DRUG ADMINISTRATION i, PDF; ii, Word 97-2003; iii. PNG for image files: £, 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) hardeopies 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); a, 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: a, Pharmaceuticals (contained in a bubble wrap package); b. Food supplements; and c. 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. a, Upto ten (10) application details may be sent in a single email. b. 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. ‘a. A separate Document Tracking Log (DTL) will be issued for every application. b. 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. ¢. The schedule of submission of application will be indicated in the DTL. 5. Scheduling a. Schedule will be set within ten (10) working days of receipt of application form through pair@fda.gov.ph. b. Applications will be received daily. Page 4 of 6Republic of the Philippines 9) Dea ereHath FDA, C FOOD AND DRUG ADMINISTRATION cc. A daily quota on the number of applications scheduled for submission will be set by the FDA. d. ‘The FDA reserves the authority to schedule the receipt of applications. 6. Payment Collection a. Land Bank of the Philippines i, Proceed to any LBP branch for payment; ii, 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 iii, Present the Oncoll Payment Slip to LBP tellers together with the printed application form and document tracking log and the corresponding cash/ check payment. iv. Bank service fee of forty pesos (Php 40.00) for every payment transaction made shall be shouldered by the clients. v. A validated OnColl Payment Slip and assessment form will be retumed by the teller as proof of payment in lieu of the issuance of an Official Receipt. vi. For verification/ posting of payment receipt, a scanned copy of the validated OnColl Payment Slip should be sent through email to accounting@fa.gov.ph. b, FDA Main Office Cashier i, Proceed to the Cashier for payment; ii, Present the application form and document tracking log and the corresponding cash/ check payment: . An Official Receipt is issued by the Cashier as proof of payment. iv. 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 a. Only applicants scheduled for the day will be received; b. The applicant proceeds to the FDA Central Receiving on the schedule indicated in the Document ‘Tracking Log; c. The documents identified in Section B. Requirements, Chapter IV. Guidelines of this issuance are submitted; d. The FDA downloads the electronic copy of the application documents from the USB device of the applicant; €. The proof of payment is presented; f. If payment is made through the Land Bank of the Philippines, a machine-validated copy of the On-Coll Payment Collection Slip is collected; Page 8 of 6j a Republic of the Philippines 9 Daeeerik FDADDC FOOD AND DRUG ADMINISTRATION g. The Central Receiving returns the USB device of the applicant with the updated Document Tracking Log indicating the receipt of the application; 8. Reschedulingafter Forfeit of Schedule a. The following conditions shall render the schedule for submission forfeit: i, Incomplete requirements during submission, including failure to provide proof of payment; ii, Failure to appear as scheduled; iii, Failure to complete transfer of electronic application and supporting documents from applicant to FDA; iv. Other situations that lead to the failure of the completion of the receiving process within schedule. b. Applicants with forfeited schedules must send to pair@fida.gov.ph the RSN of the original schedule and will be processed for rescheduling. ¢. 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 unal, such declaration shall not affect the remaining provisions of this Circular. VIL. Effective Date a. The Integrated Application Form will be available for download from www. fida.gov.ph starting 17 February 2014, b. Only the Integrated Application Form will be accepted for schedule requests starting 3March 2014. This Circular shall take effect 17 February 2014. Page 6612345678901234 er Apis nat Deportment of Health Food and Drug Adminstration ANNEX I PLICATION FORM zANNEX II sent ening byte Feodand Ou rnin PETITION We category dca tht al deta and information stitein connection wth hs apphaton 2 wearer submissions nh Vee ante dy etre toate alone dedaatan on beta ofhe Company: Demonstration sabshrent | Tei etabtahman abe open for buses hous under he supers of PRC epee profesional appeable) ar ator sesonne 1. Tepharmast anther ie eat poeta, veo and duong emolomentin hs establanment are ot awa any waybe connected wth any cine DA eutedesatisiment ape) 1m Te aprouedand vices to Operate sabe dled na conpeo¥s Hao he establishment Chr Aen, or #the Oa ules ater tat tiene \. Taeatached cron coo es/scoumentsfnioration othe 0 app Contents or wil mieresentation on any othe Gta thre alte a rund for dsapprova of apteation ne he i torte company apn for tomar 1 Hae Hed he poor an have pal the complet & apororie ene fe eorex te 8. Tater are no changer varios nthe elastin the arene of TO peal but nat ited te change oct change fovea hogs ovine name chang of egateedpharmecst sang n warehouse ie anal spptr a roduc rs changin activity canbe in key The prac emanate tote and/or ll ae eitered or tbe cepted with FA pir odin o ale a that we asume primary ‘espa nor star ve the producti case i hai, adverse event ana cther publ safety ie ‘The atchent hetero nial ene or aomatranmwal el uj to nspecton by FDA autotaed epresrtathes a areas ie Ueto resond ond compere uy wth the FDA wih rea Yan ubequenpostmanetig a 1% nencomplanc ith he egirements andor ire toe not the OA a he change in burns den, busines nme owner of anyother ‘reumsances inition othe apres he ppation en grand fr eocation he ante to Operate, Any lation fhe above rovilone ane res an epulatns wiauamatcly be sje othe SUSPENSION CANCELATIN) REVOCATION oh ent ‘8. We mak ths deraton nfl knoe ge and ayarnes cf Republi At No. 3720 48 amended by Repu et no 9711, tere knw asthe Food and Or ‘ariniation At 2018, er te sane ther implementing res nd eins pation fo cent Operate be pate ater compan wth he oad and Grp Remeron equrerent WAWER [ACKNOWLEDGEMENT SUBSERBED AND SWORN TOBEFORE MEAs ___sayot 0 Prippines, sonal appeared te following ana ae Sratre UerttestonNunoer xy bate D Peed Lana Tarsoratonotee (beer sb25436-789 iim 1) Fst Name Middle Name Family Name a 1.08036 2) First 2 Mile 2 Family 2 now tome and ome noun te be these persons who eves the appcnton form ae ths gto form, ad they anonANNEX III DECLARATION We assume primary responsibilty and/or stewardship aver the product nate of ably, adverse events, o other publichealth safety sues avin from ts use, We apre 1 have exerted ot least misma! digence i ensuring that intellectual property rights ae observed We further agree nd ond curselves that he abel of he product shal tal times conform tothe labeling regulation, and shall ot be presente including any vertiementof he product ina manner that false, dacegtwe, misleading, or contr to public policy. Nor-observance of any of the Undertaings inthis declarations deemed misrepresentaton whch 2 ground for deapproval of this application of approved the suspension or cancelation ofthe peduct registration nation. Brand Name A; Wecateorcaly dca that data andnfermatin atmitedinconnscton weh ths apotestion a wellasotersubmision nthe Mae ing "ecoify tht we have sumioes te fog sateen and wees! tothe cerry nuts: 1. Theanached een cpr of lesdocuments/efernatio ths aplaton rth nc upset td copy a ny eee, ‘cepany, prev cater or wl msepresertatn on ony of he ete otal of pasion enor the Fig ‘Fiegl acon pein the underigned andr the cman, products anditnened 3 rode rec 3. te documentation afer tor ered ht plain eaelale freien daring an auctor a rpecon, | Anchangein fomultion labeling. tecnica spcteation, oan vation on any information gvenineapect ofthis pcan wi it have ob own, ested, andr pprved by he Food on ros Asmar WAIVER RESOURCES THE AUTHENTICITY OF AL THE MFORMATION AND OOCUMENTS SUBNATTED. sexwomencavet | mrss lho iit Philippines, personally appeared the following. | ae sel gag beret reel Uyreatane nae ame amitone ome 2) First 2 Mile 2 Family 2 ms noun tome ané ome nowt be these ptzns who ence he applet om ad ths dcaraton form, an thy aknowledge tome tate seiANNEX IV ‘ine the declan form for pharmaceutepofuct agitation the ook ané Dug Adminstration fhe Pilppine. DECLARATION We assume primar esponsibity and/or stewardship over the product in caze of labllty, adverse events or ether public heath & safety issues rising fom ts we, We ogre to have exerted at least minimal dlgence in ensuring that intellectual property rights ae observed We further agree ‘and bird cues thatthe label of the product shal at limes conform tothe labeling regulation, an shall ot be presented including any vertisement ofthe product na manner tat fale, decetive, misleading, or contrary to public moral pubic policy. Non-observance of any of the undertakingsin this declaration s deemed a misrepresentation whichis aground for dsapprval of ths application or, approved the suspension or cancellation ofthe product region, cond are the documents atdin the Chcit of eguramant for Regtaton sd representatives ‘Wecategorcaly dere ttl ate and infomation suited inconnecton with he appicaton at wel ‘wane are tue endcoet oat he tna eration nab, Weary tat ne have examined the alowing statements nd we ‘The fermaltion er donage armen areemant wth the master ermal and wah the batch manure recor fos. "ne manutictunne procedures exact aspect nthe maser formu and bath manutcuingr eer rod cored tha daaraton wnt undergo any cane in frmulton dosage for, rngh therapeu nation, manufactures, Imerfactring proces, bling or comers pesertation vithowt pr approval a the Food nd ig Admnstation. 5, Tachtanctat srengmateraisistereé or cars fev sczompaning crate basso ta bc) gn tefl specications inthe tecormpaming documentation nd fly compte wits hove pectin Cedi the cared eletene ofc monoah beer Rs tea or Imaufactrog purposes lattes actve pharmacetl maresen/ AP) te obtained rom the folowing sures: nena eit Asus 7 wobath five parmaceutal intent wilt ved ules copy fhe ath cerca etabed by the acbelngedent mana sed | tach atthofthe tune rot etre and cere (nan acormaring ceria of nas for tat batch piste fall pectin in ‘the accompanying documentation sn hy complnd wa the specetons ted nthe aed ference ofa mongeaph before bles fo 9, The person elening he proctor sls an authoriceandlor quate pein. 10. The procedures or entalofth frishd product have been vated for hs formulation, The assay meth has een vakdted or a0, precion specie nana 11. Themartetmuthoration holders astndard operating rece for handing averse eacn reper, implementation cea produc 12, Alte documentation refed tats ppcations avaliable for review ring an actor map. waiver {RESOURCES TMEAUTHENTITY OF AL THE NFORMATION AND OOCUMENTS SUBMITED. ACKNOWLEDGEMENT tines eon append te tig area entre Wdeofston Number ry Osteo ce sued 1) FirstName Midle Name Family Name (Crnereeazse-a8 sexi Seeity SNMEITHESE nag 2) First 2 Middle 2 Family 2 7 ‘om ome and tome nan ta be the se pions who meat the appa erm and ths Gearaton fom, an they ahnowldged ome Cathe Me