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24 June 2011 FDA Circular No. 2011- 903 SUBJECT: PD 1856. |, Background/Rationale: Republic Act No. 3870 (as amended by PD 200 and further amended by PD 1858) otherwise known as “An Act Defining the Functions of the. U.P. Law Center, Providing for its Financing and for other Purposes" expressly mandates that: Section 4. In order to provide for the support of the U.P. Law Center and the University of the Philippines Law Complex, the additional amount of one percent(1%) of the filing fee imposed, but in no case lower than Twenty Pesos, in the case additional amount of one percent. by their respective clerks of court, or equivalent functionary, for each action or special proceeding filed therewith and for which the fees prescribed in the Rules of Court or in any statute or regulation as due and payable. For this purpose, “special proceeding” shall include any petition or application, Paper or document seeking official action to establish a status, @ right, privilege or particular fact or command the performance of a duty. Such additional amounts shall be receipted for as Part of a special fund to be known as the ‘Legal Research Fund,” and shall, upon collection, be immediately remitted to the University of the Philippines and deposited in a separate account in any authorized government depository bank in the name of the National Treasurer as Ex-Officio Treasurer of the U.P. under this Charter. Letter of Instructions No. 1182, issued on December 16, 1981 identified the Food and Drug Administration as one of those covered by Republic Act No. 3870 (as amended by PD 200 and further amended by PD 1856). A copy of LOI No. 1182 is attached to this Circular as Annex “A*, in compliance with the above provision, this Order is hereby issued concerning the collection of Legal Research Fee (LRF) for adherence of all concerned. Detaits: 1. In fine with the implementation of the above laws, the computation ~ of the Legal Research Fee for the University of the Philippines Law Center (UPLR Fee) shall be based on the schedule of fees and charges implemented by the FDA and assessed only and exclusively against the following applications/ transactions: 1. Fees for Licensing of Establishments regulated by FDA or any amendment thereto. 2. Fees for Registration and Notification of, or other Authorization for Products Regulated by FDA or any amendment thereto. 3. Cost of Laboratory Analysis. 4. Accreditation of Testing Laboratories Including Bioequivalence testing center. “§. Fees for appropriate Advertisements, — Promotions, ‘Sponsorships and/or other marketing activities. 6. Fees as may be imposed for Other Special Proceedings. 2. From the date of effectivity of this Circular, the Cashier Section of the Administrative Division of this Office, including the Bureau of Health Devices and Technology, is directed to immediately collect the LRF corresponding for each services enumerated in the list below and thereafter remit such fees without delay to the University of the Philippines (UP) following the procedure of remitting LRF established by UP. The said list may be revised from time to time. | free forLleensing of Establishments [Foe "URE Tota ooo) soon, yoo | {6 lotized Sal tiporers 40000 | 1000, s01000 |! zon00n)2n00_ |zoon00 | F : ' i eat 400000; 90.00! 303000 || 6.90000 160.00 _Ie060.00 | i i i Distributors: 30000 | s000| 303000 | 600000/5000 leoenen | _lnpute ores Vie oo 8. Drug Manufacturer | | i 1 i | | | | | t 8.1_20 Millon and below. 10,000.00 | 109.00! 10,100.00 | 2900000 20000 12,200.00| . } i i i Jj i oa T j-~82 oer 20utonuttebw sion | 00060 | 15200! 15, 15000 {2200000 30000 [3030000 t | i | i r ciel (eit i | 02 sii nd eb 20,000.00, | 200.00! 20,200.00 | | 40,000.00 (400.09 |ap 400.00 T t i (2 Dua Tragers: - Tt | | + Heat i | i | i i hb 9.1_20 Malian and below 300000 | 3000303000 800000 6000 eno | 100.00. | 9.2 over 20 Millon but below 50 Mition. - E | S_| 8.3 50 Miton and ebore 7,900.00 | __70.00| 7,070.00. wl : Cosmetic Manufacturers: | | 104 20 ion and ton 5,000.00 |. 1! 100.00 ss F ae =e _-| 10,000,004. 100.00 10,100.00 a | F | $03 50 Mion and above ‘saga ‘ss000| 15,8000 2000 [ansn000/ 11. Cosmetic Traders: 1 r i } 4 ‘1.4 20 Mion and below 30,00} 3090.00 2.00 |soeo00 | 18.2 vet 20 Millon fut below 50 Mion 11.3 50 Millon and shove | aimee aa 3.0000 | 300] 3000 | 00000 !en00 Igoano0 : (eae | + / 42.1 20 Mion and below it | | 4 122 ore 20Mibonbutbetows0Miion | 700n00 | 7990! 707000 |! 1490000) woo [4 14000! i 80 508, 2001 ae i") “Ti Renewal i See eee L 423 50 Mion and above 00000 | 100.00 ae |e 20,200.00) 4 1 ia 13. Medical Device Traders: Ee + i 13.4. 20 Millon and below. —cncssunch | 132 ot 20 Mion bu blow 80 Mion sooo | sao) 5.05000 | | pea sa "433 50 Min and above, {790000 | 70.00} 7,070.00 | | 14,000.00] 140.00 14,140.00 Ht [7 Food ilar {41.1 Millon and below 490000 | 10.00} 1,010.00 |} 200000 20.00 !20200 —. 1.2 oe Mn bat ow 5 Mn ti al aon | 143 San patton onion __ | 3an000 a go%00 || goonco|ena0 [6 osn00 i soma _ |__144 10 Mion but below 20 5,000.00. | $0.00; $,050.00 | { 10,000.00 | 100.00 | 10,100.00 [eee coeeecceerec mn 145 20Miaon but bow Soon | 14.00000 | t0n00] 10,000 || zn onnc0|200.00 {20 20000 in aati: | _ 14.8 50 Milian end above $5,000.00 | 150.00] 15,150.00 ee 300.00 | 30,300.00 | 45. Household Hazardous Substance | Manutscturars: | 45.2_over 1 Million but below 5 Millon 153 SMilion bt bet 10 ion “| 3.00000 | 30001 3.03000 || goonen|e0.0¢_ {e.cen.00 154 10Miionbutbelw 20 Mien _ | §.00900'| _s0.0|_ 5.05000 | | tconn,0| 10.0 10,100.00 155,20 ion bu below 50 Mon 10.0060 | 100.00 18.8 50 Milion and above 15,000.00 | 16 Chere snassias [16.1 Presi iepecton of Etbtshmenis |__ 182 Clearance fe inert Anibiois zon00 | _ 10.0 16.3 Amendment of {TO or Reesuance | 3,000.00 61 Reition or Deleon of Sources 16.5 CerticationyClearance for BOC | purpose and Donation cat O0.| 1000) 310.00 16.6 Change of Business Namal Adcrese a (oh Sumpter i oom |_10.001 319.00 B. PRODUCT REGISTRATION (Drage { i fd 1.1 New Drup/Monitored Release. 25.00000 co) 2000 Tp 4.2 Unbranded { 200000 nooo] 2,020.00 | |_7.500.00|75.00 i | 13 branded 01000 wa.00 || 19600 09| : i : i ia 2. Medical Devin fae 1 Sais) Samo ie 5 Dano Reagents 1 ssin00 | 1500} 151800 |} g00ut0|s000 [525000 ri pe 44 Category | 200.00 so 210.0, I 4,000.00 | 10.00. | 1,010.00 i A2 Category 2 | 2so0 | 1000! asnoo || 125000| 1250 |125250 I t t 4.3 Food Supplement 4,000.00 ‘ut 01000 | sooe0lsoo0_|sosnc0 1h, Extension of Monitored Release |. Compassionste Special Permit except drugs fo cancer HVIAIDS ond other |e trecering dsenes) 4} Reclassihcaton (Rx to OTC, OTC [to DRHR, : aad 84 Approval tx change ms paclagg eileen of pct dec (ex 7.8.5 Changeladdiion of brand name. 7.8.8 importation Clearance for Cinical i Tat _ {18 Cosmeies "7.9.1 Approval for product label claim Ln | i { i 0001 31000 || ‘AO 5032001 00] 151500, i 20.00] “2.6an00 20.007 2020.00 ae 60.0) 1600] 36000, [cracot 510.00 ont 510.0 sf000 mgr li i } iy 1.50000. | 1516.00, COVERAGE | NATIONAL CAPITAL REGION only or in CARTAL RESON oi More than one (1) regon but exchuting NCR Several * within [aseaeren _ t FAmiount of fees for sales promotions (except! — Hor dacount scheme type o promotion shed be| in accordance with the schedule enumersted| {hereunder or in accordance with geographical es which ah) Amount ot Prizes, Pano { 50,001.00 {ssogen0 sence | 1000] _ stam 450,001.00- - 300,000.00, 11,000.00, 40.00} 1,010.00 | 7 woo 1 5100000 2o0v0n'| 20001 zara | Eo : T | somnpoacn : sooo | 2000] sc000 Hoe S08 | som sooo] sex0mn i Peer ! | ern face sooo | to] yoo | Bete | som | nol soot | || oo + | soote | 10001 31000 || | This FDA Circular shall take effect after fifteen (15) days following its publication in a newspaper of national circulation and upon submission to the University of the Philippines Law Center. st E H. FAZO, M.D.; FPSECP A Director IV : M, Bulletin ~ Juty 4, 2044