Agriculture Minister Regulation No. 18/Permentan/OT.140/4/2009 stipulating terms and procedures for the issuance of Animal Medicine Business Permit

26A TERMS AND PROCEDURES FOR THE ISSUANCE OF ANIMAL MEDICINE BUSINESS PERMIT (Agriculture Minister Regulation No. 18jPermentan!OT.140/4/2009, dated April 8, 2009) WITHTHEBLESSING OFll1E ONEAND ONLY GOD, TIiEMlNISTER Of AGRIOJLltJRE, Considering: a. that with the issuance of Agriculture Minister Decision LetterNo. 324/Kpts{TN.120/4/1994, tenns and proce dures for the issuance of Animal Medidne Business Permithad beenstipulated; b. that dueto changes of the organization of the Depart ment of Agriculture, and with the stipulation of Gov ernment Regulation No. 38Year 2007concerning Divi sionof GovernmentAffairs betweenthe Government. Provindal Government, andRegency/City Government, it is necessary to reviewarrangements on termsand procedures on the issuance of Animal Medicine Busi ness Permit witha regulation of the Agriculture Minis ter; In viewof: 1. law No.6 Year 1967concernIng Main Provisions of Husbandry andAnimal Healttl(~tacute BookYear1967 No. 10,Supplement to R.I. Statute BookNo. 2824); 2. law No.8 Year 1999 (BNNo. 40:1.3pages .fA -3A etc) concerning Consumer Protection (Statute Book Year 1999 No. 42,SUpplement to R.I.statute Book No. 3821); 3. LawNo. 32Year 2004 (BN No. 7183pages1A-1.!A etc)conceming Regional Govemment (StatuteBook Year 2004No. 125, Supplement to R.t. Statute Book No.4437)j 4. Government Regulation No. 78 Year1992 concerning Animal Medicines (Statute Book Yea,. 1Q92 Nn. 129, SupplementtoR.I. statute BookNo. 3509); 5. Govemment Regulation No. 38 Year 2.007 concerning Division ofGovemmentAffairs betweenthe Covcmmcntj Buslncse New:> 7823-7924/6-17-2009 ProVincIal RegIonal Government, and Regency/city Government (StatuteBookYear2007No.82,Supple ment to R.I. Statute BookNo.4737); 6. Presidential DeereeNo.187/MYear 2004 (BNNo. 7128 pages30A-3tA)conceming Formation of Indonesia United Cabinet: 7. Presidential Regulation No.9Year 2005 (BNNo. 7182 pages 2A-23A)concerning Position, Mission, Func tions, Organizational Structure, and WorkProcedure of State Ministriesof the Republic of Indonesle, in con junctionwithPresidential Regulation No. 62Year 2005; 8. Presidential Regulation No. 10 Year 2005concerning OrganiZation UnitsandMissions of Echelon- I of State· MinistJieS ofthe RepUblic ofIndonesia; 9. Agriculture Minister Re]ulation No, 2gQ/Krt<;fOT 140/ 7/2005concerning Organization andWork Procedure of the Department of Agriculture, in connection with Agriculture Minister Regulation No. 11/Pcrmcnbnf m.14{Jj2/2007, andAgrtQJlture MinisterRegulation No. 22/PermentanjOC140/4/2008; 10. AgriCUltUre MinisterRegulation No. 341/Kpts/OT.140j 9!2DOS conremlng OrganiZation Accessories andWor1< Procedureof the Department ofAgrlcuJture, In con junctionwith Agriculture Minister Regulatlon No. 12/ Permentan/OT.I40/2/2007i DECIDES: Tostipulate : TERMS AND PROCEDURE ONTIiE ISSUANCE OF ANIMAL MEDlaNEBUgN~P~ CHAPTERl GENERAL PROVISIONS Artide 1 In this RegUlation, what is meant by: 1. Anim~1 ! •••• 1. Animal medicines are medicines particularly used for animals. 2. Animal Medicine Business Pennit is a statement in writing issued by the official having the authority to Indonesian citizens or business entities to earlY out business in the fieldof prodUctiOn, supply, circulation, importand/orexjX)lt ofanimal medicines. 3. Produdion Is an activity process In the processing, rrnxlng and/orchanging ofanimalmedicine raw mate rial to become animalmedicines. 4. SuPPlY is <2n activity process in the procurement, own ership, control, and/or storageof animal medicines in a place or room withthe purpose to be circulated. 5. CircuJaDon is an actiVity process related with trade, transportation and/or deliveryof animalrnedldnes, 6. Import of animal rnedldnes, hereinafter referredto as import., isa series of activitiesto import animal medi cines from overseas into the territOry of the Republic of Indonesia. 7. Exportof animal medicines, hereinafter referred to as export, is a series of activities to exportanimal medi cines overseas from the territory of the Republic of Indonesia. 8. Producers ofanimal medicines areIndonesian citizens or business. entities. petfonning business on the pro ductiOn, supply, and/ordrculatian r:J animal medicines. 9. Importersofanimal medicines areIndonesian citizens or buslness entities performing business on the import ofanimal medicines from overseas into the territory of theRepublic of Indonesia. 10. ExporleP.; IJfanimal medicines ere Indoueslen citizens or business entitiesperforming business onthe export of animal medicines overseas from the tenitoryof the RepUblic of Indonesia. 11. Distributors are Indonesian dtizens or business enti ties carryingout the supply ami/or drculation of ani mal medidnes from producers or importers. 12. Animal rnedidne depot or pet-shop, hereinafter re ferred to as depot, is a business unit performing busi Business News7.823-7824/6-17-2009 27A ness on the supplyand/or circulation ofanimalmOOi ones from distributors. 13.Animal medicine stores, hereinafter referred to as stores, arebusiness units performing business on the suPPlY and/or drruJationofanimal medidnesnttu;.r than strongdrugs. 14. Biological diagnostic substances arebiological prepa rations used to diagnose diseases on animals. 15. Head of the center is the Head of Permits andInvest mentcenter of the Department of Agriculture. lG. Service is the !3ge:ncy in charge of functlons 011 hus bandryand/or animal healthin a province or regency! city. ArliCle'l (1) This regulation is purported as a legal basis for the provision of permits and the pertormance of animal medidne business activities for governmentofficers and business performers. (2) Thisregulation has thefolloWing obje<liVes: a. to protect consumers from animal medicines not meeting requirements of quality, merit, and safety; b. to provide busineSS ~inty for Indonesian dti zens Of business entities to perform activities in th~ field of animal medicine bu~iness. C. to prevent the enttv andspread of contagious ani mal diseases. a-tAPfERII ISSUANCE OFANIMAl MEDICINE BUSINESS PERMIT Article3 (1) Animal mediCine business covers the followingactivi ties: a. production of animalmedicines; b. supply of animalmedidnes; c. circulation of animalmedicines; d. importofanimalmedicines fromoverseas; and/or e. exportofanimalmedidoes overseas. (,Z},Tba , (2) The animal medidne business referred to in paragraph (1) maybe performed by Indonesian citizens or.busi ness entities. Artid~4 (1) Animal medidne business permits are issued by the official having the authority to Indonesian citizens or bualncss entiti~s to perform business in the field of animal medidnes. (2) Issuanceof Animal MedidneBusiness Permit referred to ill pdldYlaph (1) rUi pn:xJuU::15, lmporters, and/or exportersis by the DirectorGeneral of Husbandry on behalfof the Agriculture Minister. (3) Issuanceof Animal MedidneBusiness Jo>ermit referred to in paragraph (1) for distributorsis by the Governor. (4) Issuanceof Animal Medicine Business Permitreferred to in paragraph (1) for depots and/or stores is by the Regent/Mayor. a-tAPTERm REQUIREMENTS OFANIMAL MEDIONE BUSINESS PERMIT Article6 In order toobtainAnimal Medicine Business Per mit, Indone$ian dti7Eln& or business entities mlJ~mf>f>t ad ministrative requirements andtechnical requirements. Article 7 The administrative requirements referred to in Article6, are as follows; 1. Producers of animalmedioneson biological, pharma ceutical, premlkand/ornaturalpreparations mustpos sess: a. Taxpayer Basic Number (NPWP ;:::: Nomor Pokok Wajib Pajak); b. Right of Building Use (HGB ;:::: HakGuna Bangunan); c. Business Location PermitLetter (STIU ;:::: SuratIzin Tempat Usaha); d. Nuisance ActPermit(H.O); Business News 7823-7824/6-17-2009 2M e. Company Registration Proof (rop ;:::: Tanda Buleti DaftarPerusahaan); f. Trade Business Permit letter (SIUP ;:::: Surat Izin Usaha Perdagangan); g~ Cithen Tt1f>ntification ("i1rdI Company Management Identificationcard; h. Approval letter onenvironmental management ef forts and monitoring effor1:$ (UKljUPL); i. Recommendation fromProvindaland Regency/City Heads of Service; and j. Recommendation from the local regional manage mentof Indonesia Animal Medicine Association and/ or central AnimalMedidneAssociation. 2. Importers must possess: a. Taxpayer Basic Number(NPWP); b. Rightof BUilding Use(HGB); c. Business Location PermitLetter(SITU); d. Nuisance Act Permit(H.O)i e. COmpany Registration Proof (TOP); f. TradeBusinessPermitLetter (SIUP); g. CitiZen Identitication Card/ Company Management Identiticatlon Card; h. Import Identification Number (API =Anglca Pengenal Import); i. RE!COOlmendation from Provindal andRegency/City Heads of Service of the location of the head office of the companyconcerned if the location of ware houses and office are In one province; j. Recommendationfrom Provincialand Regency/ City Headsof Servicefor Importers using ware houses outside of the locetlon of the head of fice; and k. Recommendation from the local regional manage mentof Indonesia Animal Medldne J\SSOC:IatlOI'l and/ or central AnimalMedicine Association. 3. Exporters mustpossess: a. Means I equipmentto carryout business activities; b. Taxpayer Basic Number(NPWP); c. Rightof Building Use (HGB); d. Business ...•• d. Business location permit/business location pennit letter (srru); e. Nuisance Actpermit (H.G); f. COmpany Registration Proofemp)j g. Trade Business PennitLetter(SlUP)j h. Citizen Identification Card/ Qmlpany Management Identification Card; i. Recommendation from Pmvinri<ll and Regency/City Heads afServiceof the locationof the head office of the company concerned if the location of ware houses and office are in one provlncej j. Recommendation from Provindal andRegency/City Heads of Service for exportersusingwarehouses outside ur the location of lts heall uffic.e; tmd k. Recommendation from thelocalregional manage mentof IndonesiaAnimal MedidneAssociation and/ or central Animal Medicine Association. 4. Distributors must possess: a. Means I equipmentto carry out business activities; b. Taxpayer Basic Number (NPWP); c. Right of Building Use (HGB); d. BUSinesslocatiOnPermitLetter (SUU}; e. NuisanceActPermit(HO); f. COmpany Registration Proof(TOP); g. Trade Business PermitLetter (SIUP); h. Recommendation from Provincial and RegencyjOty Heads of Service; i. Recommendation from the local regional manage mentofIndonesia Animal MediCine Assoc~tIon; j. Recommendation from Indonesia central Animal Medi9ne k,:)O(.idUun Ir there tile 110 Indonesia Ani mal Medidne Association in the area,; and k.. Appointment letter from the producer or importer. 5. Depotor Pet-shop of animal medidnes mustpossess: a. Means / equipment to cany out business activitiesj b. Taxpayer Basic Number (NPWP)i c. Business location permit/business location permit letter (SI11J); d. company RegiStration Proofi Business News 7823-7824/6-17-2009 29A e. Trade Business PermitLetter (51UP); and f. Recommendation from the local regional man agement of Indonesia AnimalMediciM! Associa tion; if there are no Animal Medicine Associa tion in the area, then the recommendation shall be issuedby Indonesia CentralAnimal Medicine Association. 6. StaNOs of anim<ll mer1icinee. must f'ln"-<;5<;~ a. Means I equipmentto carryout business activities; b. Taxpayer Basic Number(NPWP); c. BusinC$ location pennit/business location permit letter (STI1J); and d. Trade Business PermitLetter (SIUP). Artide6 The technical requirements referred to inArtide 5 are: 1. Producers of animalmedicine biological preparations, pharmaceutiCal, premiks and/or natural medicines, mustpossess: a. Factotyof animal medicines, means / equipment to calTY outbuslness activities; b. Quality testing IaboraCDrt andstorage iRresofarU malmedicines: c. Veterinarians and pharmacists working fun timeas technicalresponsibleparties. Producers notpossessing a factoryof animal medi cines may use the selVioa of other parties possess ingcertifICate on methodsof producing goodani malmediCines (CPOHB), and/or laboratory for test illg animal medlclne quality of other parlie5 hC:lving been accredited. 2. Importersof animalmedicines must possess: a. means / equipment to carry out business actiVI· ties; b. storage places of animal rnedidnes that can as surethemaintenance of quality;and c. veterinarians or pharmadsts working full time as technical responsible parties. 3. Exp!:H't§s .• ; L..O 3. Exporters of animal medicines must possess: e. means I equipment to carryoutbusiness activities; b. storage places of animal medicines that can as sure the maintenance of quality; c. veterinarians or pharmacists workina full time as technical responsible parties. 4. Distributors of animal medicines must possess: 3. storage placas: of animal medicines that can as sure the maintenance of quality; b. veterinarians or pharmacists working full time as techllia:l{ responsible parties. S. DepotorPet-shop of animalmedidnesmust possess: a. storage placesof animal medicines that can as sureme maintenance orquauty; b. veterinarians orphannacists wolidng notonfull time basis, or pharrnadst assistants workingfull time as technical responsible parties. 6. Stores of animal medicines must possess storage places to secure the quality,merit, andsafetyof ani malmedicines. a-tAP1CRIV PROCEDURE ON lliE ISSUANCE OF ANIMAL MEDIONE BUSINESS PERMIT ~8 (1) Application for Animal Medidne Business Permit as meant in Article4 paragraph (2) shallbe submitted to the Minister thru the I lead ofCcn~rwith copk:s to the Director General of Husbandry, usingModel-l form. (2) Mer receMng theapplication refetredto in paragraph (1), HeadOfthe center shall WIthin a penoo of nolater thanthree(3) work daysaccounted for from receiving the application letter, immediately give an answer whether It is accepted, postponed or rejected. Artide9 (1) An appUcation.shall be accepted as referred to in Ar~ tide 8 paragraph (2) if it meetsthe administrative re~ auirements referredto in Article6. Business News 7823-7824f()';17~2009 3DA (2) An application shall be postponed as referred to in Article 8 paragraph (2) if there are still some short ages of the administrative requirements referredto in paragraph (1), which must be equipped and notified to the aooncant by the Headof the Center in writing usingModel-2form. (3) Within a periOd of no later than five (5) work days accounted for from receiving the notification referred to in paragraph (2), the applicant musthave completed theshortages of requirements. (4) ffwithin the period referred to in paragraph (3) the: applicantdid not complete the shortage of theadmin istrativerequirements, the application will be deemed asbeIng wlthdrawn. (5) An application shall-be rejected as referred to in Article 8 paragraph (2) if the administrative re quirements referred to in paragraph (1) are not correct. (6) Rejection of the application referred to in paragraph (5) shall be notifiedto the applicantby the Head of the Centeraccompaniedwith reasons for the rejectionin writing, usingModel~3 form. Article 10 An applicationhavingmet the administratiVe re quirements meant in ArtIcle9 paragraph (1) shallbesub mittedto the Director General of Husbandfy by theHead of the Center to be studied as of the fulfillment of its technical requirements. ArUdt: 11 (1) After receiving the application from the Head Of the center meant in Article lOt the Director General of Husbandryshall perform a stUdy on the teel1mcal re~ qulrements. (2) In the perfoImance of thetechnical study, the Director General of Husbandry, within a periodof no later than 20 (twenty) work days, must have provkled an an swer: accepted, or rejected. Artide 13..... ArtiOO13 (1) Anapplication shall be accepted as referred to in Ar ticle 11 paragraph (2), if it meets the technical re quirements meant inArticle7. (2) For an application that is accepted as referred to in paragraph (1), a business permit will be Issued in the fonn ofa decision of the Agriculture Minister signed by the Director General of Husbandry on behalf of the Agriculture Ministerasshownin Model-4 form. (3) Thedecision referredto in paragraph (2) shallbe de livered to the applicant thru theHead of theCenter. (4) The business permit referredto in oaraoraph (2) re mains in forcefor the duration the permit holderstill carryonactivities. Article 14 (1) Anapplication shan be rejected as referredto in Ar tide 11 p.'Jragraph (2) jf thP l1>rhnJr.aJ lPQujr~J1lPnh;; meant in Article7 are not met. (2) Rejection of anapplication asreferredto in paragraph (1) will be given by the Director General of Husbandry to the applicant accompanied with reasons in writing thru theHeadof the (enter. Article 15 (1) Individuals or business entities intending to expand business activities must hove on expension pennit. (2) Theexpansion permit referredto in paragraph (1) can beobtained in accordance with the termsand proce dure referred to In Chapte~mand 'N. Artide16 .,he expansion of busJness meant In ArtiCle 15 covers: a. expansion of animalmedidnebusiness as producer in the form of addingproduction units in other places or locations; and/or b. expansion ofanimal medicine business asproducer in the form of adding the numberof production means, adding the typesof animalmedicines produced. Business News 7823-7824/6-17-2009 31A Article 17 Holders of Animal Medicine Business Permit re ferred to in Artkle 13 paragraph (2) areobliged to submit reports periodically oncein everythree (3) monthson its business activities to the Director General of Husbandry thru the Head of thecenter. Article 18 A permit holder intending tomove Its location must notify inWriting to the party issuing the pennit. Article 19 (1) The business permit referred to in Artide 13 para graph (2) may be transferred after receiving an ap provalof the party issuina the permit, (2) The transfer referred to in paragraph (1) shallbe per fanned in acoordance with applieable legislations. Artide 20 Holders of Animal Medicine Business Permit re ferred to in Article 13 paragraph (2) are obliged to submit reports periOOically once inevery three (3) monthson its business a.ctivities to the DirectorGeneral of Husbandry thru the Head of the Center. CHAPTER V RLVOCAl1ON or ANIMALMEDl~E DUSINESS PERMIT Article 21 A business permit will berevoked if: a. Ills proved thallt has no mcmpower responsible on technicalities; b. in a period of one (1) year after the issuance of the Animal Medidne BUSiness Permit, no acrMttes were performed; c. it is proved that It produced, supplied and/or circulated animalmedidnesillegally; d. location of the animalmedicinebusiness was removed withoutthe approval of the party issuing the permit; e. transferred the business permit without a written ap proval from the party issuing the permit; f. did not..... f.dld not meet the provisions set forth in the business permit; g. did not makeany reportOn activities in succession in a period of one(1) year; Artlde 22 (I) ReYocationofAninat MedicineBusiness PemHtasmeant inArticle21 lettera, letter b,or letter g shall be made aftergivingawaming in writingthree(3) timesin suc cession withan interval of 50 (fifty) workdays respec tivey,were not heededby thepermitholder. (2) Revocatk¥l ofAnimaJ Medidne Business Pent1it referred to in paragraph (1) shall be made in the form of a decision of theAgriculture Ministersigned bythe Di rector General on behalfof the Ministeras shown in Model-5 form. 32A No. 324/Kpts{TN.120/4/94 concerning Tenns and Procec/ures for ltle Issuance Of Animal MeC1rcine BUSi ness Permit. (2) Animal Medicine Business Permits already issued be fore the stipulation of this regulation is dedared asstill applicable, however must beconformed to this regu lation. 0tAPTER VIII ODSING Artide25 Withthe stipulation of this regulation, Agriculture Minister Decision LetterNo.: 324/Kpt5/TN.120/4/94 con cerning Terms and Procedures onthe Issuance ofAnimal Medicine- BusinP-ss Permit, i~ revnk:PC1 and cWJared ac; nnt in effect. CHAPTER VI on-tERPROVISIONS Article 23 Forthe purpose of protecting the national inter est} andto assist the taCkling of animaldiseases Inother countries, the production of biological preparations where in its isolate parentspecies arenot available in Indonesia, it canbeproduced underseparate requirements and must meetahighbiological safety level. a-tAPTERVll TRANSmONAL PROVISIONS Article 24 (1) Application for Animal Medicine Business Permit being under process before the stipulation of this regulation shall be performed in accnrdMcp with provisions of Agriculture Minister Decision Letter Business News 7823-7824/6-17-2009 Article 26 This regulation oommences torome lDeffedfrom thedateof stipulation. FOr pUblIC cognizance, [hIS Agncultute MlnlStet RegUlation shall be announced in the State Gazette of the Republic of Indonesia. stipulated in Jakarta On April8, 2009 AGRIOJlnJRE MINISTER, sgd. ANTON APRIYANTONO ===={0 )===