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.,ERATURA6: MENTERIKESItATM

REPUBUK:1.IDDII~JA

N'Ct _DR :HftD&~S!OJJDm011

D1FASIUTAS ,'ELAYAN'AII

K1fIIIAJIBAH'

.

MENGG'UNAICAH

KEIEHA:TAN' PEMBUrlrAH

o,ru:r 'GI!NatK

Nlenil:milJsrlg:::

a,

bahwa keteJsetUaJan gbat se_'rik ll:lahml ,j~umlalil (fall janm 'yangl cwrkup~terjanlkau ,oleYl Rumr.arat:ld ,CIlcBa 'edarnin ml1ttu dan kemMnmllil\YEJ, -flatlu df;eraltQ:n dian rJtr10rang 1';- 'l'gg~MM"iP,til 'fa$iUbis p '~aJl:MnI~Rtan 'pemerifnah;

.b. bahwaa.,pr pangl1un.lDfi- obaf :p:nBnk, dapaibe~\araf1 efek1if parlu lme,nlatur kemba~nltuan :r<e:waj(iba:R.MejlllunSJ~an :~eep dSlnl2tau MenggII nBkSJl1 Obal Gene~k til FuUit\as Pelayanan Klmmhamnl !Femedn,ta11 d:engan~l:m~ilJmnMlsnteri

:Keatmian;
111",,",,_,,

11M;N1i1g'

i-I .. R~gal,

: '1., Urldang~ndan,;- ObatKims (Sib. 1949 Nmmalr,'1'91~
'2. UM:~n.t-U'mdan',m Momor21' "'ra:P1wm ,2Jrllt4 'lelliMn:&t IP.r-aldik ~edDMenin l(~ll:aran Neg;ara Republl!l; I'ndo",e~$d, ahun T ,2004 rN'Q,mC,f 1181 'Tambahan L.emlbamnl Neg'lriI, Repub9'k l'ndtl'nfiSfa'NI~gr "11);

8., Ultdiang-Unimg Namar 32: llbm ,2:13', 't~'bu~g Pemlerintaban, DalFllh (lBmlaan Neg-ra RliJub-r- tru;;lfJnesia Tshuln .2D04 NQRJr121., "iambahml Ilsmtmmn NlegiltaJ IFi~pu1lUk ~l1ctDfl' - "'a N!lUIBIf ·4a1)IS_:lfmana ltebh diu'bilh dangan Und:u1g..Und;nqlllNom,ClIi 12 '~dhun .20:0.1: tantang

. Pem:Qbefum KedUI A_

ZlJD4 TSrKa"S :F!emerintltlan

Utna'IfJl~Undsng Namgl U Tahun

Rep,gtdik l'ndo'n'lsia "ia1'llu~n a001, :N'Dmor 591~ Tamb,ahiiul IAfnbaru IN!agma, RfIfl14b11ltlnd,DnBSEa,NmllQr,4Bt4);
"

Oaerah (le:mtarran

Negam

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I, 110

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~:m.r ,ali TMtlin 2DO'S' 'tentan:s IK&lel1iatan (.. Ala~Jil :N~lam lRepgjpRlc Ilnd';nllla 'J,' ",un 2001 Na'mDl' "44·" TaJrrllul'han llemt!a'm:n Negva, Repu'IJ!k ~Ing:£ue&la ""amer B'D6!~,::
U;ndan.~Unda!nm

fl. Undang,-U'nda-ng INCilTrcrr' M 'TBhun 201lS. ~ngl RlJmah ,satit ,(L.emb.anl .N,eg'- .~ R.J)utlr~· 18~USOneeiaTalnJ"1 ~:UlO9 lem........ '-.-~v-_._ "l"QOOpUu_ltn. 1.... ..1. '-e'...... "'""'f'll.; n,NOBEU:;il N·IOII:iIiiiUOlJ!l 15. 'T __ . _ n,....,~ ~'::,~, _:~._uaJ,.,.n Nr-'fti
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'1.. Plft!ul'BoP'iIn3dntah. 'Ra-ma'm" 32!'TBhuDl 11'. ten~.'I!n.1 'Tenaga I(us:h:9t6n (Lelltb:aran iN~'a!B: Re;Jublrk Jndones~a Ta,tM1 i1M N_0J1"tiW'1~:-mI:Iahanmlimm'l N.... T .R&pllbrlk,

IntJ.Qn'fJSit :N'olfl:cr:' aBm')~

8. Pmratu~alnl Pemetfntah NiDmICl'"
_11111,Tambahi371'1):

'(2

TabllllD,

11BI 1Entans

ip ~.';:gamarU1Jhl SaIl' ~ I~Btm';l· d -'n Aj'at. IKeft'llll1a1an 11 I,Lmnb,am:o, ,....-Isna ~pJbJiik rndeneala, 'll h.ulfiJ'19:91 N'aIno:r
.:ILfMlibBl'lft NfJ,ga~~''RepuJ:Ii: .'[Ildonesa, ,omor
NCfmClJ .'

g"

Pem.~an ,ljr~ 'P~[n9111 du Pl ~." 'mttah~· Da mil KabIJP'B,' ~nn<ataGLlmtJ:am11 ,MagiU.. IR'- :pubJik~ fni!:l.Dr'lJBSfa Dhun .10m NomoI" .Il. TamBatl 8'11 L -mbarnn INega.Fa ReJ:nf~Hk In4b.nulaNftmor 4787)1; .
c

P91bq~an UIiU$In

Peratulan

IPe:mrintBh,

f[-tllun

P8m,el1ntaftsn,
1

.AntaraPI.me~n!I:"~

2007

tentang

i

110. Ptmlturtan
IL......

IP.~:_n twarm.uan

I~emen:nmh NOBlC!r
6Uutll
~Aj!Ij

;111 ~ahunl 2()OI '~n1anlg ,(Lemib_rim N'eg1ara ReputlI1iJl;,
-

'N ;-:-- a R-pllJbnk.~nd!omieSra NcmJlDf 5 04il);: r
1

UUi.I'IJn8618

T'-'L ~tUlDI

10.11 . ~",Jiilmr ....i!'II>I I.oi.:.,

~ IlD'lli1mdUIi

11..-.....

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1Al'~IIWaran

1'1. Kep~n,

.I:irJlI'l"'li1tm1 '~NI

Nama, Qenerik, Palla
Sl:r trlcJ~OOI· . .,V ~.,t!'~'" .-- J'

f.~~___

m~ . r~OfT1I~I'. '. ~Ira -,,__ .. . odo_ U!u:;Ill1g: 1°...... '< b:rIIi lpi,e~. ~-~- ~. 'p·enmllil~'Uan ~n

Wented

iKeteh -tan

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31A ,I~amor.'...' D ill' 1._ ....1' .~111i1!ll'1!:1'!l'Iift.~
llill .

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na' 'felah dlubah

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.M,E_,U :O!lJAiftNJ

1:2. KeplilNlal1i

IMJlJnten KesBi1atEull

nlm(UJ8.""~.b~

_tl

ObBt asional;: N

INlontclli"

'S9IMenkeGlSII(I

13~ K"puklsan Menteri Kesuataflll INDmDr' 111IMlem~"sJSl<J VUrl2~OOB' terttln~DaftaF'Obat Esensfal Nal,i~;dltnJI: MBUllU'ElifCA;Nl :: IMenafapliarl : IPERAtiURA:NMEIlI&RI KelJEfl:kIAN:

MIENae:UN1AKAN' alAT BeJieRJk lIl,I'~AS:tUTASlPELAVANAN
PEMERJNTA-H"

II(ESEHATAil lWITANQ

KE_WAJIS~M

BAIl
K9ENTUAH UMUM

D~8jla.mP:eta'Wran IMenbud 101yang d~makSwdl denQan:

11. Obat Peten ;ad'"lah chat rangl maslh memHUd· at paten. h 12:. Ob~ Glene.rik ladslah abat, ,CI:eaQ,al"l nam-a aml ln~em.t1on81 Non ·Pro,plemty Na~ ,rlNNJ'yang dlte.Pfmn daiamFannakope rndGne8~--,,atau bUku :rtandali ra~nny:s:llilnifukat ~erid:1Jasiat yang dkarndmg:nya. 3~, JObst Gan.s,nk BamterallrlS·mamB ~;1Jn:9: ada.hm; ctmtlBrliB11k IdBftBan ~ha!1": }]I-; m8l'lluurBkUl nmnBl'miJllk pccd uSfH11 'C'J:JiEd yang: bSf'lUgFmfm\
1

nama

4,~ Ob.: Es~s!al adt.:l:1;$ lo~at teJJl'llih 'yang pdng d!bmuhkal1lu~kptavan'lm kete l1atan ball mss.ya'maat Rum~ U~I rtUapGSIs~,.Pirdll.k$J~il ·.;e,mpi: dM~8mantum;daJam Claftaf Obet lsensilaill,,"UlJl dfefaptanl tJhih ,M8!nte:ri. . ~
t

~e;,. f;ag it$s :P,e~~anlh Kes!ftatmJ ,adaralh SlIImu alal dMtatau tampa!: yaJriI d;:w:1Iamm Lj'rh-Ulic flJIerrnYelelllsmftarl Y"lnl p.e']S;yan&n, :keseJ:I:aial'll Dent
i

IP'fOnilG'gil

,rehl)~ml!StIlf ~g Pemerinltahl p;eRleJintM daeral\ ,danJa)au masyarakfd

:~rIVIlH\tif~ ku:ra,g "mau,llln,

1llaIWIkan .h

8.

~nsitaJasi',Farm:a:liIRumall SaNt adial\lh iJrlstala:l~rumahl ,Slkft yanEi mamp\II:nyaf 1U,gSI imenys·"_kin. menpl'~_::I mandi3bihlii.lshllll .Informal] dM'l1 le·yaJluils·· ltentarrg1 ,~~rd.,
~fl_IJU5~ moMer

'1. Do_r ,adah!h ,dO!def~ d~.kteJgjl~d~
kefarmasiian ,oliSJl ,~t~otfieif~

iil:i: ~e!;l1iatJs.

8. Ap:rJtek ,ad's,I!a:nlfaliUtas pelliyanan klfam1aJIan 1lmpm, dila'tdl:an I!,raktik,

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r-gnElU 'MlIBHI-tIT.'

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iINI1UNI~.

BAS II

rUGAle DAN KE¥ltYJl,EMN
P'i ,AI:.

'·n,BIan hI' fem!l11nmbi· menyediiakanl cb:at ~g;en_dk,Il[fttuk kabutuflSllI palian-rat, ,~u
,d&!am bntuk fonnulairittm.

fasUitlis

lP'el:a,anBmJ

dan rawat' map

DaaJilh

waJI:!

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IP.r, 1"'

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[I:ttkief

'm:el"1lult'Sl l~eSEIlp aba1: sens.fitk: Iball '~emua pssll!m -::_auai Ifttdlkal~':nnHlts'o)

'ranil bBitUgas

en fa_liltsa ~~~aql

r.t!Utiat!npcme'rintab wal!lb

'D·Gkfer dapa:t Imeftuiis, I!8G~PrI umuk d~i1 di All-__!( ata:u Idlil IllJal fa:siJirlaSi ai' li;e,..:~.;!11 . ,..._ pela,- !II;~- kesahaMn'. IdaJam In.. aDs'I: 18 s'tkse.!iti'1Ila~M>@Ia~· h IllI1iQ11!,Jiii!Il\,I!'IO! paw:a ·ra ~n .. .' '_ . - - - - '"'"tf - In uu ,. ,d~ ... a~ (,1)1 ~,lfakm_ilcsdJa Idl ,pI~&)1IlIan keu'Qamn..

'~mras
j'

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~-i _;J "' _ m_ ,ahr __ . _,_~_UIRIL;98--- ,e!I_ ~I, ... r~ n rElS_ ,1~U~c~ 8. ~r _wa.'ik -:--- J1- ,l~'li , ifJL...l •

..!tIl' EilL . , .iOi., 0" :'7"lI' seC! Fa U ~I!i.WlmB;n "",.,Inn .,' , --,IpefmUJ~BaJ11
'. - - . -

bfllrda;,a
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gunSt

,d. A De!rbasUluna,,,

pensadaan~ pe~pa-nanl, panrSistribu ian 'da_n pmantauan ,d[lumdmn, aslll. palaySl1'Fan kesslhDrfll~ f

-I'- Mi... f....- i - 'at· ~ a~. "' ~ ,',.I ,_ ~, L!iI, _-tr"'"~--_'bro- ,II, plilmleuu!r f"~lfDfi!li~Ii' BlI11\1I'tIJ 6, ... -. n!;li~'_ __ __.J'lU me'~,,~_::1II1a,~- -Ai

,00111 yangl

(11)

Dinas, K~'batan ,Pro,vinl~Dup~:b1 'WiJ]fl1 memhuat: pem:rm8JJ1Mn~ peng,a iifUl,., PKlJI'm;pansr:il, Ipmmyecl1unl~ 'paagata_nl ,den pcndlstribg5mn chat klpada puskUlmlllml peiayaAlln' kese.hmsJlI raJR..
1~lbm, saqalmafJ'aJ d1r'rUlksudpan Iden;g'M _Ienltan :peramanpel'Uliildan,rr-andmr:

(2:)

.,11::

(1') ,dlIa.• MaIIum

~Si!lJ'a~

.. n..

..

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MrEiN~mIIDIDltI:MI!Ii R,!PJ.:fIUJK INJXJNlrlJ.A

1~1i1~7

Apl~~ker dapat: mensganti obai: lmeNk: a~ag:'U'll1hbiat, p_en -n.gtaJn Qoat genenk·
y;u1gsam;a kcI~p'''ft8n IBkUfnya mau abat melek _an:g~B.I;n .. dQki:er d$1/_upM~lIn, . .

pede, 'lJlu:~nj

'Pla_1 B
Ccd\1er'lcI Ru'mah S:aikrt:a1auPuslHm:as clan UI11t-Pela'ks:an,aTekrl~ llralftll1.ya ,dapat :m,EH,,~tului pe~an~lian, ,obat ,glsnerik dengan t)b·at :9'eni.erlk: bile'FmfM':~erm ere~k:d~Bga.n;;1aH,Bm 'h,al '=lbat '91e:nem'l: 'taderl1u' ,:Dalum 'tel11il!Jfiil' • d

Ms",.

.AI:"[111'
P'EIMBJ'NMN' DAN' IP'!'I\I'IGAWASAN
P'_raliS
I

.

Pemllrintah~ P'emedn:tah ProvlFlI~lbupat.,nrK~

piE!:l"Isawasan

lpe~akai!lllaani PeratUI"M:

ma\$~Mg,-mUing.

nfll,em'ilkukan lpemblr1Bs.n danr ,M,ertI.tlu1~nj~.IIlJa:1 ,aengM iYg'iSlB darn ru,nss.~

Pall110
(1} Pm¥jn;l.i~Kabu,~alle!NKota, d~:at m~mbe:ri o - '. -"""-r'i1l'1ia~in'.. 1:;:~ClIi'II ~,.... u 'te4'li..t~~1 lbo~"'l'''''l..ta ITlo~r; ~ "'Ien . P~h~i_J!~ ~~ "i'!i!"i;!I ... nlt.~1 ~._N!I';l L -Ql.gs ~.-I:"I-.','.':.a:iI!iJ.~...GOII~"LilrGlill n!!ii'J""'l"Inll:a""U .' !i.,"". ~]mplnan", . pe:llayatmn ·~asBh.1n1 pilmetl1ntan ra'ng Mal:a'~lJkatll pelafllg§aniln 'b!:ma'_p ketentuan da~am p.,cm,1uran M'e'liI.ri ~nl ..
~_~i_ •.

P;em:.rlotah.~ Pemsdntah

i.,

• 1

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(2)

li.tuI9.,iman~. dJmabil!u:~pada, '1.pt ('1') ~iibsrl'£i:at1,pIling bairwafC ,~ {I'mll) ,•. Uclanl rgaJ:l!llllperiffgaf.an wrsetl'l ..t "ti"dlk r ,[r~aWh~. PamBrinrtatt den ~8DilBrilllitak [P·mu;:":,~·~?,!,:"'k.(.·.~·~"'"i'·-'~~·:_.11'. ',,-~ ..l.!J,a.paiIL -.Ip.;IF' ..... -_.. ~n,!!,g.~:~!;I1~up,"'j~~n!~~a: me~j:ambkan :131.1 admi'nii'l~mfl' kepega_lM kef/':e'a yang tU!rlilllnglkumn.
lI!i:5lit!l. abulJ 'tertl.dil
... ..... ··-1 . -, .....

Pa,nnlg,atan

BAI ~V
KEi,TEllfUAN P!NUiIJiP'

PII,al1:'
Padre ,sam ~Pje:ratJlJI~M':Menite1f KeSSniBmn ini lriuJlIai ~Bftu~ PerailJhJn M:enter.t Kesmhamn 'Namor IOe&'M:;f1I~!,EMl1!9'191_Iillan.g K~iiJib:anMe;nu'IEkafl ~a:ep·

danlalau:Meng,LlMJ<an

IPemenn·tah~. Uaabm dan· d'iny,atakB!fII tkt:akbsr!a:ku. (

Obat

Genemk: eill: Fa.IUitatsi

IPe~EWM;Bn

KftB..rdls:tan

5

I.M.Llm lim~lfi3.tl

,-- '1lI'EiU IW . I'MII

msngetahumya~ memer" hkan ,pengulrn*qan p&l'tdufa)l ini ditl:ngan pe:nempatann'lfIlld!il~amlBema Meaara.ft~w[ik :~nd.;'iln,a. .
Ag'ilf

ul.pcU'lirll

D~~tan

pads

'_aaJ

di J.rb1

1~·4 'Muad 2010

.. I

'~I:..u'M!l

SIiIJ!""JU!',,,,.ll..ill.·._alU ""~I'n,

.",nlbll .• rn. IADDU ~

IITI

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