Council of Ministers Regulation to establish the Ethiopian Food, Medicine and Health Care Administration and Control Authority (No. 189/2010)

4oFolrA 'I :J&T :JILliJ FEDERAL NEGARIT GAZETA OF TilE FEDUo\L DF.:MOCRATIC REPUflLIC OF ETHIOPIA Ml.·ll.i':fl·l'>.' '1<,.~· •t:'t't: :/~ hPr,fl 11011 'itl,fl. .C', ·t··> Vt"i.H 'l 'I'' , mt.·}1All,·p .i.$../.·'I'P. JVI"Il/.·fl.f'l! tT-MJ1 l'ril'IHI ·f·(Oit\"1· 9"llC n.·}· m•H:'r)· f(l)fll to"' Year Nu ~I ADf)fS ABAUA 23"' 1\ugUSt 2010 ""1 0)· Gr.). t.'HI -/:'PC M·Ji·u/fii.Oi l'.'l;l·f'A·J' 1'9""/ill \'noY::>'t:)·<; I'm.'.' hflltll. lofl•f· .~.v.cr; of?'l"rc tlfiP't.l"n "?'~~:"'1 . .1' 1'"7.'tflrC':l·· l"'hC II.·)· .e. rll ....... 1(1 ?;71.?;.\t 1'"'1. 'U•."f·c:·:t· ?"he n.·l· .~: '}·n ~=·rc ?W·Ii'iii!Ui.!l Cb ,Z.I"A·t> f?""J-0 r CauY::>'t }'i yms hfl'llb M·f·P,f,C<; 1:'1"}'C rwu,:vrm 0"?•t:l'2" fm"l Y"'f't 0 i·C'{ f'hC wl· t:}-0 £Qt.'Tf;NTS Regulation No. 189 /2010 l:.thiopion Food, Medrcme and lleallh Care Adminislrution and Control Authority Es~Jblishmcnt Cuuncil of Ministers RegulatiOn ........ Paj,'C 5500 Council of Ministers Regulation No. 189/2010 COL';\'('11. OF ~m-15'1 ERS REGULA TIO'I TO ESTABLISH Til£ ETHIOPIAN FOOD, M£DICJNF, AND IIEALTII CARE ADMINIS1R.4TION AND CO'ITROI. AUTHORITY f"?).ii•}•C':l'· ?"hr. n.·)· l'>d·lk~·J' .I .. Ji .. I.·"'P. This Rcgula!ion is issued by the. Council of Mimstcrs P,,•l"ht·O.f'l! t1'·0fl.h llflt.l\"'1. IIIJ'Ir') /''tl"l'}<; pursuant 10 Article 5 and J4 of !he Defmilion of Power~ 1·"/<lC f\t7D(l/{l'} IIID"IW· II'I'J:· ·~·rc !i.~f.'ii/i:iJ.e@ (IWI'J': ~!'PI: '~J:f./!(i'i.h ),'}.l'.·f·'lii'ifl) l'.'H'/1 (i ')',<,' <iii! 'h'o' O?''"Hil a:o.l':-;>'d·<; I'm.<; hfi!JO. MNI.~.C'i ~:'I''I'C M''f:· •/!'rf~ Y,Y.?i'?i/!{(i.ll 1·1>1'1.' !{(:-it) ),<; :lt(li) un(lt.·l· i·U'} Y.'Hl l'.CD·'I':I;t:l:: /i. b"V'C Ct!/1 ,l',lJ .I'.' HI "\' 11:2·1'· II· ,1' \'?""/11! I' uuY.•;)'d·<; l'tOS h·OIJO. M·f'J~.I'.C'l ~:'I''I'C 'lfl/"'ll''l'l "'l'k~l"'i.Y l'"'!.'tOrC':l: ?"ilC O.·i· .~·t·O ¢'l'C liY·Irii/lli'i.ii" ·l"ilfloo fl.m·Nt ,e. :Y·'It\:: !:. ·l·C'}"'J. I':N\· ),'/IJ•(l fl,'\ •}·t:'l-2" I""U'011W)· IJtlll'~ llfl1"PC 011.11 Y. rll Ol·fl'l': /i) 11'1''1:" "''M· 1'?"'71Jl l'on.f:':>~.·)·•; rms tr·ntJn. M1··•t~:c'l oJ?•r•rc 11'1'1: op.•rr. ~~~WiN7i.~ 'tm· P) "?"'7·11 I "li'J,I';;~'d·"! "I'm,<; l)f\OI>·J'"! "\'Uh?"'i <ll\ou·J' I "1'111.'1 ·1':1:9"' /l'i "htlt\ n>.•rJl: IIHl\' !i l'·h'\"l'fm··, ·rCH" f.,E'.~fl· I rl "\'ou.e.--;>H· IUiun·J'" "'11\·l· 1\"l,'lfl IJI'ICD /,It/.1 I'""',(' {l(,. 'i'..<P Y.· \'·l·flmOl• 1·Cnolfl. o-'1·; f:t··l.flr oJJ!.?" 4-C"""· -kll't.'li'l ~m· 1 JJ•}~. (p ; I Unit Price 3.35 and Dulic> of th~ Exceu!ive Orgons of lhe Federal Democratic Republic of Ethiopia Proclamation No 4711:!005 (as amended by Proclamation No. 603/2008) and Article 2( 43) and 55( I) of the I ood, Med1cme and Healli1 Care Admnus~ration and Control Proclamation No 6611'2009 I. Short Title This Regulation may be ci!ed as rhe "Eihiopian Food. Medtcinc and Health Care AdmintSlrBtion and Comrol Authority Estnblisluncnt Council of Ministers Rcgulauon 1\o. 189t'2010". 2. l>ennition~ In !his Reglllntion unless the context otherwise n:qutrcs: 11 "Proclamauon" means the Food, Medicine and Health Care Adminislration and Control Proclam<~lion No. 66112009: 2/ the terms "ti>od", "medicine", "health professional", "med1cal practitiond', ·'beallh 111sti!uuon" and "Region" shall have the meaninj!$ ass1gned w !hem under Article 2 of the Proclamation; 31 "phannacy professional" means a pham•act>t, druggist or phannacy techmcian licensed by an appropria1e orgon; ~,:J(,.)• ;Jt1."1 7'.~1.<1! ii'i'i.?i Negarit Gazeta sooo1 chilot.wordpress.com http://chilot.wordpress.com "1'1.' (i7i.(;.~~ J,.JI.,/.·t.l 't;JI.·)· .:nL"l ~:'l'C :iii ~,h(l. ·.;:~ 4•') ~i'i.~ q,!>". 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Ot·t'l· M" .ell <'lA: .ehMA r on) 'lll"'l£JJ-'} ll<''iflt..'J.9" f'"'l.lJl. fl.t'l·~·· U;J<f! -I•"JflC'l·'} Yh'lar'i'A:: !1) IJt'I/"'AflJ't· Mll-.111. 11'<:' fU'11CD· hP'A ti)J'7 ·1''?11<· !lhll...t\ >.'?1111 IIIITar fllAA nl-JII;I. Oa>·hA'i t'l.t'l'l' ,e:fiiA:: 3. Establishme-nt If The Ethiopian Food. Mcdicim: and Health Care Administration and Control Authority (hereinafter lhe "Authority'') •s hereby established as an autonomous govemment office having its own legal personality. V The Authority shall be accountable to the Ministry. 4. Head Office The Authority shall have ils head office in Addis Ababa and may have branch offices e lsewhere, as may be necessary. 5. Objectives The objectives of the Authority shall be to protect the health of consumers by ensunng: I t food safety and quality; 2/ the safety, efficacy, quality and proper use of medicines; 3/ competence and ethics of health professionals, medica l practitioners and pharmacy professionals: 4/ the standard of health institutions; and 51 the hygiene and environmental health protection suitability for individual and community health. 6. Powers and Duties of the Authoritv i f The Authority shall have the powers and duties to: a) exercise the powers and duties provided under Article 4 of the Proclamation; b) collect service fees; c) own property, enter into contracts, sue and be sued in its own name; d) pcrfom1 other lawful activities as may be necessary for the attainment of its objectives. 21 The Authority may, where it fmds il necessary. delegate part of its powers and duttes to appropriate regional organs. chilot.wordpress.com http://chilot.wordpress.com M ~.0'/IJ t. 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Oonlf'} l'llt'IP'Afi'J'r"} 1'-'t-9>)"· ,eoot-A: J'fl·I·P,~· t-A:: !!I l'lLV 1\"}<f'?.' 'W·fl )o"HY." (?i) >•m:PI\,e >•'1,?'/C 'A'>~·I·mn·l' rr•;• :<pr, )\.et..tH·cr: u) OII.V .P.'}·rl ),'}of•?.' ~; 1'-t·oullh·l· to·'} \'{j(Jp•t\11)'1·'} p•f.\11)'}'1 -t·"JilC':f l"'t 1\,1.'. J'(l)·t\ l\ i ll) I' 6.,$!..&-t\ uoYJfl·t· t'lt.··l·"i":Y. V"l'} UDII'L ;J-'P. UDCif911'· ·l·h·h'l· nun'}'? p•·t· 0"'1.?..\':~· OIIQrl(,J' tn•IPL:I. 1''111 rf.ltiJ'I·'} wt-·1·1':)'. .e•l•'Pt.·A l )'{'H· llf.·t.·A ! n•) I'CJIJI"N'l~··} 1\oo;J·'I? I' P't- b•r.lt'<l rl:.!.'f· 1\ti,.:J:e:·-f. ll0 '1.'1.M:<- ,f'4'CIJA; fl./.. •I• .It'?" fil» t,. 1\,1.' • • f'Ol·t\A ! 7. Oreanization or the Authorit' The Authority shall hav<;. 1/ an Advisory Board; 21 a Director General and two Deputy Director Generals to be appomted by the government; and 3 · the necessary stao· 8. Members or the Advisory Board 1/ Members of the Advisory Board shall be designated by the Minister upon the nomination of the Director General Composition of the members shall be from a) associations of health profess1onals; b) higher education mstitutions; c) consumers associations; and d) other appropriate associations, institutions and professionals. 21 The Chairperson of rhc Advisory Board shall be designated fom1 among the members . 9. Duties and Responsibilities or the Advisorv Board The Advisory Board: 1/ shall advise the Authority in respect of policy and strategic matters; 2' may establish different technical committees as may be necessary; 3/ may adopt its own n1lcs of procedures . 10. Powers and Duties or the Director General II The Director General shall be the chief executive officer of the Authority and shall direct and administer the activiti~ of the Authority. 2/ Without prcjud1ct: 10 the generality of the provisions of sub-artic le ( l) o f this Article, the Director General shall: a) exercise the powers and duties of the Authority spec1ficd under Article 6 of thi~ Rcgulai!On, b) employ and administer personnel of the Authority in acconlancc with directives approved by the govcmmcnt following the basic principles of the federal c ivil service laws; c) prepare. and submit to the Ministry. annual plans and budgers of the Authority, and implement the same upon approval: chilot.wordpress.com = 'II, 1;1\.l;rr' ~J'./.·11 '1,H.·l· ,:>ILnJ -1:'1'1: Vh ),j,l\. •7. 4''1 i:ltj!' '1.?". fc:.knl l\egam<.iaz<U "" I , , .. AuguS1 !QIO Pafe 550' rll>) ll'tflr(.'I'Tt't· 0·1-.<.·l•.l'.(l ·/· II~·)·•; I' P-'t.· n·-,.. .~ . 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O"''J!,'l'CO·)· '1.11. 1·fl,I!.·F· m·llt.\ 'i \'·t·(lmcv· ?"ll·i·f.\ •pc; Jlf..t..h· t-r. fl'("j P.Y.t.ll-1·<;. l'•f•(llfl•;l·'} ·f'"/CJ(r;l. .1' h 'i lll• 'i t:l :: I~. I'C)Ot='Wll'z· og} l'•lfl /"f.\ "l'z· 01. ·I· OwT? p•·l· y,on Y.CJt.\: : Ir. I''L'111 on11711t ?ii llt\P't.\"l't· 1'-/·"J.fl·'i ·/·hhM' l'lf'z· 1''/. "/·0 <1'"1/'?·fl·/ · uoJ'11 ~.~~o~·:: ~I \' IJ(lp>f.\fll'r \"L '1·0 ctoll"/·11·)·<,· 1111·0 'th (I'J)t..:}'- O'P'im· >.J\.·1-C CV&9" 'P';a>· M. ·t·C 0"'/.M.oua>· >--'l·I·C: M'ion·lo .e.ont. uu&-fl·:: I!i. C1D1lt5 1Po:t M"'l(l:f·•VIlf OM':!'. •I:'I'C ti.~~·:tJ.i:!rf:iti ·hJ:ol:'ln l"tOlm· d} effect payments 10 accordance wi th the approved hudgct <1ncl wor~ plan of lh~ Authority; ~) represent the ,\uth<mly in all iL~ dealing' with third paruc~. I) prepare and ~ubmu to the Ministry the performance and fin3nciat reportS of the r\uthonty. J/ The Director Gcncrul may delegate part of Ius power~ and duties to the Ociluty Director Coenerals and employee> of the Authority to the extent necessary for the efficient performance of the Authority II. Powers and Duties ofDepul\' Director Generals 1/ The Deputy Director Cicncrats shall: <~} assis t the Oircctor General in planning. organi71ng. d1rccting anc.J coordinating the activities of the Authority; and c) perform other activities specifically assigned to them by the Director General. 21 The Deputy Director General who is specifically delega ted sh ~ll :tel o n behalf of the D1rcctor Geneml in h1~ •tbscnce . 12. Jludeet The budget of the Authority shall be allocated by the govcmmcnL IJ . Rook~ of Accounts II 1l1e Authority shall keep complete and accurate books of accounts. 2/ 'll1e books of accounts and other financial documents of the Authority shall be audited annually by the Aud1tor Gencml or by an auditor designated by him. 14. Transfer of Rights and Ohligations I he nghts and obligations of the Drug l'ou.l':;'•'l . .-,. llil·l·-'l.<'.C': •t'l"l'C fJI'I/"t.\lfl'} Administration and Control Aulhority established ou·O·)·'; '?f.'.,;t·fO'f- nttv .('.')•0 11111'1/"Aifl'l· under Proclamation No. 17611999 arc hereby ·1·<'\f.\t.'l't:l:: 1ransferrcd ~o the Authority I~. ,f.10= f"'l.&5M· 1,tl. IS. Effective Date .eu .<'.'}·0 nt..~t-t:l ~ :>t·l· ;Jtl.lfl :H·'I" hm"IO:I. •I•') '1'~9"C' l'll.<i f,lf'it.\:: ),P,,ll Mil ~,h(l. !:'!, •I•'} !li'iJI '}.9" tm llil tiS 'P. r~~.·'l-l"lt J' t..~&-1\'f .1\.'f"ht·(tf'P. t T·Ot\.h m~<'l.e "'1. ~.M·C Tlus Regulation shall enter into force on the date of publication in the Federal Negari t Gaueta. Done :11 Addis Ababa thi> 23'" day of August, 20 I 0. MELES ZENA WI PRIME MINISTER OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA chilot.wordpress.com