Food, Medicine and Health Care Administration and Control Council of Ministers Regulation No. 299/2013

\' h.+!'f'l f ~Y.t.t\'e ,1t'l"n,HI.Y'e tT·OIt.h 4o~t-A ";1&:'" ;Jttt1l FEDERAL NEGARIT GAZETTE OF THE FEDERAL DEMOCRATIC REPUllLlC OF ETHIOPIA ..... ------ .. -, If yr,:. ,}uo'1' ·r.'1'C ni ' ""~h hOli ..,·c X); '~'} Mn .• 'l.?"' . 111'.'1'\"1\'$' t..J.Pl'e 'l.'/oht.(I.!"E tT·llII.h r;h1111 -!-roIll')'· 9"hC fl..). m~1!'r)' flO"! 2QU, Year No. 11 ADDIS .. \ BABA 14'· January, 2014 "'I(JJ-""I. n·o ,r.'T'C ~f1iil~iU 't.9" f9"'?111 f "".1:';)\ .• ).'0 fmS hl1~f\. M ·'·.o;J'.C'i </!'T''T' f"'l.'l.Il-rC')' 9"hC 0.·)' nO ................... 1tl titHifr f.."'I.'L!rl:C']~~IIC;lkl:J\~I·O' . 1L'J'c...f.ell1{il!.1 hil9"'?l1 T an!':2).:C'! fl1.'U't..I1'JJl) ,M'IY.C'i 4t'T''T'C fro"lI''''l.'!.lltC'f 9"hC .n.t . f.111 .Y"'l. ... hrCO)·· 9"hC n.·r Yh.,rl"l\·Y t"y.t-~'f -'\.'1"h &.(LY'e tTl1l\.h Mt.1"'l. 1."<\')") I~A"l'!'i 1''?~C "'""'''''''1>. ",lldDlDfI 'I IlIll"llD' h'/' J': 1,'T'C XY.'lli/fo.r I. '!4'l\" I'i h'i ' 09"'111' ooj(>;)). ,).~. mS "·Ol,fl. 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V"'I.4·Cl1 9""J·fl V"'I.yuoC·)· .,.*9" )(0. r 11,9" IjV~ 'l? 9""}M"1 f"'l.YH,?~; 'T' ;/,,/>')<; 1.)1\,,'''' ·"";"~'h hj'.Q;\.9"C9"' n.o;· '1';> Unit Price 14.60 CONTENTS Regulation No ,299/2013 Food, Medicine and Health Care Administration and Control Council of Ministers Regulation ............. ........ ... ... Page 71.83, COUNCIL OF MINISTERS REGULA TlON No.29911013 COUNCIL OF MINISTERS REGULATIONS TO PROVIDE FOR FOOD. MEDICINE AND HEALTH CARE ADMINISTRATION AND CONTROL This Regulation is issued by the Council of Ministers pursuant to Article 5 of the Definition of Powers and Duties of the Executive Organs of the Federal Democratic RepUblic of Ethiopia Proclamation No. 69 112010 and Article 55(1) of the Food. Medicine and Health Care Administration and Control Proclamation No. 661 t:!009. I. Short Title PART ONE GENERAL This Regulation may be cited as the <;Food, M~dicine and Health Care Administration and Control Council of Ministers Regulation No. 299/2013". 2. Definitions In this Regulation unless the context otherwise requires: 1/ "Proclamat ion" means the Food, Medicine and Health Care Administration and Control Proclamation No. 661 /2009; 21 "food" means, without prejudice to the definition provided under Article 2 (I) of the Proclamation. a product that is produced by food manufacturer for more than one regional state or foreign markets. 31 "food manufacturer" means a manufac turer producing food intended to sale for marc than one reg ional stille or foreign markets, excluding micro and small enterprises en gaged in the preparation of traditional foods; );>t·)· ;>1b"1 T."f.</! 1!'i·i. ii Negari! Gaze!a P.O,box 80.001 ---'- ,, - .... -- ... / / m :t7ltitjf'g t..1.(,·{;\ ~.'t'l· : JILI1l {~'l'C It! '1'C X:( ·V) ~i"U~ 'lo9". Federal Nt:g:':lri tGazeuc No. II 24111 Jallllary.20 14 P;lg-f' 71 fO I "".c .. ===r= iii "1'9"''}'O J:!J·n·)·" a~.H· 9""HII un'}1J(; nfl~7u/ .. )-; W'"W,:J»:,).r O"'lh"'l;I'-)'<; OU7'Flli lI-tm;l·"'I. 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II.(Il-A 1'G'j, :Y'A I'M'P')- 'I''I'? ~(Il- I 41 l~ fGod sa fety" means the proo r , ~:l d control o f food that is safe for use in the process of delivering food to the consumer Ihrough proper manufacturing, preparation, handl ing, storage and transportation; 51 "food irradiation" means the process of exposing. food to radkuion energy to kill harmful bacteria and other organisms to extend shelf-life; 61 "potentially hazardous food" mcans food exposed 10 or capable of support ing the growth of disease-causing microorg3nisms or the production of toxins ; 71 "pre-packed food" means food ,hat was already packed by the manufacturer before reaching the seller; 81 "food supplement" means a type of food' that supplement the normal diet and which is a concentrated source of vitamin, mineral or other substance with a nutritional or physiological effect, alone or in ' combination, designed to be taken in measured small quantities and is prepared in capsule. pill , powder, liquid, drops or any other similar forms; 91 "infant formula" means milk or milk-like product of animal or vegetable origin formulated industrially in accordance with the appropriate standard for infant formula and intended to satisfy the nutritional requirements of infants starting from birth and during the first six months; 101 "follow-up formula" means a milk or milk-like product of animal or vegetable origin formulated industrially in accordance with the appropriate standard for follow-up formula and marketed or otherwise represented as suitable for feeding infants and young children older than six months of age; II I "complementary food" means any food processed in du~trially. sui table as a complement to breast milk. infant formula or follow-up formula when it become insufficient to satisfy the nutritional requirement of the infant. 121 "genetically modified food" means meat and edible plants modified through genetic engineering; Ii.'/ "I'I,AI'('\ Ullm'!''' 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'};J-f!,T' "'1M, II!l:'}7''''i' 1'1\1\&, 07i;J 1'.?Am'l'A 1Df!,7" OO7i;J-(I)O "'f!,II'1'tI "'1111(1)0 l''''I.mllll';' IIP''f'') Mh.l.??'!' !l:lll 0'''''1' n;J- h '}.<\, 4' ~ "'I !l: L."I ~ (1)0 I Federal NcgaritGazene No.!l 24th January, 2014 P:Igc 7185 13/ "alcoholic beverage" means any beverage containing alcohol, whatever its strength; 141 "sell" means to offer, advertise, keep, store. display, or deliver for sale or to exchange "food, medicine or tobacco product in any manner for consideration; 151 "certificate of pharmaceutical product" means a document issued by the Authority or the manufacturer country regulatory body confirming that the medicine is manufactured by a licensed manufacturer; 161 "good manufacturing practice" means the basic principles which any food or medicine manufacturer should consistently comply with in manufacturing safe and quality food or safe, efficacious and quality medicine; 171 "complimentary or alternative medicine" means a raw or partially or fully processed product which is neither indigenous traditional medicine nor associated with modem medicine; 181 "dangerous chemical" means a chemical that can cause severe injury to human health if not cautiously kept or utilized and categorized as dangerous by the Authority; 191 "hazardous waste" means any waste deleterious to human health and that cannot be recycled; 201 "recyclable waste" means liquid waste that could be treated to avoid injury to human health or waste that could be transformed into usable thing through various mechanisms; 211 "frontier port" means· international airport, controlling station at border or dry port designated by the competent body; 221 "communicable disease" means disease that can cause major epidemics by spreading rapidly; 231 "quarantine" means separation of persons who are suspected to be exposed or infected with emergent communicable disease until the infection is confirmed; • .~ -- ~=== !'ig/ "t'l.e·f· "'NI l")'" "'11\')' 0'/''1'1&, 07i;J' f'l" J'II t'lw· o7i;)' <II") ro.l'.t\.I1":): IlfDT ).')-'l)'ll'l·'Itllj: M'mM liL Il-flfm· '/·il,l'.-f· )'lltfJ.', "'1.1';(."1 'lCD- ; ?if;/ "f"'l'l'l'lf ~,')1·1j"!-7i" "'Ill')' Yh(Jl-C'T'I1 wY,'l" f~(l·C 11'[ 'k') roY.'l" filA "'I"r(Jl-'l" "'I'l'I1 r 1,'H'I,,!-7i ~m'l ti! 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"1''l''''111 ''''1:9"'' "'1t'I.). 0,,'I'jl: ,,'14')\' r(M) ODIPI.·)· l''l''''111 1"1.1';') l''''1.J'h''rD-·) 'hl:'l" If':' 1''l''''111 ':('C1'C'1 hY,Q;l.9"C'l" I Federal Ncgarit G<l.7.ctte No. II 2-l'h bUlJJr~'. ~0 14 Pat:l.: 7 J lS6 241 " isolation" means scp;::.ration o f;J person who is infected with communic;)ble di sease for certain period so that he may not tr:m smit the di':;cJsc-to other persons; 25/ "conveyance 9Pcrator" means airplane or trai;l captain or the driver of any other operator of conveyance; 261 "health professiona l" means a person registered as a health professional by the appropriate organ to protect human health or provide health services and includes complementary or alternative medicine practitioner; 271 "health service" means a service provided by a health professional as per the type and scope of practice permitted by law: 28/ "insumciently available health professionals" means health professionals regarded as insumciently available by the Ministry of Health where the national demand remains unfulfilled; 29/ lIimpairment" means a mental or physical condition which reduces the competence or judgment of a health professional in performing his professional duties; 30/ "mental disorder" means a disorder of thought. perception, feeling or behaviour that seriously impairs a person's Judgment. capacity to recognise reality, ability to associate with others or ability to meet the ordinary demands of life, in respect of which treatment is advisable; 311 "unprofessional conduct" means the conduct of a health professional contrary .to professional ethics or obligations stipulated in the Proclamation, this Regulation or other relevant law or standards; 32/ "client" means a patient or user who establishes contractual or otherwise relationship with a health professional to obtain health service for himself or for a third party; 33/ "inst itution" means health or complementary or altemat ive medicine service institution or food establ ishment; 34/ "food establishment" means all estab lishment undenaking food trade in accordance with Ankle 2(2) of the Proclamat ion. but does not include food retail trade; .. , .... , ' , ...... - 07;f . "9""/-/1 "'il.:lft':-" "'1M, "'rl'i'(1l'9U 9"'?O') 0"'19" L.-r· i fl"'I,),,·ufllr (M!.?" O{/tJl\tJ 'I"})'; I'I/'. (!l'I'I'I' !I9'''''} .:IC ')hh, Nl(1)o (1(1)0 ~£D'l 0'!f "9"'7f1 "'IflA1."l" "'It.:;. O"~unL.M· (Jl~9" O"'lUOUlIJ. r- f'<lll'l ~ tJ't:tI l'a'l.;J'~-) 1'1,')'; (Jl~9" r·nt:· 'I'I'L. 9""I£l1' 1>'I'd''I /lonh'ltJA (1l~9" /I"'111(Jl7)'; I, 'IS'; w~9" hlU' 'Ol)~ '1'1' L. ~1C:r·') 09"'7f1 (1)oil'1' ou/Xl,ouC ',(1)0 I ifJ'j,/ "111.'1" OM-c' nr,7i;J- hl\ov.l'1t WM" ... lJA 1''<;'/'<;' Nlovlf') -or <'l~ln N"l'l I'hlJtI rM9"C'1 l''''IUfll,.,/? J.u')'j')· ~(1)0 I "I'UJ'.(Jl')· {hJ'.(Jl-)"} hJ':'} S';')I'/'<;' uI,9"'1" ~,~:> r,f!. 1''''1. 'I'tI 07i;r 1''<;-)- 'I.:Imov(1)o Von9"'/':;: Ou~o'i' rutJ9"'i' MA'7I1-')' Mh.n:'; ~'L.I'I 0"'1')';'(1)09" iI(1)o W~9" ooilL.;r'f? I' (hY./V-)· h)';') )';')1"'''' (htJ9"'1 Oilllm', ilor f'"/.iI'I' 1,1A '7/1--)' ',or I iiJii/ "1'.I1:'I1't'i' ;htJ9"'1 MA'7(\· ')·" "'1(\-). h"l'<;&. h'i' ;hf!./V-)·') M.:I 'If!. 1''''1.'1'A W~9" II"of: I'm'i' l'7C ro~ . .rOP"l 07i;J' (1).1'.9" '/-.<;-). ".:Imon(1)o Uou9"-/'<;'Om'i' -,.,1:"'1-)' (1l'1l'l' Om'i' IlMa.y 1''''I,c"\'1' rutJ9"'i' ~11A'7I1-')' ~(1)0 I ':'if "(hfll.-1'Pll" "'Ill-)' \"/',!,M'. h'I"-)' I'tfH'-} M"IIC i iI.·c IIC i l'iI.'L·'i' l'aJ'}~ HC "'Ioo'J""LP'l'J I 7iA h 'J ..... (}O9" 01.9" M" tV:,>,)· 1''''1.WIV;. 1.9""" 1'1.9" "''1' I' P''f'l f),('.Q;J,9"C hc"\(1)o~7' I'h'IA h~lI-l 1''''1,(J}(lo'l. O:'>Cl\' I Of!.I1-)·" flo/''7IlC -I'ov""~ rtf'1 rU'!'ll llflll'O ~(1)0 I {filii '''):'>iI ,,'M" "'1/1')' Mf'· '1'1<; r;lltJ9"~' H~ O{hf!./V-)· '11'1 /V,('.9" ;t.,eaH ',iI&' c"\w, I'-NI1c"\') fMtI 1,'I=tI wy.9" ;'>11L.-1'1'1'I Oou(1)oil.l1: 1';r'I"'1.'I OO7i;r I"/'m:l' rof.9" Oh'71l0' on1.n'" -/-'7IJ{',} 1'°1.1'h~·ro·-) I'''''IA h~A wJ',9" ,hfll-1'1'1'I "",/",,). ~al'l ~jll.l "illl~ (\t·o "·'·'PM'· · UlIY""" "'1M, I'W-»';') I'IIC ~:~ flo/' t. '1'C' h"'1.;r(lI</,(1)o 111. Mill' ooAh· (JlY. iI.:J: (lIol\fll'f \'00/' ·0 . .1' hll"')' /I(Jl/l . .I1: ~""'1 "'1{l'/',,/I<,: i'l.tf'l O·/'IXl."'1tyo 1'(Jl-»'; 1>'i' l'iI.')' IIC '1'Y"l')' (1)om')'-) IIi:: h-/"lJJiI.I'.(1)o "'1,n?') (1)01'1'1' /I"'1I'1-/-'IM: hiI(Jl·~-)· hilA (Jl.r.b1. I'm-).\'; l,~' l'iI. ')' IIC') "'1</,'I</,A ') Y-(.!.\.9" /,. tu ~m ..... h'l. •.. e" "'1M' Y°'7-0 mf!.9" ao.'{,· 'd''J II ... '})'; IrAA lillY, II"'1M·t.A p/.. II~ Federal Ncgarit GJzette No, I I 24'j, Janu:1ry , 20 1:t PJ.ge 7187 351 "food handler" means any person involved in food manu facture, import or export trade activity having contact with the food; 361 "food forti fication" means (he addi tion of one or more micronutrients to a food to prevent or correct a demonstrated de fic iency o'f one or more nutrients in the general population or. specific population group; 371 "health"' means a state of complete physical, social, mental wellbeing and not merely the absence of disease or infirmity; 381 "life saving emergency treatment" means a service provided by any person or trained professional 10 a patient who has encountered imminent and life threatening disease or injury until Ihe palient has got access to regular health care services; 39/ "emergency medical treatment" means a medical treatment provided in health institution by a health professional to a patient who has encountered disease or injury which could result in imminent and life threatening or pennanent health problem; 401 "tissue"' means collection of cells typical in structure, composition and function that are taken from organs excluding reproductive organs such as male and female reproductive organs, testosterone and progesterone, fetus and blood or blood products taken during blood donation; 411 "transplantation" means substituting, through surgery, a patient' s infected organ or tissue or that which is unable to perfonn its normal function by donated organ or tissue from a living or dead person; 421 "artificial reproduction service" means the introduction of semen into a female's vagina or oviduct for the purpose of fertilization by means other than the natural way and includes uniting spenn and egg cells externally with a view to introduce the fenilized sperm and egg into such female's reproduclive organ; 431 "distributor" means a person who distributes food or medicine products in more than one regional state; IJ~'" INI7 1'9"'7j)'i'~~.I'.'~LM'tllf.C'l 'II'l"!,C 9"06-'1: h').I'.' \T''''Ifl .r.JW7-'!. ~6-:t h?d~'ra! NcgaritUazcltc No. I I 2·1'10 J;mu;w-,", ~(il 4 Page 71!S8 44i "Authori ty" means the I:lhiopinll Food, Medi::ine and I-Iealth C:!re ;\dmin j~lrat ion and Conlrol Authority; 45/ other definitions provided under Artide 2 of the Proclamat ion shall be "pp lic;'h l ~. PART TWO FOOD AND MEf>IClNE ADMINISTRATION AND CONTORL CHAPTFRONE FOOD SAFETY AND OUALITY "'I'i'l'arr lim,'; '/'1)0'1"'1. YtllJ'~ (lJg.9" '/-7fl.ar') V.I'. v'n')'" '1' t·')· .1'.01 Y tlmtH 9""I·fl il.no/.'l· ; 3, General ro.r. h1C m·il'!' il,7fP m.l'. (lJ'''1'' h1C il/I)I' il.h"·(f· i II.M.t. A ; 11.'1'11/ aJ)'.9" il7i.P"1" my.?" IIVfll.·/·lIfl· 'l'T?n 1I.(lJ·A I,Y.i· ... 9" :: Ii . 9" "'I fl') M "'19" I. 7 iiI ?U"'I'W} h/,'},I': ))(.\(.\ fl/I,e 0),l'.9" il(lJ·r.tl. /,1C 4. 10Y 7iY"l.b 1'°~ • .I'4·Cl1 h9"6-:)" OIJIlI»(.\fTJ'r III <'IYilontl"l'(]" t .. 4'.I'.' <'1.1'1"1 .I'oDI.·I·ar'l 9""111 il'liY"1" "'I:rl.fl m,l'.9" I'9"C')·; r'l,{'.~·h· 1''1..r.')' ilar'l' "'1.1'.'1."1 h,{'.'f· ... 9":: IJIlp'Anl~' OILV /,'}-I'X' 'lo·f1 /,'HlI' (ii) UDIII.·)· \''''I.UDH''IOar ro,{'.9" 6,:/>.I'.' 1''''I.ilmar VooNI9" 1'11006-1.')' Mt-C I 1'9""111 .r. ~·)·" '1'6- ')' "'0':·.,·,: 9"CoD':, 'h" fl.il· i·'l" hIlt.o\'/, onM.Cf·':(· UDO,.";J·'far'l fl"'lI.;>1'l' ,l'.If""':: I'/\,V h'I-/')\' 'IMI h'}4')\' (Ii) .I':').n. 'h'l.l'.'/'mfl4' ! ill] 'fm· 'l J!,mil""':: If'> 1J1IP''''fTJ~· 1'9""'111 hJ!, H·T ~. 9""1fl,) MUDhltfl'l Mcn>fI(r M"'I~ 1.-11 iiI fl"'l'l'l'm'9" 9""'111 f\J!, OO/ll'r') 1111.r.·f:'l ilUDIX\,OOC I UD ... h·'l 5. m,{'.9" J./ (I m J!, 9" M.o\ -t aD '" '" J!, '1""'1 il)1 tI aD Q;l, UDC m ,{'.9" no -I' 1\ -I' tI r ./' hil hil ~ (II- : : "'I'lt;'m··)9" 9""1-11 h"'l'l'i'ro'9" fllar'l mS 11.1.<1 h"'l. Ttl (liM" 1'9""1fl''l 'l'6-'l-'l .r.V'l~·)· 1I.!'1.1'.'tI h"'l. Ttl ~1C ;>C flh& .... 9" If~ on·n, Oon-n· uU,I'.'lI'lT r 'I-hI'lhn ~ar:: "'I'I'i' ar ')9" 1'9""'1'0 "'I7i'/,! I ooM i I"l"'l.l': 'l"tll1-j'; V·}U}.I'.' il9" mJ!,'I" "'I'g'ar'l9" 'l,l'. ~.). tIf. 9"tll17- floom4'9" 9""Ifl' O'har~'/''i'ar 119"':·':(· 'h'l.r.-tool.·1· fl"'lilooiltl m,{'.?" 1'9""I0''l 'l'':. ')'" .I'.V'l~·)· M.I'.'(r "'ITl.fl r'I'hilhll ~ar:: No food unfit for human consumption or not complying with appropriate safely and quality standards may be manufactured. imported. exported, stored, distributed, transported or made available for sale or use to Ihe public. Food Manufacturing II No food manufacturer may, wilhout registration and pemlit rrom the Authority, sale food product intended for distribmion in more Ihan one regional state. or for export market, or change the type and production process of the food. 2/ The Authority shall register or issue a permit in accordance with sub-anicle (I) of this Anicle upon ascenaining the fultilment of good manufacturing practices, food safety and quality laboratory test and other necessary requirements. 3/ Without prejudice to the provision of sub-anicle (!) of this Anicle the Authority shall adopt directive determining the kinds of foods that shall be registered. Food Adulteration and Counterfeiting II It shall be prohibited to add or mix any substance to any food so as to increase its bulk or weight, or make it appear bettcr or for any other similar purpose. 2/ It shall be prohibited to partially or completely embed in any food anything hannful to human health or that can affect the safety and quality of the food. 3/ It shall be prohibited to present any food as if it is produced by the real manufacturer or affecting quality and safety by imitating its package, identification, trade mark, trade name or any mark. n' i.7i.Iif-irilt .. f.t·1.\ t'kl' .7!Lr11 'i~'T'C X,~ '1'C .~· X ."') ~i'i.X ~.~. Federal Ncgaril Gaz('ttc No. II 241b JanuaJ)',2014 I'ilgc 7189 ======~======================= I 6. food Stor.az~TrRn50ortation and Disolav !il "'I'g'oH" \'7"~J-fl M " t. :1" , 1111. ' M1""(,I;', o>~,')" ~\M.4. ,e .r;c:6· .'j.ft- 1l.0117i 1"'?:r·tI r"l 'Il'} (1°Y .. l'll"'lTO·)·; til)}?;}' n"'I.J"~C:1ln·)·; no v ' 7i"ln,)· m)',9" na U'l1'7JfI')' UI. IH·?o.o> roo·d· OI'lll 'j m!.',?" N '?I:"I\' (l'I(ord' t'l)'{)'l' ooU"i i~tWi~~":: '1.1 "'11>;'0)09" 1'9"°NI ~\rt·:r! o>J?r hhH.l'. J'.·C1':·)· 1''''1. T(Oo>- h9""I0' .X 1hh. MuuGr.i. "'I'1'l11 f°?'l'l~r h<j:tI ')frll If~' \1'''70-1 (0"'11>;'0>-9" h. "'I.IJI\'E ! h 1111 'I? m,e9" "'I,ehC: ~r·ft-)'t Ij tI 11M')' n"'lf ,?A'l' avAh· o-oU"} MO')':: !.'I "'I1'i'm·"?" 7'''7 ·n h'~nht'l 9""I'0 ! h9""Ill "'·C<j:6·P hODC1" 1· )t hlf;" ~?C'f ! hh'){) ft,)· Ol)'.9" Ilt>(o°',f· OilY. 'I?C'-:;' ;JC "'Ih"'l :f')'\ U"&·L') (1),('. , . "'FFl'1I ~1,MltI '/11).:: ~. r"l-n1 M"'InA)\ '1 til ~1Ip'tllTJ~' rlJlll 'l·ron·') m.'J l'loomn<r rr"l'o "rt-"f' J,·C'f.+ f"'l.)'avC·/·0>-1 r"lll n'rM' \( "'IM:C;')'C; i'iJ?;J-°?S'f h1.<t0Illl'''1 "'11111 ,e 1'..-. tI :: III "'I""W:9" ?7""I·n '1'*9" Oil.lJ h')1'1I' 10'{) h1'~lI' (ti) opu'l.t h1.<t01\l\,"1 r'rllf r"l-n1 "'9"1.')' f "'Iflt1Dtrl'}. f "'I114.U\ O>J'.?u oo7i'l' 1''''1.1-110>- ~MtllTJ~' ~mffJO>- oo{)&,C')' 00(01.')' rOil?? fo.lf·) ~o>-:: i:1 rnl'l"'1 9"'111 711-l" ?' lJ·<j: 7"'10, rnl'l"'70')"} "'101:1 O>j'.9u ii,e;J' '''I:1 r"'l.7Atl IJI."1 tlSlo>· Y.7CJA:: . ~. r"l1l1 "'.",." [il r"l'o r"'l.,f'£Ll.C ·/,\I;r '!'7flavl f1.V1'I')'" ru,e;tt') ou{)&'c,H') n"'l.)"',!1 ouAh' .<t~y,'} ouf-I.,,} .rscn;J·t\:: ff.! 0"'l1<;,o>-r 9u "/'n ft. 'lC 1''''1. 7~0>- 1't.,IU' 'Lo>-h-ll,e ,j' tA· '~ 1'~J?J j-}. 111'10>- oPm') oullt'l'l' rtln}9":: I I Any food manufacturer. exporter, importeJ or distributor shall store, display. pack or transport perishable food at appropriatc tempt'rature or cold chain. 21 AllY food manufacrurer, exporter. importer or distributor transporting food on or in any part of a vehicle may only be possible where that part has been cleaned to such an extent that chemical. physical or microbiological contamination of the food is prevented. 31 It shall be prohibited to store, load or transport any food together with contaminated food, waste food, poison. any hannful substance, animal or any .other contaminant. 7 . . Food Fortification 11 For the purpose of protection of public health the Authority may order any food manufacturer to fortify food with different minerals and vitamin . 21 Any food establishment may only manufacture, import, distribute or sale any food identified for fortification in accordance with sub·artic\e (I ) of this Article where slleh food is enriched in accordance with requirements adopted by the Authority. 31 The labelling of fortified food shall contain the phrase stipulating with what mineral or vitamin the food is fortified . 8. Food Irradiation II A food irradiation establishment shall be designed (0 meet the requirements of safety and good hygienic practices. 21 The radio nuclei remain in any food may not exceed the acceptable limit. /I. r"l1l 0>1. MC M .... ,\h O>-{)'l' M"'IIl7CJ=,/''j' (J}!'. o>-~ 9. Food Import and Export \ [il "'I1'i'0>·r flo>- tlVlll.1't'I·n h1A"}ft-') r"'l.o>-t\ 9°'1111 0>1. ,,7C o>-fl'l' "'I1l7/j.). f"'l:NI(J}' /j1'lP'tllTJ'r \'9""10,' Y.vntc; 'l't·')- il"'ll,:>7'r c'l.J.~.£: ",lfC;t\:: II Any person may only import food for public consumption upon obtaining permit issued by the Authority after ascertaining the safety and quality of the food. 17t' :~o.tirl t.,~',(;,C\ ~.7t} ?IV'l 1:'1'C Iti 't'c n .,.-, MTLl Ii.?". Federal Negarit Gazetle No. II 2·I,h .lall uary , '.' 014 Page 7190 """""'========""""""===;~==,,,=------.-.-.--'=~- - '1f1P't\f'l'r hm'''1i> MC 1'1'1 9'''']'0 )'.tJJH:<J 21 Where the Authority ,!Scemin, that imported V-I 'l',H: YA'I'mO '~ ",,[J'~-') Ill,:J7m h"l'111 food is not safe and is of poor quality. it may (U:O)' ~oj'}I>'.· h '}JtiD?~' m,£.9" ro~ oofTlO")' order its appropriate disposal or may cause to h1C ),Vtaollfl Yfl)'.C;;tI:: be returned to the country of origin. L'I '111P'C'.fTJ'r :wu"l'r, "'h.m· '1'9:9" ItmN> P9"C'/O 1'I\·I1&'-I'·t 9"Co<>&. f9 D ilhC (1)<'.4")" nh1C IDN!' '101' 'If. 1,')P.ortl l'-t-t ,/,I MdO[J'~- I"'-om f9"flhC iDl,/,')- mf.9" I'mS l'9"flhC iDl<j>')- f.offlA:: I. M:t..Q;I, "'I t it <J tlor'!' ",yor 9""l(l'f 'fil "'I')I1m'9" flor '/,Q;l,"'It 9""l(l'l-J fl1i,l'''L' "'Ii'lll 1""/. ):flw- 1-Q;l,"'1t 9""l0 11'1I'\P' .00"l',- '!-0"'11'10 o.t,</' J': ;'.U'<J iii:: fl "'D'i'ar9" OiD' n:rJ':"'1,J' f;t-j~1 ),<J "'rQ;l,"'It 9D "l1l" I"''I.A 1'l"L' )\ U-~ "f.<:' lor "'1JI1orJ9" '/'a;a,"'1t 9""l11 ooi'i'!' hf.'I'Mo:: fl p} (;1 "'IJ'i'iD-9" I"f-tn "'1t 9",,/,0 1""L" )\ ().~ I )'4't-ll1 CO!!,9" "'Ifl;t-co<f!Y Nnufflm~<J I"MYI' hdO?1'O 1-1fl.or1 1'1' r.c'. 9""/11 onm') ),1)'. "'IJ'M'1 iD$?9" '!-Q;l,"'1 t 9""l(} VOiD") n7i;J' ),1,t"'/,hIlhA iD$?9" ),')'."'I.,J':1 1''''1:1A7.' ooln I'MI')'9":: "'I1'i'orJ9D tlor'!' ih,l'or 9""l1l fI"'I9"I.')·' IDJ( MC oril'!' fI"'IM'l')' f iDf. or"L' h1C flOOl\h w$?9" fI"'1M.t.tI lJrlflp'tlffI't- tI r. t.:I' J': ,I'flt.A;;A:: "'1'l~<or9V (tor Aor'!' ,'h,or n:t- f.''''I,J' I' ;t-7i1 "g.If'l<J "Aor'!' 1''''1.A 111"L" l\'iJ'~ "$?<:'lor hf.):A?u:: U. rQ;l,~I\<J r iMI<J'}' 9"'?(I"f<J "'I"U' 9°"/(1':(' iiI "'IWor19" 1'6tl.i''''' tJlI<J'}> 9""/II"f'l iDf.9" "'I"'J.J' 9""lIl"l···) 11"'19"1.')" Wf. h1C iDil'!' iI"'IIl?Il ')" IDf. or"L" h1C fldOllh cof.9" fI "'1M. UI h'1 fI P' tI ffI'r A r. t.:I' J': NIt. tI;J tI :: fl IlflP'AffI',. I')'<J')' m")- OJ'/"}' 9"')-h "ll1f.')·'l I'°'l.onflll'l· 1JC1IC avlt&.C-I'· if') "willA:: II. hMI .,.l\;;t I'or'! )'i'C(l1 "'1'l'i'ar9" oor htlA -t-'li;;t l'iD''1 h:t-cM· h1A,,/I\·')· avflm')' l''''I.ifflor M (Jl-'/or '.tJ'l~')·<J '!' t- ,). hIl flp' A ffI 'r "'Il?1 ""I. c'I. om or 111 ~ or :: Ir. Mhtl/lt\ 71r"L' iii "'I')'j'iD'9" OMltlJ J(l)1 ,ruoC-I'· h),Jf: hAA o 1If. 1''''1.0 t- "L' ; II or "L" h 1 C 10J' fl7iY"L' I' "'I. 4'C 11 iD .e. 9" (!J .I'. h 1 C or II'!' I' "'I. 111 l'),tI/lA oom'!' h"l'l'O ,I'flor h!JtI ,I'lDfflorJ J(l:q \'°'l.,1'''lll ODU") MM·:: 3/ The Authority shall, when requested by the exporter, issue a certificute of lab~ratory analysis, a certificate of authorization to sale the product at the local market or health certificate. 10. Food Supplement and Genetically Modified Foods I I Any person may only sale food supplements upon the registration and .. permit of the Authority. 21 No person may sell a food supplement unless in pre-packed form and its labelling contains the phrase "food supplement". 31 No labeiling. presentation or advertisement of a food supplement may describe that a balanced and varied diet cannot provide appropriate quantities of nutrients or attribute to the food supplement the property of preventing or treating a human disease. 41 Special pernlit of the Authority shall be required to manufacture. import, export or distribute genetically modified foods. 51 No person may sell genetically modified food unless in pre-packed fonn and its labelling contains the phrase "genetically modified food", 11. Infant and Follow up Formula and Comple mentary Food II Special permit of the Authority shall be required to manufacture, import, export or distribute any infant and follow up formula or complementary food. 21 The Authority shall adopt specific requirements regarding the marketing of breast-milk substitute. 12. Trans-Regional Water Supply Any person may only carry out trans-regional water supp ly services upon the approval of safety and quality of water by the Authority. 13. Sale of Alcohol I I Any alcoholic beverage produced at industry level for distribution in more than one region or for export market or imponed for local consumption shall comply with the standards prescribed by the competent organ. • . - .. -. ~I OII.U (,'H?" 'IMI {,'H'?" (i» OOU'/.') ' t'l7is'''!.'' I''''I.-/'C't! 1'l,Ai'A n"m'" IlMlC noo'f, n;J')' rtf', if1J·i:~m·9° aom'·P ~11't6~ ~.h,G~ 1'r,IA"IIl-')' 'W:, ",'''Ill'!; ,l'.';·Cfl;t'6I.:: ;;1 '111/~Af1l'/' 1'{,tll'A nUIll'r '/:'l"rC) /H'(/O 1I1l'/' aunut..r ,l"m"lA:: l",p&,lj: U':'l-t \,un!'--;'-) • .:).: J,j),r.lll,G£ 1:'1"l'C Ii1. {'.!!!t' ,\f, "'I',>;'m'?" 'rl.,'/:; ,f.u"H'l t,'I'n~'~ YA'/'/.;J '1m uuY:;Yd' "'19"/.')'; mY, (,lC m'Il'r "'IM'1.)- i m,f, CD'''!!' ('IC uul\I]; "'111"'1'1")'; "'IM,',A; "'I'n-II {Il,l',?" IIny"!." ro,e.?" lIu,n/.·/,I'In' 'NY" ",l'. ),·).<',,(O,A "'I!,-'/',,/ r'l'hIIhll )m·:: Hi. Mao!'.';)'!,:}' 0'19"1.·}<; ?"1l7'1 ?"llhC m/.';'} iii "'nr;'m'9" \,un)':;:>';:)' ),Y""'1'· roW/" roh.A "'I?"/.'l' my.9" <DJ', r,'IC m'Il'r "'IM'l')' 1''''1. i'lIm' O,ntl"lr'p' au )!:;>'l.'} oollCllC m'Il'r \"/'Il'I'-I-', UDJ':;>~:)' '110':: ;;1 "'I'Ili'm'9" n·lI,h,I., ,!? onJ!:;>'d' uullCl/C mNr YA·rll'l"r<;, I'oo)!:;>'z:)' 9"1/1'1 9"llhC iD/.4-·"" I'II.tlm' au.~;>'I:)' lOY 1If!, lI.m'A r,.e'l'A?":: !iI 'I IIpA"l't· aot:;>U' lOY 1I.e )',}.Il.m'A I'au!'-';>'d' 9"1/1'1 Y"llhC m/..p,), 1''''I.llmm': U) rou)!:;>~:)' r,y"t·;r' 4,111,1] l'auAIJ9" r,au6-t.·)· Mt,C, 1',1'1\,/'11 nolf)' c'l.t.;J'I'r r II) l'1li au)!:;> 'd: !'-WI) ,). ! 'r Ir ..,.. " .. 'I' 7i) .j, I''''LY /. ;J"/m' fI)}!. 'f '/'19",,/aum' aull "C·n,'} Y",},II hlf)! ),,, th) au!'-';>'d: I'/HI,H·,t. 'rlr')' ?"COU6' ooll .. C·j'·:jO·, .I'''J,I\ lit"" r Iii "'I'}<;'m'?" !'au)':;>):)' n9"t-'f I'oo)!:;>'z:)' .?"'/I'I'1 ?"1l),C ml.oj> ·)' h'rflmm' 0'),1\ n?"1tl'1 m'P''''' Ollmm' aul,Jl I\.e "'I'1'i'0l-,}9" 'H', ).). tlm,'r liS j',C"1 I''''L :1'11/0' J'.UT/' Mil p tI "l'I' (1)1'U,lj: n "'I 1\ 10 'P 'l 'r ./>'1 WI')' c'l..r1 '1 Y.(f 'l A :: Federal Ncg.arjtGazl:lI~ Nn. l\ 24\h J:"lnuarY,2.01-l Pag~ 7 19 1 2/ Alcoholic b~vcragc supplied to mnrkl'l pursu3m to sub-art icle ( I) of this Article hovin, less than ten per cent of alcoholic content sh:11! state it s expiry date on its label. 31 The Authority shall issue directivt: regarding regulation of alcoholic beverage. CHAPTER TWO MEDICINE ADMINISTRATION AND CONTIWL 14. Gener:" No medicine the quality, sofety and efficacy of which is not ascertained may be m;mufactured, imported. exported. stored, distributed . transported or made available for sale or usc to the public. 15. Manufacturing and Certificate of R('.gistration of Medicine 11 AllY medicine manufac.turcr or an agent may only manufacture or import a med icine that i's included under the nationa l drug li st. Notwithstanding sub-article (I) of this Article, domestic medicine producer may produce medicine not included in the national drug li st and have it registered in a special circumslance to sell it to foreign market. No medicine that is not included in the national drug list and not having certificate of registration may be supplied to market. 41 The Authority shall issue a certificate of registration of medicine market authorization afler: a) assuring the medicine mnnufacturer's compliance to good manufacturing practice; b) the medicine dossier is evaluated and found to fulfil safety, quality and efficacy · requirements; and c) the medicine fulfil laboratory qllality test requirements. 51 Any medicine manufacturer may change any information submitted during application for cenificate of registration of a medicine after issuance of the certificate only upon written notification to and approval orthe Authority. = :';/ 41'rg:m·?" tmx:;"I'1:1· fflulJll'/O ),9"/,·:-", 1'''''.1': yd· 9"'11'1'1 ?"IIIIC (IIt. ·I'· I:') (\"'I"Y.1l 01.'1':0; 1,'HlI' inn f'I'an(\Il'I'(II' 7.1~ 1l'~I·n:I'·I' hll,e:10· mlr')' ot.,)· (\qt\/"tI (fl',· o'/anl.\h'J: ,"/+t.·11 t.I\O ')·:: Hi. OO~2'!:)' '} "'lll"'lf')' i "'WI'll') "'I11<1-t..:I. fil "n'i'(IJ'9" fG",,~·;.l~,+ MOt·i'·, I\h.' ~I Moor.T.l. (II g.?" AM. i.,!'. au!l.·;.l~.')·') O"'lJ'lIoH ·O.)-' OO~ • .I':17·1IO')· ~') O"~ .. PM· ',:t, 0')' (1nrn~} mf.9" UDlri idHl')':: 1.1~ O'/·10.m· fon·4")· Nll.!1' lb 0',(\(\ ,)· m'll'!' "'l'g'm·?" ruo~;.l'd· 1,9"{.·:r·' 1\11, i Movr.r., oJ,!',?" AM.i·,!', oD!I.·;.l~,')·'1 "'1'1'111 1''''1. )'-(\m· /1(1\> !I.';.l'/.'t' :>C 'Ihll, f"'lS t.ID f"'n'}~r II<;:tI ')O'U if';' OD~;.l't'~') (\"'l'f'j'm, 9" /1,"'I,IWe r AIIl\'/? (1),!'.9" o'/.C',he.' III"(\-)'UIA 'Oh(\')' O"'l.l' ?A'!' UDAll· 00 If'! A(\O')':: Xl. on~2'!.:).:1.1I{1~Jl ')Il. M Moolln- M"'I-l-t.ll (if O"n'1m'9" OD~;.l'd· I\,!', ovm',·,}r ,l'.II-/"1 (1),!'.9" . hllJ'.''',) f,ooq'fC I ootlh·'1 (\"'I"ooC (1),e9" (\(\.1\ ',.oo"",!'. 'll\"'l (tll.:l. lIoY: ~lC ovGI;\,onC (1)/!.9" 004'I\4'tI l"I'h(\lI(\ ~OJ':: ~I i:/ "'l1'i' ID- 19" aD Y:;.l'd· mS '~:I-'l h"'l.ltl II"'1WID-9" 1'(lID-I m,l?1" foo.~·;.li .. ~·1 .;. 'P7i'I')' (\ . .I''}~tI 11"1, :r . .:I. )lC ?C 011&,.\9" if~ -fl· 000'(\' ooJ',IlM· I'-/.ht\ht\ ~(1).:: "'l'g' aV19" f 00 !I.';} 'd' "'1'01 . .1' ' I'T'lY: 9".:1.11')" f'}'7Y: 119" O~'}'i'ID-'I9" 'l,!'.~,). Afo 9"tI)),)· Ooom4'9" oo$':;.l~ .. " O),m·Hli'm· f,?"t·:r ),')J'.'/·oot.,,, 0"'1 il 00(1 tI (IJ J!. 9" I' 00 $':;.l i .. h ,). /!. II')' ') 'lU': flm (11 "'l~'l11 1'·/·ht\M ~(1).:: !~. oo~2'I:r (1).1'. Ale ID-il'!' M"'lIl1'l-r iii "'1'1'1(1)'9" (\m· 00.1'.:;)'1.'1' m.l'. A1C m·il'!' "'lMIl')' l''''I.1'(\ID- No$':oo "'IIl1Il.l' &.:/' J'.' c'I,(lmm·') 000"10 . .1' h.I\ I\,I? hll(\/"A<I\'t ';':f>.~' (I.rn ,!',If,)(.I:: 111 '1(\/,,(.1<1\1' hm·r.T.l. A1C \'00<1\ oo$':;.lH· .f.U'}H;' '!'t-,~ ro,l?9" ';''P7i).~ .I'.:I.mn4' IIlf~ A"J'lll '1i'\ar oo'11Y: ~, 'IP,,(1)l$': ro,!'.9" roy. au<l -)' ~,lC h'J.'I,OD(\{) .l'M'.C:>(.I:: 61 Any manuracturer who h,,, 'l.OI regis tered medicine shall submi t J!l application to the" Authority for the renewal 01' th" certificate of rcgistrution of the merlicinc s ix months before the expiry o f the per iod stipulated under An iclc 13(3) of the Proclamat.ion. 16. Storage, Transportation and Oistrihuiion of Mc!lieiD~ II Any medicine manu factu rer, exporter, imp0l1er or distributor shall store, transport or distribute medicine at appropriate temperature or cold chain. 21 Any m~dicine manufacturer, exponer, importer or distributor may transport medicine by any conveyance only where the compartment of the conveyance that has link with the medicine has been cle.aned to the extent Ihat chemical, physical or microbiological contamination of the medicine is prevented. 17. Medicine Ad"lIcration and Counterfeiting 1/ It shall be prohibited to add or mix any foreign substance to any medicine so as to change its amount, content or weight, or to make il appear better or for any other similar purpose. 2/ It shall be prohibited to partially or completely embed in any medicine anything harm ful to human health or that can affeci the quality, safety and efficacy of the medicine. 3/ It shall be prohibiled to present any medicine as if it is produced by the real manufacturer by imitating its package, identification, Irade mark, trade name or any special mark or present it by altering its content and nature. 18. Importation of Medicine 11 Any person may import medicine upon obtaining pre-import permit and a penn it of entry from the Authority at a port of entry. 2/ The Authority shall calise the disposal or the return to the country of origin of imported medicine, as may be appropriate, when its safety, quality or efficacy are not up to Ihe standard. • rl '1(;l-"tI"J~' MNIYIP,Ol' cTD7:;>,d' OOD~'~ ~:), M 'Iftar {'em';' ·} n o/,HI jill&") ""'IllL:<l .eO"l.:', :: Ill. MooY:;;>'I.'}- '1'':' hfr' t.'1 ""'I7i1J' ~I ""'11>;'(1)'9" (lOr ruoY:~'I.·l· '1'6. '1.:1''1 "'Ii'i1.Y "'I7"uM "'Irwo"I')' I ,,"''In I ""'IM·&":\ 01$'.7" ""'1)1"'1'(-')' I' "'I. :(. illD' Mill-" tlllJ'/, 6.:1'Y: rU'1'i j!./fr,I:\:: ~I '1l1l-"tI"I~' \' (/D!:,;)~:)' '1'6. 'I.:1'r, "'l7i1.Y O"'l.""lIh')· IICIIC aDoot.j j(l)llJtI:: r~deral Ncgarit Gazette No. II 24lb January. 20 14 I'ilge 719} 31 The Authority shall issue appropriate evidence for the disposed medicine when requested by medicine importer. 19. Raw Material and Pacldng of M('dicine II 21 Any person may only produce. imp0l!, export. distribute or store raw materio.!s and packaging of medicine after obtaining permil from the' Authority. The Authority shall issue detailed directive regarding raw material and packaging of . medicine. It. fAt"""10 uu~·2'1.,r Ol!: h1' orllT 11.111 20. Import orMedidne Not Registered OO"'l.TMt !J:'l.;J' IIl1l-"tlllJ~' h"'l.h'l'I\+ 7"h1Yf·i: On1~ 1'7"11'/'1 7"llhC OJ/.-I+ r .... ilm· UD1:;)~:)' OJ.". n1C OJ·Il'!' '1.111.11] tW 6.:1'1: 11.0'1' .f:', 'f"A: Ii! ilihh9"'1 oo'hrr m.f:',9" il .... " I'\.e'l<,\'l? 9"C9"C I '1./ O,hh.9" I';r II 1111')' r"'ltl~(, OlU'}- "ilOl' t-m:l''''l. "lIlMll 1:/ il7"'/l111 'FI"'I I'II·n~·r-t. '1't+ 7"Coot 1'1 "'III'IS: ! §/ /\1'6.'I'C' m.f:',7" (1m· ot-7i n.".:J m.e7" 1'I'~aoM.e M'fl) . .e '1.11. oc.~;t·! l;1 ilIl.1n- 07'I-/;11 "'l.1I.r·>1' ;...,A "In-t I ID.e7" 'j,/ OMaor.tl.?''f ·)·h·/.')· 1''''l.ei'lllJ'for on!:';;>H':Y") (D,e7" IIi: "'·I!·/.,r ,\1\,/1 07i;r?':f ;),119"'1 1''''I.orll· ao!:';;>'I.,r·1·J II "'lll?IJ' h fi~. ilOouCtlT'i Q.)./.t- M~'H: OU!:';?'l.tT "'I'lli'm·7" (1m· hl]ilp'tlfT]~· 1'11:1")' "'l1..:J1""J. 9"lll1C 01/''''')' I'\y'/,\, auCII:l") OJ!.'.9" 6t\,/..(r >,<t:II4! oo!:,;)'!.+:),·') "'17"I..,}-l m!. MC orll'l' "'IMllt I m!: Ol··t" oo"h 1 "'1M· t. A I "'Ih"'l'ft my,9" uoj'll n.e'f·tl9":: fill. ilOthh9"'I -ht fil "'I')';'or9" 0i'I0l' 1I.e I''''PI'l.7: I'thh9"r, ao·ht- lI'1i'1l-" tlllJ'r 1''''I.t.4'!:or I'7"C9"<;' TC'T'IA hflj!,'){Jl hth"l'1 hp'~-7""lI]C o J'IC '~19""l'l" ""I'I]J!, ~.) . I'l.Yn j?lfr, tI:: III "'I')>;'or9" 'l'oot·"'It. OtI.U 1.')4'7,' 'l0·1l o'H7,' (Ii) aul'll. ')· 1..:1'Y: il"'l"l1')' o.m.er fll]l'IP'A"I'/, I'7"C7"~· J TC' TIIA 1. MlMr'1 '1-1]'11.. MIfH· lIt\an.y?,'): N .... 1. aol..}ll I',MI9n 'l ao·ht· f"'l • .I'./.,,}II·)· (7O.l'.·~~:)" hihh9"'1 on·ht· I' 1-"~-9"·II]C /l"'l:k I"~ilm 6.:1'Y: '1.'1 fl.il·l· Mt.1\7. MF.:V) "'Irl.lI Mil')' : : The AUlhority may, on anyone of the following grounds, grant a special PCOllit for th(' import of medicine not registered : II for clinical trials or any other scientific investigations; . 21 for personal use of a patient. when prescribed by physician; 31 for conducting laboratory quality test for registration purpose; 41 for natural or man-made disaster or similar emergency aid; 51 for use of diplomatic missions; or 61 for medicine lacking motivation of importers or for medicine used for the treatment of diseases not given adequate attention. 21. Poisons and Radioactive Pharmaceuticals No person may manufacture, import. export, distribute, store or possess poisons or radioactive pharmaceuticals without obtaining a certificate of competence from the Authority. 22. Clinical Trial I I Clinical trial on human subjects may be authorized by the Authority after the research proposal is being evaluated and accepted from scientific, legal and ethical perspectives. 21 Any researcher applying for authorization in accordance with sub-article (I) of this Allicle shall submit to the Authority the research proposal, relevant information about himself and his associates , the medicine for the trial, permit from Clinical Trial Ethics Committee and other necessary documents. [I q(\ ..... J~.tTJ·,. t. )J>.'~.: \'011l0Jo'} 1';1>119"') OD·ht Or?.ILar OouAlI?" I' (),h9",) OC~')' onIPI.1' ou&.Otm·'} ,I',.p"Jmt-A I MtA?, if'> 0.1"-; ,!,'),~ h1.'1.*I.,!, 01.£.9" hVI,4I9" YJ.C;JtI i 1"1";')' (J>·f1kr.') f!.?CTD"I"'ItI 1,').'I,V·9" (\'i'O~,f'{lfl' 0"7.m~·9° V·'!.T MtI'''I(\'+ "y. h·)o'\.(I)·t\ Y,6.:PP,tI:: Fc.eeraJ Ncgarit Gazelle No. II 2·)'-" January,20 14 Page 7194 = 31 The Authority shall regulate the progress of an authorized clinical trial regularly in accordance with good medical procedure, suspend or stop the clinical trial where necessary. ev"llIate the results and authorin' the usc ()f the result In such a way that it benents the pllblic, tir. I'mlll''''' -lit· ..... ~-9'''7IlC n°'l.1; -t-4'tTJtTJt 23. Clinical Trial Ethics Committee Sunervisorv I'LlJI>\ Body lif 1l(\ ..... tI tTJ~· r mh9",) -ht- ..... ~-9"'7IlC n"'l. t '1·.p(f]tTJt hll'" Y<J:"''''ItI:: f.! r ,'hh9",) oo·h/,· ..... ·'-9""/IlC n"'l.· ~ 'f·.y.''ltTJt ht)(.\ nrY.L }~(J) · {'0W}.**(70. , .. tl,h9"" oo·ht· ..... ~-9"'7IJC It"'l.·f; ~1'1 )'(I).:p'l ,1'./1 'r""'! 10'\.1)09" M\&.'11. ),10'\.<J:<J:uo· )'Y.C;JtI:: N rill)!?"') OD·ht· ..... ~-9"'7lJC I,"'/, t -t-4ItTJtTJt hlttl 0'11<'10. I'fJ(\ ..... t\tTJ'r- 'PC; P,,I',toHC iiI I' ;hh9"'1 (7O·h&· ..... ·,-9"'7IlC n"'/,'~ N'tTJtTJl. hl'JA ?"t'~'I:') (\UIl(l)tTJ')· f"'l.YIl:r·(\(J)o 'tIC'HC uoool.Y Y(I)tTJtI:: til!. I'mhr", ov-ht- b1:?·l,(J)o ''It...:tET iii fmh9"'1 on'ht- 1\1:t-1.(I)' f9"C?"C 0:P 1.' "'I. Y (\'l(\ ..... t ]". <'IY<'I(J)o:PC; Nq~· <'If!.~.I:':P "'IM·Q;\,r M'.';f·t.l9":: II fmh9"'1 ov-IIt- h1:t-1.(J)o 1l(\ ..... AtTJ'r Oup ·llt-(J)o '1,1', (\"'l.YJ.C1(1)· hrrtl fon·h b-(I).'} (IT') (M·.T 1''''1/1'1'''0170., fon,,.1l0C "1>1..;). MO'r:: EI hmh9"'1 dO'lIt- ;JC 0'" NH h"'/,(I)tTJ ,,.UDtTJ")"-; (l)Q,1. OIl"''''C I' ,'hh9"'1 ""'lit 11.1:'/'·1.(1)' 1',).tI?"') t7V·ht- (\°'1.;":'700)- il(l)' O'!'to niH] (l)J?,9" 0'},I'.~1' h<}:Y on&.~9" 1I,1'.1··t\9":: /'il:. m'!:r'l(Q=C'T I OIl'!'fl?J:fl llbltll ODI1l') 1lt\.I'.l.c'I r'l(J)o (I) g, 9" 0"'l1J ,n (!)oil'!' 1111 ~,}II 'I g, 1''''I..I'.l '7 I'mhjl"'i' -hb nl.'P~ I.')"''''' H;(ii) nor'll·)· m<i:llm'C''f I Oll'!'o.~~f 1 1\11')(\ uonj'} '1A.1'.lr'l r'l(!)o (1),1'.9" "'IIJ~ ') (l)Nr 'll\ )\")11 1),1', I' .1,h9"'1 dO·ht II.h'lw') 1''''1.1'11(1)' l''''l.h·foI\·-l· v·'!.:t· ~':): dP"l"T'f(J)o t'l.l;J1'l' 1.'.If'lA:, " .... ... "- '-" , I I The Authority shall establish a Clinical Trial Ethics Committees Supervisory Body. 21 The Clinical Trial Ethics Commitlees Supervisory Body shall be responsible for recognizing and monitoring clinical trial ethics commitlees established at different levels and, where necessary, for establishing them. 31 The Director General of the Authority shall be the Chairperson of the Clin ical Trial Ethics Commiltee Supervisory Body, 41 The Clinical Trial Elhics Committee Supervisory Body shall issue directive necessary for discharging its responsibilities. 24. Obligations of the Researcher II The researcher of the clinical trial may not disseminate the result of the research without notifying to and getling approval from Ihe Authority. 21 The researcher of the clinicallrial shall have the duty to allow access to and cooperate with the Authority in inspecting the place of the trial and the trial documents, 31 Except covering reasonable costs incurred in the clinical trial, the researcher of clinical trial may not make any payment, in cash or in kind, to the person subjeclto the clinical triaL 25. Clinical Trials on Pregnant Women, Nursing Mothers, Minors or Foctus Clinical trial on pregnant women, nursing mothers, minors or foctus may only be carried out in accordance with Article 15(4) of the Proclamation upon ascertaining the fulfilment of the following conditions: """." iiI auJ:;>~'I' n;h)I9"'1C1l' IICc,: 1",G~,)m·C'f'}' n'l'fl. 7, '1·Y·l·} i M,I]n aom') Y AY.!.II· II?''.)'') my.'1" "'Iu:n arll'P Yfl )'011') ms llauovCm'C! fl71;t·'} nODMhA roJ!,'1" lI"'Ih9U r"'l.Lp. f!tiaotfi· t'lj?,')t'I'e onal ou:"LfI' l I;.! I' fhh9"'1 UD·ht-ro· h',c,:lIm·C'i··' hM'fl. 1.'11"1: r M,lJfI uum') IIA1.LII· fI?''!'· my.?" "'IU?') arll'l' I,ll )1"}11 m·m fill· M"i' ItJ!, I' "'I. m (H (I" ' j h') Y. "'I Y.fA el M,'l'fl. I.';'}' ,,)'. 1''''I.tJ'1.!1:: \','hh'1"<; on·/!tr !l.tf') flm+ m·H· 1l"'l1]1~r m.l'. UlI',· 1''''I.1'lttl6.m· I'on.l'.·;)'!.:)- onm'} OUl\~' ItJ!, 1· ... ·)· rO~J'l'Ih')'A onln· : iiI mc,:flm'C my.?" 111l'l'11. }.'l'}' '1Y, I'"Y.II'I..I'." I'fhh9°<; on·ht· !l.tf·) 1'lI'\,'hh9°'1 aD·ht-ro· 1M '1·.I'.C'IIt·)· hl>')fI· m)'.'1" hUlI~' 10'1')' ;JC I';J/r 1'1'1"9"1')' m.e9" I')\")(r mJ!,'1" rUlI'7- M')' f\t\,tIn')· 0·'!.;1' r~"-:flm-;::: my,'1" 1'10'1'1\. 1.<;;1: 1l'1"?"~')' on1'H 1 ?il 111011/'1 aum'} IJtlY.LfI tlJ':' Ity. fI"'I..I'.L"l I' fh h'1"'1 on. ht- (\.In rAil: 'l' ~ '1" '.1.1:1'100". If .. 1'1.<;.).'1 M." mJ!,'1" I."", CP)'.?" M't. O"'l)'.':CO')· /1''1.;1' 1'1o'} ... 'fm· 1'19"9°1'} m)'.9" m"J':' ytlJ fhn hlf1 rM ... tm· 1'19"'1"1'}' (7011'/: I ~I 0"'1 I!l\ ') m·I'I'l' CJI\ }\"'}{) '1r, 1''''1,1] '1..1'." r ,loh9"<; aD·lIt· !l.lf'} O)\")t\· 'I.e 1· ... -l . 1''''I)'Y.CIl onlf'7-" 1'1.<;.).<;, M'" my,'1" M'" 0"'1 )'. .. <.11·)· li·'!.;1' I'h ".t. 1'1'1"9"1')' on1'H;: Feoeral Ncgaril Gazette No. ! 1 24th January,2014 PlIgc 7195 II scient ific evidence is produced proving Ihal the medicinal product is intended to diagnose. prevent or cure diseases in pregnant women, nursing mothers, minors or foetus; 21 clinical trial carried on persons olher than pregnant women, nursing mothers, minors or foetus cannot be expected to produce satisfactory test results according to scientific or medical knowledge; 31 in the case of a clinical trial on nursing mother, the amount of medicine passing into breaSI milk may not cause harm to (he breast fed infant; 41 in the case of a clinical trial on a pregnant woman or nursing mother, the informed consent of the pregnant woman or nursing mother and the father of the minor or the foetus or, in absence of the latter, the consent of the pregnant woman or nursing mother is obtained after being briefed about the clinical trial; 51 in the case of a clinical trial on minors;wilhout prejud ice to the interest of the minor, the informed consent of his father and molher or in absence or one. the informed consent of the other parent or in case of an orphan minor. ·the infomled consent of his guardian is obtained; 61 in the case of a clinical trial on foetus, it is confirmed thai the trial may not cause harm to the foetus, and the informed consent of his molher and father or in absence of the latter, the consent of his mother is obtained. ~~, ObbP"r:' ihuoP"1''l'x 11£ M"'I u., rihbp"'i . 26. Clinical Trial on Persons with Mental Disorder ~ 111o'l'il: Io'H)\' n;'(ii) UD/PL')' I1loh9"C' fhaD9"1''l',!·· 'I.e I' ,MI9"<;' au·llt- l''''I.h<;ro~(IJo l''''I.h'I'fI·.'f· II''!.;!'?''!'' aD"" 1I;1''fm· lI.L;J1'l' r,lf'1 tI : '(;.I 1','hh'1"'1 uo'ht-ar <J.'1"'1 uo.l'.";>t." I'loh?VC' fhau9"') IIUDUOCUOC 1 fluuhlthA ' my,?" fI"'Ih'1" 1''''I.m·tI uolf',·! ~I I'fhh9"'1' o"·ht·O)· hlo/,y·C' ,)\on'1""''l'~' (Il'''V' I)t\. fI 7'':f- 'I y, 11.1J'I..I'." f"'l.t.t\1CD· ') f(7U·ht· 01'1ll,')' "'IY""]')' h')Y.",?;ftl "Y,')I\P, IOY,9" 1','hh9"" au':}l aD.ft:n·: 1.'1 Clinical trial on persons with mental disorder may only be carried out in accordance with Anicle 15(4) of the Proclamation upon ascenaining the fulfilment of Ihe following conditions: II the purpose of the clinical trial is to diagnose, prevent or cure mental disorder; 21 clinical trial carried on persons other than those with mental disorders cannot be expecte-d to produce Silt is factory test results according to scientific or medical knowledge; and i'l fM,9"C' <t1CJ'D9""'';'W' t .. <J>.<;··) lluo"/M, !""(fA hli"/ \' ,),!I?"<;' ""·ht.·IIl· ""IAY-II} flrr';-j: 0071·!: mfJ9° t..;I>p,. ' ) {]<I: ft}'.ln (I. ·I·e V/,<'Vl(,(I)' 0077"':: ?lX. Om"} ;I=?·"'i.P''f 'I.e M"lU"} fluil9"'! -M iii Oh'l';>; h'H7, i(i(!i) uov'I.:'· O;h'7 ;/'t.."'/. fig, 1',),))9"" """Ilt- 1''''1./'''(1)'/(1)' V"'!.lI tl\.". !I·'!.;N"): 00 "J."!;Ffw· ttl.:>1'!' g,lf<; t.I: ~/ II) 1',),),9"<;' uo·II(.·(O· O'/'M, liMit··)· :>c O·I·.!'.I'11 0,),,,/ ;I·/~"'I. P>""· fig, r"'l.hfl·)· Uuu9",) II I7OI7OC uuC ; lluoMhtl (Og.9" fI"'Il!9" 1"1' •• 111 hlf) 1 ?,,, (t) n,),II9"" ""'ht.·(1)- fig. r"'l.ft·htlD ;I't.."'I. llooft·,·tj: nao·fI· )lI) ')' lI(I)II~:: Ott. U ~, 'H)\' 1M! h '}oj'?' (Ii) uuv't.·)- Q,U"I t.." '/. 1If. f ,),119"<; "",·ht- Il.h<;w') r"'l.onflll·l·w, "'It."'!..!' Q.~' i.t,-t.<;Y.C /').<t.!'(IH·m· f uP Y. I. "J onl1'" ,"C"), Ml •. fll(l)·'} ·)"O·OC r"~ !l: t. "J fI.{, ~ .,. g,<;'CIl tI .. 1ft. r mil9"'1 lIt-1 M'!Jj:1. '!' r a,il9"'1 on·ht- ?,').<tq'L!l:n+ I'-t(l"'l"'l (1(1)0 0"'1<;'1'(1),9" 1.11. "",·ht.·(1)·1 "'I*I.'!' .ei··"t'.:: 9"ot-tj: Y'fI+ l'IIU''1'f'1 -t 1,,7?~ mg.9" h"'1t-'L" mil9"'1 oo.l!:;?'!.+ M1'-'\Y,C" 4l'!''l'C t i!, M!l.IJ.I) If on !l:;?'!.+ 9"1/111 {if "'11>;'(1)'9" 11(1)0 I'I]Ut'. on!l:;'>'!.')·'} fI"'Ifluo'U111 llf\an!l:;'>'L'" 9"1'L"; I'hm.4>4'9" 11'),;1'<; i\1\.'-r- Mt."'/. uul.J\p'i· Mil P'tllTl'1- O"'li·l.11 "'Ioot'.h·)· g. 'f"t'.:: '1.1 <1f1p't'.ITJ~' 1'<10t'. 001.';'>'1.'''') .t'1'7i~')'1 .f. u·})·)·c; 'I't. .. ). 1l..I't.:>'7'I' 1'9"1/1<1 9"flilC rol.4'·)' g.lIlTJtI:: ;:/ <11lP't'.ITJ'/· Otl.u ~,'H)I,' '}D·fI h14'l\' (ii) anllt.-)· 1''''I.·~CO· ·)·') UDI.}\P''f "'1.fI'!'t-'f~·'· ronm01> "lY.;/' MO')':: q), '(1-Y,22&' (l)g.9" h°'lt-'L" mil?"" 9"111<1 au!:';)'!,-r Ollu Y.111 1114')\" Ui(lI) MOD!l:OJ'!.·)· 9"1/1<1 r·~'.)l1(Ir ),·}Y.h"lQllH: r·~y';J;)&. rog.'I" h"'lt·"V' a,il9"'1 OO!l:;'>'!.1·') 1I"'1f1dD1I1'0 ·I't,lI"'/. ~lf'1t:\:: Fl!d('rul Ncg:J.rit Gazette No. \1 2·1 '~ Janu:lry, ~ Q 14 Page 71 96 - ------ ---,.-.- .,------ .,- --- 31 the informed consent of the person with mental disorJcr is obtaintd if h(' is capJbl l.! to give his consent o r, where he is not c<lpab!c to give his consent, the consent or his guardian is obtained afte r being br iefed about the cl i n i~al tria l. 27. Clinical Tri al on Prisoners II Clinical trial on prisoners may only be carried out in accordance with Article 15(4) of the Proclamation upon a, ccrtaining the fulfilment oflhe fo llowing condilion,: a) the clinical Irial is to diagnose. prevent or treat a disease th :lt may particularly affect prisoners; and b) the prisoner pal1icipaling in the clinical trial can make decision whether to participate in the trial free of any undue influence. 21 The concerned prison administration shall h~ve the righl 10 be made aware of. and have Ihe respons ibility to provide Ihe necessary cooperation for, the conducting of clinica l trial on a prisoner pursuanl to sub-article (I) of this Article. 28. Withdrawal from Clinical Trial Any person, who has given his consent for a clinical trial to be conducted on him. may wilhdraw from the clinical trial at any lime. CHAPTER THREE TRADITIONAL AND COMPLEMENTARY OR AL TERNA TIVE MEDICINE ADMINISTRATION AND CONTROL 29. Registration orTr"dition.I Medicine II Any person may apply 10 Ihe Authority for Ihe registration of trad itional medicine by submitting information with regard to the source and use of Ihe medicine and other necessary information. 21 The Authority shall issue certificate of registration upon ascertaining the efficacy, safety and qua lity of the traditional medicine. 31 The Authority shall ensure lhe confidentiality of the information obtained in accordance with sub-article (I ) of this Article. 30. Rcvistration of Complementary or Altrrnative Medicine The provisions of Article 15(2) of this Regulation stipulating on the registration of medicines shall, mutatis mutandis, be applicable for registration of complementary or alternative medicine. /il 'III I'-" N'l',· au t: ;>~ .. ). n-/'1"iar ""M.C·)· J.',tJJil.<\6\ :: ~-- ... - -" 00:"' ~ 117iJ"1." 'I.e .l:'lJL. tJJ·[fl.-) I' "'I S' "'J."t n-l'L.n 9'''? ·n tJJ)',9" 1n.r .p''j-). J'II '/.A6\ i oool'l'9" ·~1n. ro··} V'<;' fl. 1~ hC9u :q f.1 "'I1'i'ar9" 1'9""/·n '~?:9n: /I) 09""/'0 Y.U'li·)·<; 'l't,·)· ft$?, J'6\-!'mM 'i''?C fl. ';'C t.'1I11'-"6\llj'/· l''''II'lro.p i II) Y.u-n,),'; 'I',H, J'6\'hnO'" "'1 -1';'(1)-')9" 9"'7'0 h"'l {)t· (.I;\,,). I'oo,fm'(j l h<; tI,) 117iJ''!.'' f1'L.Oor "'I')'i'or?U 9""1,0 1.U-}~.,,<; '1'&,,/, J'tlmn-/' hlf~ nauo 1li'l11 'I () I'-" N'l~' 'I (lIlfJ or au oa t J' oao L.')' l''''Iil(l)1.1:' i "IP..;J- MO')':: rl "'IWor9" I'mS '1-:1:9": /I) Ooaj':;>~.-r ,]'t.-).! &.. 'P7\~'r<; !t.lm·r L~lY: fUTLP ,;J'1'ouro·'} il1rp;:(o·"}y'" ·/~Y.·'/P I' "'I J.',;t. (I) .p ':f. '7 C ! (lI;P 'f I' O'D !t.' '1.1 0'DL.:<lP'1',,) roMn h')'16\':>)" 1''''I.'I'Cl1 :tt..;J- I\lll\I'-"tllfJ)' D71'l1D:t) h'J 1'1) '1111'-"t\lfJ'1' ou.l:';>'z.·~ l',l:u,)'11- 1 1'&..'1'7\'/1- 1DJ.',9" 1''1'601- "I""IC Mro, 1111- fl.J'I'l(ll . .p \'oa!t.';>'l.-I>·) ilC'!."-} 1''''14'9"1 '7P..;J- Mn'r:: QI "'I')'O'or9" 1'9"'711 ro$?,9" I'mS ,~*? '11'11'-"t\lfJ~' 1I"'I.J'tl 'U.ro' I' Y: vL. 10J' :t'H' l'oa·t-'10C '7P..;J- MO')':: '(;1 1JI'II'-"t\lfJ'" Oll,v ;"H7, ')O,il ;")>/')1\ (i~)(t'I) ooOL.')· 1';'') !t..,) tTD~:;)~.,)· I'-"C'!." ·)· fl.Y'7!t.' l'auY:;>'l.·" ;'9"6ol- (liMn (l)lttl f-/'{)606tli-l,') oaY:;>'z.-l',i', ('uD{\NHI<; l''''Ii'lro1!t.' ;>ft'(''11 ;'1'10')':: if "'I1>;'ro'9" 1'00 ,1:';>'1.')' ;'9"6oi'-! MoolXl, 1DJ.',9" ;'h'i-'i-J.', !t.'C:f.+ 1'10J' t.:I'!t.' '11"i0-l· oo!t.';>'z.1- f\J.', -t-tl;t-;J-J.', l'oo!t.';)'z.1- !t.v1~1 • 111-1-t\ 1''''I!t.'t."/ ~,<; "I'''IC fl.M1-9" M&..ft1.(lI'1 hOTo.). IID?!t.'L."1 1'°'l.J'i'li'lIro,1 I''i-C'''II>n.:<l,ft 1il ilC'} 'r ootlC .:>'), MO'r:, Feder;ll Negarit GalCtlc No. 11 241h JallU <.\ I)I. 20 14 Page 7197 CHAPTER FOUR POST MARK ETING SI:RVF.ll.l.ANCF., FOOt) ANt) MEDICINE SEIZURE ANt) DISPOSAL 31. Post M:lri{ctilH' Surveillance 1/ 11,e Authority shall underlake post marketing surveillance on food or medicine supplied for sale, and based on the results, take necessary measures against non compliance with the relevant requirements. 21 Any food establishment shall have the duties to: a) inform the Authority where there is unprecedented problem in food safety and quality ; b) refrain ITom distributing unsafe and low quality food for human consumption; c) collect and dispose, in accordance with the directive issued by thc Authority, the food, he offered for sale if it is found unsafe and low quality, 31 Any health institution shall have the duties to: a) reporl to the Authority on unprecedented adverse drug reaction, product safety update or complaint on the safety, efficacy and quality of medicine; and b) refrain from distributing any medicine that the Authority has notified as having safety, efficacy or quality defect. 41 Any food establishment or health institution shall coop,rate wilh the Authority in undertaking post marketing surveillance, 51 Where the Authority orders the rccall of any medicine in accordance with sub-arlicle (3)(b) of this Arlic l., the medicine manufacturer or its agent shall have the duty to recall and dispose the medicine. 6/ Any medicine manufac turer, importer or distributor shall be respons ible to establish a pharmacovigilance system for continuously monitoring the safety of the medicines for which it has obtained market authorization and to take corrective measures in case of irregularities. 1,! "'I'Fi'm'9" I'mS ~Iluo,y I''''IS ;>'l'uom" I'ffPJ~: :'~3' '1·lL Quty-'· "tv·?" \,uo).';;>'d· J.'P"li'f'!"j mf!,9~ '\'(r')") hiluoAI1-Y' Y"'I.Y;;'1'"nt1l"j i"1C m.'\.Ym·'" tlIltlP'tV'l'r "'l.\m7 (,,'In-)':: ~)~, 11''',/·0, ([J,e'}" "").';2):'1', MauJ'1t'i "'lllCD1i!: iii 1I"I<1'n Yllm· "~IA ' IJ) 71ly <'I.e h '.'\.([J,tI Y tI 'hlA Y. r II) MonMo l"I'lO l ,Il) \'(,7t1 '1Il o ,) ' 7.1L([J· Yll&.: 00) \''l'6'')' Y.l)1m·' I''''lY'''}/'oi tI') Ott.v n ·n uotl'l')' 1'11,1")· "'ll ;>7'"1. 1'"IlllC ml4+ Ot'l.lI()}o OiD' I"/'hon" \"/'1,"·'(.11 [ liMA I'1'W rof!.1'" I':N.II : rof!,1'" l) IItI-U.4'.I'. 1''),111'"'1 oo·ht- 1''1'11: O"I:;>'I:h m,e l'" 1'"'71n nooJ'1/ h'Jl.m7Y.' (J)f!.?" ro.¥. (JD''1n')' ),7C h·),I\.ooM II.YY.C"I .e :rlltl:: MI ,,"1'1'0 fllro· ill)tI OILU ",op)\, ,0·11 ",op)\, (Ii) 00 fit")· II -/'iD? Y. iD' I'" "111 ro f!, I'" ooJ!:;}H' 09"''In· ro.e9" O"".f:;>'I.·" 'II'\/l.')' rof!.1'" 'ltlj!. ,I;I' II.mr.'/> '''It.;>7'"1. I'"IlI1C (Ol4")' ,!',o "1 t'. :: n'i:':" Y'M' 1")'T''l1f 1I"I~r 4t'l''l'C @~, t,fJL1Ji1"'1lJM1: "'l'o;'(O.,9" \"r9"<11f 1I"IJr,.j. "'llloo"1r T "'l h '\..!. t\ ro .e9" uo 7i'l' 1''''1.''11 (!)- 11"1 ;f.j: aull.!.C f· :r·, "'l"'J. II·j: '1' t.;>"1 (TI hfJ liP' tI "1'1 .!.:I'I: f1"i II. If'' ~(!)-:: c!Ji!. lJII1J1'\ oum1 ftlY.lllll(!)- h 'r9"'I1f 11"1~r Moumn.'/> "'lW(!)-9" oro· 1")'II"~1f 9"Cf'1- ' 04''l';I' ro.e9" nTH,/,,/, t 11111'1 unm1 IItlY.t.(, Il(!)- h lo'!.m</'I'" un7i'l' ro.e9" uo71·1-·)· I"/'hf\hf\ ~(!)-:: @?i. MrP"fJ If 11"1 'l':r "'li'iV'i 111 ~ )\'rrlj; iii "'l,'i'm'l'" f-l'?"Qlf 1'''I~')' ?"C-)· 7'1'r' IW·<j: \'rl'"<1lf 11"1'f:~' 9"C'r <1Vt,T I'mS 1-"IC "'lilh''''''' h'i 1I .~1'\H" f"'l.1AlI' If~' O</>'l';I' ro f!,9" O'''H'I''I't I'",~ frl'"lllf 1/"1'1':')' 9"C'r '/'.<;,). hM I"rl'"'llf 1/"1'1':')' 1''<;-}- y~1l uolf~" 1''''I.'ltI)\' uolf, I'IIO'r9":: 11.1 O?')'i'(J}'1'" l"r9"'llf 11"1J>:·)· ~m'l ;J'h.,r T 'l':r tI "'l7i 1J''i 1'iD''r' "'l7i V' 1'1 'r' l\' '" <j: , FI:(kral Ncg.:u ;t Ga7.c!tc N(1. 11 24!~ January. 201·\ Pugt.: 7198 71 Any health professional shall immediately inform the Authority any adverse drug effect as well as problems that he encounters with respect to the efficacy or quality of medicine. 32. Food or l\1(~dicinc Seizure and Oispo~al I I The appropriaTe organ may seize food or medicine and order disposal or sending back to the country of its origin where the food or medicine: a) does not have market authorisation; b) is counterfeit; c) has expired; d) is of deteriorated quality; e) is stored, distributed, alTered for dispensing or dispensed by a person without certificate of competence issued in accordance with this Regulation; or f) used in unauthorised clinical trial. 21 The appropriate organ shall issue a certificate to the owner or possessor of the food or medicine disposed in accordance with sub-article (I) of this Article upon request. PART THREE CONTROL OF TOBACCO PRODUCTS 33, Requisite of Permit No person may import, distribute or sell a tobacco product except with the permit of the Authority upon confirmation of the product's compliance with requirements . 34. Protection of Minors from Tobacco Product No person may directly or indirectly sell to or create temptation upon a minor to use tobacco products. 35. Packaging and Labelling of Tobacco Product 11 The labelling of any tobacco product shall describe the characteristics of the product and the health problem and hazard it causes, and may not directly or indirectly create the impression that it is less harmful than any other tobacco products. 21 The label of any unit packet, package and outside packaging of tobacco products shall: 0) M,j'?"IlU' f'rn.c; Mh6.'1'l' Vm,Cj "'Iilnj'}'H:,r \' ,I'll'; ,c',V?" (>n~i'i1 ,rm") 1f,' (I) lluu,Y· wg.9" hll O'l ,!'. 1''''I.i'ifi:,} ' {lMA "'lfU.1l 'O(lG' \' A 'I! OJ ,!'.?" ,nC',',f/)-o1 Uan ?" yonfl]A m,!'.9" ',M.'>:·"'/, f!. 'Il:'IA m.e9" (\.(\"1' 'l'?"Il!f') ooom','?" I''''l.oom- M:'I->;' I'mS , '''Ie' :)''') 1''''I:IA'iO I ,,,) O,j·A·I,'1 '71:1''' If~' 1''''I.;rf!-'i 1''''OOfl 1,'; Y"'IJ?,t'I:P If';' Oh"'lC1 (flY.9" 01,1''](\:111 \"1' 7. •• 1 1,'1 0 0 ) ,j'9"lJlf' I' ,rllm''}')'!'':: ~?C'1 Oal,o- OJ-l'l'!' r"'L ·f~(lJ·'} '1''1 'I'~' '; )0 '}'r.:: ~'IC 1'''1.? A)\' I vall") hlln·)·;: tl IIllu n'}-r? ~1 •• 7.?9" "Ym·"l.b "'In1.f" "'I(\.j 1'1'9"lJlf' 11"lJ.'o·)· 9"C')' lI:rc;fc I''''I.'''C·OO·)· "'I1'i'(])'9" "'I'fi1.y ~ro·:: ~7i. "'I mil I' "'I.hII hM 'f (I}- .Jl2:. P'"f iiI ,j'Y"'1I/") O"'l ' )'i'O)-9" ,M/fl O"'LllnllflOr (f>f!.9"" 0"1:IMtlll')' (1 :j' "'IGQ,{J t,AtlA ~cn· : : ~I .1,1/fl 1''''l.lIllllfln·j· (I>j?9" I''''I.'IMAO·)· (l;r 1'''1.h·/'(\'')·') j?GQ,9" t·A: /I) omS '1-*"'1')' h(I~A m-ll'r I II) O')-9"UC')' "'*"'1.). h<j:A (l}-Il'!'! ,,,) nUllfl "'I'l 'l'trp':r· mNr I on) h·)Y. If''M''':)~'1 MH'·t-,}f·:f 1](\. I'oot!" 1n.y (l;rP'1: i h'1 u') l, "I'1·n .I'lIm· hIlA h ')-'I,eGtl.lIllr(l} 1'''1.m{]'1rm· (\.(\":)' (l :}·p:>:r·:: !'.I I'II.U h'H)\- 'iO.{] h'H)\' (ti) f:').n n.~oC9" n '1111-" tI fl]~. I' "'I.I'Ir. ;Il '//'0 I' "'l.1I n II fll] r (I} (]),e9" 1''''I.1I11M'l'·co, '1''.1:'''1.). (l}-1I'l' ')-9"1] [/") "'I Q;j, II I''''I.;J:(\(]). III /.(}. 'FI"'I n'MI' 1'°1r.tl,·!i (l;r j?tf'1t1:: hlj:tI Mo)' n,g,l!. '}I I' hl-t'1n. illS nmflOT'1 1'.,.1\1\", n7i;rP'1"' 4l'l''!'C (Ill . ilIIh1.1'i' h. "'!,lJ tI iiI "'I'}'i'(I}-9" ny.?'i' h."'I.' ltl 1I.001.:/- ' col'. n1C arll'!' 11.11]' lI.h"'l:]'- ' 11.'1'111' 1I.h4.t.A ! 117i)' ·1.~ 1I.1·C·fl my.?" MAoIII"')' 'I.e (I.m·A nu·OI.·/·(1) ms 'If!. 1'-'1')' h').'\N'.C{] '1(\ I-" A f1) ', . I' "'I.)' OJ f1j(ll. ') OD (] t. C ,1, "'I "J. f] ·1· MO')':: Federal Ncgarit GazCtlc No !! 24~1 January. 2() 14 Page 7199 a) bear hea lth warning dc, cribing the harmful effects of tobacco lise which slJall constitute 30 % or more of the principal display areas; b) descr ibe the health warnings in .words or picture that smoking causes cancer, cnrdiac or bronchitis diseases or immature death or' serious health problems caused as a result of tobacco use; c) be written in Amharic or English in large, visible, legible and irremovable manner; and d) contain infonnation on the maj or const ituents and main hazardous constituents fou nd in the emissions of the tobacco products. 31 For the purposes of this Art ic le, the term "outside packaging 01 in relation to tobacco products applies to any packaging used in the retail of the product. 36. Places Prohibited for Smoking II No person may smoke tobacco in a place for public gathering or use. 21 Places for public gathering or use shall include the fo llowing: a) rooms ofhealth institution; b) class rooms of educat ional institution; c) public conveyances; d) dining places like hotels and restaurants; and e) such other places prohibited for smoking. as may be dctennined by the appropriate organ. 31 Notwithstanding the provisions of sub·article ( I) of this Article, smoking in places for public gathering or use identified by the Authori!» may be allowed at a designated smoking areas. I'A RT FOUR , HYGIENE, ENVIRONMENTAL HEALTH AND COMMUNICABLE DISEASES CONTROL 37. Dangerous Chemical I I The production, import, storage, transportation. distribution, sale or use of any dangerous chemical shall comply with the requirements set by the Authori!» to prevent any hazard to public health. lU nll.1J h1n. 'IMI tI1</·?' (Ii) uo()t.·}· fro"Jar ""f1"C·)· '1' '1'(1 ().1'>; h"ill ·n filar hl]lI 01.1>;' h."'Plt.·') {,uof11 0).£,9" h1nJ' 1,1.'U'llitHI )..e; )"1-'tGJ1.!!' (IJ.£,?" OJJ'.uo"JO'}· hK )..',-'tonM! "'I.!!'t.'7 )..e; t\l't-i' M6.1\'I. )..c?"P.~:f·'/ anar().!!' ,e.)'·'IlI:: (i);\:. rMh&.1 M'I11e; )..ro;n!l: iii fjt'lJVAnl~- O"'l.f(IJ"J~:ro· uofl6.Cf·'f· uo()t.·) IIA·/'!.."'.I'. ntH-"'C Mh&"} ro.e.?" I.?'?" roY. h7C (IJ'f1'1' 1I"'1ft7I]·}· roJ?,?" hh'lC 1I"'1l1m fTl')' ilg.):A?":: ~I ",,~C!I: 11.')' ')'0' 1'11 ro.£,9" 1."/1]'0 <lllro· ;11'7 uool')' {'on)"n<- (l;r lI.hl1{1 'I'-l'?" fl.t.II'7 I]AIf~ nft-l--/'c Mh&.1·) h·I'."Ot.n·)· 'l.tl. :r:jI"C' (}f).). '}(70.). fI.£,·f.e, h·I'."nln,)- lI.ro"J n.l',)··AjI":: 1:1 flIl.lJ h'H?' ')0,11 h'}.,.l\· (Ii) f·I'Y.~11ar ohCh.I"(Ht rog,?" II'M1/?" f"'l.U"'I fl.?'?" "'I'l'l'ln 0"'1. un 1111') ' • hl. lI "'I. h J?,1f 1?": : <j)ii. r4li'ji'i hfJ'JI'i QJD~1.!!' Federal NegarilGazctll! No. II 24!ti Jan uarY,2014 Page 7200 21 In case of violation of the requirements ,prescribed pursuant to sub-artic le (I) of this Artkle, the appropriate organ mJY seize or recall from market and order the disposal of the dangerous chem ical or scndi'1g it bac-k to its country of origin and take other necessq,ry measures. 38. Transportation and Disposal of Dead Bodies 1/ It shall be prohibited to bring into the country or send abroad a dead body or human remains unless otherwise permitted in accordance with the requirements set by the Authority. 21 No dead body may be exhumed before seven years from the date of burial except by the order of a court or where burial place is required for public purpose in accordance with the relevant law. 31 The provisions of sub-article (I) of this Article may not be applicable with respect to the transportation of human remains for archaeological or tourism purpose. iii h"'llJ{I' filar hilA fI.e&.;PJ:' ouC~"'I flf'r 39. Wast. Handling and Disposal :1. (j)J?,jI" 07i;l' t'tfil'l·ftA9· r"'l.i·lI· 4I'ij'ij?,:-".,) II It shall be prohibited to burn or dispose by any "'I:I'mA ro.£,?" Ot\ft "'I·)>;'ro·?" oul1Y: "'IftlIl'/J': h,l',;J'A?n: : ~I O~'}:;:/iJ.?" oa~ nIJIIJVA"J~' froil1' onflt.Cf·:j'·'} n"'1":!.ft·)· h"'ll]{I IllIar hilA 6.:J'J:' flY1~ uoC'I"'I roJ?,?" n7i;r lI.fMftAIj: 1''''1. 'f'A 4I'ij'!i1 ).. '}~ 1'i 'l'-l'?" ft.£, 11"'1 'P A ro.e.?" n"'l fI ro1.!!' (tt- t't () "'I1r h.£,'f·(;\?": : EI h'7lJ{I filar niiA 4I7i7i "'Iflro1P. ro.£,?" )..1Y.'I'i 'No?" 'I.e, r"'I'PA t1lr f"'l.olrn'/' (lr) hon(}\'uv· n~.·)· rf7i7im· n(l;rm' OVal·l.!!' ro.£,?" )"'}!'.1'i 'I'~'9n '1.1'. )..'}-'tarA ov!'.l'7 nUllt. ·I·()·n mS ftJ?, 1',11,')' h1.1'."'IfY.CfI "'Il.:>7'1' MO')' :: 21 "'I1>;'ar9" .lAo 4'7i'ij roY. l,111]1l. fl.M';P l'''n~ l'Iar h"ll]ll fllro· hltA r"'l.,l'ro"Jar1 Y.l;il t'tf":!.ft .£,lfe;A:: fmS ~h 4l'l''l'C I'~l"ll]'far 1-*"'17 h"'l'1{1 fllro· hl'A m.'i ~h 4l'l''I'C r"'l. y.l'7'1'l'ar '/-*"'1.). ' /·11l.(]J·1 1''1,1',;1/, 1'i \' 1.111]0. In. e; hmI]O'} ouflt.C'}· "'1":1. 'I;r'l'ar') fl.:>"'I"JA i Mt.'I'l.ro·1 I.C?")! J?,roflP,lI:: ~-. other means a poisonous or contagious wastes without obtaining permit from (he appropriate organ. 21 No person may engage in recycling or disposal of poisonous or contagious wastes without obtaining permit from the appropriate organ upon fulfilling requirements set by the Authority. 3/ The appropriate organ shall, prior to the designation of a place for disposal or recycling of waste, confirm that the disposal or recycling of waste at such place may not cause damage to public health. 41 No person may discharge liquid waste to the environment unless treated in accordance with standards to be issued by the appropriate organ. 40. Institutions Subject to Health Related Control The appropri ate organ shall ensure that institutions subject to health related control satisfy the necessaty hygienic and environmental health protections requirements and take necessary measures thereof. Federal Negarit Gazette No. 11 24th January, 2014 Page 7201 !'i/i, f1:'I"'1;e; J:,M'J; '!1i,II'f. 141. "'1'}'i'iD'7" om' fjo'lr('\rTJ~' fUl1L"'01I 1I1.'i"} lloomn~' l'I,tI \',(79")\''1 I'h\'C '(JIJ(t,)-,) (tuDMhtl l''''1.yrorTJ'fro,'} oull&,Cf,:j" "'111tlC MIl'l':: Sound and Air Pollution !'ill, ffh]l1 CD/MY onM:<l 11'f. "'11'i'oH" \';h'Hl1 tID7MY oo)VPl (1.'(' 'lllr tI rTJ'f. Y rofl l'fro'1 oDIl&'C f':Y' "'1":1,1\'(' MO'(':: !'iC. f'ill'l" Mtt: OD'}7r.7t'f lYl'fj'f. /il 1''lII'I'' h~''f: oo'>?J'."!'): 1l'(''l,H f"'1.l'Im"(· 'lllrtlrTJ~' O"'1.f'II.',"'1'for 1'111.'1 'ht:"'1'(' .r,lfe; tI:: '1.1 Oh'l')\: h')1')I, i'lZ(li) anol')' ror. h?C or!!'!' h'}.~,I'.·FI 1'""'I.;J'7f!: Oo"'} yavrTJ "'1'}:;'or'l" M'l"ir f;J·?.r.m·'} (UD· f4',I'.;1-m·') mr.r.\, Oooo&. '} my. oofl]O,). h?C \,oooot'\ll '1>'..;1 ,I'.<;'CO;J·tI: : !j/i. Ooo"lo.Y'i' ODor"', 11.'\ 1''''1'l'l'JfE:f'i' .... ~.y.:f ",,'I"l'C (il "'1'}~~llF9" IliD·"!.'· OJ),. ~,7C 1''''1.7'1 ro,l'.'I" Oh7C roNr MC{Il I''''1.YtI'f: "'1'l'l'lf OId'\"I\'Y y"'HlC htlt\. orll'!' "'11'i'or')9" ol'7i'1i m),',9" N'Ii''i 1/:1'.... h"'1.&..,.1:1'1'(· Mt·c OJ'r.r.\, "'1111'1')' roM" ODrTJt\ I'I'IO·)·?":: fl I'tLU h').,.l\· ')0·11 h')"')\, (Ii) rn.n o.~"C9" "'1'}'i'or9" 110" h')y'?" '!':r9" 'I),'. 1''''1.ort\. 4'i'ii'i iD),'.9" ·/·L&. 9"C'(''} 'll'lrtlrTJ'f.') 0"'111&."'1: my. h7C m·1l1' "'111'1'1'(' ),'.:r·'ItI:: rl "'1')'i'ro'9" ,/'1\11&. OO;J' YM·IIt\4.tI ,/,,011 1''''1.mLmC In. mM" mr.r.\, "'1'l'l'lf mJ'.9" 6J}'~.). mY. I,'IC 1""I:I'lor m,l'.9" h,,?C I' "'I.m rTJ or C 6J}'.). '; GL1. 9" C· ./.? n. 0" fillS hlll'lOT 4l'l''!'C ,/·r.O"n-)· n'lllrt\rTJ~' &':I'y.' fl.J'71 ,l'.lf'itl:: iiI Y.'I'" 1'J'.9" orll1.,Hi I'oor hlJ'If·:Y·i 0'1'1' m.r,'I" 'if!.~ 9u 1:C my. MC m'Il'r "'1111'1'(' rof!.9" hh7C "'1llmrTJ-l- 1''''1.rt\m· tl'lt\r tI fll~' {f. t . .,. J'.' '/OJ':: (if "'1')'i'or9" m.r. h'IC m'Il'!' ),'Mf!.1'l 1';1-1Y:) 6J}'~'(' OJ),',9" 4'7ii'i my. ,,?C YIl'I'l \''''1;I'l'lf h')"'<'I:I'O nt· ... ·'i' O'll'l')11L'~ OJGT.!. my. uurTJn')' "IC !'oDapI'I1l '1.r.;1- Mln-)':: !'if;. 1:,}OC') Oh'1C M"'1.N:C01' '1<'1t\(l:f mLCo"i'i' f!:')?'/''i' I' u·nL·/· ... l1 illS hr.:> o"'1.hM·n·(· ·1.lb nh'1C ."':'wc· M:C(ll 1''''1.OJrTJ OJf!,9" 1''''1.1'1 "'1'):;'01'9" "'01' nav'1n.Y'i' avm·"'. hA 'I),'. \'mS hlll'IO'''' ·/:'!"rc f}),'.J'.L "10')''1 f}),'.&..,. y.'I'I.). oD"]'1')' my,?" avm·'Tj·)· h),'.:r·t\.9":: Any person shall comply with the requirements for the prevention of sound and air pollulion set by Ihe Authority for the protection of public health. 42. Toilet of Pu blic Facility Any toilet of a public facility shall fulfil the requirements set by the Authority, 43. Vaccination of International Passengers II Vaccination of international passengers shall be given at health institutions designated by the Authority, 21 Any conveyance operator who has brought a person not allowed to enter into the country in accordance with Article 26(2) of the Proclamation shall be obliged to return the person to the countty of his departure covering the expenses of his stay, 44. Conveyance and Consignments Control at Frontier Port II Any conveyance entering into or transiting Ihe country may not bring or dump any waste or remains of waste in Ethiopian territory except in accordance with accepted manner. 21 Notwithstanding the provision of sub-article (I) of this Article. any person may import recyclable waste or by-product upon the permission of the Authority, 31 If any conveyance or consignment entering or leaving the country is suspected of transmitting communicable disease, it shall enter or leave the country after undergoing the necessary sanitization including spraying and permit from the Authority. 41 Importing or exporting blood. blood products, human tissue or organ, urine or stool may only be allowed by obtaining permit from the AUlharily. 51 Any conveyance operator who has brought a consignment not allowed to enter the country or waste shall be obliged to return same to the country of shipment at his own and the owner's cost. 45. Individuals Crossing Boarder on Foot Any person entering or leaving the country on foot at the time of epidemic and public health emergency may not enter or leave the country without undergoing health inspection and obtaining permission at a frontier port. iiI O?'j>;'m·9" mY. ~7C au 'j1.1'.~' fU ·OL·'·I' ·') t\I) ./,. '}-I;') 1:'I"1'C 1'0?1Q 'tMo ~"'Oj: m,'J l\<fOmO'} f\.qt\ n:1>t1 my.?" OJ\' fr Oj: !II OW rot·}· 0?'}>;<(D'9° "''1'1&, o'li;t- Mn1· '1'1111- 1""I.mLmC no'}?Y.>;' (I,';'C 1'00'l'l'lf ~'}"''':J>i'i· n~tl,· n.J'lD- 'IfllD- ro}.'.9" 1l'''I.J'cr,:nl \',,"'70S'; aU(D'''''L I~" ;.'1116. f07i;I-(J)") 't}.'.~')''J 'P'J 'P'I 9°t\hf'1' h VUh'" ~fto1' M ,VI7. 011 LP')7':'h o~"ro~' j.',<;'cn:rt\:: L'I OIlU ~')"')\, ')0,11 ~')4'j\' (Ii) ootlL'}' 0001 I' .I'.LtI(I]· f 00"10 . .1''0 oom-""l hll ;)'It, Ohll(ll fI"'l.7~ 'H"'l"lt oolP.ro·'} (iJ.ll.J'lD-'" tTC')' O?.I':l"l ~(;n-} . :: !il (II\'U A'H?· ~&.l\?'9" "l'oo"lfU''O aulD-"'/. h/I ;)'It." O? II ,). I' hll (Il- Mi !(. 7i'} ro }.'. 9" 1'10.)7'')'''0 '/·9"<· h qllp't\"l,} ''In.J' ;)'It. ~lD- :: !'ii. '.!.t-H" MO?1:l."I'O I\&.f. M"'I4IfT ,iiI "'I')>"lD-9" I"rmlml tllD- ro.ll.J'lD-~ tJ.t·,}-I;') uo.l'.l."1 MO')' :: qflP't\"l'r I',rml.ml. (H"',) f).t· 'It'} ' h').ll.J'.I'.C?lD- flU'OL'rtl'O tn.'! .1'," 17'1'>;' ~,Y,;J , 4:'I"rC Atlt\ (I).ll.J'lD-~' .rIl'''"M.t.\ :: ~I 'l(lP'tI"l~' 0?'}>;'lD-9" f).t· 'H ') NY..l1 (1(1). 0'1'''"&. 07i;J' on,fll' (Lt.;J?'!' roJ: tn.'J "''1:9'' (If!,f, 0?<f>J' h~:t\ au'lro? ,}'J M&lI'l.lD-') fl. (J)oll 'J J'l. ;J "I ''It. :: ;:1 fulll. ,t-MI filS Y..',}1'/'>;' ~J'.;J ',:,!,,!,C ~lJtI O'P'J 'P'O au"ln.J''J aulD,"'/. 11C':f I't).t-'H;,) " A7t\"Ifto')· ooll"'/. "~ah'l1' '} "'I.I'.t...Y,.) . roM" O~tllJn.lD- 1'°'L1~ tn.'O ''''II9",} (I}.'.'Y· "'I4IJ' "'Iaht. AY..'C'l oul'll'9" MO'r:: '$. .,.",,'" 07l;t-)7' To ') hC9";Q)7'r iiI 1J(lP'tI"l~ ''''I''':. n7i;1')7'1' '} lIori4l"lmC: U) T9"Ue')' f1..f.'l',}'J I\.(lo:f ;"1/11 1''''I,MMIIJ'f(])·'} .,..,/:0'/,), 1I'/'OlM 1.1b 11,11:) i II) 'I.ILJ''e 1'4:'!''!'C ''In..!' )7':f'} 0\")->;""'9" 1'~1t ,~ hOj:t\ II,N:4:9" I h'O "') l1.li-1' Mt/ll. hcrJi)7'1''} fI.IDN': I y.'f-'lt.:: Federal Negari r G,IlI:U,' No. 1\ 24\~ January, 20 l ,1 Pag,· n02 46. Suspertcd Person a nd Dnl,. to Re po rt 11 An)' international entry passenger shall be • obliged to respond to quarantine inspection through verbal or written request for protection of pub I ic health, 21 In the cOllrse of trave l, if an)' passen'ger is suspected to be infected with any comm unicable disease, the conveyance operator shall inform the head of the nearest or destination rrontier port about the type of the disease, principal symptoms and any other relevant information. 3/ The head of the fTontier port receiving information in accordance with sub article (2) of this Article shall immediately report the in formation to the inspector at the port . 4/ For the purpose of this Article "head of rrontier port" means the head of the rronticr' port aviation or Revenue and Customs Authority station. 47. Quarantine and Isola tion 11 Suspected person shall be quarantined immediate ly. The Authority shall immediately send the suspected person to the public health emergency management body for quarant ine . 21 The Authority shall ensure that any suspected person upon confirmation of his infection be transferred to an isolation room in a health instirution and provided with the necessary curative and rehabilitative treatment. 3/ The public heal th emergency management body shall organize quarantine centres in the main rrontier ports or designate the nearest health instirutions as isolation centres, 48. Measures taken to Control Communicable ' Diseases II The Authority may take the following measures to control communicable disease: aj ordering the closure of schools and other public places for a certain period; bj establishing temporary controlling posts in any part of the country; and cj taking any other necessary measures. ~I r"'l.onllh.~-:I'm· 7111''')' p'an"ln . .r,;, unm-o"l.i hAP''f' ~Y, 'llvvAfT]',· N"J..rs.C'/(!l· r-/'<,\fj6, I 07i)'p'i' 1:'P'PC \'av'!-QilC "l?;i- M~:for:: I 11'i:;:-' h9"ll·j- I rIP.';' 111l!J[l, 9" at· <;: Ii '} 1: IlI\m,';' tr1l11[], h?A"I(\-1 Federal Ncgarit Gazette 1 II 241h January,2014 Page 7203 2/ Th~ relevRnt bodies shall cooperate 'with the Authority at frontier ports to effectively undertake control of communicable diseases. PART FIVE HEALTH CARE CHAPTER ONE HEALTH CARE SERVICE !'ill. 1ltt"'lllh1'l1 h1Aj(t:1 "I?,J-p"'h' rh:f.hg"iVh.1:1l 9"trc 49. Vaccination Obligation and HlV/AIDS ji/ "'I'},;'or9" I'm,';' 'r,!;9"';' n''',!;m>- (!l'Il,}, ,/-,~'}'c: 1''''1.[1'6· \' m,'; 'lflov,y I' fhf,9"';' .I' l:<ior·) ",;, \,°UllnaV) h1A"I(\-')- auIPl') O"'l~·l·' fl',',:fl m·c fI,-f.'f- ",;, fl"';"Y'1' l'auh'lhY l1,).(l-f.'f.'} "'}.Il.(llIlJl. ",;, 1'h.'f .. hY,.'I1jr.,.I':il f9"trC h1A"l(\-') ,,'I-'t)'71' 'rI.:'· r"91:l"l "I?;f' Mn'!':: Vi (ll",l!'l' (llU" M"l'l.P'1' lIP}>;')e; Y,U') ~')11 t'I"'1Il6.7.Y~ O"'l.(llfT]or ooautY aunl.')· thW')") r"'lllh'f'l1 ?f\&,~')' M(Ffor:: 2. I'm'" hm'lO:t "'-9"uC1 "'I')'i'or9" I'm,'; ''''1:9'' !,"'I.(\(fl(l}-') MA"Ifl")' aut'll')' O"'l1:l"l I'm.';' hm'l/l<P 1--9"VC-f'1'';' OJq.;r'/? aut.'P,7''''' M'1A,~I''f' r""Il(fl')- "I?:i' MO')':: !Iii. l't..or{J'l 1'1''11:(1 thh9"'l h1A"Itr+. iii "'I'Fi'OJ'9" l'an,}"IIl'r I'mS '/-<}:9" !{I h1A "11'1 • ..,. gollmr 1''''I.1'fl&· MfT]'}' q.l1·ntl·7j I-"C'H'}e; l"hl;'<7»") hq.9" 'l1e;tlO auAIl· !,-Ife; A:: I'fhh?Ue; h1"""/0-:" h·''111 O"'l.YrofT](I}- .r.t.:<i annt.-)· Yoor htlA OmS 1'<}:9'" 01-" t\- (I;f'1 O;f'lJ"'I.m· <70'0 tY [l,'r! h~;J 01'h01'O')- I-"'i:t\- 1 Oh9"O'f\'}1l (ll.{J'}' CDJ?,9" nfl.(\-:r· auoA (I;f'7''''' flo'}' .I',:y.f\A:: 21. l';tiJ"'I.or1 m>-fr J.:j:1: M"'I"I"i1 fill' ;f'11 "'I. (I)- 0"1')'1(1, 'I J?, I' 'f' on IP t. ,,, t.:I' .r: <'I,e'/"i I' ,MI?"'; ("I (~ '7fl·')· "ullin} r'/-Mhfl ~(I)-: : II fillIJ Ii 'HlI' ')0·11 h 'N')\, (fi) 1'-1'.1'. m(l} n. 'i'C9" O"'l.h,f·fl .. )· "''l.;f' 7''1'' I' ;NI"'I.or t.:I'.r: <'Iy,n I'fhh?O';' h1Ct."I(\-·)· auillwr J'.!i''1A : Counselling Service II Any health institution and health professional employed by the institution shall, based on the medical standard and the service provided, have the obligation to give vaccination and access to HIV I AIDS counselling service to maternal and pregnant women, 21 Parents or guardians shall have the obligation to vaccinate children in accordance with the directive to be issued for the implementation of the Proclamation and this Regulation, 50. Health Education Any health institution shall, based on the services provided by it, have the obligation to provide health education and current infonnation to clients. 51. Curative and Rehabilitative Medical Service II governmental health institution shall provide medical service in accordance with the referral system and its capacity. 21 Medical service may be provided at a health institution, at a work place, at the patient's home, at the place of accident. in an ambulance or at any other similar place according to the standards to be issued by the appropriate organ, 52. Patient's Informed Consent II Medical service may not be provided without obtaining the patient's informed consent. 21 Notwithstanding .the provision of sub-article (I) of this Article, medical service may be provided to a patient without obtaining his consent when: 0) ~ ;HI"'l(J}- 6,.4>1: n. If 1'1 &..4>"~ j"/'{lm n.lfl: ouilm'}' r"'l~"fA 11"'1,11'/"11+ On VI. (ii) ;Nt"'l,m- Ol\" !I''i': &. .9>-'\.") }.'M.1'l 1'1\-)- OWhI'\(J}- (W)'l (~) 6.:P1: lIaollm'} (J}-htl<; I"f"(lmm liar l1f1.lI fl;HI"'lar I"/'-'\C '\1.>;' i A:e:! wI\:e: T WI!!: V" W J'-V" }.u'l-! w~9· (n OU") CJJJ',9u O~c.(" o.'}' ')-(\'111 •• :P.I!.' }.')ltil1' ilt\"l1 ONlmar flm-l lI) lI;J-I) "'I.m· ihh9"<; Mouilm')' 11 <j:'/"lj' I'U1U.·,·il·O mS nY.;J 1''''l'lIhh'l If~· il.11l ,II) ;I-llo~,or o"}tll\" ont\h- I' ,hhV"<; OJ~V" O"'l'}lj'arV" Mt\ "}f\o.p') }'11. "'I MIll" <; or 1 "'III ''If .}. J'-&'.'1"} ',,'I<'\OJ"'<; 0;1'1]"'1.0)' m.I'I'} I''''IJ'ilh')·t. n.lfl:: II~ 111\<1: '1--,\,). el "'I')lj'OJ'V" I'mS '11100', I';t'l) "'I.or') O"} '}1J1l. IIJ'- I"/"ouu'l'/' &.:P!!: 1I"'1"}·'i-}· '/"1Ilarl 1'l'} "'IY:l"} MM·;: §I .,j'-'\.'} "·mJ'-.f' ,1l[IV"o;(Il"} nllUD t.M·1 MI\O ;JoI,"'I. I'm.'; 'IliaD. fOJ· 9"Il;t'or OmScll' IIJ'- ilt'I"'lf{lh""I\o)· W'IIb"" 1A?I\"" .eUl~· Iloo·<j; "'lil-~uo1' .ec;-c n;t't.:: ?if Ott,u nl-"Y.· gOlPl:'· (1-/-1)°'l.W· OJJ!,V" O/V\ Y'M'';' (1)11 l''''lf'l1' &.iP!!: "'11 I'I.rIA I''''l ~:I\w' f'j-(Ilil',' I' ,),hV"<; '}J'-~ ·Y."fl n"'loollh'} OiPt\ m.eV" OY:C'l.T }'I-'1.f'l1' nonooty I]t\,t-•• -~J'. nil,t-.,.c ny.·th·<j; 1'·t-1Illl (L1f') ~(/}.:: 2C. fY:l1H' ,r,IlV"C; . iii "'I')';'clI-9· I'mS ''''1:9" fUJ'-OJ·)· nY:'} Y:'l'''' ' 'j' !"hll?°o; n1t\"}I\" )' I'ooilm')' "}i!.;t' MO')';: ~I "'I')lj'm-V" I'mS ,/"!!:V" Ollb<; .t-!!:"'I'}' 1.l1l oulll'}' 1''''I.mON1·)·') r Y:')H'i' l'ih)]V"<; ?'1A"}I\")' I'ooilm')' "}i!.;J- MO')':: ;:1 j'.t:''}?'/'r,' ;h)19"~' hC-'\;I' >.'7'111 lJl]:f(/}· n'III '" ;JC nunlf') hY.;J<; (lllC7i1 O·t-hll ,t-O '} (1;1' !I·Il· uD{lrn')' .l'.;fllt.:: Federal NcgaritGazclfc No. 11 24 110 January,20 14 Page 7204 a) the patient is unable to give his consent and such consent is given by: (I) a person authorized by the patient 'in writing to give consent on his behalf; (2) in the absence of a person authorized to give such consent, th~ spouse. child, parent, brother or sister of the patient;or (3) a person authorized to give such consent in accordance with the law or a court order; b) failure to treat the patient, may result in a serious risk to public health; c) the patient has not expressly or in any other way refused to get the medical service and any delay in the provision of medical service could result in irreversible damage on his health. 31 Any health professional shall make reasonable effort to obtain the patient's informed consent. 41 The health professional shall explain to the patient who refused to get medical service. Ihe possible risks of his refusal 011 his hcallh and shall record same in writing. 51 A consent given under this Article shall be valid when it is obtained tram the patient or any other third party in writing, unless it is permitted by directives to be expressed orally or through conduct with respect to specific types of medical services. 53. Emervenev Medical Service If Any health inst itution shall have the ' obligation to provide life saving emergency treatment. 2/ Any health institution shall have the obligation to provide emergency medical treatment in accordance with applicable standards of health institutions. 3/ Emergency medical treatment may be provided in all emergency and epidemic cites in collaboration with lhe relevant organs. • . !I!i. I'mll?"" M."l'l' o/·1l11t't> TI. p'c'}t iiI ""')>;'01'9" \' illS ."'~9" 1-. "i'l1l fllro· ;'llA O"'l.J'IV"lro· \' ;'1A "ill- ')' ;.(I"l'!' .l'.a r°'l.mOq,n·r·) I'mS MI:IGM-r l'onl1m·r '1?;r MO')-:: rl ""')>;'(0'9° rmS '/'*9" t1;I-II"'1.ar 'I'1(lar'} 'l"Cont-" mIl9"" "'1J':t.'1 r"'1f,'fA (\.If'} I'mll'l"" ;P·nllt'l-7i P'C,}1>,} -tllrt'l ;t"1J"'l.(O·') ·f··IfLro··) "11:1°/l'I-r ro.l'."'l.lImro· ,,'1'lfl J't1ar I'mS 1'\1:9" "'111-tilll~ MOr:: rl "'1')'i'ar'l" I'mS ''''1:'1'' I' mll'l"" ~{lfII'l-7i P'C,}'!>'} 'I'lIrll- I'on"lt'l')·'} ;t"11"'l. I'on.,.ntl" MII,IV' I'mS '1'*'1" "l1lt. onAIl 1'00I1m')' '1?;t" Mn')':: 9.1 "'1'}'i'ar'l" I'mS ''''':9'' M:,}H'i' ihll'l"" ;rll"'l.') roY. 1'1.4\ mS .,.,1,''1'' h""ilh' Ot-·)· 'r<l'(l\~ rmS '1'*'1" ;r1J"'1,a>-') ""<I'nt\ 111'100 1'11. \''''It.;>1'!' "l9.;f· MO'r:: lil "'1')r.'IV·9" (\m· I' .l,h'l"" ;Pflllll-"Ii /uC'}r ;"r1ll0C oooot.J"} r"'1hOC "I!!.;r MO'r:: 'l~. IltIUA&.1· mf,(O')'" I'Mht. '} 9"Coo/r iii U"~.'" m,l.'.(O,)· 1'°'l.t..:I1mar r{\ar I',,'}')A I rlMI" roo'/·,}t.7i "lllIn·· I'M/rC ' I1CQ'r') ootll'l' ll.l'.t.1 'l"Coot· om.e.(O·)· h').I'."'l.1'1 '1"')'1" '}f,~')' 9"tlh·r·:r· h').1'."'1f,;rf,n·)· 11 ,/,,)' 'ltl (I}o r lOS IJ 1'1 00' J' tl. t.:>1 '!' ~ (I}o :: II I'Mht>·) 9"Coot- I''''l.h''ro~ar \"'l)~ r')'''Ic '1.1'. 'i' I lIhlJl'I oom'} I' .l'.t.1'I tI~ I roill': I '1"'1t1..). ro.e,'I" M"I1.(1)0 ro.e,9" ",,}llll y(',(1)0 hlJtI 1''1''./:') 'l"h')J")" t1"'1(O~ 1'1.10,1.'.:' f,1J''' tI:: rl I'Utlt.·/· ihJ!,ro')' oo')M, t1"'1ro:'- 1''''l..I'.t."I 'l"CoolI· ll:H' '1/\(f}o I'mS .,..,1;9° fl.h"ro') ,£','fill:l:: ill I'ltU h').,.)';" ,}(}11 h'}.,.?, (!{) J':');>1. (l'i'C'I" "J.:r. nm.e,ro')· hrtl &.:/'J.\.') OlW'<j": hllm (JlJ!,9" ~'f ou.e,(]J')· l/uP'r htlllil lJ'If.t.1" 1'0,.1- f1.-ttl·n &.:/,.1'.' h'''''', t1,)-9"UC')' (Of,9" 1'1 'I" C 9" C '} 'I "'l I'M h to '} 'I" C uP II- "'1 J': t. "I .e,r'll:l: : Federal Ncgarit Gazette No II 24th January. 2014 Page 720S = 54. Referral System Ii Any health institution shall have the obligation to provide medical services :n accordance with health service standard to be issued by the appropriate organ. 21 Where any health institution is unable to provide the proper examination or treatment to a patient, it shall refer the patient to the appropriate health institution where he can get the proper service in accordance with the referral system. 31 Any health institution shall have the obligation to admit a patient sent to it in accordance with the referral system and give fced back to the sending health institution. 41 The referring health institution shall, before referring a patient for emergency treatment, have the obligation to make sure that the receiving health institution can admit the patient . . 51 Any person shall have the obligation to observe the directive on the implementation of referral system. 55. Death and Post-Mortem Examination 1/ Death shall be ascertained :-vhen there is no sign of life as approved by a competent health professional based on examination of functions of brain, heart and breathing organs. 21 Post-mortem examination may be conducted only where the spouse, child, who attains majority age, parent or guardian of the deceased or the appropriate organ requests to know the calise of death. 3/ Examination to detennine cause of death may be carried out by a competent health institution. 41 Notwithstanding the provisions of sub·article (2) of this Article post mortem examination for education or research purposes may be carried out where the deceased has given his written consent during his lifetime or where the deceased has not prohibited such donation during his lifetime and the consent of his family has been obtained. 'lX. I' mll'l"" 9"11 h C (JlUr "'1'}'i'ar'l" I'mS '1".1:9" r J'1l r ihh'l"" 'l"l1hC 1''''l.II'/·II'')-·) 00t.:<lP')'- 56. Medical Certificate rDt.4'"r t1;:"'I"'l. fl.tI'!' Every health institution shall issue medical .£'.1'1t1: /il 1';t"11"'1.ar'i fI'I"; 0.1'.''''1.'' h.l'."6·7\! IJ./ I''I''C 00 II· (1)0 ') ar rn. 'r" t1;t-1J "'l. (1)0 r-t .l'.t.1f1 ."I.') ,hll'l"" h<; ,.),S!. t"">;t"(I}o I'·rllmro·'j ot.<j":·)·" rncJ': !D'<'I~> I certificate to a patient containing the following infonnation: I I naI11e, age and address of the patient; 21 examination result and medical treatment provided to the patient and, as the case may be, sick leave and board decision; 1:1 \' ,MI?"'; "'1(,0:(1)' \"1' (\11\0 ')") 'I"ll J !if ·1·t1;J' ;!';', ",),7"'0 MU?M,t'l" '~' f;i'lI"'l,tD·') O)~';/,T fmS IFI.;/' I 'he; <il fl.t'l- i" hflt,/I?, \'If'I' uul)lp-'i',,):: n. (\M~M:-'1L3''I'Al',~\h?"e; /il ,,'711'11 J'I\III' ,,1 '61 t,:J',~' OO'I.f\1I1tD· \. inS 'hl;?" 'he; inS Ilt'lUD'Y (lm' f\t·7i \"/,'Ptlf, a,ll?"" uofllll')' .\";':"61:: ~I f\m, (It:1i " ''I'tlf. t'lu~I"U: "'IUO') "'Iht, \")'9" In ",,11';·\")' f·/'hfIhfI ~m.:: i:1 ',,/')'1'(1)'9" (llll' (oY,9" f7"C7"C '/'<;1:9" f\(!l-') m:r."'"T'j ';"ll{:'il"n :fI)\) :mC /I f,:}'·t\9 1J :: j1°M-50i:1'l-1' ()M.e'j'}'..~...:I~'I'r nL~.b!:ItLb.~E'i I'UlIl-U'P<\-r A1<\e; 1:"1\ -t-hI\ Feder;:!l Ncgallt G.rlClte No. I I 2401, January, 201-4 Page 7206 = 3/ date of the issuance orthe med ical t.:'ertificatc; 41 whether periodic medical treatment is nccc~sary and the patient's current s ituation; and 51 other necessary information . 57 Artificial Reproduction 1/ Artiftc il1 l reproduction service may be provided by a health institlltiOl; and health professional authorized by the appropriate organ. 21 letting or hiring of womb I(>r the purpose of artificial reproduction shall be prohibited. 31 No person or research instilute may engage in the technology of cloning of human being. CHAPTER TWO 'DONATION OF BLOOD AND BLOOD PRODUCTS AND DONATION AND TRANSPLANTA TION OF ORGANS AND TISSUES , ~I 1'1.7"'0 \'.1'.7" "''PM, tl1<'1 i "'IMl'\lI'O .56. Donation of Blood and Blood Products I'P'C"lC" )' P't·flJi' 00llq'f~')' OOClfP-'1·· II Blood and blood produCIS donation, collcction 'If!., ,~uuftC ,/'tD· aoh'OtD') 1.1\1l;fCf~:: and distribution shall be done based on r.1 \'c'\(!l- Ilf!.,Cfl') ·') /1"'1-'11 ,,1t1 "llI-'r mJ.'.?" MJ.'.1<\'f ?"C?"C 1''''I.(!l-tI .I:?" CflK,?" I'.I:?" '/''I'}, M;>i'i'9" If~ " '<j>fll! 1''1111'0 '!':J>?" I''''I.YM''i uulf') I'M') '?";: 1'.1 "'I')'i'(!l-1r' r 1.9"'1 r 1.?" 'I''/'}' /IN' flr. fl.1'\'!' r"'l.i't'lCfl' f.U1~'"'' ,!"I--/, fl.l;>?'!' ~Cfl':: !III, ft111.lltI hlj:lI-'1''1 rUlIt.-tJ'I'<\'} A1<\'1 1:"/1 1'M uuClfP-''f /il f1.'IA )1fj:1\-1''J UlI{.-U'P<\'r 1:"1\ 'rM "'Ih~-tD'} 1''''I.fl\(!l- 1"/'4'<]1(1 UJ.'.Cfl')· /I"'I.JIr')· CflJ.',7" I'(I(IJ<H' M-'} t'l"'liH"llhA (\,II 1'1·7i1\ 1."'It·~ uu'}1Y: I''''IM'1 uul1''r Omh?"e; (ICY: (I,l;>?'!' ~(!l-:: MI "'I')'i'(IJ<9" (l(1)' OUY,Cfl')· t1UD~' Cfly.?" Uy.Cfl '" 'l(l.(. 0".'1 I'n1ttl lllj:lI-'1''J UlIl U'P<'I')"} I\UDMft CflM" Or'}?" qf!.,~')' II''!.;/' ~,')-'lJ.'.Cfl(l1\. (luuhAhtl J.',';f'ltl:: L'I "'I'}'i'(IJ<?" (l(lJ< OUK.Cfl')· <'11\11- CflM" h'l"H" R".'I 1'1.'ltl h'l:I\-'f1 CflJ.',?" UlIl-u'P<'Ii'·'f1 /I"l7it'l11- 'Ot'l- r1fl (IJ< '} :J>tI Il"'l'}~'(!l-?" 'l..lt Illf1 /I.7ic J.',i,,,tI:: iii . f1.1ltl hlj:tI (1)Y.9" Ulll-u'P<'I'r /1;>0' Ilh~ A(I'O '1·'/<'In-r· 1'1<]CfJo'} :J>t., 011, U n 1~'?' '}D·1l n'}</'{) (i:) ".IPl. ')· f'lil. 'h'i.l'.If~ '/'t'l;Jo' IlHlln(!l- "'01, ""IPd' 'If.l'/(!l- wm. 1I't'l' 11"/ /.').'tllt.t'l(!l- uum\'~' K::'j"'ItI:: ~-; ... ---",-:, ~-- .. '~,: ~ principles of humanity. 21 Blood and blood products used for the purpose of saving life or scientific research may not benefit both the donor and recipient financi ally. 31 Blood and blood products may only be given to a recipient after their safety and quality are tested, 59, Organ and Ti>suc Donation and Transplanta tion Principles II Transplantation of organs or tissues may only be carried out if there is no other better means of preserving the life or physical integrity of the recipient as proved by a medical board. 21 Any person may donate or prohibit the removal of his organs or lissues in any other way while alive or after his death. 31 A person may, at any time. revoke the act by which he has promised to donate his organs or tissues while alive or after his death. 41 Where a person who has promised to donate his organs or tissues revokes his promise, pursuant to sub-article (3) of this Article. in bad faith. the recipient shall be enlitled to be indemnified for the expenses which he has incu(\'ed due to such • f;1 r"'l.h"·I1··}·1 rmt:NI" NMhII !!,If'OA: V) f'>lliA n<j:l\oi'<; tHIl- U<P<\,l ' ')"11: ""lj~i'f,Z' l iI) filll A 11~1\·)'-'l U1Il-U'1'<\'}' nqnll7i1 fnll-fl9" If', nll'/1 ~n fAIf~ h,'}:f on4'OA i ovilm1- CD.e.?" nqnilm'}- :1'1:1 on"l(t·}-! til) fil'IA lI'}:n-)'-'O U-fll-U<P,'I-}-1 <j:"'H CD.f!.9° ~'-fC(l'l- "'1M-POI'} I federal Negarit Gazette No . 11 24th January,2014 Page 7207 51 The following acts shall be prohibited: a) trading in human organ or tissue; b) receiving, giving or promising ·to give monetary or non-monetary benefit for organ or tissue donation; c) advertising demand or supply of organ or tissues; on) f7'}M')-1 I'hl]A 11'i:/'\-i-'i' u-fll-u<P<\')- d) using animal organ or tissue for the punpose lin(/}- 1'1-11 '1-11''1 "'1'1'£\:: of transplanting it to human. ~.. U,eCD-I> I]IIL flO)- I'hll.1\ tl'i":II·:r-'O u-fll-u<P<\-}-1 60. Organs and Tissues Collection from Deceased ilfloofl-flfl-fl Person fil h,}1: (\(J)- nU,eCD'}- n~nlo'l' CD'1-')' fh'IA 11<j:/,\-'I"}'O V-fll-U'i'<\'''1 nonf\1i1 h-/-il"'l"'l ffl(J)-fCD- u,eCD·I- il.fM: 1I'}q.n "-M 1''''l CD-l\- I'htlt\ h'i:I\- :~,}'i' U-fll-U<P<\'P,} oufl-fln-fl !!.r'\b\:: Ij'/ "'I'I~(!I-?" I'mS 'hl.'9u h'lnp'AIfJ'r Ar L:J>!: <\11''S 0It\! h 1-1'1\ '}O-il h '}ojo1\ (~) oo(\l'r I'hl]&I h<j:n-i-'I ~'O ulll u<Pil:'-1 0011111\1\ M',:)'- A?":: 1IiJ>- nu,eCD'I- ~NI M<\ 1''''L.4'CD?'' ~ ,}-'I~l1 l''''Lffl!!, 1'1\ 1I-<j: ODlJl IIA'I'71'l I'..,.:r- f-l--'!C 'l.l'.'i''i' M\i' OJj!,?" ~'l'r'i' M'r CD!!,?" CD,}!:'1"i-'O ~u-r·i: h'}.l'.q..l'.9" 'I'I1-1-'I1'(Il> OA'lilCD' h"-il"'Iao. ho:t:r Mht.'} n'IN, 'I'M !''''l.CD-l\- l'illJl:I h~n·:r-'O Ulll-u'I'fl'r'} aoflllflll ,l'.;f"A:: W OILU h1-1'1\ 10·il ,h'HlI' (e) CD-il'l' 1"l-IlllI-:")- '1Mn'f' 1Io:t:(: '1".)- ?"In,l"} Oro,})(A I""mlm-:' hlf~ h..,,:r- Milt. 1 t'nq.t'I ·,.M f"'l.CD-l\- f~,IJ&I h~/,\-):'O Ulll U'ffl1' Mil1 ou'}:;r.."; h,l'.)··I1-?":: (;1 1I.7i'i- n;r.fI -HIli !:1.7'lP'i·1 '/-h')'/'\ h,)!: 1';1'(J}.p " '-I'I]~, rMftCD- ,rm.4''''l. h'M.If'} lJilllIt OilN'C I'h111o'\ 1I'I:fI-i''O UlIl-u<Pil'}' '''-I''1I':r- 1: &I.l'." I''''l.CDfI ~CD­ Othl1?"'i'CD- M7Jl~ Il''I.;1'P'): h1-lW-?" O~'rU'O C'}-(J ODclf>"i' 'If!. nononfll'l' ""If') ilIIO')-:: XI 1'11.70") u&I&.',- U.I',ro-}- r°'l.,I'l.7"1m·') fmS '111""'f>"1- hll-fl·)· J'''~fI' ""If') ~'i' • '};r.n-'I'h'!CD-1 h"'l.flJ'l.-'!.'I- I'II\S (tn f>,,:r- NIIIW f'l''1-?'' '1')1-~')' ft'lNfCD ""If'} hf\ll'fCD':: I I Where a person has consented to donate his organs or tissues upon his death, the organs and tissues that can be used for transplantation may be collected upon his death, 21 No health institution may collect organ, and tissues pursuant to sub-article (I) of this Article without obtaining special license from the Authority . 31 Where there is no wrinen evidence showing express prohibition of donation made by the deceased, while alive, and where the spouse, children or parents or siblings of the deceased, in the order of their list, agree with the donation, organs and tissues that can be used for transplantation may be collected from the deceased. 41 Where the individual, listed under sub-article (3) of this Article are suspected of crime for the death of the deceased, they may not have the right to give consent with respect to donation of organs and tissues of the deceased for transplantation. 51 Unless the donor ordered a particular recipient as beneficiary in accordance with provisions of transplantation, selection of organs and tissues recipients shall be based on compelling medical reasons and the principles of justice and equity. 61 Health professionals who declare the faCI of · death of the donor may not be less than two; and be different from , and have no monetary relationship with, those who conduct the transplantation, ',-' , Federal Negarit Gazette No, II 1.41/1 }wlUary. 20 14 Pa!;c n08 ~=======================r====~ = t./i. OUr.lDo}· .lJfl oor fhll" . h'/:{\:'1S'JJjJt:IJ'f.'I.:r1 61. Organs or Tissues Collection frolll Li \' ing !'l.f\ooOl1l'lil iii nUy.01'j-. Ilfl OlD' I'hllA ll'/:fl-:r·'l 'Hll U'P<,\,j-.') unarM: f"'l.;fflar Ol'l?o. m.')~"l.<; Uy.ID·)· 'If. PM.'; 11'11: hY.? I''''l y"Vl'C uoll"r fI:I>-)' <JilTeD- I'm,'; IJl'lou'Y?>'!' l'I.;1'oo·)fl')·" I''''l.h·/,I'I·')· 11-~.;1' p>~'. 1'1.":1,1'1' f.1f"A: 1/) fI.:>o. fl,),,,} 6,')' ~:fl-". Yflar If, (I"}')tj(l. 11,1:'. O'I'ooOl'I' 6.J'J: oofl"'l "'l'~') II-fl')' 9"flhC'1' IJfI'{I')' (Ill' II''/: 'll.:>1m I he; fI) fl?o·: (Ii) h'/'1' QV, ?C f')',I\C "}'r'i-~')' O1~9" I' f! ? (]l f. 9" 1'.:> fI;f 119" J: e; J' fI eD oolf~'l 01,1:'.9" (11) h'I'</'<J~ ?C \,')·.I\C "I'),hl' 11JJ!,9" ffl? (]lUG I' .:>fI;f 119"J:<; 1'1I.1'IeD (l,If') {lII-I'\'/: oo'lhA 9"')9" ~~~'l' 1''1'0}>9'' "}'r'i·~'l' Moot;'.;. I !IIlu J'.'HI h')-l'f, ;li~ (I'I'm</,oar l1t1"t·'f !'hiIA ')o}>fI 'I'M /'I"'l.'" h.,·t:?7m:: V,I I'ILU h')-l'1I' ')o-f! h')-l'lI' (Ii) UA 'I'&- (II) J';').:>1. n,<;'C9" flhllfl 0010') 'IAJ.lO (lar nM.<!7.1D' 6.:I'J: rCf!A</: h'l")o)' Ufll U'I'f!i oo(\{lflfl y,;flltl:: tl "'l')>;'O1·9" 1'11\,'; '1'*9" h<JflP'AtlJ~ A~ 6.:I'J: f'lJ'1~ flll,U h')<j>l\' ooM')" rhllA h"~1I-1") he; Ufll U'Pf'l 'j-.') OOflfl(lfl hr.'!' A9":: ~11. M1o}>(l 1-M iii "'l')'i'ID'9" I'm,'; '1'1:9" h<JflP'AtlJ~· M 6.:1'1: f'lJ'1~ I'hllA h'i~fl-'!' he; Ullt: U'Pf'l,j-. 1o}>fI 'I'M ,)'h9"<; h1A"}fl--r') ooflm-)' ~1f.~··A9":: MI IJflP'AtlJ~ I'hlJA h<j:fl-:r.') h<; uflt: U'Pf'l')'') oo(lllMI" ')o}>fI 'I'hll rhh9"'li O'I'OOflh'I' "'" J''l! P'~ 9""}I)';' ') '/-h')'fl MODh~·(]l~· I' "'l.J' t: .:> "} 'I' 1l,h.t· 'l! !'hIJA ')o}>fI ·/-M /1"'l.'L- n:<I<"'lA:: el 1lrh.&.'l! I'hllA io}>fl '/-hll /'I"'l.·~ar hJ">,I\'),I\. ') i")o}>fI 'I'M 'I' N' f'ln1::" 1"):"fI 'I'h'l rhh9"e; h1A"lfl-'j-. "'l'I'/,1: h~;fA9":: 1f'~9" MI6.'I'/. I', (l, 1~ 'n,h.&·'l! I>"'/.'L·ar "hAA .\:,:)1 fI"'/. **9" I' hlJA 1:"fI 'I'h'l 1>"'1. 'I; r P' t\'IJ') ol·IIt1" fI.(l'l' ~'f"tI: : Person ~ II Collection of organ or ti ssue from a living person may be carried O,Ul where competent health professionals believe removal Qf organ or tissue from the donor does not pose any serious and pennanent danger to his health or life and where: a) the donor has capacity to give consent and enter in to juridical acts, and agrees in writing. based on infonned consent, in the presence of two witnesses; and b) it is established by the National Transplantation Committee referred to in Article 62 of this Regulation that: (I) there is spousal bondage or relation by consanguinity or affinity between the donor and the recipient; or (2) in the absence of spousal bondage or relation by consanguinity or affinity, there is no monetary relationship between the donor and the recipient. 21 Notwithstandi ng paragraph (aJ of sub-article (I) of this Article. bone marrow tissue may be collected from a minor upon the consent of his guardian. 2i No health institution Illay collect organs and tissues pursuant . to this Article without obtaining special license from the Authority: 62. Transplantation . II No health institution may transplant organs and tissues without obtaining special license from the Authority. 21 The Authority shall establish National Transplantation Committee with a view to ensuring that organ or tissue collection and transplantation is being carried out in accordance with professional ethics. 31 Any transplantation may not be perfonned unless the National Transplantation Committee approved the transplantation request; provided, however. that the National Committee may, where necessary. give delegation of power to a transplantation committee established at regional level. 7l\" :.1lMj'jJ t..s.t·A ~.'t·l· ."Ln, 'I'~'C Xli 'rc :;~ ~"l KiU ~ .?". ~-~~iP'F MmS fjft-$'9':j~ ?"o&-'I: h1f: M-f M· l.:!,f: M"l'r'1 4J'l"rC gr, rillS -f?,'f1 M(TUM'iro '1 ll,~oo'f I-"t- in.: Ml."1.~r iiI 'lftIUAffJ~' fmS ~IIOf>.f?':r-'} ,l',OffJA! )"oull"lflel! V .f I-"t ,l',O"lA! I' (1U. Y IV (" CD(I') R-CDfl'1 tI:: Ij) 0n~'(I}9" I'{TO'Y 1-"('. /'.:n.: f'/'Om(/} {'m') 'lftOO'f OAf. 1>111.'\1'0 (1.'1,;1' h"l'l11 YIICD' Nitl O"'lJ\m(D' tlf. (/}IJ'L I]tlln OM'4'C hoo.,!'(D· {,flt· (DO') (D."};'. "'l1'i'(D")?" 'H',~·)· I'm') h1A"IIt-')· oullm')' h,l'.)··tI?,,:: el hh')J:': O'l.l'. r(}'~ !'mS""'$' YoOl' !IO)' M/,.'I1.CD·') oufl;'.C·)· MI]"J." f: I.fl I'm') fllll7D·f Olf~/Fr·(Il· au·;?,'·),· I)·ft· oo{]t··)· f"'l.Yfl :l'IICD' I' an·~' I-" t· l.:}> f: "'l"l7')' j!.)~'ItI:: g§. hl\m'j' Ijll-,I'?''f 01>11111 iiI '1111-" Nll~' OId'I'II'Y CD·ll']' I-"t- I)j!. 1''''l.1'5 "'l1'i'CD''l?'' I'mS Ilo-f fl?"! tt"l~')' oof.(l~' \'oo';'I.Y') I'rut- hf:Cr7i 'h'1 1\.1t-~'9D Mit.'\? onl.p.9''l~1 1''''l.WIt 0011111 ,l'S/''PtI:: fl "'1'l'J'CD'?" I'h<j:·/,'i' ')'9"UC')' 'hl:?" OmS 00'.1' IIC'i: 0I'1.1I.(/} f"'l.YflooC:}>;I'CD·') 9"<; :1'1 11C11C t'IIJoruA"l'r 'h'1 h"lll11 'Io(/} hl]A 00'1)) MO')':: ;:1 OIlU h')4'?;, '10·11 h14'l\' (Ii) ooll/.')· 1''''l.Y1I 00'11111 ),1Y.M6JI1.'I·I, o;hll'O "IA'f. (TOY.I."1 MO')':: ~l; . . I'oo-f flt- l.:I'f: Moullmr /il "'11'i'ar?" I'mS IlIl00-f Ililrutl"l~' om') oo·f fit· l.:I'f: YOJffJ'foJ-') oofl/,.Cf·';f· h":l. A f. 0. 1 'I I'm') 00' ,!' rut- l. :I' f: ,l'.Om'PA :: '1.1 h"lIl·O YIlrJ)' hl]tI hilA II1mooar I'mS 1l0{TO'f 'h1Y. h"lIl11H 1Y.11 \,·J-.r.1.10·)· I'mS oo·f rut· ;'.:}>I!: oJI'r ,!':')"'ItI:: ;:1 '"11"'(0'9" rIlL <; 'lOuo· .I' O"'l'g'(Ir?" (TOAI!' roo·f III.· /,.:1';;") 111\.1) (IIJ./.", CD?') t'l.YII·/''ItI<j: CD)',?" o.fht·)', h)',~~Mo:: Federal Ncg..tril Gazclh: No, 11 24'h Janu:lry, 201 4 Page 7209 .----~~ PART SIX HEALTH PROFESSIONALS CHAPTER ONE PROFESSIONAL LICENSING AND REGULATION 63. Designation of Health Profesliions and Requisite of Professional License II The Authority shall designate, register and license health professionals and set Iheir scope of practice. 21 No health profess ional with professionalliccnse may provide health services beyond the scope of practice of his profession unless with special decision of the appropriate organ in exceptiona! compelling circumstances. 31 Any person qualified with more than one health profession shall be entitled to a professional' license to practice all of his health profess ions so far as he satisfies the necessary requirements. 64. Health Professionals Register \I The Authority shall have a register for registering every health professional practicing in Ethiopia comprising his name, nationality, principal residence and place of business and such other necessary particulars. 21 Any higher education institution shall send its graduate lists in health profession to the Authority and appropriate organ. 31 The register to be kept in accordance with sub article (I) of this Article shall be open 10 the public as may be necessary. 65. Issuance of Professional License II Any health professional shall be granted with health professional license upon fulfilling the requiremenls set by the Authority for hea lth profess ionals. 21 The appropriate organ may issue restricted professional license, as may be appropriate, for impaired health professional. 31 . No health pro ressional may in any manner transfer or rent his professional license to lhird party. 81. r-r flt· t.;Nf: M"'If\UI (il OI,'P»; h'Hr, l!it(~) (]Vrll:')' O~'l'i'or9" VmS flt'lno·J' l'un.J' I»t- '.:/,~') t'l"'lllf.it I'I.·/'Cil:· II) 000'.1' IlC1· '~Il;J';J-~ v=-y "'11AM' (]VID·M.·) YD 'l.J'l.'1"I'l' r9"ithC ID/''''')'I ).<; t'l) (]V·J'ID··) 1'I"'lh<;ID') V"'1.Yit'l'A VmS II' 'b;J- ). ').I" t'l or 'to'Z,J't. .'1"I'P V .nh9"<; 9"ithC m/.,H· 1 "'11'/.·0 ,eSCO;J'A:: !l.1 I'ItLV h1.pl\· ll'1A "'~h;J-;J-~ 't-Y "'11t1 0;1:" "'1(\.). '1fl1»A"l~' O"'1.Ym"lor (]VootY ooM.·)· "'11'i'or9" VmS 'IlIu!).! 0P't- II)?, M'II non'J'or Y1'ior') ).or.p·)·<; hvlt-·)· m·tH'- I\·i,e",~,e. 1,'1 \'Uo.J' '0:'''1:') t'l"'l~AO')' nY·W.m· 't"'1.lD!lf.lD· P'Am'l ~or:: ~. !"Hlm r-! itt- "N: r"'1g.itt-ot '1~ iii "'IWlD'9" rmS flt'loo·J' hl/·t'l·)· '100')' 0I1.e O"'1')'i'or9" 9"h')f·)· n-!or II~(\(" hollr IDf.QU·! P'':·ID· hooooM· n.,·)· h"l'l11 IIt'lor hlltl "'111ID:r MM·: : iiI h'7'1 'O ,l't'ltJI- nllA OIl.V h1.pll' 10·11 h'''''lI' (Ii) r·~oot'lIl·"'J}o '1t'loo-Y ~,1f. h"l'l11'I'~ 'I'h;J-;J-~ 't"".y "'11AOf oom·fl.'\.·) '1 "'1.n .'1 "I 'l' "'1 itt. :<I ). ·i·'tt 1'C 11 ; II '" m <; ).'i"l.(JJII.I': ro$W' nllA flt'lP'A"l~' nO'Z,uoc m or 't mS 'hf;9" or II 'I' nO'Z, 1 ~ 't mS flt'luo.J' P'C Mlllit~ 1,tL nh')--)'A ).1-'1,(\(,. O"'1.1':t."1 O=-Yor )'·M.itt· 1'I. .. :r.l':t'l.). ~~"IIt1:: i.'1 '111<70' y(O. h 1i·1I-)· 'I""')' Oll~ 000. Y(II 1I~1'I6· .~ Y,'y, n'7'1'O 1111(11- hIlA IIyllar'l .I': .'1°'1. Ou!). YID' 1'I.1'It- n.1~ Ylloo·Y itt ":/'.I': h ·if .... ,:· .e·f.m':·A:: 8;;;. nor'l" h1C 'tMm~ rmS flIIOD-! . ~ ... ,... ... ~ ""'~ . iiI mil .I':i11 h·).pll' ;';'?i(?i) .1':').'11 ).').I'.·I-m01' lf~' ).ID·~·<; 11 ... 01' rm·"!." h1C '1'*9· itAm<; (OM'. II"'" Y 9"111'1'1 '.:/'f.' 'l' Yot 1'0000Y."C11 "'01':, tI) I»Ann '111m- "IIA 1"~1I1Il 1")'9"VC')' "'111t. Jl h f "19"')' "'1/' .'1? ""L "'1;p l. 11 MO')'! II) 0"'1·i'1m·9· m·"};" h1C O""'Y(II- t'looll':··)· '.:/'.I': ',m"l'-f' hll·lI-)· 'l""')' OilY. YAII6· hlf~ h"l'l'O YIIID' hll'" O''1.uu.l':nm- fillS ''''119'' 1111.1':11')' IDC Mh h·).e: '\UD')' f"'1 . .y.y, \'''-·i·I·C')o.T T (:' "It· 9" "'I fIl <; 4':to ~ '0' C 0;1' '" :: .. ~ .. .-. - . Federal Negarit tiazcltc No. II 24'ft January,2014 Page '/110 66. Renowal of ProfessionAl Lieense I I In applying for renewal of professional license in accordance with Article 33(2) of the Proclamation any health professional shall present: a) certificate of completion of the required continuing professional development in his profession; and b) medical certificate proving his fitness to practice the profession. 21 For the purpose of this Article "continuing professional development" mean$ a training periodically anended by a health profe~sional during his practice to maintain his professional knowledge and skills and enhance his professional competence in accordance with the directive to be issued by the Authority. 67. Inactive Slatus II Any health professional who did not practice his profession for more than two years for any reason shall notify the appropriate organ prior to resumption of practicing his profession. 21 The appropriate organ may authorize the professional referred to in sub·article (1) of this Article to practice his profession upon requiring him to produce evidence of completion of continuing professional development or causing him to anend training, or to work under the snpervision of a competent hcalth professional working in a health institution chosen by the Authority. 31 If a health professional who did not practice his profession for more than two years engages in practicing without notifying the appropriate organ, he shall be deemed as practicing without professional license. 68. Health Professional Trained in Foreign Country 11 Without prejudice to the provisions of Article 65( 1) of this Regulation, any person with a duly recognized foreign educational background applying for professional license shall: a) produce evidence of equivalence of qualification issued by the competent body; b) complete from six months to a yearlong intemship program at assigned health institution by the appropriate organ where he did n<?t practice his profession in any foreign country for more than two years. Federal NcgaritGazettt No:'1 24lb January. 20 14 Page 72lJ ~~~~~~~~~~~~~=========== I]) I'II.U 1,1'~)1; ·}D·h 1,"'/')\' (Ii) J:1:n fiSC?" 21 Notwithstanding the provisions of sub-artic le = hll·/I·)· <}oo')' O'lY. (lCO·"!." h1C Y1I11/1 I'mS (I) of this Article, a health professional with fl/lOD'J' 1'·""'Il.fl')· coy.?" I'M·fl·)· h'IC more th"n two years of professional practice in I'flo;.!· p'C"l."·)· hlt,')'l'k,l' fflO;.l' P'C"l."·)- any foreign country shall complete internship .?C 1''''1.e''l''l?'' hln 'l1\P'A"I~ fl"'1.coll)ro' program as detennined by the Authority if the f'flJttL')' \'n.~H·C·i?i.T TC"lt.?'U U'fmc;'I'~' disease pattem of the country of his training or Practice is incompatible with Ethiopia's disease j?<;'CO;.l'A:: pattern. 1:1 1'1I.1I h14>)\' '10·11 h1,~)1; (ii) h<; (lI) 31 Notwithstanding the provisions of sub-article t:·'.n?':-': fi.':'<,?" <I11P'N']'" hco-"l." h1C (I) and (2) of this Artic'e, the Authority may IIh"l."C 7.tt fl"'1.·P.\'. I'hClI;.I' Ilt· i 11M • .? 7.t1. issue temporary professional license for a health 1'(\11<}'l? hell;/, coy,?" (iflIlI"A"I'" fl"'1.cofl'" professional with foreign educational lIt..tr:f. I'mS 1,1A"III'.r,:I: 11"'1.0011\' background, where the professional intends to provide health services in short tenn charitable CJlloo-J'?':f 7.llJ''l? 't .r Ilt- /..:I't: II.fl'l' activity, emergency humanitarian crisis or other j?'f·I\A:: health services to be determined by the Authority. iii fillS Q/lun',I'co"} O?lt,l''f'n· ,l'lloo"lco' 1'*?,,: II) CJlloo· YeD- .~ MI'eD-" II.J'Ill<;H' (1)1\. J'CO'''' 1IIJ1lp'A"I'" 1''''11'\co:P<; /..:I'P,. h1·.tooflll "'1J:/."I MO'}'! II) fllloo·Yco- o "'1. I'l III CO· fillS h1A"Itr~· 1I"'I.J'.C{t 7-1I~' r"'~'hh l1,h.C ::>'l&,)') .e<:'Cfi;/,A:: ~I!. f-f P't- .!..4'1.'1 !lIIooooll!l "'11'i'co-?" fm.<; '111-Y f'~flmco- I'-Y itt /...4'1: (t;.l'1 J: CO j?9" (t fl /. 71 CO j??" I' OO"lfl'}'1 ,,.,M/1 (tlm'l:":P COM" f-f flt-CO-'t fl,'I'm f' 00-lilt- /..:1' J\. 'I IIIJIl P' A "1'" f' 00 00 M "I ~ ;/' M n-)':: 9" 6t-'I: trfl-r f'm", flfl-f I"~ 9"'?flC it, hm.t"& ODC If E:f "'11'i'co-9" I'm. <; 'lll -,1': lit M':<t'l! j?U') .l'.'Hl roj?9" h"l'lll ,l'lIar1 "'1"'i'CO-'I9" U"/ 0"'1.'1'11 ooAh· P't-CO-1 "'1h<;C01 fIlO')'9" ! ~I J'It?"1?" hJ: A?' I'm. <; 111'1A.?.e oollm')' MO')' l [I 1I-I'1A.?).'. m.1)·)·<; '1:1\'/')' :PJ:"'I.f oollm'} hlln~':: it Ii . I'm. <; - f P'~ 9""I'l C /1"'1.1: iii f'm.<; oo.y P') 9""ICJC 1I"'1.,t (hllU OJ.I\ "/1"'1."''' hl'-rCJ1I l''''I.mt-) OIlU J'.111 "'*4<",-A:: 1/ 1't>"'1, ' ~CD- M"~' 1,"Ifl11H' tjl\'fco· 1''I:'''1T I' "'co'''Im' CJlloo· Y 9'1'· tnco- 0"'1. '1. 11 T';' .eM"'1I1· j 4<'I'&· 'fco'?" h1J'.Mt.tt7. H, j?CO fI'lA:: 41 The institution which brought the health professional on temporary basis shall: a) upon the completion of the professional's mission, notify the Authority and ensure the surrender of the temporary professional license; b) bear civil responsibility for any damages caused by the health service provided by the professional. 69. Surrender of Professional License Any health professional shall have the obligation to slU'Iender his professional license where his license is suspended or revoked or he completes his mission or relinquishes practicing his profession. CHAPTER TWO HEALTH PROFESSIONAL CODE OF CONDUCT 70. General Principles Any health professional: II may not practice his profession in any manner that violate the Proclamation, this Regulation or any other relevant law; 21 shall provide health services to the client without any discrimination; 3/ shall give the utmost consideration for the health and need of the client. 71. Health Proressional Ethics Committee 1/ A Health Professional Ethics Committee (hereinafter the "Committee") is hereby established. 21 Members of the Committee shall be professionals drawn from the relevant institutions and be designated by the Minister, and their number shall be determined as necessary. Fedcnd Neg&rit Gazer..c No. 11 24'" January,2014 Page 7212 re-'=-- .. = = ---,= . ====~"'i""~~~===-=-""""""""'"""""" !fr. 1'/1~:!:(]l. ~t1~5 .. ~1!,.jiJj:. /1"'/. ·W}:· iii .l'.lJlar') fjAmn.p I'mS h7A'7(1o·)· ).·)~tr9" flj-·)·<;, oo',f"e 1"'~·9"'7I]C O1.1'.lIar I'mS 1]11-f 'If, rD'l, .pcn- il't.;J-JD"!',} 1-.pfl(lo J'''1t·t\ I f,ool9"lrtl ilOlll.l'.' 1III"'/.71]ar hfH·P,Y.Ir'e ).C9"Ji rarl'l'l. '11'1'0 Mill'" A"1~' f '~C'lA! Jl.1 !'4>lnll ')"} nil 11"'11':" 1''''1.0:1' "'IlllJi 00'1';") ilJ'l.?'7'J' I'mS fill-far 0lj?9" 'r!!:"'" ""tll'l") Ml .p'} arll'l' ).'}~f4>CfI Oou'J'6J'ar 'If, 000'71111' il't.;:I-(1l. lI."lno·} hIlA f,Nltll l'1 ?'I'lflOl'/ ;P,;,;t- 1I°7"1Ir')' ).'})'.Mt.'I1. ~,,, M.~I"'.VT1~· .?C non"'lhC 711&11->;' 0"16 ~\'It\ 7')·V,.ffl](,·tI,)· tI.II)'.!!" f,':j''IA I iii ~'7 flar (J)o''1'1. hIl h"'/. 0 'I' Y: III I' - f Illr t.n: mj.',9" I'·o:l"}· "'Il.?7""1. ?UlIhC Oll</>')' ).'}~;J-1Y: I'arl'l'l. '11'1-fl MIII"'A"1~ 1lJ'4>C·jJ )'.'f'ltll (; f Il1-y..? .? "'/. I' "'/. ."cn- iI' to;J-JD 'f '}<;' M . oj, ;J JD~"i up'IIl'l.JD'f 0"'1'1'<;")' ,'"le''ll ml'l<f:~')' M"'I .•• ·pn')· I}·'I.;!· I'TII.i'l. '11'1n:h foo~ :;; II.II-'f Ol]tll"'':V'1~ 1''''I.om')·'} ''''7'lIr')' fh<;,ar<;'A:: itr. 1'1l'7'1:tar lIf1MEX {ill> "'/. 1; ar III'" /.. ar 'litt.1I1 aum'} f,on M A :: MI 1I1>"'I.1:(D· M'.-l· h"l"'li'i O'lf, r"'l.If'rr 01>"'/.1:cv- Ilflll'l ttf, 111-71' 9"A't1- 7·'l'l. )'.1f<;'tI :: rl I'I>"'/.'~Ol· 0l·I'I'I. 0.1'.'9"1.' flA65j, .I'M·A! 1f,9" .1'.'9"1.' ).h·A O)'I1'A h~·ht.t1 itfll'lflCII I''''/.Y. '7 t.m· 0l·I'I'I. ,r tI 'i·A: : v.1 I'llo iI'}'l'lI' Y:V?JD'f ),,}y.1-m041 If, /1"'/. tOl' I' Iro''} 1'1If1o'l I"'~ I"'C'tr Y. '}fI ilfOl"1 )'.1··'ItI:: itli. !'m,','ll\oo'}' .'!''i''E'i. '11,i-HJ· iiI ). ,}1.llt· .I'.·C7iOl· o"'/.omar I'mS h7&1"ltl- ,).<;, O"'l.Olll~ar Cll-I'I'I. ''''JlJ'oj:~'). MO')" if 0 "/l]fI I]tlCII- 0'7 oulll'l' I'mS 07&1'71'1")' lloullm1: 06.')' l'·r7&1.:>f.') -it· {,.j-.I'.' D~''I1-)' MO-) ' I 72. Powers and Duties orth. Committee The Committee: 11 shall examine, investigate and propose appropriate administrative measure to the Authority on complaints made with respect to substandard health services and incompetent and unethical health professionals; 21 shall, where il proves availability of sufficient evidence to support the complaint, send summon to the health professional or institution against whom a complaint is lodged with the notification to respond within 30 days; 31 may, where appropriate, assign an independent researcher in consultation with the Authority to investigate the complaint; 41 may propose suspension of license or certificate of competence to the Authority until the appropriate decision is passed on the complaint; 51 shall, upon identifying the root causes of frequently lodged complaints and grievances, propose policy directions intended to provide sustainable solutions to the problems; 61 shall perform such other duties that may be assigned to it by the Authority. 73. Meetings of the Committee II The Committee shall meet as frequently as its functions requires. 21 The presence of more than half of the members at any meeting of the Commi"ee shall constitute a quorum. 31 Decisions of the Committee shall be passed by majority votes; in case of a tie, the Chairperson shall have a casting vote. 41 Without prejudice to the provisions of this Article, the Committee may adopt its own rules of procedure. 74. Main Responsibilities of Health Professionals Any health professional shall: II be accountable for the health services he provides and for his decisions as per his assigned duty; 21 obtain informed consent from a patient, in accordance with the relevant law, before rendering a service; 1)1; liUE;: t..f.<'rA l.ot·)· .:>'1"1 ·',1'C 1:6 'rc IX i") ~lI.l ~.9". Federal NegaritGi!2C!te No. 11 24· Jan uar)",20J4 Page 7213 =-==~-=-==-=-=-==-==-=========r========='----- -' --CI hao'J' >,;J<-9" In h"'1t1)j?, ,;>C 0"'1.,PJ'.C10l· uo.,p'I! 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Ilil O·!-uoJ'.OO·)· (l;l"r, 1'1lt· IIq,)· Ollt· 10;/'ro 'III, iluo11-l- "" .. y'!! ~1A"JI'I- ')" oullm ')' MO')'j Ifl I'l)fll,NI-I1 mS TC'"Jt-'l"~"} O"'l,>/>Cl\,n-}-'1 0"'1,'1'1-0CO')' 7,tj, 1'1)'01.'1·1\0· '} .I' .... ;/' ~ .. /7·'i t.:j>f, "M- "'1l,;>7')' MO'}-, If:! au·yOl·'} O"'l,<1Ol'Ih')' '/'P,y, 1,'7'l'fI J'f\Ill' 1,11/:1 1''''1.tlmlll·'} U;J'P. ')'0'111'; 1''''1,,!'mfIJro·'} I'hlP/'·C I"Cq,} ",/),oe MIO')':: ~~. l!O b7A7o-t h'Ef'1 /1"'1, 7i1 fil f\"'I,lImro- h'ltI "11'1-'''' h"'1.mj.'.>/>w· 1'~1t1"1 fl-'} h<;:,i' .ro·m, h"'l');;'cD'9" IIcD' cD)?9" fillS fll\ltu-..f' mJJ.?" -I':J:9" tltfll.7i'} my.?" 0'l~' 'I'a)o'}?O ')'~,?O (I"ml")' OJy,," f1o'~ntl I'fIn:"?" I MI 't1A;Jj?, h')Jl"ht'l'-" lI.tI 1'I"'11'i'ro'9" flw· tt"'l,7i'} uol/t.tI cDy,9" o'J'1'1'al-'}9" 'ro/? <1OlIm')' l'fIn')"," I !.'I DO·Yro· 11"'1,6,')'.<'.(0' ro'G1J, h1JlYh'>ro·') (O~9D t1"·.f'm- \JO'l,mf,·f>(D·'} ), 1~J'h{";m'1 '1'0<;' fl"'lI'lY.C m.e?" ;I"I"'I,cD' t1uhU\ 11"'1, ?lJro· Oil,!'. h<;:.I' h ·)-'\,t!<;:tI n"'l Yo'l "I 9"19" qj?,"T h .. .I' roM" M 'I'~,9" uollm')'9" If~ f1O'~nA rflo,}'9": 31 provide genuine and during profess ional colleagues and clients; adequate information communication with 41 respect patient confidentiality. privacy. choices and dignity; 5/ maint3in the highest standards of personai conduct and integrity; 61 discharge his professional duty in a team work respecting the contribution of other health professional ; 71 provide appropriate counselling service to the client; 81 update his professional knowledge and skills to new medical technologies and innovations; 9/ maintain proper and effective communication with his patients and other health professionals; 101 register and keep accurate client records; 111 avail himself and provide professional service in his working place during assigned duty hours; 12/ ensure public participation and acceptance in designing and implementing public health programs; 13/ comply with any lawful instructions and procedures of the appropriate organ with respect to his profession. 75. Fees and Commission Any health professional may not: i l accept commission or any benefit apart from service charge from a person or another healih professional or institution in return for the services he renders; 21 pay commission or offer benefits to any person for recommending patients~ 3/ offer or accept any payment or benefit which is intended to induce to act or not to act in a particular way not professionally indicated or to over-charge patients; • iii 11(.·1\· m,!',9" MII1L!O' mJ',9" r.flC'·)· O"'l.l\t·(o· mg.?" 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Fcd\!r.l1 NegantGazctlc No. 11 24th Jm~u:lr)', 201 4 Pllge 72 14 4/ charge or receive fees for services not rendered personally or by his employee or pallner or substiiute; 51 receive payment or allY bellefll for recommending or referring patients to another health professional, for treatment or· for participation in clinical trials or other research; 61 provide health service, for his benefit, thai docs nol serve the needs of his palien!. 76. Practicing with other Health Pro["ssionals II A health profess ional shall employ a health professional who is licensed by the appropriate organ. 21 Unless for training purposes, a health profess ional may not work with or give any kind of professional support to another health profess ional not licensed by the appropriate organ. 77. Profession.1 Confidentiality II A health professional may not disclose, verbally or in writing, information regarding a patient unless the appropriate organ believed that there is a prominent health risk 10 Ihe public demanding to do so, it is ordered by a court, he gets writte n consent from the patient or the patient's guardian or it is permitted by law . 21 A health professiona ' may release or transfer information regarding palients for the purpose of conducting scientific research or studies where the information released is in such a manner that it does not identify directly or indirectly any individual palient. 31 A health professional shall encourage a patient with communicable diseases to disclose his status to individuals with potential exposure to the infection. 78. Preferential Treatment and Referral of Clients II Any health professional shall render the same level of care to his clients in ilinerant and resident practice. 21 Any heallh profess ional may not provide any preferential treatment to a client by considering the relationship established with him in another health inslitution where the same professional works. i.'1 h1t1"II'I"'r. (lmS " ';:(lD' r"'1K;I"i Mlltllf'6 J' II(IJ- ') 1''I'~'9'''' I' I~' t- "I') "i.~.). "I t:I'/; hj!:C7- 1'1 ,1-1 I"'I.W· MlJf:\1f\)\ ~:/.{I "'1'):;'(1)09" I'mS 'MODo.!' hh').t': I'mS .,.~?" W.~ (VI 1""I.I'II.·n·). rmS 1'~?" ;NI"'I.aJ·') om'lh h,e.'··t:l9u " iii flit u h ')",'/; ')0·11 ~, ')1''/; (Ii) ht.l\l\?" "oo.f.O>;' lit-" 0'il\,). I'm,,> 'll'l-J'W' M:"'I.~+ t-.,.'I'C' 1''''I.r'imw· I'mS h1t:1 "11\0> • .,.. fLlf') I "I'+C~ 1.tt. lit-" "'11'1:,. Yo "1'1" 'lI'lOO-J'(I)o 1100Y.n'i' lit- aJ·c.n, 1''''I.r'im(l)o I'm,~' h1t1"1I'1'~' ~aJ·::. (til. "'1.11 'I' t- 'e '" n?"" M (lDht\ 11'" '{if "'I')';'m·?" I' .l,h?"" 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(Il.') 1I:j> O"'l.,!'YOC"l (}' 'I.;J' 0011") I't'ln:"9u j • "') 1''''I .. !'YoC1W· 1'00·J' "'Iil-I' 'I'w~' ·t-"I'lC nt-fl· l'-t-7it'l f'uo'J' '0:/,70<; I'bw·",~· I'n<'lf!,'".,.. <'Ix. f:II'. ·""h·':·). r"'l.J'fl'l' 0011") I't'lO+?" 1 Federal NcgarilGaz¢ttc No. 11 24111 January, 20 14 Page 72 15 31 A health professional may not refer a patient to another health institution where he works unless for services unavailable and necess itadng referral upon declaring the vested inkrest of the professional in the referred health institut ion. 41 For the purpose of sub-article (1) of this Article, " resident practice" means a practice which a health professional conducts on full time basis regularly while "itinerant practice" means a practice which a health professional conducts other than the resident practice. 79. Prohibition of Secret Remedies 1/ No health professional may use secret remedies. 21 Every health professional shall, in the conduct of his practice, use only an apparatus or health technology or intervention whiCh is proved upon investigation to be capable of fulfilling the claims made in regard to it 31 For the purpose of this Article "secret remedy" means a medication or treatment that cures a disease or disorder or relieves its symptoms that is known by only a few people or professionals and intentionally withheld from general knowledge. 80. Advertisement of Profession and Service I I Any health professional may not advertise: a) his services if the advertisement IS unprofessional, untruthful or misleading; b) his services unless otherwise he is authorized by the appropriate government organ; .c) in a manner that directly or indirectly encourages the unnecessary use of health services; d) his services in a manner that affects or undermines the services of other health professionals; e) his services by drawing anention 10 his personal qualities and superior knowledge; .. t.) Ii 1\ "'!.II m (I). \''''I{j'J '1' (I)~' r 7' ;> ~,',-Ii 1''''I..rM'~ l'IIfI')'9": : A7A'?Il"'''' r"'Lyy.r.7(o· .J'''I'1r. 1l·!·1A;>f. {jm;}'! (OY.?" Il/\ "'I01.;}';r 0I'1r'i") Oou"l,'\)" nnlfi ~I "'I1'i' or 9" I' 'O;/' .). "'II. ;> 1 "1. 9" {j I1C Iv /.<1"'" o (j ou· I' (I) tTJ I'mS '11\ 0"" , I'mS 1" 'I: 0"" 1'll,IIi Ai.,,)\" iO·{j A')"')\" (ji) Y:i7I.sP1· p?hO~,i "'It.:J7'r MIM':: j"li. ouY:;)'t.ti'! Y;fJlJ9"5 ou<,\Ui IlO'''Il1t'/'WT til "'Ii>;'W'Y" I'm.'! IlI'lUD·f hn?"(~:f. (lly,9" hAII-\'<\'I~ ;>C 1''I''I'r. "I'}"j.~o). ...y,~'I.(Jlo<; n"JCJll 'lI'l(Jlo \'00 ')'1/-"+ niiA {..;/,Y: ... .l'.l'Im(l). "n>;'(1)")9" ouY:?',. + (l)y,1'" \',),I1?"<; '00"1('.1' I'I.YM·'I'or'l' M?,1"A?":: ~I "'Ii1m·?" 1'm.C; 'll'lon',r I'IS11w· 1''''I,'fI\W'i ,!,~,9" 11'79"')' /D·ll'!' O"'lIl1CJ'''' I'I;}'II"'I.(II· 0'1';> (l)y,?" Ot. '1'0',·.,. A"ICJ·m+ 1'1'1.1'1(11.') oo.':?~.·)· (I),e9" 1',),\)9"<; ou"'?y 1'(\l'Im m1''''/,;}' n1'A1' "'1"'1' . .,. 1'1IfI''''I'":: 'ifll, OI'"CI'"C llt!on"'t'E "'Ii>;'W'1'" . I'mS CJI\O""f 0(\0>' '110 0"'1,.1'.1."1 '!'<;;I''l? P' (~ (II·iI,!, 1\.'" .,.r,: 1''''1, :j'·I'IW· '!'<;." ""/fl,W") r P'~ ?""1'lC "19"1"'1 O"'ll'l<j: I')\" (I.<j: t.:n: Y'/"iC; nU'!,'<;-9" 'J""CJj0~'''' ,1'11(1)") 1''1'<;0)' TC'H'A I'mfl4' !llf', .l',II'<;A:: j"e, j'0""j' Y: 2t}: wg.1'" ?"hC llIIonml'olo5 Moollm+ AI "'I')>;' ar9" I'mS Il (\ 0"" .I' 1'\-1'1 tI;>f. 'l'olo I'" lI.tI nmt-tTJt wy,1'" AII'f;>t IJ-'I.;}' Oontf.,. 'r Q;\, "'I t 01109" h<j:,)->;, ~C-'I;}, llt..tI"1 h"'l')>;' or 9" I'on" CJAY.lCJar 9"I1C CDj09" Y:;><j: ooml'olo MOo)':: '1./ Oilt· 'l Af.1. '1 (II. jI"11C I"/'tnl'''' "'Ii>;' arl'" 1'm.C; 'll'lou·f l'1"mI'4'ar') on'f'e I'"I1C<; n1A'7I\")' I'on·far 1.1.;1\ O"'l,t..~.I'.ar OOlll-l' oollm')' MO')':: j"/i. I'''ltl ~I'"~+C; n1t1"1l1-'''' I'onllm+ "19-.;t, "'I1'i'arl'" I'mS '11'100', 1'''1t1 ~I'"H'i 9"11"+ 0"'11:1."1 ~'H'. WilY: OD·~tTJmU; 1I;>'e arOI<; .1'.1'" "'IiI'r'll'lt}: I' onM I' .h119"<; MA "11'1",). ntlll'l'l'" "'Ill')' nY,:'j'/:I?D:: 'if~, U2'l? ool.JlsPri ill\onilm+ {il "'I'}1arl'" I'm,'! 'l1'l0""J' '!·1A;>f.'} 1''''I.ool'lh·p l''Illt·f·t<; 1'I\.o'l jlUCout- "'I1I'1(C; w,m,')' I l'ooY:?~,')' "'Ill'lfi I'l'"lIhC CDI..,,')·; 1'J'.io>;'ar') "'IU1.C' I'lfilT;}'tI CDj0l'" /\,1\ tTC'Y'1' i Illl'!' 0""1'1' ilO""i<; &.C"'I(J)oi "'Iilt..C MO')':: , ' '- 'n Federal Ncgaril Gaz.cUC No. II 241" Jauuary,20l<l Pa~c 7216 f) his services in a manner that promises a gift, discount or other inducement to attract a person to use the service. 21 Any health professional shall ensure the advertisement of a health institution whose certificate of competence is issued in his name respect the provisions of sub-article (I) of this Article. 81, Medicine and Medical Instrument Advertisement I I A health professional may not advertise medicine or medical instrument unless he is a direct employee of the manufacturer or distributor and authorized to do so by the appropriate government organ. 21 A health professional may not, in consideration of the benefit he may derive, advocate the preferential use of any medicine or medical instrument that would not be clinically appropriate or cost-effective to the client, 82, Research Participation A health professional may only participate in research performed on human subject if the research has wri"en approval after appropriate ethical evaluation and is being performed in accordance with the approved research protocol. 83, Requesting and Providing Professional Support or Consultation II 21 In case of any doubt or difficulty and need of supplementary or higher level of care, a health professional shall request support or consultation from any other professionaJ colleague for the benefit of the client, A health professional consulted by a colleague shall provide the required professional advice and service as per the standard of his profession. 84. Obligation to Serve Despite Belief A health professional may not refuse on grounds of personal belief to provide services such as contraceptive, legal abortion and blood transfusion. 85. ]ssuance of Official Documents 11 A health professionaJ shall sign official documents relating to patient care such as laboratory and other diagnostic requests and results, prescriptions. certificates, patient records, hospital and other reports after "Tiling his full name. 1l'C :ill.Un ~trl:\ ~.?M· ?IL'~ 'll'T'C Iii 'l'C !~ "'./ ru '1.1"'. Feder:ll Negarit Gazette No. II 24" Janua,y. 2014 Page 7217 '-"-'~=~====='T"""'======~=~== 11.1 "'I'}t;'ro'9n fmS IIMn .. <' 1'.,,0,.1\'1 I.())o~.~>;, I'Uou9" !,.j'Y: (Jlj.W" 1''',li9''',' 9"1I11C rol'~'}' ""lim'}' MO'}':: 'ltl. Mup~~'!,'} "'ItI'lf JDl·H''1 1..1'.1\ (il "'I1'i'())o?" rmS ~lIuu,)' M,l',I1"''1 ooro· hIlA I\f, 1'lII"'I.J'lIh·}·lIar arm,·}· 1''''I)'ar 4'ro·'} auy:~t·), rof,?" 1""4'auuo- I'au~~t,), l'''l1':·r·)'·) "'11111 I'M'}'?":: '1.1 "'I'}Ii'ar?U I'm,'1 IIl'1au,,r au~?t,},'} 1''''I.J'11n·}' l'au~~'L'} "'I1I'lf rol4''''' M* .l'.l~'1 O-,rar hf,'!')' aulPlT 1'-I'1I,:J)('1 .l'.l~())O,} I'm04' autn MO')'" ;:1 "'I 1'i' ar?" \' Ill. '1 111'1 uo-,r h Mil;£>: 0 If ~ 9"h,}J"} IjAIf~ Oll'~4'C 1''''I.J'lIar au~~'L1' 01l,h.t,,!? \,au.l'.·?'!.'l· ootlC'IIC l'-I'ooll71l auln MO')':: !il "'I'}'i'())o?" uu~)'d' tl"'l'.A '.:I'~ I'-Nlm())o Iltluo-J' "'I'}>;'ro·'}?" O,h.?'!? au'}?': ,rA1'1"i OO.l'.·~~:},'} "'lUI OIl.?" au,l'1l I'tlO')'?"" fl. M 41l'il'i ~0I?1~'1 071.:1='} uphl\M (il "'I')I;'OI·?" \'m,'1 fltlun.J' uoro1~ J'tlO')'') hm,'; ~,·Jt\"lfl··)· 1''''I.(O''l .f.i'ji'j flt,I'I" 1'I·"lt1.,?r.'1 1'I1l·lll·,·M· mS 1'I.lltl. "' 70. Olf~ oot\h· "'Iil())1>': MM':: {'(fl.'. 1'1A? y, I h"'7A? y. 01.1'. ·,'7A? y, (0.1'. (OY·?" On;!, /JoI'1A? f, OJ.I'. Ill. '1 Iltlau· J' I. ') Il Y""I\ M: I' "'I. 4' UP Ill' \' ,. u'l'r)' ~'},np':f") "'lhOC MO')':: 'ltg. 07l;t= l''''I.tilhTtl())o lJ-'!.LMou"ltllt 6.1 I'm,'l Ill'lon'J'ar O'1"'}· M,'j: 1\.1', J'1I'1 f\.~,} o "'I.e r A ro f,?" 0 M ~ n 7I;!' 1'.,. til T Ij "'I. '} l'u009" IJ'''TC; On;!'ar fOUlIh·)'tlar'} ())om,')' tlTIJ"'I.ar rof,?" TIJ"'I.())o IIMau M?" Yt\.I'.lil rof,?" I'hl.?"C' (hOO?"''''i' hlf~ tlMlltar ft.1t\lttl1' MilA:: fll I'ILU h'}4'7\ '}O·iI h,} '~7\ (Ii) ~')?'/, o''l'C?'' fm,C; Iltl-J'ar O'1"'}' h'\.'j: I\.e ttl'1 ft.~'} O"'lf,l'A ro.e?" OM.I'.' "7iT I'TJ't\') liar I'07iT 11'''T'1 071;1-1))' 1''''I.,rllh'}lIar') ())om,.). tlTlJ"'I.lI)· Maul ,:J ,:J .}. T lJ "'I. ())o UO')lC Oau')!,.lI t-lI'') MIlt\ 1I/'r lIOU~ .eu')') ODl~ I'ITII"'I.o>- 'l.-,.Mt /oIl1\')' 111' tlS1C J?'fl\t\:: 2/ A hcalrh professional shall issue genuine and complete sick leave or certificate of illness. 86. Prescriptions and 1\1cdirine Dispensing 1/ No health professional may prescribe medicine or fonnulations about which he has no knowledge about its composition atld pharmacological action. 2/ A prescription on which a health professional prescribe shall be standardized and prepared in accordance with the standard of the institution and type of the profession . 3/ Any health professional shall prescribe medicine registered in the nation'al drug list unless for compelling reason. 4/ Any professional dispenser of medicine may not dispense or keep any medicine obtained through illegal channel. 87. Waste Disposal and Disease Prevention 1/ Any health professional shall dispose of disposable healthcare wastes in an appropriate . manner for the sake of himsetf. the client and the public health . . 2/ Any health professional shall respect safety provisions that ensure the non transmission of diseases from himself to client, from clienl to client or from c1ienl to health professional. 88. Disclosing Prognosis 1/ A health professional shall explain the nature and possible outcome of the terminal or sever illness to the patient or, in case of a minor or mentally ill person, to the guardian. 2/ Notwithstanding the provisions of sub-article (I) of this Article, a health professional may only communicate the nature and possible outcome of the terminal or sever illness to family members of the patient where he believes that the patient may haon himself due to emotiona1 instability. 'ltll. 1.11 t\ ') 1. 'l uo-J' 'I: J'to. If ~ -I' "lIlC,) • 1''''1 ~ l "I "I Y.;t tTCT 89. Reporting of Impairment and Unprofessional Conduct "'I')'i'(O'?" \'m,C; Ill'lau·,r 1''''I.h·/'I\--)-·) h"lll·n 1\1I11~ hilA t?'C')' o~Y:l'7 MIl')': Any health professional shall report the following to the appropriate organ: fil MltI 1'1''1'';1·tI l1t'1- ,l'UD~Il')") I't'lA I'm,'; flt'lolJ·.n I.tltl i ~I I''''L,I'aH'(/)' (/)f,9" 11.1',4. I.'M.,!'(/)·:Y 1"/·.I'.l1 htf'/ (/).1',9" n'hlllmlar I.hll· 9"h1,1'1' Ort· 'I bll.Ln'J, ·/·10.W··) j'; :>~: 1.·}-'l.m,l'.:Y 9"IIC 1'·I·t'\'JOm· h tf~ I't·O··) I.lltI: U I'OD·J' /'.:Jo.l'.' I't'I.t'I(D. mf,9" 1'00',1' t.:I'-'\. I' ;1'11'.0')' (/)f,9" Nc'llllfl'l' c'lar I'mS /'1t1"11l'+ I.I'c'lm ootf',·') I 1.'i §I 1'11.0'1 flt\oo·.n O?'g'ar9" -,I''f ,l'tltf~ I"~ 9""I'lC):: h'f:tI Mr M·t-1!"'Ir j. !1M2'''' "'ll2-'1~U."()bC .@l.j'± Federal Negarit Gazette No. 11 24th January, 2014 Page 7218 11 an impairment in another health professional if he is convinced that such professional is impaired; 2/ his own impainnent if he is aware of it or has been publicly infonned, or he has been advised by colleagues to obtain help in view of an alleged impainnent; 3/ the provision of health service by a person without professional license or whose professional license has been suspended or revoked; and 4/ any unprofessional conduct of another health professional. PART SEVEN INSTITUTIONS iii "'I')';'m'9" t\(/)' 1'11:1'1' "'Il:>1"~ (/) L 4' 1- /'''1'111 l-jt\ lD- /, l-j tI <'1,1"1'1 9"fltlC 90. Certificate of Competence M:4!'1" fit· 'IJ', ooO"'l?-')' /'J','ftl9":: ~I II"'1')'i'(/)'9" '1-:1:9" Nt\m 1'11:1'1- "'Il,n~ 9"flhC (/)L4'1' Ol',}oo'" oo:N.fI M01-:: rl "'I1'i'ar9" r*9n 1'11:1"[' "'Il:>7~ 9"flhC (/)l.,,')· O(/)t\.I'.I11- oofiotC')' 170M'''' fI?-lD-1 "'I h 'ian J',';' C n:1' tI : : 21 /'''Ifll1 ,l't\(/). /'l-JtI 1'11:1")' "'Il:>1"i. 9"flhC (/)l4")' oa'l.I~'1'n-l· (/).1',9" 1l"'L,I'.~fIn1- tl1. I'9"C1:1 (/)J!,9" I'h1t1"11l-1:1 '}J',~1'i hoo&·l')· i M1Jl:P:')' i hhoo;f'f1- 1.'i 1l.1l-'f Mot"1. I'tf'1- !W"C'I: roJ',9" hh1t1"lll·'" '1'&")''i !,.U1~')· pC I"/-,!',I'll- "'I'i'flD-19" '}J',~')' IJ-'!.;I·?Jf1 1.11. .,.*- "I$!.:1' 11.,1' fI.,,9"'1' J', 'f'l tI : : (;1 1'11:1'1' "'IlP7"i. 9"flhC rol"")'1 /'''Ifll1 Ij II lD- /, Ij tI ot:l' !': lD-al, 11"'11'i'lD-9" 00 till II{l M' 'i' (/)71 "'I fI.,."" <j: /, J',;f tl9": : 'Ii. 1'.11-"±- "'llZL·''I..2''1JIlc...JIJ.l.tl.L1I11ap ooilfi "'IW (/).9" 1'11:1'1- "'Il P 1 ~ 9" flhC (/)l4' 1 1':1'1.1'.l1r 1 I'-/-lPllIll')' roM" 1.!':"Ir r'/'hllh IIllr roM· 1"?-(/)'1 f*lm "'*9" 1'11:1'T "'Il P 1 ~ 9"11 h C ro t.4' 1: 1 /'''11)11 ""lD- /, IjA 0000l1li MO'r:: jl. MI)II-,I'?J'f I'm.'i 9"Coot iii "'1')';'(/)'9" '''*9" h·/··/A.'JJ', ;JC "I·n·~·)· ,l'lIar I'm. .. '11100'.1'1 (/)J',9" 9""1·11 Mp~1 11',.*9" (/)·fI'1' hoo4'm<;. Ilt.·.,. 1.1-'1.U·9" 111''100'" . hl1.1'./'J',.1l.!lb.l':II IlM'~C I'm.'i 9"Coot· .,.')-'l.fY.C"I "'I!':l"l Mil')':: "'~- ---"'" .,..,.., 1/ No person may establish and run institution without obtaining a certificate of competence from the appropriate organ. 2/ A certificate of competence issued to any institution shall be renewed annually. 3/ Any institution shall undertake its business in accordance with the requirements on the basis of which its celtificate of competence issued. 41 The appropriate organ may issue or renew a certificate of competence subject to restrictions on the type of the product or service, means of production, processing, storing and any other necessary conditions relating to the quality and safety of the product or service. 5/ It is prohibited to transfer in any manner a certificate of competence to a third party without the penn iss ion of the appropriate organ. 91. Surrender of Certificate of Competence Any institution whose certificate of competence is revoked, cancelled or denied renewal or which has ceased operation shall surrender its certificate of competence to the appropriate organ. 92. Professionals Health Examination 11 Any institution shall make health professional or food handler who has contact with clients to undertake pre-employment and annual medical examination'-except for HIV / AIDS. !l.1 "'1'I'i'ro'9" rills 'ltloo'J' OIl.U n'HK' '1M' h 14'lI' (~) oow I. 'l' t\t,(r rills 9"Cou{" "'1Y:I.'1 hj'A'tl9":: t:1 "'1'I'i'IJI-9" 9"'111 nll;l)'; n71;t' n"'1.J'1/Il'l· '/.11. .e'i'cn;t'tI:: n9" '111 0 "'l.1' ... tI <i: (\01-*00' "'111'CDP fJJ "'1'}'i'IJI-9" r9"'111 1'*9" n9"'1'o n"'1.1' ... tI<i: R7i;t' r·t-J'I! oolf~' r;t'cD4'1 r9"'111 M1:>;t>; 07i;hD' r"'lY,.f· ... tI'i:o·l · 1,1.:<1 Mh.I.CfI Y:l.fI h9"'111 :>C 1hh. '1''I'J'1JI- flt.?''T ?,'I-'I. 7t1t1 "'IY:I.'1 Mn'l':: al I]tlp'N'1~' h·r7t1;J.!.'. :>C '1TH'). J'tl1JI-1 rills ~tI-J' roy.9" \'9"'111 Ml?»: 9"Coot. Il.J'.I',C"lO·). M"'l. 71]1JI- rn71.r nj.'. ~-). n-/,outlll-I' llCllC ououtJ' J'CD"!tI:: 11:. M1'*9" ",,{lloCf.'f'i htlM?''f iiI "'I-I';'IJI-9" -1'<':9" f''''I.tlJi''J'1JI- 1 7-:tt 1'l'1. ~7r: ')' '1 .jI7i7i?' ';f (\ un.jl "!Ill C IJI- fI"! 'l! r .jI7i 7i hYY'lf'1 h01:>7Y: P'C~"'- (\.<;'I.IJI- ,I'.1l]tI:: II "'11'i'CD'9" -f'*9" hlJl-~ MC 9"'11l'l CDj.'.9" ouY::>'d-1 n"'l{lou"!-)- M'l';t' CD~ t\A MC t\au ... h /II] t\P' A "!.,. A r. 4. Ji' Y: "'1"11'). Mn-).:: 1'.1 "'11';'01'9" -"'1;9" NMM (]lj.'.9" I'MtI"I(\o-). 7.1\.1JI- J't\lon-)· 9"'1·(n CDj.'.9" 001::>'1.-).'1 "'I{lao"l')" noY'l' w,e9" "'II'lt,lXl.-}· h.e '):tl9": : ij,/ "'11';'01'9· Mou(.T.l, roy.9" )';9·... hhM.y. '1'*9" i'11Ji'-)' "'11.?7"'L 9"{lhC CDI.4'-)· M. fl IJI- 1'1 IJI- 9""l1l'l m .e 9" 001::> 'I. .) •. ) "'I M. loA h.e'ftl9":: (;1 "'11'i' IJI-9" r . 1'"1'1 C tl9" 9" I: 1'1 "'l. J'f.C'1 '1' "'1 t i' Ill. '1 n 7 A '1 (\0 ·l· ?, 1-'1.1'1 'l' r.t 4' ~ i' Ill. '1 '1' *9" 1''''I{'ro· O;t","'I.w· ... y. fl"'l.J'.I',CfllJl- '1-.<1-). :>II.1.H' J'.'~CO;J,tI:: h<i:A il9"')·). Af. Af. 1:1?1?''f ~!i. "",,;II i'oo{lm-r '19.;t' iiI "'11'i'01·9· i'1ll.'1 I]flou·f n"/lJl1 I]fllJl- n"A O"'l'1:far9" 7.tL rno' ,!' fit· &,Ji'-,\- ' ) ?,1-'1.,!' ... .e Wj.'.9" rt.fl·1 mj.'.9" \'1\,<'\ lJt\uo'f -J''f ?")i'fI,4>(~ 1''''I.fllY. uul:<1 h')-'l.f4'Cll 1l.1ll1'i' l'au'I'I]OC "I$'.;}. MO')':: Federal Negarit G37.ctle No.1 J 24\h January,2014 P<1ge 7219 21 No health professional may undertake medical examination for himself in accordance with sub·article (I) of this Anicle. 31 Any food handler shall notity the institution where he is infected by food borne · communicable disease. Any food estoblishment shall screen a food handler infected by food borne communicable disease. 4/ Any food establishment shall remove any food handler who is infected by food borne communicabJe diseflse from activities involving contact with food until the disease becomes non communicable. 51 The Authority shan issue directive on the type of medical examinations that a health professional or food handler who has contact with clients shan undenake. 93. Institution Requirements a nd Prohibitions 1/ Any institution shall develop intemal waste management system to manage its hazardous substances and wastes. 2/ An exporter institution shan obtain special permit from the Authority for transiting medicine or food from foreign country to another country. 3/ No institution may impon, keep or distribute prohibited or expired food or medicine. 41 No wholesale or impon institution may distribute food or medicine for a person with no cenificate of competence. 5/ Any health institution which permits a student on practical training to provide health service shan be responsible for any damage the student may cause to a patient. PART SEVEN MISCELLANEOUS PROVISIONS 94. Duty to Furnishing Information 11 Any health professional shan cooperate with the appropriate organ whenever requesred to show his professional license or provide information about his professional performance or that of others. .. fl fJl'I?'tllTJ~' fllLU h14'7i 1frll h14'7i (Ii) ov!pd' J'11or1 ovG>: nu"? I-ttl1't.4'1. nll'~"'c O"'l.il'l'C <fOmf1:r Mn7'" 'Ii, "Tc'l' 1''''11;1.'1 '71'.;1' jil "'I1'i'or9" {lco' h'}Y: 1'/1\,'1 Ilil-J' 1'/1\,'1 1I''I.;t-or 'n-/< 1''''I,J'1.C?or Muvlf'r1 COM" ov'J''!! ytlU"/ ?'~ Y""IfJC ovt.1.uv·'> lJov~O '}' h"ll]lI 'I(leD' hlltl 1''''I<'IeD1> "I~;t­ Mn'}':: 11/ OILU h'lo/>\' ')frll h')4'>\' (Ii) UOIPG'/' h"lfJlI 'I(lor Itl-ttl n:r'i tI(l'l uol.Jl I'l'Im {lor nu"? 1'mJ'<t hJ!,lf')Y":: n. l!~.:'IkT t!<j:J' "'11>;' co-9" "'I G :n "'I. 1'1"'1<'11.111 9"llhC {lCO' I'tID.J' fit· t.JI>Y: CO~Y" NIJ1>7' 9" II h C CO I. H· 1'1"'1 or 1TJ7' CO J!, 9" ouY:;:"I;l'1 {l"'lllau1l?'n aJJ!,9" t\il-l' aJl.N·)'·')'I MtI"II'I·,H1 (I"'I"I1r nov1"1?'-l' n1..I'.o/' ,,'au'> tID{ll.')' h"lfJlI 'Il'Ior h!JtI I' h?tI "1(1")' h<J:, f!,h<J:'ItI:: Federal Ncgari( Gazette No. 11 24lh January, 2014 Page 7220 2J The appropriate organ shall keep the confidentiality of information obtained in accordance with sub-article (1) of this Article unless otherwise permitted by Jaw. 95, Duty to Report 1/ Any person who believes that a health professional is unfit to practice or commils unprofessional conduct shall notify the appropriate organ. 21 Any person who in good faith nolifies the appropriate organ in accordance with sub-article (1) of this Article may not be legally liable. 96. Service Fees Every person shall pay service fees to the appropriate organ at the rate approved by . government for obtaining or renewing professional license or certificate of competence, registering medicine or receiving other certificates and services. U. I1I1T7i<;-'I Tt.Il"'Ur flII"'If.<;6-Tor u1l' 97. Repealed and Inapplicable Laws /il l''''I.h-l'(I--)· ntl.U .I'.'HI '~7il.'I'tI:- 1/ The following are hereby repealed: Il} I'/I\,~' h7t1"lt'I- ,l' '''*9'' t.JI>Y: MITJ'l''I a) the Licensing and Supervision of Health of:'l''l'C 1''''I.'LIl')·C:''''· 9"hC o.r .I'.1'n Service Institut ions Council of Ministers "''l'C H~!!IIi!!ii'l! h'l Regulation No.I74/1994; and II) rn.-rl"fI'Y illS fJlI-Y?Jr oo"'lhcr 1'Cl't "'1**"'1.,1' r"'l. 'I.1l·h:l' 9"hC o.r .l'.1-(] 4!'l'C ~!ilIiir'.l!i:: r.1 J!,Ul .1'.111 1''''I.JI>G1 "'I,'i'or9" .f.111! oouot:J' aJJ!,9" I'hIJJ6-C tl9"Y: flIl.u .f.111 (lI'll'l' I'TOD(lh1> ?·.II1"1'-1 n"'l.ovllh+ Tt. ''''I.~,r hJ!,<;l.aJ·~u: : ,1:. oouo ?Lf~ITJ:Le~~ 1l(l?'tllTJ~' J!,U1 .1'.111 11"'111&.1.9" 1''''I..,IlUNI auov? J' ?J:j:1 lI.'aJlTJ f. 1'-'ItI:: 7/1. .1'.111- I''''I..K'IOr 'I.!l. f.U .1':111 n.l...r,t·tI ~;JM' ;J11.1TJ ;t-,)-qu haJlTJn')' ""1 ~Y"C' 1'1.'1 Y,lf'itl:: Mil MfJ 'l'C J.~ 4'') f71~ 't.9" ;:. J!.II"'I c J'9" .1'.1\ II ~ 1'n.'}·I"A·' .I...I'.6-II'/! )(. quht-fl.J',/! "Tl1l1.h m'l''IJ!. "'I.. 'I.llrC b) the Ethiopian Health Professionals Council Establishment Council of Ministers Regulation NO.76/2002 . 21 No regulation. directive or customary practice shall. in so far as it is inconsistent with this Regulation, be applicable with respect to maners provided for by this Regulation, 98, Power to Issue Directives The Authority may issue directives necessary for the implementation of Ihis Regulation. 99. Effective Date This Regulation shall enter into force on the date of publication in the Federal Negarit Gazene, Done at Addis Ababa, this 24'~ day of January, 2014. HAILEMARIAM DESSALEGN PRIME MINISTER OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA