Food and Medicine Administration Proclamation No. 1112/2019

1. Short Title Ii. Ji"l"C C6fl This proclamation may be cited as the "FOOd f.U Ji'I'~ "1'1"'"1-fl >,<; fool:;)'t:,. Jifl•l'ISI.C and Medicine Administration Proclam111oa Ji'I' ~ -IITC liitli l I!llllitUi" -,.-ot1• l\.tn+fl No. 11 )2/2019" f.1•'\An r. +c~"'l z. Definitions In this Proclamation, unless the conteu r:J>I\. Ji'l'l-fl "'" +c1-r f"'l.fl'11nm- IJAtl'~ otherwise requires: Ofl•l·+C OrW Ji'I'~ a>-fl'I':• 11 "food" means any substance, whcdier Iii "9""1-fl" "71\•"t- Oh.t.A CDf,9" =I\- fl=I\· processed or semi-processed, which is _,.,,_.,~-,. 1\1\a>- 9""1•m+ f"tm-A ~'IC 1\.11'') intended for human consumption, 111d 'lflf '\f, f'l'/1 CDf,9" l\'l-flt::,f-1\,fl Ji'IA"J{l•:,0 includes plants, and plant_ and animal r+i::n 61r'l'+1 fbir'I'+ a>-111.+ >.'i r>.1t1ti produC!5 placed on the market or offered fer ,f-'f'lr'-1 fl"'"l-0 ~ID-I a>-;)1 JiAl>A CDf,9" use by the public; salt, water, alcohol cc I\.'\ ODffi 'I' ), ', 9""/-fl I\ "79"t:: :,0 CD f, 9" other drink, and any substance which has 11"7 hi"' f "7.a>-A "71lj'I a>-19" been used in the manufacture or treatment of f"tflJ:,0:,0 tl''f DD.(-;)),:,0')J food but does not include medicine, oumfl<l:J''} >,<; +1"''111'') }i)'t1++l"'I cosmetic, and tobacc:o products; fl ·rr"l-o 1-,1: ,t,tr• "711+ 9""1-0'} I\ '}"J1: 2/ "food trade establishment" means an 'J'\"7 "71"'l+1 on'\h1 "7flon"1:,01 "7h<f.LA1 institution involved in the manufacture, fl:fC7(!'10Dj'i''J' CDf,I"' A.,,.,.. "7i'i'"1 "" ,export, impon, wholesale, retail sale, or f,f-1\"7&- ,f-Jtl"' ~ID-I repacking of any food for profit; Cl "fl"'"lfl •l'ltl"'" "7/l•"t- fl"'"l-fl '}"11: +ltl"''i' 31 "food establishment" mean any food uade I\.'\ h'}"II: 'J'\"7 11>-"l" 9""1111 fl•N\J'f establishment and other humanitarian and OD')'JI: flAC ~:J• CDf,I"' f1Ji1A "ltl-•l- OD{IAj. service provision institutions that provide 1:C~•l· fllt"t~:,. 111fll·NIO· f"t+C-0 +ltr food for public consumption on a regular ~ID-I and non-profit basis; Scanned with CamScanner tt Zl'Ufl Fe4cnl Nepril 0.,,,0. No.3921-.FcbN,,y 2019 ........ 11101 ~U">'H•• -,,H· P"-,il') R·M{l.01- 4/ "food safety" means the conditions and R"7P"l•l-1 practices that preserved food. is fit for .human consumption during' 'manufacturing. handling, storage, or transport; ~ "P""1'f1 -,•L"tc• "7i\-l- P"-,il') i\•l-a1M 'l·.e~-l- SI "irradiation" means a deliberate exposure of til'-') L"'lt i\11') Ql&. -,.:>/IT )OI- I food to ionizing radiation; ( I/ "t'Q~,\ Ull'J r-,,a• -,11-l- Aflh fll:fl·l- 111C 6/ "infant formula" means industrially At:oi 'II\. ~:,.'I Ull'i"-l- -~n'i' . rr-,11 ' . ~ formulated food to satisfy the normal ,, ; ~'1'):J-1fC1Jo') i\"7".l'I+ • >t-,q,n ~l1f Ill\: nutritional requirements of infants up to six months of age; ! ' aawt+ Rof.fltll f"'UI;,)!: P""lil 'IOI-I .' 'I,/ "f'Ull') 5''"7-()-" "7i1-l- h"IIJil 'li1C0: ~lll' ·-,,,l+ 7/ "follow-up formula" means a food prodl!Ct of ' .. ' hfl '>M.:i- rJJl,'r b1.1'-l- +1'1.1' •04-fltlt f"tDDl·+ Mil t/'i' A.t':"'1J'lfCIJo hi IJJC Ai'lh . animal or vegetable origin and industrially . formulated ,. in accordance with the t 'loa,t /It/). . Ull'i':,• Mil'l-l- 04.-0t~ ,tlJt appropriate siandard for feeding lnfanls and f"tll.:>~ 'IOI-I ,, ·~ •~ ' \ • young children from six months up to three , ' year.; of age; ii -.,"l.f' ,.-,,a• -,i\-l- "7'>7i'Ol-9" ' roa~O'i' 8/ :'food supplement" means a conoentra~ source :1'00.:>1'-fi f'>'l'l Mil ~'11-l- i1"7"l'l-l- 'I\QA of vitamin, mineral or, other substance with , • nutritional or physiological effect, alone or in f"'l.11.:>~ f'>Tl r-,il mvr •RI\Ol-~•1- • I . . •t-LTC'h'e ~l\t-C 'If. C1Jom.-l- fq1,;f-"7.'); "761:') a,f.r A.11-'f '>Tl' 'l1C':f J''lrOl- .. e;ombination prepared in a dosage form and intended to supplement the nom,al diet; .. I - IU R)m'I rJJf.9" 0"19"t- t"t1°f.R-l-'i" R.,_a,I\', ,,, ' .. ' oom') A'},\a,{I~ ;J-fl(I RIJT(I.A1 011 ')h-0A1 ., , .. I •, ".: R~<t:t'-1' O,Vlih Rm-fl:J- rJJf.9" · flA." •r.· J • •t-on•Vl.e 11'~:J- f"tll.:>)!: r-,,a 'IOI-I · ' • - ,.. -~., . ' 1 ,· . 9/ "!nedicine" means any substance or mixture • '>' fif "onl::>'t-l-" "Til-l• fl\a>-1 071;1-1 f.,.•IIJ : IPVI" ' ' of substance used in the diagnosis, .,.,.,irr m.'t'i' '""" "''""' mY.r M1rC1''1! o-i;1- mvr rAh+l·'> i1auooc"'."c1 treatment, mitigation · or prevention of h ~ disease, disorder, abnormal physical il-,hr• i1..,il:J•1il , IJJVI" I\ODMhA1 Ma>-'> tiM! mvr hb?-1!1'! 1-.1\t-c 0111:J>"t ooAI~· ·' ·· or mcnt11 state, or the symptoms therwf; ii"7il-f• '1hA I IJJ1. 'I fll0 "1- ii ovoail ii IJJP, V- . used in restoring. correcting or beneficial il "7lfll'A I 1JJf,'1" hr-,,o flil-t4'C fl\a,.H•'} · .. . ., modification of organic or mental functions ~ in human; or articles other than food, , ou'l'fC a,f,'/" '"7'>7i'ID''>r fl\a>-'t•l-1 -r-L'l'C.1-.'1! · intended to affect the structure or anY. .,..,'IC flm:J>"'l. ouAh, /lovil11J1' f"'l.o>-A function of the body of human and it "71'i'a>-r . -j'1'l•'l1C IJJY.9" r'>'1'l·'t1Cl- a>-'1.1~ includes articles intended for use as a L lf'i' ii'tlltl rc+"f 'l't. bf'tt f"tOI-A . l component of any of the above specified "f')'i'Cl>'')r '>1'l·'t1C J',;1:J>A"A I {. ,' •f • articles; I 1 ' Scanned with CamScanner :u •ruu.~•:>~.·} IJl\m>•.f" '"lll·l· h"IIJ-11 IJl\11>• IOI "pharmacy professional" m.cani l'tlL'i '11\nn•J' ·l•.f,t1Jt1I(. >,ltf.1 fm,,f /,,:1'f: pharnacist. druggil>1, or • ph.1,'1lll';y r-N'lmm· -S.c:"71\fl·l·1 J':6-'l.fl·l· 111f,V" technician licensed by the appropriate ~!Ui <l•C"'II\ ·!:h>. ~·} ~m-1 professional regulatory organ; 11/ "naicotic drugs" means a medicine subject to control in accordance with !hi 00 '}"/.,,,;J ..l• 0(11''1m- 1.'i' h.•l·r-A-y IIOl.•l•:r•a► Convention issued by United Nations and f'i'Cl•·l;h m,J.:•;)).-f•:r• il?"ll"H• '"'"'t.·l· •l:'l''l'C. ratified by Ethiopia and include a drug that f"'I.F.t.'?0-l· UbJ.:';)).•l· .,~- llhM./l"Y. hit/\• is categorized as narcotic drug by the 1- '> F. 'i'Cl•·l;t1 m•J.:-:>t ·H·l· 1••1•,mF.fl unJ.:-:>t•l-'} executive. organ; fm?A'IA, :nu "I\J',l••l-C'·,:t, on1;;)),•l-· "71\•l- fl•l•lllJ~.•l· 12/ "psychotropic substanceff means anJ OD')"/.,,..;J ...,. lllll"ltn- 1-'i' h.•l-r-A-J' '10J:.,.1·m- substance subject to control in accordance f/'tf.l1·l-C'·,:h 1'1'l-~1C'1· flll"ll"~·l- """'l·l- with the Convention issued by United -ll'l''l'C f"'I.F.l"/0·} ')'1'l-~1C lf'l' llhfttl.11"'1. Nations and ratified by Ethiopia and include a drug that is categorized as h 111\, 1-'}F./'tf,l••l-C''l;h '}'l'l-~1C f·l•tmJ:fl'} psychotropic substance by the e)(ccutive OD .I:':>).·l- J' Ill :J>A "A i organ; !.!~I "i;Q.lt- >,uo")ai_ onJ.:-;)).•}" "'II\·} f(lm-") 13/ "radiophannaccuticals" means a medicine 0 if :J • ii ononCm>C: mJ?. 'I" ll "7h II" r '"IJP-/1\ which has one or more radionuclide h'JY: iJJf,11" hrtf nii.r. flf~ t--'!.r-tm-h'IJ',1.: substance used in the diagnosis and J'{lm- on1;;)).·} tl''i un.t:-;)).•} {IOD(M,•l- treatment of human disease and includes f"'l.,l'1ll"//I\ "4l&- >,tJD')i;u_ ff.II!) ID-111.: non radioactive reagent kit used for a preparation of medicine and radionuclide tJD1A11 1-'i' &-1:1'-'l.h•'IJ?.1: ht111"Ji;u, '> generator; ,l'm.4'/1\'IAI !fjj "T t.hCl'lC h."'Lti/1\" "7ll•l- O•Mfl~••l- 14/ "precursor chemical" means any substance OD")"/p,;J••l- n111"l1D' ,.., >..•rr-A-, or mixture of substances subject to control IJ0F-4':f.lD- f'i'Ct•th 1-'i' Mf,l••rC'',:h in accordance with the Convention issued by m>.(";)).,f.q• 1'1·1D'1''}'71.:. "1'1''1'C ill"''I")·} ' the United Nations and ratified by Ethiopia ODlPl•l· "1'1''1'C f"'l.J:l"/ll•l- "}'l'l-)1C lllf.'I" f'J'l'l-~11!'1· m•IIJ.:- l\t/'') llhftt!.11'"1 and include a substance that is categorized htil\, 1,")J:. T t.hCl'IC IL"'l.ltf.1 M•anJ:.O') as precursor chemical by the executive h,"7.'1A J','1l,'1"6-A i organ; lJ;I "l'un.t:-;)'l.·l· "?ll'lf" "71\-l• foo-f "--"'.I:' '11\o► I 5/ "prescription" means a paper or electronic fUhll"'i' IJl\=,f •NtC: 1.'i' ·1-tl.C'I" hlltl.11'"1. order' for medicine that meets requirements hilt\, IJID"IID' Ob{l,I.C-} DDWt.+ •t-,t>IJ.e~+ set by the executive organ, and written and /JillD' 111t.++ 111vr f1,.l\.h+c-th ...,,,..r signed by a duly licensed medical OD"'f(,f h"7'1'fH· f"tl'l'I' +1.1111 ~11>'1 professional; Scanned with CamScanner ► Fodml N...,;, 0 - No. ltll"F -2019. .......1110) '!.XI •'l't. IJ:t-• "71\•l- '41'1''1'C f"7.,.l"IO•l-') 161 "raw material" means the basic material 9"C•~ l\"YV"l·l- f"7.1'111"1A "1-fl>t•l- ),n,1 from which • regulated product is made; X~ .,,._,_ •H'l\'1'" "Yil•l- 17/ "blood product" means a product prepaRd 1\-1•1\f f. llh!l'"i from human blood or liquid blood for l'l'IA"lll••l- f"Y.O"A hl\a,, ,.,,. dlf.9" ,,.,,. medical purposes; O,.IJ f"Y,11,?~ 'l"C·l- ~a,, , 18/ "blood" means include human blood, '!.tl •1.r• "711-l- hl\,n, f"Y,I\Ofl,fl ,n,IJ.t:' lf'i blood collected for ir.nsfusion or 111\.11 {l,n, 11,mll'II\ 1111,'I" 111\.11 ,,_,,_ •l"l'~l> processed blood; ll"Yr l•l- f•l'fll f 'l.,.+l•'> Ill'- .,...1\, ,,.,,. f, ll•l- fll ,n, a>ll.t:' ~,n, I XIII "hl\an l\fl• ..;:t-l◄I" "711•'1- "771'1.f '>t - 111'>• 19/ "counterfeiting " means a delibcnlc or fraudulent mislabcling of a product in r •t"II: 'l"At1•l-•h f'}"JJ:' l\'I"'} Olf,'/° respect of its identity and/or source "Y'J',<,n,')9" 'Jf.~•l- anl\f '/°Ah•l-') IQ.'/"C' including the packing material, ft,').(- '} rr.•l- 9"'))•l- >,,; '/°'}"I." 11') ◄Ill• h•V1'.f· tlll'~ ,,.,,,t- "771"1 1111,.,- 'lll"I." identifi cation or trademark, trade name. any 5PCCial mark thereon of an authentic A'll-'t: llanl\m't: >,,; f,tr>> fltJll•l·'i' -n.i: - product and presenting such falsely f ;Nf1') 1111,V- 1'1"f.• 11•11-,: r,r•,.l'lfl.-,.') labeled product IS if it is manufactured by 9"G·l- O•Ntlllll'i' l'lll"t-lli >.'Jl.•l'""l•I• the genuine manufacturer; 0"71\.0Dl'IA -?<l'l◄l ~co, • Yil "anhl\1\0 "711:t- fl'l'),t,') 9"C·l- "111L•l- 1111,'/° 20/ "adulteration" means adding any foreign substance or ingredient or substituting the h◄l,.•l- 11-IQ.DDCI '!'6-•fJ') 111,,.,. "''''",n,') A-♦)l'I 111,.,,. I\OltilQ.OltCI content of the product in whole or in part by such ~ subsw l« so IS to increase >.1,;J•o>- ,.,-,r11 111f.9" rn11m >. ')-'llf'> its bulk or weight, or reduce its quality or O"Yl'IDDl'IA lllf.9" 111\.11 _,._......, . '}II., strength, or make it appear bctta- or of

11.IJA 116.(- )'IC 111,.,,. ,,,,.-,. -IQ.UDC greater value than it is; 1111,r f9"C•t,') f ,ll·l- 111\11 'J'l'l·~ 1C DD•t-•1•l- ~a,, I 21/ "pharmacopeia~ means a document accepted Jlil "096mL.- J::)\- 'I·• -,11+ nll""Je::)\-'I· ,,.,~-h f UDJe;-:)\•H-'1· , .11.:r• fl\ 111' ,.,, by the appropriale organ containing the particulars of medicine prepara1ion. physical tll.l\a> 'J'l'i:•) 1C LJtll'\'Z: fJUtf,1 f 11'7~-'I• aspects of medicine and non-medicinal 9"'J)•h f,11-'1•1 1'&-•h .,.-,1,'- >,,; >,)1W'> substances. pteapcrational aspect, content, llllt/-1 - O•t""IIM• "n'l- l• fl\fl:fa,,'} intensity and sw,dards and aiterla's 10 be ODODll'1JP'f tllf,'1" 1.t.JfJP:f• , ...,.... ,.,, fulfilled related to such particulars; ., Ol11t·li ,,-.,.fJ~ )+ Illa> cUJe: \111'1 Scanned with CamScanner ~ 7n • ra , 1 G~II<' t,,'o Jf 21• rcbcuary 2019. P1;;tJI IOC .,._"I • -,,r. t1Jff rt1t·l- fi~ ♦, ti'f,!.li 1.r ~;::.t;;;..=;~-=~=~~:_:~~~~1 - 2:;.21;r-:.::;.,;;- 1n e 11,g ;,: JJ~ ~:,t-l- fcd~l'll N('t,."1• --;;.",u;. 11 ;c:-;dli ic~aJ1-;d;c;vTci;;;e-:: ' 7;,n;stru;;;111;;;:e,. .. -;m;;'.ea;;n;;s-arun~)-;- ih1 ·ru t9'"i ao"lt.l'' "'lfl·l· l" "f.i/.tt1m··t ·l·"l'lf: ·, app ,aius. implement, machine, appli~ 1,r:"'/l•~•)tltf.\ 1 h.'"/.rn·'l'/l•>!'IA tJJJ','I" implant, rc ogcnt for in vilro us.e. son"' art, "'l.;J-llft.h II.I-'. (im•1tl'l'I-'" 11•/"r :J• m3 terial or other similar or related anicl~ r=,.l'h'i"n•·.} '"J');;'m•·t~• ,,.,.,A'IJ'I :i,·Hlc'.· and their accessories. which does , <m"tt .<' ! t,Tft.,l''UII . "~ on•f•'7fit,,f't '"J'(i•t , achieve its primary intended action by t\m•~·l· n>l'l'I' I' '-'1.•I-' rm 1' ·,·1t:1 Cjm••'i') pharmacological. immunological or ht'lm-~-)- m••L'" (\ ,m ,.m(: unf: l'tt'/,lJ; ~HI.I'.' metal>olic means. in or on the hulllla OlJ','/° fAIL·l· "'1t. :}1...,, ' (l<,:•}~!C ! /J:P body. and intended by the manufacturer to wf.9" t\.~ •1•1.m •V\f, •l:ft lf'i' IIM"t,.:1, be used. alone or in combination, fir J'.·C~•l- /\·llil'm· wJM" llun,f•<\•/•A /\tllfl• medical purpose and includes dC>itt 11119"', 'J':r•II'' ~f. 1,tJ!.m·A f·l·lf;1)'; 111•"/(..(' intended for related medical use ard I\IJ'') ·1•.f'.f''fr 1'11119"'i h1A"//1•·1- ttm•flm·r conirol of coniraception: OIJ1,r 23/ "in vilro medical device .. means a dC\'k t. tl:J ' ht'lm•}·l- co••Jr 'i' nu,',') ,.m,mt: ,mt,.,(1 whether used alone or in combinatio~ l'llh9"'i' ,m.,/(,J'r, "'I ft ·l· -ti;J'm•'t tJJJ','/u intended by the manufacturer for the in. rl '"I 'I"/JI; IJJ,l','I" /lan4•~•/'A II h 'I"t-1· vitro examination of spe.cimens deri,!11 J/:C: J?:·I: untP t, •l· 'i' UD•'i'') hftn>H· /llnllfl•t'l.1:- from the human body solely or principally ht'ln>H• 111-61.• llh.'}ii. •r<~ un'l1t.' ,,,,,:JI' to pro,·ide information for diagnosti~ fl1mflm·l· {lqnanc,mc;, ftunh;J··l·A u•J','I" monitoring or compatibility purposes, and ft ·l·ft"'l'"J.H• '¾<\'"I f"'/,,n~•'I" ll'';' Ol•t).f;t includes reagents, calibrators. control fAt~·l- "?l,n"'l.1"1·1 ,m,f>"lm(.J' -1:fll·• materials, specimen receptacles, softwart uu .r-ir (IJ,l','I" or related other articles: l'llh9"'i 24/ urefurbishcd medical device" means a medical device whose service year is ye1 to expire or has already expired and fl,'IA "/11•·1- II""') M•t-'fn> l\ll''} f'-.1'.-ft·l- undergone the appropriate renovation and effectiveness testing for use in medical ,mt,. f•Mt-/\·l· >.'i' n>m.;J•"'IH: f •1•,:;,·1m purpose; /\1Jh?0 'i h'I/!\ "Jll•·l· n.1'.-;J'"/, f'"l.rn·A ruh?"'i ,m 1tf ~a>- i 0 'fi?';J •>,'}Jl.1'i ·l•onC•f, ,,.;i,9u ~f. f"'/.111-A 25/ "remanufactured medical device" means 3 medical de,·ice which is taken back to 3 fUh'l"'i <m"tt,f' "7/\•l- h9"t-';)·, t.'C:i?:•I: manufacturer after use by a health h'"l.J''lft'?All-l· ·l·*Y" IJ){l/'. onA(I >.'U,h.1!.ft institution and rebuilt based on th< ·1·'11-tlf• n>m.;)•"'IH: >.'i' 11.U'}H: hh.ll.ft effectiveness and safct~ specification of 'l"C·l· .1c lll>IJ)JIJI.~. ·l·t:,,"11n 1. 111.'l'i' 1rl.t' the original manufacturer: <\f, f"'I./D<A ftJh?"'i' un"/t,f >n>t J Scanned with CamScanner Frdml Nepri1 Guenc No. 39 21.. Fcbnra,y 2019....popl IIOl n~, ·rohr'i" -ht-· -,,H· f.O")H· )\', 26/ "clinical trial" means any systematic study 4'.'f''/SH·i 1\-?t..?11' l\'lA -.ht- 'If. J'l\"1 on medicine or medical devices in onY.';)).•l- a,,.r ruhr.,; ua"tt.J' fl.J'flh·l-A volunteer human subjects in order to f"7. ':f·l\m-") J'A ·1-mll.,. 1)( 'lilt, 1\-?w:i-• discover or verify the effects of, and/or m-i'IT f"" un ffi 1'I identify any adverse reaction to the f,mflt-~•h "i:J·ll'IJ'.11 funf.t."/ A'i products, and or to study its absorplion, f'<m(ll1Y.° 'lllt,m,"} l\"701:,. l..:"1."1 lllf~ distribution, metabolism, and excretion with the object of ascertaining their ;J-11"7.P>':f, IDJ',?" 111\.11•':f· fT',•} ·M:ht. efficacy and safety; flp>':f• 'IJ'. l'il:"·l- "?t.;11"°1 1191'111C. lllt.-,.,} '111· h 11A r."'f.f.t.-, <'IY:M'l! T',•l- }ct>-1 71'?,/ "'ll'-h.11-~1·1\'}fl -?llhA • -?/\•} 11•1\~ 27/ "bioequivalence center" ·means the center '} J', H· r- Y.';)). •r 1I•1~,r.':f· ll't:-1,1~;J•=t:m-'i in which two types of medicine productions are ascertained by research as llf.ll")};J•lfm- f'"7.""'°lfll\. unlf<;:f,m, 111'',·l· to their similarity of efficacy and safety; l'"'l.t.:nTO·l- -?llhA }ct>-• ?,';!;/ "fl'Hlt.·l·fl·fl ,ns f"Y.m-A Ot.- ·l•'lf." "71\•l- 281 "public health pesticide" means any l\c'lm- ,n.,; hm'lll:,O -r:,.r 'If. f"'lm-A substance or mixture of substances used 10 prevent, control or destroy pests 10 protect i-!·'lY:> l\cmh'lhA I l\tm<f,111m<; a1f.'1" human health and includes pesticide- 1\-?1'<$.•l- l''"f.f1l\•/A ii.If'> -?'J71m-?" treated mosquito net; ')TI. }1C IDJ'.'I° r'JTl }1C: a,,IJY.' lf'i /11,l- •Mf. r-nht. h10C") fJIJW• "'" un(IA 11-,~•r") f.a.&.1.'l"t-A • 29/ "cosmetic" means any article intended to be t i/1 ."fa,,IJ•l· unmfl4!J' ll"C.-1·" "71\-1• ll"'ni·h used · by means of rubbing, pouring, 11"7\:(1(11 11.....-,..,. 11"7fl\1't llun'H.•l-t steaming, sprinkling, spraying on or - /I01>C.a.&.1.-l· (J)j'.'/'" 11•1-tn•<'\l\f. oo'J1f: 111'1 otherwise applied to the human body or any (J)f,11" llfla,,)•l· h'i!A 'If, f"'l.f.l'7 1\0►):J•:1 part thereof for cleansing, beautifying, I\ "7 ~ '1-1·1 I\ "7 ll<r ·11 1 f.11"'711-1· I\ UD"4 u,,(; promoting attractiveness or altering the (J)f.'/'" f1'l1A') fCA''i h•Pt-~.') l\f.+f.c; appearance and, any article intended for use 11,•;J•'J l\un+fc; f"'l,a,,A 9"C•l· 'h'i fo►ll·l· as component.of a cosmetic but such articles unmll4!J' 9"C·l· 1'&. b7H• f"Y.a►A )1C excludes laundry soaps, articles intended for fl.tl"l• f'la►'Jf.6 ll...,.'iS"l·'J1 llif:J•"J the diagnosis, treabnent, mitigation or l\t11>hl\hA1 I\Ol>UO(;OIJCI l\"71111" (l)J.',,,. prevention of h,uman disease, and products j\UD/,.(11/1 ;J•fllla► 1'fl/" I\J', f"'I.O►I\, intended to affect the anatomy or of a rc-r•l·'J 'h'i 11"7'Jli'm-ll" l\m- ffla►~•l· physiological process of a human; f·l•/..1't: :,.er.· (J)f,'/° fhflt-C Y.f.:i• 'IY. .,.,..b... f"'Lfllt:~- rc,r.l•') 1.,11·l·-l•!l" i : Scanned with CamScanner Fedtnl 1-1,pril 0111<11< J',lo 3928._F,bnwy2019, .....111111 30, "tobacco product" m~s a prOduct ~ '!ii "f-rll"'llll' Y"C·P "71\•l· tlht.A Olf!,'/" .,.,.1\, or partly made of the leaf tobacco rtm>-fl. lt-l·l"'~·lf ;J,111A •l·ll;J~•F· fl"?l.lJ,ill . a.s lb, material which are manufactured • • lo lie O""ti"fh 0 "7,11! f1"7'i1•H · wVI" fliVI used for smokmg, sucking, chew· 1 •ng, Iii tm'}1f: f"'l,(J)(lf: "7')'7dJ•'/" ')'I'/. ~•JC }Ill• snuffing; · <ii?il •N ·ll"'lll' 1\.'J.f.il-1•6" "71\-1· f·l·ll"'lll' ll"C·l· ) I/ "tobacco industry" mean 16bacco manufacturer. importer or wholesaler. hll"t'-1 ·• ~ll"II hh'l-4-f, IJlf.'I" >,{l,,r•(.1.1. }OJ" ' 32/ "tobacco product special regulatory Ii~ •ii~t · r •l ·?"llll' rc •r i:-.r- r-r:,,.-rc: ~:i•-"-'" "'11\•r means a permit granted by the e ~ r •r ll"llt~ 'l"C·r·, 11 ..,rt.•l-1 fl"'lil"""' ·l ·i organ or regional health regulator for ,_ ll"'lh4,LA (J)f,'I" flun7i'I' h hilLJl"'I. h 1tl\· purpose of tobacco manufacturing, i111poq, wvr hhAA 111.'i .,.,,,,,u.m- f "Y.(l•r .,• wholesale, or sell but this does not include t.:J'Y.: If';' f')"lf: t.:J'f:'J >..et1,r ·l·?" 1 a trade license; 33/ "electronic nicotine delivery system• meaiis <iii:! "fh.ll.h ·r C'~h ~l•·t·, cm{I..,, UP"f/, f" "'lfl·l· an electronically operated Pl'Od11t1 fl'l''i~•l· ,. '}.f. TC'TIIJ'. ') "lllf,liA (Jl f,'/" designed to deliver an aerosol to users by "/IIJ".{IC'A >, 'i ·l·U.I."'1 t <IJl>'I" f .f'II heating a solution comprised of nicooae .,....,... ..,_., 01..fl.h•l•C').h ,m"ttJ' J."'111~ ~-'l- and typically, but not neces~1y, tl"?'f":,O fl•l·m.4'"'1.a>- 0 -ll'i~ ,mAI► propylene glycol and/or glycerol, 111d flouilm-r f "'l..1'"111 on"ttf If';' ll'l"C•I: ;,c: often flavoring; and any compoDCllt, ,,.:,.r 111, f"'l.a>-A 1,c-rt ~ ,.,. :,·n including a cartridge, a tank and the device f tnP'AIIAt without cartridge or tank, intended for 111e , with or in the product; ,if§t ·r•'l-r 111T rc•'t- "'1h•l-'l'014' >.'i -rr.-'f"•l· 34/ "tobacco advertising and promotion" meaas "'1 f: L."I" "'/ll •r fl-,.1';J·!I" J.',t,.-} ll•Nl'l''I' t any form of commercial communicatioo, f ·r ll"llll' !l"C·l•') (J)J'.!I" ·l·tn:l'"YJ·r') 'M"'I recommendation or action with the aim, a,t,'l" a,-111,•l · .I'.1.t.1 f"'lil-l·'l'w:,. (j)f.'J" effect or likely effect of promoting • TC''l"•l· f"'lf:t."I "7'):;:a,-'J" f ') /f: 0 tobacco product or tobacco use eitba "11°5-~·h >.11•1•1r•r wvr ·1:c1.•'l- ~a,-, directly or indirectly; i[J[;/ ••r ll"lltf fl?'')(IC "'11:t."1" "'/ll·l· r:r 'l"'lll' '.35/ "tobacco sponsorship" means any form of 'l"C•l-') tJJ f,'J" •l·'l"IJII' or,m.,•~·1 contribution to any event, activity " f "'l..f0 t.;J·:J· o+l-t Y:C'l:l· wvr "Jfl{l•II') individual with the aim, effect or likely o-,.-r;J·9" f,O•'} ll·Nl'l" l't I\IW '¼11"7 effect of promoting a tobacco p,oduct or on.f..1~ }c»- 1 tobacco use either directly or indi~ly; • ◄ Scanned with CamScanner fedcql Ncprit 0 . - No. l9 l,._ februal)' 2019... -11107 · • · -titif. r11~ r•th'i'I'\•:( 361 Mother related cigarette resembling rc•l-· .,I\,._ .,. .,.,.,,,lllA A OA, , . . , tcthnolollY product" includes a11y tobacco .,., """"" rc•1:·1 product that is consumed by creating an n.,.....,. CI-Cl'i'"S 111vr 11,,-.1 -Al~ aerosol or vapour via a process of heating A·>.llw/11: f,,-.11.,,: :i-s,.,:.,.> tobacco without full combustion and Oil.II ""111: ., A'i' rt:-1:') '.ncludes any device and associated parb l\cmm+r f"'I.J'-,11 tntended for use in consumption of the 1 1 "'7 ,;ta,- y,o """It! A'i' .,-.J'f"fr fuo"ttf product, whether or not sold separately h'i:A.') J'm:J>A'\A, from the product; ~i'!,I "Al'- "16<J- 11'\m- f"- ..-r'll! Y"C·l-" "71'\•l- 37/ "characterizing flavor" means a tasle or /\-Cl:,:a,, mf.r hi\.'\ f·l-r'll! f,ll•l- ·,c If"' smell, other than one of tobacco, resulting l- • • ' from a natural or anificial additive or a • Y"'llfai- . 'lf.+"lmA IJlf.'r ·l-r1111e11- combinalion of additives,: including. but ll"'l.+"lmAll·l- 'I.IL h·l-r'llf ''16r lllf,r not limited to, fruit, chocolate, vanilla, :J>'i' 111-•1" Ill• A'>1. \:t-'i:'-1 :fl•ll.•l-1 iiM1 honey, candy, cocoa, menthol, alcohol, -,c, hl"'l'\1 11111'1 "'l1,f-A1 fhAl•A spice or herbs which is noticeable before IA>/ll'l'I l)Jt'f'•}- U>f,9" :,0uo9'" fun/\(1~. or during the consumption of the tobacco f"'l,l\f, ''16'1° IJlf,'I° :J>'i f"T,111' f,ll·l- product; fl\a,. .,.,','111-r r+r1111 9'"C·l- ~Ill', \°tit! "ir.lf• "7/\·l- h'JY: 111f,r '1h11: IMf, flf~ . 38/ "shisha" means includes tobacco products that may be flavored or non•flavored that f"'711•,..'\l\l,f •l:{I f·l·•Mll'\ll•l- A'i CD-'/ mf.r are consumed using a single or multi-

11.'\ l.'17f f ,,, OD"fl,I; lluom+r f"'l"~fl stemmed smoking instrument that contains ,,..1,Q,"'7(, "169'° fl\cn- Olf,9" f/1./ICD- water or other liquid through which the f.'J-'/°'llf Y"C·l- j\lf') f,tJ f•l-9"'111' Cll'tn.·l- smoke passes before reaching the smoker '1"'\lllll -,c1 rh·l-hA•l- .,'\f,IIC'A tJJf.'r and whose syrup tobacco content includes f·t-llff f~t,'i:.,._ "169'"1 IA9"C' II.'\ f,11:,-. molasses, honey, vegetable glyoerol and 111a,,•1 rc•l- f,1'4rt-t:,., fruit llavors; 39/ "primary packing" means the covering, '!I ff/ ••,...,. -'I"'i. "7lf1.f" wrapper, or container that has direct f"'i,1.Cll'J rc•l-'J ,,.,..,.;I· f"7.~l1a,, A'i contAct with the product intended for retail re,,,') {\tmtll:,.IIA Olf,'r ll"'7lf., f"T,lf>A sale; ~,c ~cn-11 40/ "barcode" means a machine-readable code in the form of numlieTs and a pattern of 119"C·l- '\f, f"'l.'l'i: •l'h;l•;J-f. llll''f A'i parallel tin~ printed on and identifying a -1:'l'C fflll•l- 1111 9'"C•!, oollf f"T.1AK' product for the purpose of monitoring by A")1.tm/lf f"'i.1111-,A f"T.ll'l'C rAh·l- the manufacturer or executive organ; ~,i,-1 Scanned with CamScanner 'Ill' l/ill.6U federal Nepri1 Oucue No, 39 21• Fcbnaa,y 20 19 "-"~ );as+ .,._., ♦Tc .iu r•,t·l- ,r~ .,., rif.U , .,. ~••11i. --;:~~-h~,--:.h~f.\~l,~f.\~'~'"l:..:_l\~.~'"l=-')~°1~'"'~'~'1":_r~h-A~.;,,f.17,--:y.~.,;.,,;., T- 4 41/l/~"ial~co~h\coJ-1"~m;;:;ea;n;s~a;ny~d~r~in~k~w~i~th:-ii'Qs% 1 alcohol volume; ~t hlLC' }•Ml h'l"fl·l· 11,.,,,.,.. IMJ', 1•1n rm>,O'I' 'J.t•,H · }m-1 42/ "generic name" means a che~ . ..,,ea, !1!/1 ·r,,,,,~:>).·I: ,nc'\ fl'I"" "Yc'\•l· r1.·,.I'; by which a medicine is addressed Wit~ ,m.I:';>). ·l•'} IL"'l '11\'J! J',ll·r untJ•/. •r 11"'1.l~·l."I referring to its brand name; ~ r•"t.c'l'I' un,n6J' l\l/''1 l''/"C:•l:'1 r•1•1.f.• M" >..run111i-1-vv, !'ii:/ "l"''lll;J-,JJ<f:.f' '"lc'\6-..,_ tm'l'I.I':" "'/c'\•l• 43/ "means of advertisement dissein· JOation• ,.,,,,,,,.:;: "111•;)'}'1i rm••1• "'lfl:l-c11<1:.r·) i means includes lhe mass media, Outd0o1 advertisement, lelecom, postal . l'-l;l\.1•'1"'11 I' 7fl;J•'}! I' >..:}•N:t•l-'1 .I!"/. 'Iii . • • in1errr~ website and fax services, cine111 , fi ],'," f'<l,hc'\ h1f.\ "/ll••l-'11 1U."'/'}! .C,A?"')l .. 11111. video and any other related mea it',.C:.l'-'1 IIIJ'.'/" m,(lf.1 f"'lll;l·w-l!f "'lc'\6-..A ns or · advertisement dissemination; tm'}1,K- )(I), I !'iffl "'1:'l''l'C l'"?,,_l."lll·l- 9"C•r• '"II\•)• 9""Nlr ·441 "regulated product" means any Product administered in accordance ~th lliij proclamation and includes food, medicine, •ll'l''l'C medical device, cosmetic, and tobacco ftn:J>AI\A I products; !'i/;/ ·"l'llhll"t; 'Iii""' r '"/1\•l· ;J•lt"'l.'1 /ltmonc;,m1; 45/ "medical professional" means a physician or 1'1171:J •'} '¼Y.H· l'"?./1.1'.',' /ltm.t:";'.>l•l-i >,l1t:1 '1 other health professional who is aahorized IJur,:,,Jt.K- ai,-9" 111\.'I ·l·J' J''fr fllh?"'i' by the appropriate organ lo examine and· ='11.t:- f"?.J'h'I" ·M a,, fllhll"'i' MA "Ill•:,, diagnose human diseases and treat them . f"?.fl'I' ,ltl~II" IIIJ',11" h}ILll\o- •l'"/'l&-•l• by drug, surgical operations er othet Ji 1.C:.fht;a,,'} h "/'111 '11\CD- >,lrA f1l?·l· related medical means; '"l/.,:,1°" 9"ilhC 1111.+:i• f•MmlD' /1.'I fmS '11\a,,. J' ~a,, i •j'/,/ ''"l'iS'l.J'" '"11\•l- 41'1''1'C f"7.Jt/."1ll•l- 9"<:·}'} 46/ "packing" means any article that may be flcmao-1\•h l\'"lfl'l'l·l- IDJ',9" l\w,n:,,flA used for filling, inserting or wrapping or CD.I','/" l\"7'/1"} f'"l.111-A }'IC lf'l' f1,'}.(' packing regulated prod~cts and includes ?"C•r •1•4'.11"7. un.f'l(" >,'," 1\.11•':i· f'"l'lr1,J' the immediate container and other -l1/t4l(l';f•'} .flJ,};J•A i Wrapping materials; ~'i,/ "1'1•1• l\'lt-~• '"11\•l- 41'1''1'C 11"7.,_/."lfl·l- 47/ "label "means all labels and other wrinen, 9"C•l-r •r-+.11"7. aof'lf a,J!,9" onm:,,l\f i\J!, f"'I.Jlfi:-1 f"t:J-•I'?" wvr f"'l.l\m~: P'ilA1 printed, or graphic material that is affixed l\'0-~ CDJ!,r rAh•l- ll''t• ll"'l'iS'l.fm- m-fl'I' to a regulated product or any of its flh'lt}•l- f"'l.h•r-•l- ll'tl•fi:.'} t.fAr&-A t container or wrapper and includes insert; Scanned with CamScanner 48/ "repacking" means packing of any processed or semi-processed regulated products by a different manufacturer in any other way; dl/!,V- 49/ "inspector " means any professional !1111 "h. ,11·, •J,.,.r.• "71'"1• hfll.l l"'I. h'•"· authorized by the executive organ or rhA A '!'-'i .,-.,.,,,,?tm- mw ,_,,~ _ ,..l ·l- l\<mLOV- regional health regulator to perform r -1•,.,mn>-., flA''I") Ac; •t-/l) C inspection activities pursuant 10 thi.s r117.1mJ:-t1n>- '11\- ·.f )11>-1 Proclamation; SO/ "ins1i1u1.ion registration" means a YI ·r•l- !tr ll"1/71)" "71\·l - ·N.ll "'O·l - 'll\0>- ~ "- 1mfll. C·l- ,,.,,.,... recognition granted 10 regulated institution ,. <111'1'C: l\"'l)I Y.X'l l•l- in accordance with set requi rements; •~ll " r...,.9-r Ao,-~,; )a>-, SI/ "product registration" means a recognition .Y!il ·rrc•l- Y-1/71)" "71\·l - .,.Lll"7.) ·l- l),\a,- granted to regulated product in accordance unfll.C•l- m>tU(. •l- 411'1'C: ,\"'(IJY.X-ll·l- with set requirements; 9"C•l- r 11•1.(1-r Aa>-~'i ) a,. , 52/ "quality control system" means a procedure !tNI ·r-rt -·l- .,t.: J'J-r .l''C'J·l-· "71\•l- 4:-r-rc intended lo ensure that a regulated product f"'1. 11Y.J:-fl•l-1 rc•l- -rt-•l -'i ~o·n •l- meets quality and safety requ(rements; ".,t.:n- r r"'l.llt.:> rhllt- c ,,..c<J•l- )a,, , 53/ winstitution" means any establishment Yi.'! .,,.t r· .,".-,. 4:-r-rc r...,.1,1,,:-11 -l - rc •l- involved in the manufacture, export, .,rt .•l-1 ,,,,,u u -,11 -"l•l-r "7hf .l.A1 "import, wholesale, retail, or repacking of n"f•r.:1t: oolf'f'I ooll,(l "77S? "" f ·M"7t- regulated products; J:"C~•l- )a,-' 54/ "manufacture" means all operalions !t!!I ...,II"t. ·l-" ..,,..,. 1'~ {>~1 h'I'~ ""·" involved in transfonning raw materials ·l- or>W(.•l- 4:1'1'C a,F. "7.~t.?fl·l- rr. into regul ated products under this foo- l'fC Y.F.•l- lf'i rc•t:1 "711:>J!·l-; proclamation including in the preparat.ion, -,-,.,;nc, .,,,.ox.-, -+ -c1 - -"•l -1 processing, compounding, formulating, and tilling, packing, packaging. -,7r-, a,J', 'r (1.(-,?"'1. "'lif"J')'r f,IA9"&-A • repackaging; SS/ "food - additive~ means any substance ...-"'It," "7fi ·'l- h ?IJ 11 IJfia,- .Ylil •rr-,-,1 prepared in accordance with appli cable ,,.,,.n-l- or>/11.C·l- ODWt.•'l- .,.,,. ,~.,. requi rements and added to food in order to ,,...,-a, fi .,"11.1' I fi "'/:'f,fi'rl ftr,(I " i'f give flavor, impart color, preserve, and /1"7,l>f•l- t /1"'/ftooC a,J>,r ll·,- /tltf. 00 "'°' enhance its appearance or other related ,.,.. , (19""'1,fl .,,. f"ta. l.t/ll C 1Tt.•)'1C )a,- I functional purposes; ,. Scanned with CamScanner N til c;,u,,e No. 39 ia• February 2019 ,.._ Fed<nl <P •-o<ll110 1 tt u·~~l~fl~:.•:~:"~·:t.u:.:.t,~.,._:~•:. c:t ~r~r'H: ~.J-~f~J~~,~rlf.•~!;• f~~·r~r--rji6i'~:;;ijrc;i;";;'if~ro;:;:m;pete~nc~c;::"-;;;;;;;;- 1 ""I\·1· S6/ "Certificate o means a Pb,.,~ !IX! "ffl:J>-l· "7l.'10ii r/111C a,l+-.· ·' issued for a person to carry ~"''Ill -fl'M'C f"'f.f.(.'70-l·'l rc·l· --i·l·1 tl - 17 . rt , d"1stri'bute, w1io,~·~ manufacture, 1mpo "'· l\"7/1.,,."J·l-t l\"711-f.J.A• ~ll"i\ l\""lf1'• sale, or retail trade of regulated Pl'Od ft. l\,,,,.,.c:r-c1 f1't--l· -l:1'1'C h1A '7f\••l· f\"Y.c't1' under this proclamation; quality utli ., ,. -r fQf."IL}1· .. .,ll "76IIA (II • . . con1..., -.,,.._.,. A-1 f .. ~ II~•· ... r II prOVI·der, I b oequ1valence center, or oth.,. .. .. OllU n, ,,.., ....,-,; d.,,.·, ..,.......' .,.c l\"'ll.l"lll-1• ..., ,,.,..-,. purposes regulated under th1's pr0cla • " 111at1011; 511 Mexecutive organ"' means a body wh' h . !l'.iJ "hil.&.ll...,. hl1A" "71\•l· f ,111 h'l'~ 1..' i f.ll'n IC II empowered to administer this proclarnai· h'f'~ l\"711.&.ar r...,.C11m- ufT·1 111..1.t-A . ed ICti and other laws 1ssu to implen,.. •.,t th,.1 l.t.Jr l\"711-1·~1.(; 1111'7 .1"li\11J') f•l•c't,noi- proclamation at the federal gove~ f 1...1.t-A ..,,,.,..,.,...,. 11•1A ~CD- 1 level; 58/ "region" means any state referred to Under Article 47 of the Constitution of the FederaJ .e.<rht-c\J''r. tT-flt\.h 111 uo1'7l"·l- 11·1•/>1'' Democratic Republic of Ethiopia ~d !'i~ f•f-tmi\h·hi>- "7')'10,-S"" hAA (ltf') inclµdes the Addis Ababa and Dire Dawt fh"l/1 hO'I 1.'i f~~.ll'f' h·,."'7 City Administrations; hll·,.~1.t:l-1 f.W.ll"t-li\, !till "fhAA ,n.t; •l·.J•IJ'IJt" "71\•-,. f,tr> h'I'~ 59/ ·regional heallh regulator" means a regional ,... f,U"}"} ,...,~ l\"7/ILOll" f"Y.altn· 11-f:f·•J government body which is empowered to administer this proclamation and other la"s OhAA l.af l\"7/l·t-~I.C .l"lil'IJ'J f,,.(t,no,- issued to implement this proclamation 11 fhAA 001'7.1»,-,. h'tA ~111-• regional government level; ~, "h~IJ-fl J'fllll- hit{/\• "71\·l- ,..,,. h•JCIII• 11,u, 60/ "appropriate body" means, as applicable, h'I'~ 4\,f, f•,.,n4>~ ·M'lt-·l- ll"'l.ll'ia1'JO•l- other organs that have a legitimate interest 1.1, X-C~ J''\:fa,-<; 00'7 /ltVIJ') f·l-c't'IJ:f-111- in the course of implementation of powm fl.f\•':J'· h'M·l- 'i:fo,,t granted under this proclamation; 8/it ...,_111•tc· a,,r,,r ""'l.tll•l-c· °71\·l- 61/ "Ministry" or "Minist.er" means the Ministry >.1.,:.:,..,:.r •1'11•,.fl• f,n.', "Y.1/1•/;C: lllf,ll" or Minister of Health, respectively; "'l.1/1·l-C ~CII- I ~,u "(ta,-• "71\•l- r•t-L'l't: c'tCII- 111vr 1111·1 62/ "person" means a natural and juridical fl'ICll-~•l- on-(J,l• f·t·l'tma,- hl1&-, ~111-1 person; ~ff -,,,;=Ol-9" ll111'JX- 11:J· f•Ml\"cr,- fl\·l-19" 63/ any expression in the masculine gender 11:J• f,"1,.,.t-li\ II includes the feminine. Scanned with CamScanner t. f±Lt" "l.)t Gl(\J J. Sc:opt ' ·" hf'l!- l\'>"7t: mr.r n-,'>\'m-r ,v, -nt: This pnx:lamation shall be applicable in resped 1\1-fl l•N\il 11"7.+C-fl 9"?-fli ,,.,t:~ t·h fm-ll·l- of food, medicine, medical device, cosmetics, -m04 !J' 9"C·h ftlh9" 'i' ,,....,tJ'• f ·l-r"'ll l' A'i' and tobacco product Intended to be placed on I I the market or offered, In any other way, for use IIIU, h'f'~ ""'"l· l- <IITTC f"7.1. l-,ll·l- 9"t:•l- I by the public, and other products and raw I A'i' T'- t,:I' <\f, 11""<\m- h1t·I: 11"7.IIV~ materials regulated under this proclamation. f-l!TTC: •Milt : <\J', ·1-LJl"T. J', ll''i'A 11 PARTJWO ~ !til+ lh\ bflLll" "l. hit<\+ EXECUTJVE ORGANS ! . fhflLJl""l. htil\- fl~"J'> A'I .,..,'It -+ 4. Powtr and duties of the encutive organ The executive organ shall have the power and hflLJl "'I. hf11\, f"'l.h·l·l\••r flA"I'> A'i" •1-"l'lt-·l- Y.'il'f 'A:• duties to: Iii fll""Ml l.11'}~•}') 1 font: ~t·l- 1.u·a• r·>: 1/ initiate regulatory standards and Implement Tt-•}")1 standards Issued regarding food safety; safety, ,,,...,tr 1.u·n•l-'>1 efficacy, quality, and rational use of hm:t --l'r,, ruhrc ; medicines; safety, quality, and effectiveness of -rt-·r' > A'i' co-m:J·•n•l-· > Ac; n,w h'f'~ medical devices; and other products regulated ""'"l ·l- <IIT'l'C f"T.l.l-,fl•l-') fl.<\ ll"C·l- under this proclamation; adopt appropriale ·· 1.lJf A1-ll.C1111l1\•l- Ul\-fl ,-~.... A, l.lJrP'lf: .,.,,_., ~,_ c\ox--ts ,nL,_...,A, >.-,11,m•l- pharmacopeia from another counuy or manufacturer's in house method; I ,nc: uot,UL -1:~ t·l- CJJf.'r 111co-'> ffl.<\ \ rhrt -'f rrc: -~ 114 ,.-,..11<\A , ']J issue, .renew, suspend or revoke a certificate f./ -1:'l'TC 11"7.l.l "lfl-l• ll"C•l- hflun ~1 <\ILi of competence or take another appropriale \ f'l'~· r -1:T'l'C h1A"1t1••l- 1'1~1 '1f.h.l1-i1'1\"}fl measure of an Importer, exporter or quality A'i Sl"C•l-'> hh')I : hAA fMf, -,6hA con'!'OI service provider, bioequivalence 11"'1.l+C-O hll"~ l· A'i ~9"<\ ?1'•1~ f-fl:l'·l - centers, and a manufacturer or wholesaler -,l;, 11 r11hc ail+·l- f.l'l 'lA1 11:1\11.1 whose product is intended to be traded in 1 l"llliA 1 f,c'IC•IA a,1,9" fl.<\ h"/'li l /1\ur' ) more than one region; hfl·l".111.&-'e AC11"1f f.a,fll liA t r.1 r-1:~ t•l-1 ruhr 'i _..,t,, 9"'"1-0 A'i' I\.<\ 3/ evaluate and register medicine, medical device, ; food and other products that are required to be OII.U h'P~ a,f,r f.tJ'> h'P~ 1\-,fl L,.r registered under this proclamation, or 0"'1.tD''l l.')-0 A'i ODDD {,/ UDlPl•l- 11.-11,-11 regulation or directive issued to implement this applicable f"'l.1'1 re:,., """"""".,. ·t-LJl"f"t. pnx:lamation based on uo/11.C-,.':f•' ) oulPl•l- 0"71:l"I 1V""/' requirements; issue, renew, suspend or revoke ,,_,,. '.,_IA r,n, I 1.:1-1: f.l'l"IA 1 11:1\11., marlceting authorization or take other appropriate legal measures; /"1/liA I 1,l'IC•IA a,J',9" I\.<\ o;,'e AcrJ f f,a,/1/liA I .,. Scanned with CamScanner . o.,,,,e No J9 21._ Febnllly 2019.. ·"°ltl r..ienl ,.,...,., 1111 tt uu,u ~ tx+ .,.... •..c ., ,1t-t~ r1 ~, rlt!i , .,. detain seize, confiscate, order the di5Posa) M I ~ !I niw h'I'~ 4:1'1'C f"tf.l"1U-l: v-c•l- ,..,,, recall of. or take such other legal m ~ ,..,.~ OIVr n11.11•':1'· 111:f· ,,.,,vt•l- I\.':%/\• f"t11J:f11>-'> ti.r':%" "-"'c rC•I:') l\.f,111 1.').ll.<1111: /\..fl.C"I• 1i,nl ,.., M"IIJU• on 8 regulated product that is not . compliance with this. proclamation 01 other law issued to implement this proclatnaliori; ·~ >, ')Jt(IU(l-fJ /\..f1ll flU"I h'7/J-fl /\,t11C:ll a,f,r 1\.1\ }\'711-fl /{la>- I, ••J'f.• 1.C:Y"1f I\.Olllt: .r.l·I\A I SI inspect and take the necessary admini$1rative '{;I UhllL~"T.11>- J\IIA 1.a>-~'i" 111.f a>-ll1' >, ')Jt 'Ill measures on a regulated product under lht f·f-f.l1') ll1·C::J!C: 1:C:~·l- Olf.r l,{IL~"'I. possession of a' retailer or other pei,on 'IOI hltll• f-fl?·l- "7l.?1--& S"'llhC: 1J1l.,.·l- certified by the executive organ but die: '1Ac\t11c»- 01\.1\ •Mtr f,11;1• l"C: f{I 411'1'(; product's introduction into the market "'tit f"'l.f.l-,fl·l- 9"C•}') fl-l•t- o>-ll1' 1-fl-f authorized by the executive organ; rc:-1,, fl"t,,..flh·l- /\..ff,1 /\.""trcs .,_., 11.0lflt: 1.·11t,,..,. ore,,, "'· u;,'l! 1.crJt ll.t11flY: f,l-;\A • 6/ identify ingredients that caused death, 'l,I 4:"l'"l'C f"tf.l-,n•l- 9"C:•l- n-hlll\- 111/,'/° sickness, disability, disorder, or other heallh Cl"-1\ 111•CJ>"I' t:Ct•l- rh'>.f•l- 't'•l-1 lltn>S""t problems due to adulteration or other illegal fhl1A '1-.ll•l-1 fllL'i" tJD;l•<JJh Olf,9" II.I\ f11L'i" activities on regulated products and lake 1·"1C .fflh·t-1\ 9"C•}') Olf.9" ,,,,.,.., f.{lfAI appropriate legal measures by conduaing O'i-'i"o,- l\f, 1''i"•l- .fl.C:>A• a>-IIL•I:') investigation of sample ingredients; ODIPl•l- U"71:l.., hllLl\to>-'> IJ.?'f! AC'/°1C J',a,11.11 A i '!J ;,.,.,..c il"tl.t:'7CH· re+, rrc.:r• Tt. i>:" >.'i" 7/ issue import permits and, upon request, grant -?111..r .......i\:f OIi. IJ1C f111t'7llJ' L:" f: export certificate for regulated products, r~ll">A1 >.'>.llo-r ,...,,. l\.+c-OM· co.I. a,--t.• their raw materials.and packaging materials; IMC r-'lllJ' r-0:,,.:r- ..,l;J1""l r11hc 111.::+.:r• J', 1'11 1)A I fl ODWl;J-'l! fovf:~'t•l- 1IC11C J'll,?1fA 8/ prepare and, as ncccssa,y, revise list of essential • A11.hflL'ltH: f..hAtcA i f•f-ou11111 11"'?-fl medicines, notify registered foods and >."i" ou.(-~'t•'r- 11C11C t\011-fl .fi\11>-?A1 medicines to the public; issue nalional flY,cM! foot:~'t+ +ooc J'61'1)A1 oo.(-:)'t•}') medicine fonnulary, classify medicines llllO different· cliegorics, revise the classificali(,n O•f-t\.ff. oof.(I":/• f..h<r.l\A1 ?"f:Cl•l All. whenever necessary; hllLl\tH: Y.hAtcA t I ' Scanned with CamScanner 111 uuur ._..... t""+ .,.,. •..c H , ~ " . , Ill.II , .r- F - " - 0 . - No.>t ll'Ft.....,, 201f... - l l l l l JII f,-'7il t.U1H·• r-t:~t•l- 1';',.•l-t t.U1)·l- 9/ undenake or order post-marketing A'i' l.9'7f)•l -1,· rulir'i' 00..,1,, 1.u1)•l-1 surveillana to ensme food safety; safety, 1';',.•l- A'i' m-,n.;J•-,)·l-1 A-.f"lmC A'i' 11.'I efficacy and quality of medicines; safety, 4'1'1'C fi'"tl.l '711•l- 9'"C•l- 'If. f ~ l-101 quality, and effec:tivcncss or medical dnlces; and on ochcr reautated products ~~•l- >,,-ttiy..(- I\J'll 111/, 9'" A_111v.t: and take appropriate lepl measures in f ,l•'IA • Ot."Ul ·11lJ' ~~-i, 111-m.•l- -•"l·l- accordance with the findings. hfll.'11.a>-1 u•.,~ >.crKr 1.111fl~A, "f.! ll'Mr ""'": l.lK h ·l-·l-A f""tt.l -,ll·l- rt:•l- IOI en.sure that nidence of existing and new adverse events and information about "'· Ill• r-t:~t·l- t.U1)·l- li·l-·l-A )IJt: pharmaco-,·igilance of globally monitored A'i' h"l.fl ,,c: hfl·l--f-l·1 A'i'. - a1'l·1 .,. products arc followed upon and, as .f.h:J•·MA • n~.,n.,1 ·n ~ ...,., \l.'.J~ >.t:rKr appropriate take the necessary lepl f.CPfl~A I measure; "f.lil ruin,-,; -he',. 1'J'-t1'" f1 ,.,_l_l 11/ aulhorize 1K condUCI of clinical lrial, monitor f.'-~~A r -hc',.m- 11-A.11,- ruhr'i' and inspect the process as to its conduct in _,..C'J·l- -•"l•l- ,,..11y.,t1.') f.h;J••MA1 accordance· with good medical practice, 11-,,-,,- evaluate the results and authorize the use of , .~mc',.A • a>tl\.•f:1 the result in such a way that benefit the fl 1ill•l'f\n- 1'~9'" fl'"t'il m- -Al► ,.,.,,_ public; order the clinical trial to be "'· A'>'Lm-A '·'-~~Al hfll.'1'1. 1\11'1 SU5J)Cnded or stopped; rutir'i' -11;',.a> >.'>-t:J"1.t: 1111.r A ,.ii..,. -l-A•lll l\fl1' J',l-'IA I xr, r-t:~+' > >.'i' ruhr'i' ,,...,1, , ,-..-,1111~ 12/ promote rational use of medicine and hm;t'f"r f.~m&-A , medical device; ! t / f'i'Cl•·l:h · -t:~t•l-')r M.el••l-G''Ch 13/ regulate the manufactu:e, import, export, · -t:~•l-') A'i' fT6hCflC l~""tl1A ') distribution , prescribing, dispensing, use, . recording and reporting of narcotic drua, haot.t-l-1 a,t, enc a>fl1' -,fl11J·l-t a,t, psychotropic subslance and prccunor a>"l• h1C -11111 '"7114-l.Al hfl•l-1111111 chemical, and pn:vent their abu,e; Al.'11 flC~•l-1 hm:Jo-,.r1 -a hllllr 67'C-l- 1\Ul'7 A'i' h111? 1.l': 'If. 4'1'1'C fl.C?A. I hl\h'71J-O p c',. 'If. 1,')~f.m,fl. f.h'lh'IAI 14/ regulate the cross regional advertisement of !!/ hAA •J-7f? t OIi') f'"7fl:J-a,+.f 00')1.t- regulated products _in cooper:ation with the f"'t:Mfl~ ..1'1'C f""tl.l .,O·l- r e +, appropriate government body; f""f.11Dflh·l- -,r,:J•a,+./') h-,11,0 ltflco- fao')'7r- l- hlJA ? C n- 11', ~ .f"Jmc',.A I Scanned with CamScanner , Osic1TC No. 39 2'._ Fcbnis,y 2019 oh ., f,d<r>I Ncpnl ·• lltlt1tl 'l'1; !iit6fli 4U-A I.><:+ .,._.., ♦TC ,'Iii fli•t-l· ,r6 4-l flt!~ , .,- I SI coordinate the implementation OftJic \\i "J:f;/ O·rrciir <llTTc "" ffJl'IJin-'> r'llll"" r,n.'i )'-:alth Organization Fra llr1d ~ ••••, 71'} , J!:C~•l· r-l·Sl"IJIT <ll'l''l'C: "7b4''1: I• )0. Convention on Tobacco Con1roJ " 'i ('It'} 0: '} 7i .,.'} "711 /..,.'"I. J' ;,f. f: " f.') ~~ implementing gu,'deI'me; establis~ nai· ""-""r .1•n•M-11t-A, 111,·,n:•rlf.,. ""'"t.-l· coordinating mechanism to folio~ ,._ f"" r-l•Sl"IJIJ' <ll'l''l'C') in-1n.;l·"7h· '1111.t-'I! hfl•MIJt . ,•11.,••·•l•A . hl1A 1- •1.1;.ur,,,,t.·l· effective implementation control, and work in collaboratio of lo, "lll ltf, n "'iUi fF-c:,A, o•l•rci1r '1:TTC: appropriate bodies; 1 h•"l,<m/lh;J•=t:in- hl11t•l- ;JC •l•IJ,flC' f,(1/,-f.\ 16/ regulate the content and !'.'id r-l·Sl"'IIJ' ll"C·r·1 f,ll•l-1 ,r-'l>I~ ,mt.1f'I fA• disclosure, r manu,actunng, . ~ l>Qnl. • "7.f:l•n, t.,mt-t.·rt hfl•l•'l'i1i•1 1 ·11t•J." '""88Jn& labeling. design: import, , 1,·,,-,;~1 wF. ,nc a,-fl'I' "7f111J•l·1 ~9"'1 distribution, advertisement, Promoti0n liid 00711' 1 "7114-LA 1 "7fl·M'fJl:J>1 A'i sponsorship, and related asJlCcts nr1/lci'i:r 1-'i' ,,.f flfr r•l-11"/JIT rc•l- Of tobacco . products in line · with I,, L <111'1'C ·1->1r-:-i·-·, ll'J/111" r,n.'i' .r:c:~·l- World Health Organization Framewor1c N·rllll' <h'l''l'C "7t,-,.'t: li'1ii'flf'1 >,r, Convention on Tobacco Control 8., • ,., lb l'tt')ji')7i',-') "7{1/,.1,"7.J' ,'Jf,f:f\f.') UDIPt.•} implementing guideline; f,4'>'1JmtrA • ):'i.f rh1A•J11••} '1.ILID' J'/1/..11•}') A'i A.I\ 11,w 17/ ensure, in •collaboration with 3PPrOPria11 h'I'~ <IIT'l'C f"7.F.t."lll·l- tl'l·fJl'l' wvr bodies, proper disposal of expired 111:1 'l'fl/" ltf, 1'"7f.ff"A '/"C•l-') h"IIJ-11 11'l1f-in- other non-complying product regulalid hl11t,} ;,c (lontJ''} A').ll,11111: fF.C:>A 1 under this proclamation; Oh"IIJCI• OD(l)1Jl.'}SI" f.4'>'1Jtn&-A • 1.iJ- .,-.f,'IJ"ltP•':f•'1 f,onf:IJA1 h"JIJ-11 IJ/IID' I 8/ appoint inspectors, and, as appropriat~ O-);;J• ..,.,,,.a,,•1r <ll'l''l'C f"'l.F.l"lll·r·, 0 order the inspection of any premises ii 9"C•1-1 •1":l:9" fJlf,'I" "Ill f.L•l-iiA t accordance with this Proclamation; 1- '}.11.t..•l-7i ·rl,1111 f./lllJA i nu 0"7./ltnlD' h1A"]{l••r "'· fh'IA "Jt.••.,. h';:f 19/ collect .service fee, and use the same ii J',/lllfllJA I f/lfl/1011>''} h'i:f h"IIJ-11 11/IID' accordance with appropriate law for !he 11"1 OD"'l·l- (l.t..+ f: lltn.'i' <ll'l'TC: '""' purpose of health regulation. fa>-ltA II h~A ¥'fl+ PART THREE f9""1-0 F.il'>~t hfl+.11£C FOOD S,SFETV ADMINISTRATIO!'.! • ~- m-1-'llt 5. General Iii I\"l'11t. •M-O h 1A"lll"·r '1"'7-11 f"'l.f+C -11 I/ Every food establishment who provides roo5 "7'}l';a,,9" f9"'7-fl ·l·:I:'/" £U'}H, M·mn.,. m,tJ'',- f"'ll.?11' :)/tl, ~..,. ht.O•l-, , for use by the public shall ensure its~·· • Scanned with CamScanner ,. ff C H t ltt + lfl +, ff .I f ,.r U U fl t ;.. y, . t~+- .., .1 shall ,y assessment of food r, ~,,..,ii 11t J:t11H· <l't,-.,.r, tr r.,11, .,,.H · A,; 2/ The rigor of u fc and potentiaJ risk to r-t:r-11., 11.,+ be based on its type Ol\o,. m.,; "" ft.,J:r.11 human health. -" 'l -r ~ 1 -Al ► r$ 'i A tt l shall d packing materia -tls1.r .\'71HI 3/ Every food an I'.! ""'"•r V-'711 A 'i rr -, 11 J'ai"ltn-' t, \/ t·r -k , U X comply with Ethiopia n SW1dard adopced by J'lltn- ,\l 1A . the appropriate body f" '7 .J" 'l '1 -tr, Jillll-'h I sub-article (J ) of th is article, 11 r,u, ",+,.. ,o-h-11,.,.,.. Cl'). ,.......,:n• . ,,.r.r IL, .H• 4/ Notwithst1111ding the executive orga n may use accepta bl e CD"lll·l- f)"''7'fl 'tf opced by intematiO!l&I fA .T f" t J' l I. a ( IIA Ethiopian standard ad l\" "UJ"J•l - e safety of food ,\I IL .ll "t ,\111\, V' \l. ~•I,') a1ions to regulate th 'lr. , organlz A'i •t+ 'lf .~ ·l- ndard is not issued. lt' J, \r h + i: . ·f-1!"'7•} fai"l'J for which national sta _, .,. .t,} n- ,t :l '7 rr-,,o, J'lltn-, J: a( A 11 l.l l'} H • .f..J 1m&- 11 health Th e executive or pn or reg ional ,. ,.+r.11 r- ,1 1 1. 1n H ,, 5/ mity 11 "'" .,"1 ·H tr st third party confor l';I rcau,lator may reque . hllL.11-t "' '" · "' '·" '" sa fety of food f" t. f': t'I /11\CIDIJ') ltn--, assissmcnt regarding the "lt .,--,. 11,.~,} J'l fflAA tn .'i •1-.J"l provided by food instit ution. f •l- il"'7"t~•} rl l' i CD-IIL •} fY 'll •l- 'f ai 1, ~ of t\ .m r.~ .r.'fiiA. 11 6/ Every food pr epared for the 'J'l"'7 aiJ: ·~ · 111c r-tiiJ, promote the 'Iii -, ,r :t n- r 11,-,x: shall be safe an d exporting t •t-m n+ A 'i r111c, 1M-t trade interest. si -? il · 1.1 11>-1 , country's sustainable lO•l-11 which ,- f" 'I. J' t., '7 1' -. M ,\f 1':,. 7/ Every locally pr oduced food for 'IJ >a1111Cl!- 1 .a rm11 111+ -,,r""r mnr. ,o,{),,. man~ ory m nd ar d is issued shall bear the r>a1111Cl!- t. a . rA h ·l- • t- l•l- V- '7o fl applicable marlt and shall possess f" ;I•! t1 '). t\. J'l :J'7'f' r-tl-A H certificate issued for this purpose. t\. 'i'l111-t; .f. flC:•l-1,IL•l- f •l-fl,na ,- -ir, hl \O •l-11

6. Rttlst11Uo9 o( food pnd food !IJ df 17-0

1. M:O A£ rn :0 ., ,~ t t r 1111-1 utablbhment al l be registered by the I/ Ev uy person sh /ii ""'"""r ~.,t- 111, regional health regula tor 1\111- 0, -- ,- 0 ,. ,~ executive organ or m 1 ,r . n>allL11"'7. 11•1"" before commencing a food trade activity ,, _ fl. .,t -·ll 01 .•l- llhAA m.t; .,..,.,,,,,,t ODOD111il hl\O-l-11 2/ Unless authorized by the executive org an or de ,. hh/lL .11"7. ator, no food tra ~ on al bealth regul ,., - ,, r .r fYo'7il ')'7,t, .~ fl:l'·l- establishment may ovide a pre-packed pr A m.t; •1 -.J ''l' 'lt to - fo 1'f11\- a,J',V- hh A . nn for use by the J)!ll>lic: m l+·l- "' "~ r: food "'7l.,1""i r11hc ,~ a, ,A "'7;r>lofl r- ,- 0 , h1 A '71\••l- 'IJ', A 1 'l ,' fA r1, Scanned with CamScanner • , ,"11' No ) 9 28" Fcbnwy 20 19,. Pfgel f cdc-"I Ncgao1 0 I IIt, ~ '--~;;~~::;.:..:~~=~~;.;~.;~iiT- 33 l Xll.~Ul '-U-11 i.,~-l- .,,.,. •-re .iu fl l'f;-l• It~ -t1 Ji'i.!S , _,- !'./ 9""/11 h«, rr·1-11 1•,.f; ·1·*11" r11·111 ,7 FRteeigisistrtl'llaitTcio;;;n:-"ooffffi~oo;;;d~n~nddiflboOd~ llldc e<lnblisluncnt shall be renewed wjic• rhAA ,n.r, . •n~ liit II>, (I L ll'"I. ·1•4\lll"lt m- "' "· >,IJA WJ'. Y" 11'"1.wMn>· r•1.1L .,,..n time frame required by lhc ex organ or regional health rcgufalor. ccui,v1 . ,m"'t.·l• 111.11:,.,1, un:J•f.(I J','i'C:ll;J•A 11 7 Food mnnufncturing, preparation 510 !'1 '.i, . ii/I 9"''?ofl -,,-t.~1 -,,r,7Jr1 -,11-,;,:, "'":nr ' transport or selling place ~ !l!f,9"' OD7f""l ?ii "?'}lj'cn-11" 1'9""/•fl ·M~II" Y""l•II I\ "'Ill" t.-l·1 I/ Every food establishment shall hav . edit resP.onsibility to ensure tha1 cquipllltin OIJ'.11" l\''7:):\11 n'- •1A'lfl••l · <Df,11" (l;J• '}l\'tl',(11• or material used in food manufa••u . storage, or transport is clean and free r, ... ' "&. r•hnll-,,c, ll"'l")li'm·II" uoAI~ V""Jll•'t 0111 contaminants, and ensures that it complies 1'1·0111\·} l''"/.l';JA'f' h«, llhfl&.ll'"I. >,!1/1, with safety requirements issued by ifit 1'01"lm-·t 1'1.tl')H· ,m(l&.t:-f:f• 1''"1..1'".7.i\ executi ve organ. Ubl/''1,•} l''"ll.:>1'T' ;)'1.1,H· hl\ll•}i t 2/ In addition to the responsibililies Prol'ide,i !{/ 1111,11 11'1'/•ll' ')>,.{1-h'H'll' (?i} h·l•-,,ontntn- under sub-article (I) of this article, every lJ'l.l,H· o-r·,n.'"/6 '"11i:'m-r rr·111 ·n.r: food trade esta_blishment shall have die ·l·t9" /19""/1I '"/9"l •}1 "'1ll;JJ':•'h "'llt"'/li:-1· responsibility 10 ensure that places for fOOd IJJJ'.9" onli'T' >t1A "/fl•·l· f""l.tn-A >,l11JII. !1""/11-'} manufacturing, preparation, storage, or sdl h.ClhA h"'l.':f·A ~1<: l'O>l', I' t-•/• m•ll'►'J are clean and far from contaminants. r'"lt.:n'T' ;)i\.t.~•r .>-.1111•"1-:: 3/. Every food establishment may use equi()mCl!I l'.I "'1'):;'a,,r 1'9""/1I •Mtll" hll""/11· :><: -l''T'•l·'1 or material with direct contact in the food 'thlL J'l\a~ uo"ttJ' lllJ'.'I" r,:,, llh"l'lll· only if it fulfills safety requirements and fl/lunflt-•I: "'lt.:>11''i >,<; Alt·!: unt.."J11' shall ensure that devices are periodically • J'/lll•r'} ""''itJ' 1."JIHI 'Illa,, l\lJA llr'l,t~a,, "7(1{\IJ-l• hl\ll:t·, I calibrated by an appropriate organ. ~/ ..,,i;:m-11" l'll""/-0 ·•·*9" f?""/11•1 1.11·,~·} 4/ It shall be the responsibility of every food 11"7J':\.(-A ont.l► M' >.11.11""/11• 11llt establisJiment to ensure that food is stor!id, r+11;1>11, f'l1llll•l:1 mofl~ '"lh'"l:f:,r, "7:\'l11! transported, or placed for sale in such a way ou71T u,J?,'J" "?+t.-0 Vl'Cll;hl\ tt that its safety is preserved and, if necessaJY, a proper cold chain is maintained,. °{;I "?'Jli'0>-11" 11""/-0 •t-&.ll"'l.H· 11/10>- l'Ol •l·llf,1 SI Any food product may not have chemical "7.lllltJ'I l'h '}(lfa•r tm~;)~·rl (\\/""Ml residue including pesticide, fertilizer, animal "79"t.•l· l'"'l.u.ioo~. IL~l1fl•l•1 l'"?m!L.1' medicine, food additive chemical, cleaning h.~1111•':f·i t.Q.lt-I 11.fl•':f· 1'(10>-'> ms 11.1~ chemical, a radioactive substance, and other h"'l.l•/1, 1111,e ~1e':f• r-l>t·r uom'} ooflL<:•r contaminants above the maximum level onofl/l'T' f/lll•r9" II issued or adopted by the appropriate orgJII- Scanned with CamScanner -- - ... , :.di4!&iill!.li••to.:.:;,. ..;.~- - - XI .,, .,,. rr-,,n ,.,.(' +ltr 11,i...,,11,n.,. 6/ Every food establishment, depending on the r'tofl 'lllt hi f'Wi hm!I>♦,- ll,f'•Ah•f, nature orthe food, hu the obligation to give A•f,,n...,.., fW! -tK r-flm•l- -,'-:'. adequate infonnation about handling and IIAft-l-11 use of foods it offer, to sell. :. IIM11 ttr ...-... IIA-r.t14- _,. a. Psnonncl workl11 In food nt1blllhmnt1 Iii.,,t;t.,.,. r,.-,,n •t-itr 11r-,,11 "7rt•l-i I/ Every food establishment shall ensure that .,,,_.,,:.,., '11.r"t.• mvr -,11,1-c;,1: , ..1,. "'· its employees who are engaged in the f"7,ftl-,'- l»(,.,t-t,';. manufacturing, preparation, or service IJ) '"'"'ofl .'>(; +T·f't;' -,,"f.~•'t- fl\m, l\tr, a) who have a direct contact with the food 11-,,11.,.,- 1,11, flM•n "'"' •'ft+ bll• to be free from food-borne illness and a,t, ll"t•Ml\f. trll:J•l"'l• C\o,, » take appropriate measure to prevent ilft-u'',, r-h:J••I-A.'i food-borne illnesses; aDd Ac:i,,-K r-..111:, A'i ft) ~l"tf\t,o,. I"(,. :>c: " r-tV.1: •MU, b) '!\'Ol'e an appropriate safety clothing. ft.O'J)•l- IIA'llt·l- -All"-' "7l.'11'1' IIAft•l-u Ill IIMofl "79"l•l-1 .,,,:,J!-l- lllf,'I" 11,.... 2/ Every penon who participates in the ,h.t.+ 'If, f•t-c\"7t,. -,,,;«a,,,- /la,, RM11 manufacturing of food and hu -Mt- a,,fl'f IW"'7ofl t.tr>H· .n; R·I-.r111 knowledge of or reason to believe tllat 111-Cll·Nlofl IIL'i '\f, 1'4•l- 11.lt.c:fl ,..,.:,.A a significant risk to the public's health exists shall lmmedEately report. u l--tc: l\hll•l- mf,r '.f.-,,: 11.hl'l•l- f,'.f•f\A .approprille, to the executive organ or f"T.A 'l'C:11f'- 1\-:'ltr> A')I.Jl-,'111- 111'\flLll..,. regional health regulator. hltft• a,f,9" fthAA m.'i .,-.,."l"ltG>- 111"-f•',, ,.,,..,. ~'IJ.t•l- t.tta+,, 11: M:Q IIAT~t 9. Food m111(1ct1d11 Iii .,,,...,.,. 1'9"9111 .,-,:,- ,..,.,-r.,,.,.,., I/ Every food establishment hu obligation to r'?ofl t.ll'>)•l- ft"Yl,"1'11' f"'IJ'll°fA f1't,.-l- install the required quality control system to -,l,71"'1 l"C't+ •M'lt,.'t -,,:l-, httll+11 ensure the safety of foods it produces. JI .,,,...,.,. rr-,11 l'lrt,.l·1 t.fl-Q.l. 111vr 2/ It shall be the responsibility of every food 1'111:>~ ttr-,11 "7rt+ 11,A-,11-•l- ,..,.,.,.A manufacturer, importer or preperer to ensure "''- I>~ t.11,t•f, 1'•1-mO+ -tf'i-'> 1'"7l.''1'1' the safety of raw material used for food manufacturing. ~'\J.)-l- hl\O•l- I I .. Scanned with CamScanner .. . a-•• No 39 2s4' fcbnJ•ry 2019 l>lt,t flJt F~&rtl P'itP"' 'Ill" Imf!lt IJJ,.A l _,t+ -"'"' ♦,..; !Ii flt-t-l- lfJ ~l f;!J 6 ,.r ) / Every packaged ~ood man~f~cturcr lliii1 1:1 '"l"Pl(Do?" r :J.1r1 r?il 1,rtr":f· 1:c~·7• rcpor1 to the executive organ 1f II intr0c1~ f,11•1-'i 0 "'/..f'llDC:•l·(ll< ?""Iii '}J',)•1•1 change in 1he type, conient, ~ l'htm6-l·r Y.s.'.•l· 'I f, 1\11~1' .f'J?.l 1 A'}J?.lf) manufacturing process of the fOOd . ~ produces. IO, Food import and export I. ~ 7 -<I m.i. 111c tJ>-it1' itl\..,il'IIJ-l-'i ms.'. tJ>-~ ll'IC it/lDD'\h 11 Food may be impor1ed only When . ?ii '"11:-;:m--,9" 9""1fl ms.'. 111c: o~fl1' '"lfl'"'''l·l· complies with applicable safety ~ q f'"l.rl\(1)- .,.4'.ll"'f.H• .rl\(1)-'} fJ?.ll')H· J?.lif and a pennit is s1:3nted by the cxcCUtii~ . it..l'"l-1 A'i' hhflt.ll"'l.m- '111A f-ll:l'·l· organ. 11 '"lt.:>1•'1 ?"fl!JC fJll•M· ll.f'ti •llif ~111• 2/ Without prejudice to sub-ar1icle (I) or this !(/ r,w 1,'J<l•ii.· ')lM-1,'}.,.ll.' (?i) ?,'}J?.•l•,nll•I· ~ •j ar1icle, if the executive organ has reasonto >,fl 4'.ll"'/.(T)• 1,11A rr·/11· J?.trJH• -~m6-"lt suspect the ~afety of the food it lllay IT'i c'I.J'1'fm· Mfltr-ft '/"Cuo(r ll..l'i.t: •1 ,perfonn a labora1ory tes1, or order wJ',9" Mfltr-r•t 9"Ctn>/r fltv'I y•(l•/•'I,' 1,liA laboratory -test to be perfonned by a third >. 'M.J?.t. 0 / /\..1'11 M" ww.m·9" 11?,{ltm(JJ,{ll< party and its cost' covered by the importer. .l!-CJ!!·l· >, '}-'l.ir4'.'J l'l..1'11 J',:f·'IA" ., .' 'J'i If ~~y im~or1~ food has established safety I:/ w.i. u,c (Dofl1' f "'l.'l'l "?'Jl';m•ll" ll" l·II . 0 ' problem, 'the execut~ve organ miy r.i.1nFt· :f·"/C c'I.'i't.m- M' fhr/r:il'} • determine to evaluate good manufacturing fuut,1111" 1,tn>/rl ·} ,,...C'l·} "?f·l· hfl4'.'11, practices of the manufacturer. IT'i c'I. 'l"f 1,114'.Jl"Y.(Do 1,ltA ftmf.lltll" 1,cmt,.{.•r /"C'l•} >.1.11.t1Y,.(- ll.f1I .r.l •-1/.\ 11 "· 4/ Food ' found to be unsafe under Ibis i!I JJJ.J:. 1.l'IC (Do{l'J' f1'1 "7')7,'(1)-1/" ' 9""1-fl . ..., .. proclamation may be returned to i1S l'JW1~·} 'l-.(-/1•} l'·M)"fl•} ?,'}.J:.tl'~ 'couhiry of origin or ·be locally disposed• 1)1,(lOPQ.l_CIJ' ll"'l.ir4'. '} Illa!, a,.i, 00 1'1ll·l- ,nc the expense of its importer. h 1-'l.01>/1/l a,f,9" ~V1C (1)o/l1' ?.,1-'l.OJ'l.l!- J',/!.t.:,t:,., I ?;/ "'/'}"'?a>-ll" fll""HI 'IIL ml.. m--i.• 1nr. 5/ I\. f~od CXP,Of!er, as necessary, may gel 1 , ol ' ill\ "'l.A hm- 9""1-11 ?, '} J?.liil4'.'11.H: I' Ill, 'i' health cer1ifica1e of food ii intends 10 9"/lhc ml 4'•} hhil4'.ll'"l.(1)o hltA '"/"ff ·l· expor1 from the executive organ. J',l· -1 /.\ II Ui. r,:7,() "l"'"lt • 11. Food additi~~ ' !ii fll""lfl •1•'"1t f hm:l'-,•9" cmm ·, "MJ' 1/ Use of maximum level of a food additi•-e h"JIJ-11 ft\(T)o hltA '111J"IC!l' fh.•r f'k.f' shall be in accordance with Ethiopiall .J:.lJI" ODIP{. ,.,. oot)''} ht\ll•r I : standQrd issued by the appropriate body, Scanned with CamScanner ..... 2/ The executive orpn shall dctamlne the list of allowable food additives. 3/ The executive organ may, where appropriate, prohibit the use of food additives in • certain cateaOIY of foods.

12. IP(IPt formula IDd (OIIOW·MP Cermull -,,'i'm-r '""'+., ""''i l'IIIC') •f,~ -,t 11""7-fl Every infant fonnula and follow-up fonnula 1'1'.•H-~.f 1'&-•l-'i 1.11,),')- t.l~,.:,., l'"'f./"l-,, shall comply with applicable Ethiopian quality and safety standards; its component shall 110( be M.m+11-0•l- "''- t,;, ,.,, . 'J.r.H· r11t -A ,,..,, ~fl' i ,~.,.•,v~n~, ,,. 11109&,t•l- V~•l- genetically modified and exposed to any manufacturing. and its during .,A,f,:111,n, -,_ _ radiation A""-1.t- 111 1 ...- h1•-,,H:h packaging is made from a non-plastic material, -,,1:1,,A ,A·h 'tt- A'i l''l'l:'-1:"> !,l"')4.M1 and contains a label bearing the sou~ of its tr'7~A• l'•l'ICI. -u'' ) hilO•l-11 protein. n~. "n t M:O 13. food 1■ppfement I/ F00$1 supplement may not be imported or Iii -,,'1111-r -,"l .f M~ I 4.P. 09111-fl a,t. U1C pla« d on the market without registralion . a>h'I' -'7'1 •l- a,/,11" -11'1' l'illl•l-,-11 2/ The rigor of safety assessment of food r1 ,-," l., r""' 1.11·n•l- "'"'"'r. rrr.•1t"> supplements shall be commensurate based 'Jf,i•l-1 Ofla,, tn.'i -,,. fl.11.C:il M.':film-, on its type, potential risk to human health, il,?•l- _,P l•l- '1~1 -Al ► /Jr'iA 11 and its health claim. If. M-0 OA-rRAn ,._ food ro,unqtto■ I/ Every food identified for fortification shall Iii -,,, ,.,_ ll•t-11,r. '>'l'l•!,l"'7-fl A'>.\RIIA''7 Ethiopian standard f•l'AI' !,l"'7,f) h"l'l,f) 'Illa,, ,..r,A f•t-+ -m') fulfill applicable adopted by the appropriate body. fA.•l-l"A' I t.at -,"ll l•l- AIIR-l-1 1 2/ Vitamins, minerals, or other essential II -,,fa,,,,- ,-.,,(1 A-,RA0'7 l'"t_.~ nutrients pennitted for fortification it'r,;J••t.'1•· -,()~ ') a,f,, - A.II '>1'l·!,l"'7-fl purpose may only be used if it fultills 'N1I'" . 11.f, f"'to>,\a,, h"l1'1"1 I Ila,, hiIA requirements set by the appropriate body. fa,''10>-'l t.at c\f" lll ,n;JI /Jr'iA 11 3/ Every food manufacturer that fonifles 1:1 -,,,,,,..,- l'r"l -fl Art- ':f mu, ,...,.,.,_ food in accordance with sub-article (I) and 'J0-11-h'l+~ (/i) A'i (f) -wt •l- Mll ·'J (2) of this anlcle shall accordingly label /011A1 lltf) nrr.•li "7111.I Ill, R'7A1'i the food'U fonifled. -,n+ -1' hilfl-l-11 I Scanned with CamScanner N ,-ii 0 . - No. )9 21• Fol>niary 2019 Fedcnl • ,....._ -..1 Ilit .- !~. ?:111 {)f \-,~ lc IS. _f.ood f'or Irradiation # . •• Iii r-, ,o r--,,iW.ll.a> fM -fl' > 11 Irrad iation of food shal l be Clrried t.tJ'l',•l- such a way that II' 1'sdesrg °"'Iii ' ned to "leet onflLC•l- '1-.1" 1H; J• h'i' h'7'1 -fl 111\0I' f,w .(.t, 'lf, H• h'i' on,n'} .,.,. ,., hllf H·• • requirement of food safety and U$i ~ . . appropriate type and I1m1 11& t of l'ldiation. °" II fiW .lC an,n '} <f11'1'C · h"l'l-fl 111\ 21 Regulaiion of irrad iation requiremaitVlall 0I' h 1tA n-• •·11nc t"'l. flt- r.11c;A .. . implemented • • NV,A ,...., ~ 1n """'Y"'••tion \iai appropriate bodies. · · !I. r-m T ~, t.tr>H·

16. Wa ttr spfety Iii "'l')~a>-'r f!l. '}!l,1 f;N f1 mf ,'r I/ Any pipe or bottled water or othci "'" ~ ll<" 'IO' I' f"'l.cn-A tIJ-'/ h-t t-ll water supplier or producer shall ~ 111f.'r hrt -':f · tIJ-'ltIJ- Oh.·1-l'"kl compliance with the Ethiopian sar~ t.l.K r•r- +-, na, ,'} rt.i rn•l- t.t.Jf standard. 1-.111 ""'11'~1 "'lt. :,11 ' hl\U•l-11 1(/ CD-'/ f"'l.;Mi,rO •l - IL"'l.'IA IDf.'I° fen,'/ 2/ The safety and effectiveness of every "'-II "'1"11,f -" It/ h"l' l-0 fl\lD ' til1A treatment chemical or device shall be 11..,_/IJIIIJCD- oa( ILC ~ tJDIP(.•l- regulated by the execuiive organ. CD-IR.;l.-, ',•l-'i' t.111',•l- 01li1Lll"7,a,, 1111A "11''1"C ,..,, ,.l.' 70• l- f,lf 'iA 11 r• . .11. '10 f 'It 111\~I\ M1 1 t.U 'JH• h-l--l-A 11. Post·markst u(ttv mon1tortn1 . . Iii "'l') ','a, ,r fV"'7-fl hrt-":f· 1J1f.'I" hiluo I/ Every food man ufa ctu= or imponcr CJ.l. shall T.:c ~:,. ilf\"T,frnC•l-111' IJlf,'I" MoY .fflt-""41>' have • system to enable it to COlllinuoosly ~, o 1.ll'JH• -,."lr,H• 'lf\a> ""Al► h:i ..l•A monit~r the safety of the food It producu .. . f\"tT .:l." I f"T.fil':f·A t11flt-C .P'C 't-l· or imported • !i.'il.a> l,1'1A11 . r, M- 0 011?110- 1111oauo(.•h1 l1f\DDh'.'7lf•l11 2/ If the public's health is in dan& 11f\rnli:tft. IJlf,V" ef due to 1 1111-,,~ rti ,,:i , confirmed safety problem relating to food l • r1.u'JH· 1-r.:f\:i• rn\9 ~ 'J manufacturing. storage, transport or l\l.,?11' ).'}1.11'7110- 11i1Lll"t 111111, a>f,V" fhA A handling. the executive Oliln or R&iooal IR.'i' -,.f."1"1ta> 1,0l.·1-flfl· health regulator may nocify the publi V"'711·l t ha.m-,.r >.'J.._.f,n,fl V"C •t, O+flt-~ · through the appropriate massmcdia R:i· not ID IJ-f\•11"' fl:J• •1-,.t-'/fH• 11110> f·fll~:)'} use the food and order recall of 1he ""1'i'i" f\.fo\a,,.l, M" h10 f 1. ,.11.f\Oc't-O product. f\.J'11 f,'f t\A q Cl 11i1Lll"T, h'1l\, 010 , "" ,~11 ,--, ,01 3/ The executiv e organ shall periodical 1.1 rn+ ll"tt._,,.,. nr1 ,~a, , , 1:111. ly ,n.r underuke safety monitoring of food 1">-l- /ftY )IA I IJ>Q.\a>'>r >,-,,.11"111 0• productS placed onto the marled; and m,y 11rt-111 1J1 f.r hfla .'ll_ a,, >.'}. ._ff\':') (\,f ,.c., 1,':f,t\A II order the • cost be covered by ill manufacturer or importer. Scanned with CamScanner .. IS. Ak oho llr dri nk S9le alcoholic drink Iii .,,i.'cn-r Oi- ◄Jtlt l:.l )( f"T I/ Every industrially prepared .11.,~ fl,A l•A Ethiopian °' flL •l- fhA l•A shall comply with applicable -m T GI~ in , h- ~l fl· accepted by aivr 111t·I: other internation al standard , .11-l- -m ~ fh .•l-t-1., ~t ,r, ard to its h+ i: 1:. l,r the country , issued with reg r •1-+n11l-m-, "-" 'J/111" contenL f" tr .t" ,,., .;., hill)•} I I any alcoholic drink h~ /i '}o u•} ll;J•l · 2/ It shall be illegal to sell It! "7 ')', 'a, .r fhA hA ""' mT to anyone un~er the age of 21. /Ill '), ,...,.l· -n -r r-1-11111111 ~o,, .. 3/ No person may sale alcoho lic drink Health f~/ f hA l•A ' n,n..r. ·f·,...r1 11-l·ll"IIC•l· °"f flT ~ education facilities, O.·l·• O""'l'il IJ~'i·h ll~">iiC c\•I; A'i Ol•I\.J:1 . institutions, kindergartens. universities and colleges, 111\?"C•l• n- ,., ~.,-l• ·I•~-,+ , Ohll"AI• Cl:J-t government institutions, places of "7/ lo,,•f·t, fl:J•s,>":f,, 01 \k- , O. +l· A'i r.11,, WOl'$hip, spol'.ling places, cin ema houses l:.'> ◄l _, .•l ·l· ,, and other places determined by a h'I '~ ""' flL 1. r rt- lai "J hh Al •A 7fJ'.,_• ~~ A'>.11.11' ~ ll"Y,aifl~ fl;J•S"l· regulation issued to imp lement this ""1f1' f·Ntt\t111 ~0, ,11 proclamation. h regard to the fl•} ·) 1.IL A'i 11-l,;J• 1 4/ Additional restrictions wit §I fh Al •A 0D lfl1 ' f"trfT oholic drink " O" ta, "J time and mai1ner of sale of alc O"T,on1\f1•l- J',O')') h'P ~ l\'"7flL,.11 ance with a may be determined in accord

1.')-0 .,-~-,1, 11:.-0 t\.lfJA .r.l·"A" regulation issued to imp lement this , proclamation. , r •PARTFO UR ' AND MEDICINE, MEDICAL DEVICE r-~~t+•. ruh,-'i" -• •t tf ·A'i" r~n+ COSMETIC'S ADMINISTRATION -r on tt re+ b•'l1·>1u: S« tio g On e 10-ta-h,: A Ii'>~ nist rat ion Medicine and Medical Device Admi -~~\+ A'i fllhr'i" -• U ,f hll-t-11.C III. m_..,., ·• · , I/ J!>. Geneol The rigor of regulatory assessment of oo "ft J' 4:TTr. ·\ ice shall be Iii ,- ~ ;) t·l- a,r,,- 'ru h,- 'i" medicine and medical dev llfla,. m' i" "'· duct's type, r,- c•f:') ,,. ~•l-1 'ltJ t A'i" commensurate with the pro •l- ODIPl•l- J'1.l1 an health. t\.J'1.Cla f" tl•J\O,,') /1,? nature, and potential risk to hum _. ,, hl\ fl.'h I may not lim it the 2/ 1ne exec_utive organ Gl f.' r ftlh,-'i" nufacture may ft hi ll. II° ! ltfJI\, OD ~;) ).•l - number of agents a ma OD "fl, J'') a,1 , enc o,,/11' 11"7~1'1·l- a,J ',,- ! ·f: :,c t"t 1. l -, designate for the purpose 'of distributing medicine or medic . impo.rting or al device . ,. 11"7h4-.C.A hh rt -l• ~CJ!- ,ll' )r 11 f Gift.A 4l' l'C -Olf•l-') }\J ',a I Scanned with CamScanner ., 21 The executive organ shall register and"'- 1 \ marketing authorization in a c ~ with sub-article (I) of thi s article after assesses the quality: saf 1 f"tflmcrt- fODt;;)'/:f:') ety and cffiCll:Jf( ~IJ')',•')-I the medicine, or quali L 1'7f't·l - 1''>.IC.0-9'" fUh?' ty, safety 111d "'i" uo"ttfa>-'1 ~IJ ')'t•l-t effccti veness of the medic 1't -•l-t;' a,,1n.;1·"7't ·l-11"7t.: al device. ,11' f ,lf'i"A 11 e, /lh ')f : IJOD?'"•r-7-' 1'.,,.9'° ·Ml/I• nu ot 3/ The provisions of sub-ar ticle ( I) ofthisaniclt :;) 'i.•l- 'll \- .r ,...,_.,._r r-t::,,'i.•l- , n ~ ·l- CJJf.9'° shall not apply in respect of the sale of riy 7t.,.... -t:;)'i.•I:') 'llllla>- ruhll"''i" 'II \_ , medicine compounded by a phannacist re., fo ol :;) \ •l- •l-c>1111 particular patient in a quan ov m' ) oowt.•l- tity not lltllJ . htf't 1 a>'6ll"' i\h 11 : u- r•r -7 than the quantity required -' nu hr 'i" 'l/1 00 -f for trcalmelll as n- 1: :,, t•l- "7 /l't f a> determined by an au t.+·l- f;l •ll111 hm-•~ thorised medical professional, or any medic f" t1 'l -1 ::, ,t•l -1 a, f,r ru hr 'i" un "ft ,f ine or mcfial device imported for use IH·-1\h•r- flLIJ h1+t by a pa nm .· ')0-/l·h')+t.· (/l) •r- L' l"t ,.,..,,r 11 patimt as per prescription medical professional. of an authoMd !I "f')~a,,119 n~ ~ t+ a>J', f"tDDl/1Rco- r ru hr c; ,,,,..,1,, 4/ Any medicine or medic al device shall bt hrt-=ti fo nA t,, - hunt-t.•l- P' C' H·1 registered if the manufac f ·Ml't·/1 turer com~ies IID t,') . l\l: >1 1'1 with good manufactur fll\ DD .('; )). ·'1 m 1. r fll\ohrs- ing practices. "" "it fc r,, dossiers are evaluated an JW1't•l- 1 'l't-·l-'i' L'P'lf't• d found to fulfil\ l- a> f.r a,,m,;J•-,'t·l- safety, quality, efficacy f" 'U l:>-,,n, {l' ff. 1· ·M , and effitaCY et r-,""a,, -l' IL C, f,l •'J effectiveness, and as appro l" lc \ lul''l >.'i' "" t'; )'l priate fulfills :I: m f,r ru hr 'i laboratory quality test req OP "t( ,fa ,, >.1M/1Lc\1 uirements. .'r•h fc\,f)t,.,r.t, 'l' t-•l - ,-c oo t- 00ri1.c,r.1•') J'" lc\ htr', 'rm-11 • Scanned with CamScanner -- 11t 11u 11r r 711 n,w ,.,.,.,.. ,0-11-A,+,.. (Ii> r.,- .,.-mat- 5/ Notwithstanding 10 the · provisi on of sub- cutive :J•1 'l· article (I ) of this article, the exe nsr.,- AII Lll -t Allt\• 11111'11-'1~ lt-~ stanc:cs. ""l :;)\ -l• 01,.,- ru hr 'i orp n may, in compelling ciN:Um ' "',.""1110 .. graM a pcnnil for the Importation or use of --,1,, 111 ~ t11t: Cl>-/11' A'>"-1111 IW1c Cll-111' ice. >.'Pl.m-A unregistCTed medicine or medical dev A'>" --t •l· A'i 1'1A'7/\••l· o\f. t\.L ~~ ,::r•o\A II 6/ Every medicine ormedical device 'ftl 11,w A'I')!- ,,., "t·'f- r•t- 11111 - ~ :>>.·l- this registered In· accordance with /l•l- . hu n•l1 m1 .r ftlh V- 'i llt>" fl,J' Of /\9" proclamation shall hav e its regi stration 9"1l1'1m- un;J•l./1 hfl ll•l-1, renewed every five years. 7/ Without prejudice to the pro vision of sub- '/,/ r,w h1+11: ')t),fl.h.,+11· (X) A.,,..,.,nfl+ istered article (6) of this article, any reg tf' i f •l·-11111 -~ :> \·l- m vr ru hr 'i ll pay medi~ine or medical device sha rr1111J .,., .,. . UD"ft.J' Ill. ?•O 11"'1.mfl'> by a annual retention fee as detennined ' h '\:J' llf'IUD •l1 r.111.. Afl:J·A 1 1 regulation. pro duc t

21. Variation to a reg istered ~,. ,.,._,,,nr c.J- " & OA-r.g, ., ~ • I/ If variation a_ffec:tlng registered medicine'$ Iii "7')'.'a,,,- f111J' L~ ~ '11 T -~ :>>. ·l- o\f. ~edical quality, safety or efficacy, or ,,- L'l 'il~ ·l- o\J'. IIV -C•~ 'l'&-•'t-1 ,l.t l'n •l- a,y device 's safety, quality or effectiv eness is .,.~ •l-1 1.in )•l- .• r 1 mJ',V-, 1111hr'i IID "ftJ 'm- introduced, the product may not be •4, ; t\.l .'l'C m r,r a1-n1.:J•.,)·l- ''If. .,-71 marketed unl ess the person who registers llm-1' 1\1 .l-, n and get f"Y.l·A "7'>'.'m-r '¼f,) ·l- th~ product not ifies such variatio "''' "· ' ....,... ,,,:t, approval fi-om the exccuti ve organ. J'/IUDll1fl ts>- (la, . llhl'lLJl"Y. -,/ IL -f'I : Al'\ O• h ·• , ' ,. . ·,, \ ... . A'i 21 Without prejudice to ,the pro vision of sub- ' A'>l.·f'inn +· ff/ flLIJ A')4>11,• ')0 ,{l- }i'>+11· (It) article {I) of this article, a med ,. ' icine or a,f .'r fllh9",_ n having tf,; ' .,')~a,,,- uol :;)) .•l- medical device with variatio e may be "" •t-11.•11c; r.,1 11 - llts>-1' 001 •, mini:nal pot,:;,tial on Its pcrfonnanc _. .,1,, turer or the hL l\1 · f{!U D11 1flt J1' fa~ a,f ,,,. , .m ~et ed provi~ed the manufac ""' I:/ ,." / fies the ~ rr. ,,.' ) penon who Rgi ster s the product noti ltCP h r~ :r: l'\hl'l4'.Jl"t "'' "· O"T I It ' executive organ _of such variation. 1(1J' 'If. ft.f tD- A Y.':f•'IA II ements

22. Qu ality standards and requir ff . llA 1.a A'i 09 /lL C+ 1/ Any medicine, its raw .or packaging Ii/ .,,~(I)'.,. ' OD/:;)).-}-1 ftAJ/:;)).•'f- 'f't . 6:J>I · material shall meet quality , safety and in a a,f ,'r "71f1., 111111,•li •t-+'lf.~•l - '11'l' efficacy ~u ire me nts prescribed .,,_ on e ,., avl Pl,. :}- I. Coll nationally accepted phamllcopcia. OD61}L•""1:;)). •r a,~ , , )•l- ""l'll.C·l- f'l' ~•l-1 fl.lJ') ~·l - A'i fL' f'il -,"'.l t\•l- til\n•l-, , ( Scanned with CamScanner r r..,...a ,.....- '21 AllY - ~ ~ o l9 11 • F·• - 10 19 ·-P<el H 12 ._., device shall med•'-"' meet IIUII· d effectiveness rc safetY en adopted iss ued or q u i~ by th e aPOm,,.:_ _ II) , · · -,..'41t 4 organ. .'ths J/ Notw1 tanding to th e provision of ~ I . ( I ) an d (2 ) of th is articles anicte, ...i.... " ' '<l l national standard is no t i~ cd or ~ th e exccul iv e organ may regulate ntedic j..... .,. an d· med,"ca l de vi ce in accord ance ,.,;, ........ rcqu1. rcu -e, nt s prescribed by internationai • organizations, ot he r countries, llld . ments or gu id require el in es iss ued i... u1 manufacturing co m pa ni es accept.able lo th e ex ec uti ve or ga n.

2J. Regist ra tio n or m ed ic in e an d mtdic device in sti tu tio n .1 ?iit:1-,- !.1,,;e !l a>-,- ,- x- ~ \: · .,.:t,- 11 -x -;) t-l · f•a,a,f. rvrrm,,, tl1 "'i ,_"ltJ ' 11 N o m ed ic in e or m cd ')? ¥: J>'&- " f• l1"'i ltou1'1"7&-•fl _..,t, o,,•l· insti tution may engage in medical _ device tra ic;al device medicine or de unless it is A'> M ?l lfl· Oh/lJ.'1 registered and license "'1. h 111' 1• tD f.. ,. nt m.'i" ,,..f,tf)"ltO>- i/. \/. \ d, as appropriate, _-,,,-o A'i" r-0:J> -. • by the exec utive or -,~.,,""l rl lh c 111~.,.-l· -,.,1 -l· gan or regional ·-l· hl'ICl·'h ' health regulator. Kl r- x -; ,t •l- a,J', .,. ru hr 'i' u o "t tf , 2/ It shall be proh ·1·1 :r ibited, in any manner, t-0:J'·l- -T l.71"61 to 9'"/lhC a,l-,.•l-') transfer a medicine an · O-T1'i'tD-r d medical device -A h • l\Y 'll •f-'/; institution certificate a,11 of competence to -T ll· f-4'1\~ f•f-hllh ll ~a ,, II a third party. S i. n-.(";?t.'f- A'I 1111-i,l\t- '1 11 -t n u h r' I _..,1,, -r-:tr •1 11 ' •. 24. Personnel wor king in medicine !ii "l'J'i'a,,r fa ..( "; ,t- l· medical device in st ■nd a ,f .r fU hr 'i' on "f itu tio n l,f I/ Every medicine ,,. :t r hODJ::;)t-l· a ,f .r and medical device tmhr'i on "l tJ ' .,.C-l- 11..,~-l· .?C Institution shal l '711-~-l- J'{ \a ,. hire a health '11\00- f l\on:»-mc 'lt .- fa ,, professional upon n -y a, . f ·l•oo111n ensuring that the /1{ \D Dl f), 'At; P't-a>-") {\o nf lt- T professional is duly ,():J'-l• ffl a, , registered and ontf).1 f" ll .? 11 ' ;,4 \LH· hl\O-l- 11 , competent to perfonn the task. f/ -T')~a>-9" OooJ::';)).•l- ~ mf,'I° 01Jh9"'i OD "f/, f 21 Every health profes -~ 9" m -il 1' f "'l.c' sional working for 1 lt,. 'Il l- , OonJ::';)).-}, tt 9 " Cl> medicine or med ica -l'l1' hoo.t;-;)).•l- l device institution 1' l,. •} 1 shall have the duty to ~I J') )•l -'i L 'P n) ·l- I immediately rctJC)II m f,9 " htJIW"'i OD" 'f/,J' • risks of public health sig nificance related to the ~uality, safety and efficac)' or Scanned with CamScanner 11t lflllffltli ~ ,~+ ,,_., •'PC fll f'H:+ H .., Ill.II ~.r Fedenl ......,,. o...... No. l9 21' FebN#y 2019... - I 1125 'l't-•l-1 '-U'>~·l-'i' IJlolfl.;.l•-,~·1- • ~edicine or quality, safety and effectiveness of a medical device, as appropriate, to the executive or&an or a regional health regulator. 25., Medicine and medical device manufacturing and imponation I/ The manufacturer of medicine or medical device shall have the duty to ensure the quality and safety of raw materials and ,the legality of its su!l_plicr. 2/ Ifshall be the duty oflhe manufacturer or importer, as appropriate, to ensure that .... every medicine or medical device is ' produced in . accordance with the \ appropriate good manufacturing practice. I 3/ No medicine .o r medical device may be I~! "7')2i'a>-9'" on.(-:)t·l- (Jlf,'r fllhV"'i" .un"f{,f ... imported through a port of entry unless authorization is granted by the 111'- ll1C: cu-h'I' on"}fl•l- f"'f.':f•l\cu- J\'7'111 . ' executive organ. .. 'lflm- foo"lllJ' • h,I\ I\J>, hhil.C.Jl"7. 'J\111\· ) 4/ Every importer of a medicine or medical . f"7h11l.f Lft'1: c\J'1~ ,f);.!= ~CD- 1 .• •· device shall be responsible 'for 1!I "7'l'i'm-r fDDl:;)).'•l- fJ)f,V" ruh-r'i" 0 ens~ring · that its imported product is OD"//,.f . hhDDaJ. . f"7.fhUP''la>-. :iC·l- '• • 1 ·from ·a manufacturer recognized by the Ohh.&.Jl"'I. Allfl• f•,.UPll111 OJJ','I" . ~a>-:t-'i" • executive organ. h·,.timcP- • Ar&-l· ur,lf').') f"7t:n.,. 1 ;)ljJ.)·l- Aflll•l- 11' ,SI If the quality, safety, and efficacy or effectiveness of a medicine or medical T;/ Ah.&.Jl"'l. Al1t\• device are not in compliance with the a,f.r rohr'i" UD"/t.f ,..,.,),f:'h 'l't-•l:') law, the executive organ may order the a>f,9'" L'l'°ii)•I:') fAmfl.,. ur,lf'). .,-l.'>"/tll ' . manufacturer or importer, as A"l'lfl 'lfla>- on')11: A')JltJ111: o,f,'r. tJII. appropriat~, to properly dispose or on11J(H• 111C A')f. hdl'III· Rhrt-:i: t»f,9" • ·• retum it to its country of origin. \I rlh"oo"1.,cP- A'))lonfl" c\/11 f,l•I\A 1·, I •• I • .. Scanned with CamScanner ,.. )91. . ,..,_,:io., .... .. ,14 ~ ~ .:- - :-:::i d"'::ff! , _ __ _- - ;,.. ii";I ;;;; or ;;;; mii::~ i::11;~ ~r:n~, f -... ... 811 ·• ed lc>" l..! !~ cc !!! -= ,- . . n, e med1.cu: . ie medical ckv 1c; e llls tit, _, 0( ·~ I/ anotJie1' approPOa1e person slu • Of JI ' __ .,_ . that everr . .,. --- ~ Au el ~ · 11.$ J>OSsc ssio,, . ll ..- ed. an d sol d in ilQ :oM sto red . uans.,.,.• ··-.i...tt with go od su, rag e and di st tj~ . practac:es an d in su ch a wa y tha t its 'lUilit ,. sa,,ely . , an d eff icacy or eff ectiveness . IS maintained. 2/ Every ma nu fac tur er, im po na, w ho !~ and retailer of a me dic ine or ~ device shall install a :fC ~t , f,m _t- :)) .•l: 1 quality COl\tro1 system that ensures the saf _. .,/,J 'tr>-1 ety an d ciualit) ,,.t-T 'i l\'7 t.: J'l 1' of the product. ,,.,c•H· I.'I '71 "1tr1-V- II" "X- :)) . •I: OJ,. ' ' .,. ru hr 'i 3/ Ev ery part of a tra nsp ort ati on equiPl!lC:l ,,. ,-, t,f ,"JC '>hlL f't r:'I.ti having direct contact with t' ,-,=1:J-.r h\ :A the medic ine ~ ,~ ., At ; rc -t :, fl.' 71 ~., .., . medical device shall be cle la.-t'M'f1 an an d shall ncx h'1 'l'f OJJ',r '7. r.h ~' lf,ft-1(11A ren de r the pro du ct to -(Jhl\•l - ca us e an y chemical, f'T J',;J l\1 ' uo tf" ) hl\O•l-1 ph ys i~ . or mi ao bio log ica 1 l COOtaminaiio. §I "'t 7J i'a ,-r r- .t- ;)t ·l- OJ f.r ru hr 'i 4/ No medic ine or medic al device instituticn _. .,1 ,f tt r •H>'tf.'l•l- ft.a>- V"h'>f·l- may transfer any 1nedicine or medial ",.,,.-t.a,- A' i A,~~-,110- device under its possessi l\h fl' -'1 "? 1'111\, on outside oftbe a,J',' I° I\ h A A m. 'i ,f--,.nJ"ft,a,, OJ',lf:J•a,- PC f"? 1'S f °' °'m-~ recognized trade chain without ha,ing a ') DDX-;)t•l- ,,, ,•.,. legitimate gro un d and, as appropriate, fll h< r'i DD "tl ,f h"'l.'-4' notifying the executive org ~a,- f') -,x , (t')flft·l- an or rtgional m -~ "711•,..,l\'i: hJ'."fA<r health regulator. •1 ~/ fODJ:';:)).•l- ,,,,,,,,. f1J h9"''i OD "fl ,f ':f·C;l=C' x-c~:t- SI A retailer of medicine ODJ:';)t•l-'> m.r.r or medical device ftJ h'l "'i OD "fl ,J'' > n~,-., aolf1' hf .'f A r, , shall not engage in the wh .. olesale trade of any mcdjcine or medical de vice. j/ .,,":Im-'/° fOD~;)t•l- J\h4-4..e OJ f.' r 'k ~ ~ ~c)!-:,.. n,1.11 J\'I')!- 6/ No medicine wholesale or retail institution A'i J\ 'P ~, ll.,111.Y.V- fl°ta>IJJ may sell a medicine OD OD l,f DDWl•l- unless its label contains the rctai I price of the producl affixed by the manufacturer or importer in Scanned with CamScanner 'Ill' lJllirlfl I.U-A i,,e➔ .,._~ ♦TC· fU/ flti:+ lfl +, llf.ll , .r Ftdml Nepril <luo1M No. 392.. r,......,.2019 ,pqolll27 flh!l"t.l· wJ',!I" flhlltA>t;U_(l)o r:r•c:Fc: accordanc:e with this proclamation and 'l' ;, J'A•h'\m.C.fl•l-') i'IJ'•l~ .,.,_,..;)).•} directive issued to implement this -nT hJ','f·Ar,, proclamation. 7/ It shall be die responsibility of the health 'I,/ -,·,r.'m-!I" f,n,t; ·~!I" f"'I.Y.11111- ft.mf.";)).•} institution to ensure that the type of 'tJ',)•l- 11,.t.Jl'm- f•r-.r.+1. ontf►'> A'J-'1..11·!1" medicine it possesses are in accordanc:e ,m,..;)).•f: f •r-J'lfn,, fl•r-.C.+1.1\•} ftmf.";)).•l• with its level, and the health professional ' '11\lfthJ' tmtf'►'} f-,t.:11• ;)'ll,H· . f •f-lltm,. who has a=s to the medicine has ~(1)-11 appropriate authorization.

27. Olnical trial s~. ruhr'i -ht-· 1/ A clinical trial shall be conducted on /ii fl(lp>':)', 'IJ', f"7,,.(.-, '7'}7,',,_9" fll)l?"'i' human beings only in accordanc:e with this -.11&- l\.11Y.,.. f"T.'f·l\(J)o ""·" h'l'~ A'i' proclamation and regulation issued to J',11')') h'l'~ 1\-,114.ll?" 11"'1,lll''l 1.'HI implement this proclamation. UIJII'(.•} •fl1 )n,,1 I 21 The executive organ shall authorize clinical Kl h11L.IC"7. hl11\- fllh?"'i' .-11&- Ol'IS''l· 'If, trial on human subjects only after the A'),\l1Y,_,.. l\.l.-l-,.. f"Y.l•i\lD- f?"C?"C clinical trial protocol is evaluated and 'l'C'-ft•I\· h'°IY. '>'°l'r.1 o;,'f!t; fllh!l"'i" • M- accepted from scientific, legal and ethical ·' . 9'"7'1C: IIDC:lf1•':f· h '>tC .. •M!l"-,'l" , perspective. 1 .,--,.q,.)·l- •rrr n:\'1 •flEJ= )a,, .. 3/ It shall be prohibited to introduce any change to the·tenns and conditions of an I~/ i\Uh!1"'1 oo-ht- •f•'JV"'?.,. •t-,.'lr.H· '111' approved clinical trial prot=I unless the 1•c:,r.)1A 'If, hil.C..IC"T. hl11\, '°lf'°la>-;i, executive organ is duly notified. ,..,,. 'Jf,H• """"' "11:t."I f-thl\h~ )a,-1 I 4/ The executi;e organ may require ~~iew ;, hll4..IC"7. hlll\· .. o.r.+ ' 1.a>- ruhrS:, , -h&- and monitoring of the approved clinical 1''1-1•'} h"J'l-0 J'i\a,, •fl,h.&-'f!1 hA1'1! lllf.'I''_ ' trial study by ,ail · !lppropriate national, ,f·,t'.;'1! f'7?"1'7 h l1A ,,..,ht,cr>'} A1-tJ'f, , regionaf or institutional review organ. A'i" A'}.\h:J..i•A l\.f1.C"I 1::(./IA1t SI Clinical trial on human beings shall be I A;,,. ""· f"t1.t.'7 "7'>rfa,,rr r,'!'hrr'i' x 1 0 II ft conducted if the person .is over 18 years, oo-ht- f"7.h'i'w)cr> '7i\l'IO· hXt 'JIID-l'. has capacity under the Ethiopian Civil 11'\.f. f1f)1 OIJ1t·~ f~•l-11 ,OY,C II'? Code, and agree in writing to the clinical ODIP/.-l• flJ"J l•l\•;J· fl\CD' A'i" '71\l'lfl• trial. oo-h&-cr>- 1'').\l1Y,f: OA'11'~ h·t-11'7"7 )IJ>'I I 6/ Clinical trial on nursing and pregnant women, prisoner, person under the age of ~ hllL<\'l. ruhr'i rh'>,.,. 'it': r,u'> h'I'~ 1 I B, mertally ill person, other judicially fl"7.(IJ"J ~'},() anlP/.•} II d'/flLA !I" i~capable person, or person dependent on ltA•,-'-"'~ Oll•NC llhfl4'..IC"7. hltl\• the professional or the institution llAC'l-11 'l\•,:i fU? 11'11'0. A'i·l- a,f,'r / Scanned with CamScanner 11 11 shall be the responsibility or the primary investigator and sponsor of the clinica l trial 10 ensure the safety of the participant, provide adeqllalt information lo prospective particillants about the risks, medical benefits, 111d treatment alternatives available to the "1'?1'•/:1 f"1l; J11' participant. fm,,n l}~ tM.I,} ·} h.VFf11>- 1 I ~' -,,~a,,.,. r1ihr'i' _.r,t-11>- ·t-•l'll'"f. 8/ It shall be the responsibility of the primary investigator and sponsor o"r the ,,-on&."1tP 'l· A'i' 117 ..M C h1:&.7.P'':f· clinical trial to ensure appropriate ·l ·+'IJ','l·'I- J'/111>- '1J'. 'M'l.' V.f.•} fUDh·l·Al font.J f h.fJ'1/I ,,,-,~(1)-·,r .,~ lill•l"l-'1 scientific conduct, making required reports to the executive organ, rctord t7'C •l- f"11 :l'?t•f".l.1"'1.'I·} fi\:fa>-'t keeping, reporting any adverse event, 1•c-f l•fl•l· 1 .,-.,.1,c:JP':f• A'i t1f:J'· and adhering to applicable protoeot, f"7hf1C A'i' l\hll.l.1C"'I. 111,11. ,,-,Li\7,a>-'t practices, and laws. t.TC •l- f"1.),t.11 '?$.;) · hflll·l-• 1 J!I hll.l.1'"7. hti"• 11rr .rc f"'i.a>-A') hllil 9/ In approving investigati onal medicine tn>f:; )~,-} A'i flJhY-'i' on"t t,f lll'la>- i\f. or medical device, the executive organ flrc rc A1-tco-A fi\fl&.-ft, >.'i may req11ire submission of laboratory OA11'1'1·} i\.e f·,.l. l1 oo,1,&, O"IJL •}') experiment and animal testing data in >. 'tll 4'C 11 l\.m.r.:,> f)f-i\ A 11 order to determine ,its safety. ! I llllhr <; .,.ere "'· '" A'i oo,flt ,. 10/ The use of investigational medicine or f'IOJ' l.:l'Y : fl\."cu-') ooX"; )).•} tJJf,V - medical device beside clinical trial fllllY "'i OD"fl ,J' fllJh.,.'i li'IA .,{\••'k shall have prior approval frQm the flonm 4'.,. hh{)l.1("7. hl1f1, fuh r'i cxccutive organ. 11Doht,. l.:l'I: on'J1'·} Aflfl•}t 1 .?Iii 111'()1.'1"7. ,\111\, ffMY. ;)'\J. f"'J.uot,. 11/ A -Clinical Trial Ethics CommittecS fllh r'i oo,fl& , ()).9"?'1C t•"'l.·k Supervisory Body direct_ed by a .,..,.,,,,,,t >i 11A ,.**"7A 11 higher official of the executive organ shall be established. Scanned with CamScanner

28. Anliseplig and dlslnfttlanls ., · I/ Every regulated PfflOl1 shall comply with , applicable requirements , issued about antiseptics and disinfectants. ..• • .... . '. ... . 21 ' The registration' and related . regulatory assessment of antiseptics and disinfectants . shall be commensurate with the product's potential risk to hu!"an health, . . • . . ,. II ..,., 31 In I effectively , : regulating radio ·I•,,,, ·•. pharmaceuticals .ror : radiation emitting . •!·1·-:l \ , m~icpl . - . itte executiv,c device, ' .. orpn,shall >York tog~ri with the app19priate body. ~ • ,c;_:.J, ••. t. t_ .l_t~·.J'J !). ,fll\ 1.r, , A'i fl.'I':' ffl\'>- , I 'I JO: 'l Blood and blood romponents ',\ ,.• 1ftf'l ff.'/" ·' >.'i" >ff.'/° '•l•'f'Y.''- fl.,(IIJ~iJ 'l >,<; I~•• ' II Any pei:sbn who engages ,in the collection ' .,,. .-.J .un ""' .I' ... ·, ,. r•} .., , : .(.c l,, • :-1i, f,At\. ,: and' distribution ' of•'blood Mt;! !>loQCI , . _ •. 11"7i'lt-6U.•l- P't- f"'l.1'1"7t- "7')1;!0,,V- •l~I"' l":\l ,./.•'h ,. ,,, ., •fi..-f.'"! ' •~<# I ' •• • • ' ) " products shall get i certificate of . hhr..tll"'I. hlll\· f-fl.4':l- "7~:,1-'L '!°llhr. < • 'fr •I • · t competence om ,L. • • u"' executJve organ. '1:..;"'.:,1• •..~: .. : "'., • n • • ,.,.,. ·--1 _ ii, f'1'1° ,~'i":1 fJ1.9'::,:f:~~•,- , A1/ft -,(IIJl'l-11 .>,,; ,t ,, 2/" Blood ' and blood products donation, ,,.1, ; , " •t IIC":L••l- , ~»/;, •.~ fl'th'illl~II>' OflflMl!H· • ' ·~,•collection, : •and' distribution shall be 0 , ! •,I I !,: .,t 1 f- • • ,, ' !, I t".. ~.J, " perfonnea'in ~~c6rdancewith principles of 1 ,.rfl1D-1 ' ,., 1 >••·.-_ ooClfJl'i°f, IIY.,.,' ' f-1 rmill•r- 1r'i,1 •• ttf •t r1,.r· 1 ·,··•11·1• .- )II. i. , ,,-. ••~~·11 .~ ., ,. ,_,,. ., if.t~11 In . ,1 ":' !1 ""'' :~_...,_;.i•-:- t Scanned with CamScanner humanity, and such products used f ~ Uf,a,:'f, 1'1'"7~') a,1,9'" l'l9'"C9'"C r-to>-A purpose of saving life or sci~ric 1.9'" A'i' r1.r •11'1\•>, 1'11'1.??l',9'" If', l'l•r-+'lf. r1111-11 ,.~,. r-ut11:0S -ir, rt11H·r " research may not financially benefii boci. the donor and recipienL ~I (11.9'" A.1'1 a,f,9'" l\·l'IA'"7 6 ,-,,-1.,-,. flJf,9'" 3/ Blood and • blood componenq fi 0t f'"7+'i'OC Y.1.·l- f-to>-A 1.9'" A'i fl.9'" f.ll•l- transfusion or further manufacturina °' l'lh1A-,t\••l- f"'ta,,l\o,, 1.1r)'l•l1 A'i Tt-•IJ processing may not be put into use unless '"'-ll"T. 'l·r fl\a,,'J f"11'1'C -l'ILC.• l- lt"!l<\ its safety and quality are in comp1 j~ with applicable regulatory requil'Clnerts, ·OlF ',o,, II !/ ,,_.,. A1c't 111..,. A'i 1.9'" 1,11·1- A'Jllt,-9'" 4/ Blood activities shall be classified Ind 1.9'" ll"T.i\- ,~ A'i ,_.,. ll"T.+llt\a,, (la,, <\J', regulated based on its po(ential risk to the l\.fl'lh·l- A O"T.l•l'la,. fl.111'1:'f- l'l;,•l- h'JllC. safety of whole blood and blOOd - 1"l·l- .,.,,.,:11 <111'1'C -•,v.1: hl\ll•l-1I components, the donor, and the recipient. '{;t ht.r A,,.. :,c n,.,111 01.r A:,1f• A'i S/ Every potential risk associated with blOOd 01.9'8 •t-+'lf. <\f. 11.t.Cfl f"'t.':fA A/'J.ll'j.4- donation shall be communicated to the • 1'1.?•l- 11-rAA' l\.'11C A'i l'l.,.9'"-,.,r9'" OA',1t-'i: donor and the recipient of transfusion. I\.1AA' ,.1'1A 11 'f,f ..,.,,. ,. nt.r A'i 111.9'" ,.11.fl· '"7(1f'l(lofl 6/ Health facilities, laboratories, blood banks •M1lC; <\f. f •M'"7<- fllL'i' .,.,t-,:,.1 and other eslablishment engaged in blOOd ' <\ilt-.ftp>':f'•1 r,.,- 'l')l•l• A'i' t..A•':f'· •l'lt'"7·l- and blood component activities shall make .,-1.ll-t'l-l- 'l<\:fa,, f-l:1'1'C -1'11.Cf -"f sure it is collected. tested, ~ _,,,l·l- -(lofl(lfl-')1 --c-< -11 -+'i'll< -'h screened, pooled, irradiated, wuhed, -~r-1:1, ,,..,11.._,, -~<-'>• -:J·mll-'h stored, labelcd and distributed in -t.-,:f-t ,11 11\"1~ A'II'~ -1.t-,.' ) A'i accordance with applicable rcp,IIIO!y IAl{lt-~ ••'} f'"7l.:>11' .,>'.;J• ~t\'1:f-0>- t 1 requircmenu. !11. s:cta-th -~t • lt~M:i:,;h -t;,\ t 1\'!° TtbcQc h."t!)A 31 • Namttls and PIYShOhPRfc mtdldnn, 114 Iii f'i'Cll•l:h A'i' rc'tf.la•l-f:,:.t, -1:;)\+ "f ~ PRSHD9C shemklla 11 A special permit from the executive A'),ti,,,- fT~hC( IC h,"T.ltA 1'1'"79'"l:'f-1 orpn t\'"71'1 09"1:'f- a,r,,- l\tJD<\t, hhl'll.ll "t hltfl, shall be a prerequisite to manufaclwt, Af. 1.,J,1: -,-,,-,'), fl'II.A;, A11 import or export any nartotic and psychotropic IJ'ediclnes, or precunor f/ '"7'),a,,,- (la,. f'i'C'1t h -1:;)\• l-t chemical. fc'tf.t•,!},(:,:t, ,,.1:;)\• l- Gf,.,. f1'thC( IC 21 '.'"Yono who enaaaa In manufaeturlna, h."T.IJA '"79'"l-l-1 '"71'1-"1•}1 -<\t11 import, export, wholesale, store, transp0l1, '"7h4-LA1 '"7h'"7:f•l-1 '"7=l=l1t1 - , , , a,y,.,. hold or sell any narcotic and psychotropic -111' f"'t':°fl'IP ,,.,., ht'~ A'i h1"¥.') mcdiclne, or prcc°"°" ,hcmlcal shall l\'"71'11.Ar f"T.a>"l'J 1.1-11 A'i' - - t f comply wi!}I this proclamation, and Ooah-,.A illF ',a,, 1 , ~ latlon and directive Issued IO implement this proclam.tlon. Scanned with CamScanner - ME n of 3/ A special permit for lhc lmpon or cxpo ' nm:otic and psychotropic medicines, or a precursor chm1ical shall apply for for specific consignment and shall be valid 90 days from the dat.e of its issuance• .,., f'"'l..1'11\ .,A )a,. , 1 4/ It shall be prohibited to impon or expon f!I 'tCl•·l:Ji ""J: ':)t- f:r,, At; r l\J', l••l-r.'·1:h narcotic and psychotropic medicines, or ""J :':)t -f:r ,, OT ll:J· 0.•}- Ill f,.,- e precursor chemical lhrough lhe post offic . hil " ""C CDJ'.,.,. IJl\.11•:r• ,.... r::, t-,.: r• r or by ship; or packed together wilh othe mv r 6~? ':Y· •·w• h,-.._. 11J!. fl-,1f7 CD'- medicines or goods. V1C a,.fl 'I' -,fl 1'l·'t- At; -,ll=lll a,r,.,- U1'- a,. .... v,c 091\Ji M ·hl\h,\ )a,, II s and 5/ Narcotic and psychotropic medicine f;t f 'tCl•·th A't r'l.r.l•-l· c:-r: t, - r::,). -,.:r., l invoices, registers, and ~p tio ns shal f>ll tl • "".( ':)). ,f,';f, - ll1'f l A't r'"71/'t('. d in a loc!<able mew cupboard or , , be store ',,,,.. ,. cJJ/.-,.-fl· -,iA ~ 'Illa>- 0+'11\- 11.l'IOC i_n a special room the key of which shall at A .,.,.,..,.fl 11-,J', fA ti'I' , •111' 'i,,1,'1" all times remain in the hands of the ll•N1r tK:A • 111' -+ -T A't -,iA I,.,. authoriz.ed phanmcy professional. .' fH•L-,.Ut:J- r-r :;,).·l· 1111-.r Alt i l!J= .. I' •,,.!t r -,1. .,1" 'i V-llhc: · a,t..,.•l· r •h'\ma,, A't r-r :;)t -l· '111 -J' )a,, , , :) • lesal er, 6/ Every manufacturer, importer, who in 'JI -,,\'.-,.s,- fllit:l••t:h ov~ ;)t, f':f·1 ~ lcr, or hcallh i!lSlitution involved • narcotic and psychotropic medicines, or 111'1.f.l••l-C'·ct, -r ::,t -,.:,. . a,f, .,- n1·t11cftc h.-tt1t\•':f 1»& - " " ·,.,.,...,t- 1 ·• pre cu~ r chemical ··aciivitie ·· relevant records, perform dem s shall keep and 1'fluri~1 . hh-f."-f. ' 1111,r 11 >.r&-°f• , projections, and submit reports in J:'C ~·l- A't tn.'i ,r,t r 1 ':fr.;Fc- accordance wilh directive issued by the llhfll..11"7. hf/1\• 11"'1.CD"J ooo ot,f 'executive organ. uotPt.•l- hP '~ :,C f•,.I fll-•}') uo(.JtJPl• uof 1 11 fi:' l?•l- ·l-111.f A 'f .. l,?" C·l- f"7 ~t.-f1 "IJ!..:J• 1'1\11•1-• • 7/ Any person who gets • narcotic and prec urso r fl'l.f.11-l·c:·1: h avJ :-;)l ,f':J '•1 1 psychotropic medicines, or 'I.I f'rCl ..l:h the 'f'l chemical purchase order from oaJ:';)\+':1'•1 tD.f.r fT/ ,hCftC fL"t ftll- the , f a,l'l' - executive organ shal l repon when f"l'lfr 1.J-1: hh/lL.ll"t htJA or if it is not impo rted • product i.s imported, -,,"11JJ-'r 1'10>- rc·l:1 ilt."7/IDD"l•l i for whatever reason it shall be repo rted ;. ' "-"' .,. ' 0 -,,,:rll>', - rh1 ,-l· rc -1i1 the within ten days from the ext,iration of fl\ ilao nJ ; 1111~ """'-""t 11•111, '.,'~t "llfril'I' Oh1 »C _,..,:,. '" pur . ch~ order... • . L'J-P,.· IJOJ 'fl-l• _ 1,;r c-l· ,-,,:1.-, -,.", :l' .tt11n•h , ' Scanned with CamScanner r-- fcd<ral Ncp nl 0.-C No. J92 .... , • , .• ~.-.;+ _,,.., ♦TC If/I r'>f:+ trl ,n f'/C.I F•"- 'Y20 19..:,,.., # !II.I fill ~ I -,,,- 111lj , ~K. t£Cti:t;h'i"' rtitl>-l-C'"Ch -.c:~t pmc rlpt ioll or Hry<>tic ~11d P"'t + J\n-tlftl1I Jl. mN1icl11r! ' ~ h . e:c,+ I/ Any iice11scd medical pro fcss Iii -,,,:rm-,- ruJ,,-,; 'lfl" °"J' t'i"'C:l•·l: h'i . i~ only issue narcotic and ps ~ ~ MM ••l- t:·,: h -~ ;)t +l· 1 "71111 ..,,.,::f •. • • ·fla>- med1cme~ prescrip • rapit 11,.-.,11&- n•,.J.+.r.11 ·l- m.'i .,-,t,- ◄l:J! tion 1n the ~ )a> -" institution where he is authorized to lb Kl "11 l'fm-V- I'.lih r't 'Ill., ...J' l''iC :l•·l :h'i 2/ No medical professional ma y'• ~ rtif, l• ·l-t:· ,:h un,_.;)'1.-fl•'> (I t-1\- "71111 narcotic and psychotropic medicine fQr hf,' ;f•AV-• • himself. l'.!t 'i'Cl• ·l:h ,,..,_.;)'l.·r mJ',V- Mf ,l•·rr.'·1:h 31 The prescription of a narCOtic ,,.,,_.;)).•l- f"7.;J•/ll/lf>' >.11.:t-1.r ·l·h· l•fl• psychotropic medicine shall be made er ll'i'C:l•·l:h _,..;)'I..,. "7ll 'lr a,t.4'•l- u,,.r special nareolic or °'1 1 p$ychotr°llic tif,l•·l-C'·1:h ,,.,,_.;)'l.·l- "71/'lf a.,t.+·r prescription paper respectively. -fl;i= )I!>' I ' #I t'ir. l•·l: h A'i' M,.l•·l-C'·t:h unf: ;)'l. •l-.f':f· 41 If any medical professional made a mi~c 0"7 ll"r mt.+•I: 'If, r11 hr'i . 'll\nn•fa>- on the narcotic or psychotropic Presctiptioq 1\~·'i: llt'tft•} IDf.'I° lift/I-') 11,•I' paper, he shall fold away and leave ~ lw J',l: N·O'll'f,,,., "7ll "r mt..,.·l- h11 : 1,1&, 0"7 paper containing the error intact within the m'i: ,,.,..,,.,,. tir. nm A -+ --r hllfl•l-1 I prescription folder. f;I f'i'Cl•·l:h >.'i M,.l•·l-C'·,:h . 111>f:;)'1..fl· SI After issuance of the original h;J·1111- n~11 f"7 ll"r of any mt..,.•/: 'l"ia ,.1 narcotic and psychotropic prescription fl;J•ll"ta>- Oonflm·l- lo ~](a ,. h'J',',.11- :,<: the patient, its copy shall remain in the -~t . . .il- hflO•l-11 prescription folder. 'i,I f'it:l1•t;h >.'i M,.l•·l-C'·,:t, ..,.,f :;)).-f':)'• h:J·1111- n~" f"7 ll"r mt.+•/:1 f,},](a,- .,..,,_,, 6/ Every folder containing a copy of prescrib~d narcotic and psychotropic h 11.h'?'lll- l\hf lL'l "t /\fll'I, a,f .'r (lhA A medicines shall be returned, m.'i" .,..,,"1 'ltm- ,--M• ·1Y.;J· liMJ.'h 1 1 appropriate, to the executive organ 11 or '!,/ n,w "'"~ flon f:;)) .•r "7/l 'lf mt. regional health regulator. fl(l"t:J•f.l\. +·r -fir onJ:-;)'1.+l· f·,- .,.-m- 11 Provisions of this proclamation prov x-,::>ir':f· h 11.1''?'111• (l'i"Cf1•th A'i" ided in respect of dispensation of prescription nti.r.t••rc-·r:h '"'1 :;)t +l· ...,,,"r "'·.,. me~icines shall be applicable to narco •l·L'l"'l J',l f'iA I I tic and psychotropic medicines, as ZI h1'1 1: appropriate. . fl'l.f. f'i"Cl•·l:h OfJJ:';)).•r'i" M.f.l1•l-C ',:h OfJ_t:-;)).•r Oli')J:- ...,,,..r 81 It is prohibite d to prescribe more than one a,t. +•r ...,,,,, 1i.r.;J=Ar1 ,..,,.. ,..., ,.r narcotic and psychotropic medicine on one a,t.+•I: h·t-JILO·r 7,IL )!r e h~ t- 11 hr fl•r prescription paper, prescription paper shall 4''i"·'l- fJJILm, (l;\'I 1'.f'l(l'IA9"1 I have no effect after fifteen days from tho day it is prescribed, Scanned with CamScanner .. tit JIC.lfflt I.Al-A t N + .,.,., ♦TC 411 t "1,+ ffl ♦, 111.ll ,.,. r- - ~ o.- No.l9 11.. f nN1fY2019 ...,optlllJ or pUShotropjc , r . rsct-1:h >,s: fl\~ M-C'.:th -t~ \t fh\.,I.A 33. Dt,pea lng . narcotk mtdkJne · -,,~...,- f'i'Cl"l:li -1:~t. l-'i' MT,l•+c·,;h Every authoriz:.ed health institution and ..,..,:,, t•l- >.">'Lf,il ,.,-L-,.t.fl•l- tn.'i" •1·~119 •111, 119 medicine retailer may only dispense a narcotic and psychotropic medicines upon , - .(':)). •l- :i:c,:e x-,:.t:•l - ,,..,. +Crte1>- f''i'Cl•·t:h'i' confinnation that: rl\f,l••l-e•r: h '"'X°:)).•l- -,11,r 01l + •'I- ,m.(':)\ •h'J • 'It.A f"'l.l ·t\m-:- ...,I\, I/ the prescription paper contains the name of /il fl"Pll"r llll.+·I• I\J', Yllllcn- f1~'i' 'lfl ,,...f .,,..,.,, . UD'i {,')1 the prescriber and the Institution's stamp; (rJ" >,t; f'f1L'j •~ - Kl ..,,,,r llll+·h ,-:,r. ,,.,: hfl,mlf'I- ')'i flc:11 J!'A11 2/ the prescription is ori&inal, and the writln& or rt\flll·l - ,....,.,.., , ~rint on the paper docs not contain an em>r. 3/ narcotic , and psychotropic medicine is 1:1 r'i'cl1•1:t1 ""J!':)t •l- n,;c:l•·t:h -~:)).•l- ., 11..,r 111l+ ·l-i fl\f,l•·l-C'·ch - 1::)).:,. fll\Y,l••l-C'·ch ..··• prescribed using n~tic : and psychotropic medicine prescription pape,- respectively; DDJ!':)).•} .,,,..,r Ill/.+ •} UD;J•lflj.'}1 4/ no more than one type of narootic and ~, llh'>I: """· f'i'Cl•·t:h ODl::)).•l-'i' fl\f,l•·l-C'·i:t, -,,,..,r mt + ·l - hfluu;J•mV>• psychotropic med;icine. _is n9t prescribed ""l::)\ •l- flh11: . . using one prcscript[on paper, SI the pr~ription pape,- co!1tains readable • series number; and \ " Xl .,,,... r (Ill+·•· h ·l'.IILO·l- 1.11. Jl:rc-· h 1••t- 6/ the issue date is within the past fifteen hll~M-1• t1t;11m ' fl:\I\ . ' days. h V-fl •l- +'i'·l- f ,ll''i'A I I !ff. ,-1:; ,\+ +--, 34. ·" Mtditi ne compound!~-, {"ft Iii -,·J,;ta ,.y- fltm1::)).•l- O,•l- t.l Jf f"T.ltV.I: 4. .. '" ·\t' Medicine compounding shall only be .... ~ performed by an' authorized phannacy fUDJ!':)).•l- :,.--, f "th'i'a,)o,, O·l'L+t.ll•l- professional , and within an authori zed ·1-lt:r' >.'i' fUD1::)).•l- 'ltt....., il1 ',0,, 11 I • • institution. " . ' \.. ' 2/ It shall be the responsibility of the I I L?I: J'fta,, r-1::) ).•l- 'lflao-J' h?'l-fl I .. l. .. ' II • • I • phannacy professional to ensure that any 'lfto> ruhr'i " 'lflao-J' r-u·1111 - t:~t ·l-1 • ~ compounded medicine prepared for a I\+rr nu-, c»f.'r •1'4..11"'1.'1-l- IJfta,, 'patient in a~an cc: with a prescription OW>/ILC ·l- ODIJ>l •l- f •Mlfthfl ,.11:i- f,\r\11>' issued by a medical professional docs not I >.'i" ,,.m?"Y.11>'") f"'lf,1~ tJDlf'>-1 r-,c:;,1-r contain ' an unapproved ingredient in (, "'IJ'.;J• hftO·l-i I .., accordance • with applicable law or standard and is· not unusually hannful to the user. .• Scanned with CamScanner 'Ill UUH I , ~ t.U~ .,.,.. HC fll r.1 r-1: :,t+ '1----, rtrtt Sf ~1 fllf , ,,- r<drnl ,.,...,,.. ~ -- ~ ,,_,_ "o 3921• ftbnaor y 1019. , .. 7 - , -111.1 4 r-tc'l t- .,,,:, ,,.,- 31 Every phannacy professional who is 'lti -, O-t♦r-.,. authorized to perfonn medicine -,:;) ).•l- ..,.11,. f"t1,-d>' h-,'S ,.,.l. )1C hll'- .ll"t hflfl• compounding shall ensure that any ~ctive pharmaceutical ingredients used to Oaw1111Jo,- ti.o\ -1:; )t•l- 111'111' A 1:S ,1....,. ,.,l_.,.,.,. '?J'..:J• hflO·h I compound. a medicines are an authOrizt component ~n other medicine registered b}' the executive organ. ~I hllL. ll"t hllfi• A0> -~ fAc'lm4D"'> h-,'S 4/ The pharmacy professional, health ,1'l· )1C o-1: ;)).•l- ,},llD'"Y lll'll1 ' institution. or medicine trade institution n-m.,.,. ti"'I.I.CII r,rL'i mr.-r rh•1A shall be-jointly and severally responsible '1--,.l- f - ~ ;)).·l- 'IA -f Ill' A'i f tlL'i for any health or bodily hann caused as 1 ·t-t - a,f,' r ftm~ ;)). -1- .,.,,: •-t- result of using the 11napprovcd active phannaceutical ingredient. ll)mo\ A'i 11•.,&- ·l•mf -t fA/'i fi•• • ~r,. - t~t t c'li\'711'11 AS: -,11y e11l+ t 35. Msdlcine prescribing and prncr ipllo n papt.r Iii ""l:;)).,r.:t,, -,r,·11 r-,,l•llm- L:J>f:• I/ Medicine may only be prescribed by an f ·t-c'ltnP rtlit, rc; '111- f -tl1 ~o>-1 1 authorized inedical professional. JI -,.,,_.,,,..,. ftlih r'i 'lti - 1 oaf::').•l- -,,111 21 Every medical professional shall prescn'bc , fi(I,}- h.,f: fD1' ruh- r'i hl'l1111''i a medicine in accordance with the -1:; )t·l- hf1,,-111111 p•C:'J•l-'> lltA>h•,-A'i appropriate prescription paper and uniform h'?'l·O'>·l- 'lflCD- fDDl:;)).•l- .,,,.. , Clll+-l- medical servi ce and prescription il:J= DDl1'1 hflO·l- II procedure. fl -,')fa,,,r fUh r'i 'lti- 1 c,nf:; )).•}- ') 3/ Every medical professional shall prescribe (IDD.f:;)\·11 611'1 fir "l1111 )u\fl•l-• f,IJ') a medicine by using its generic name; h~l: fi-,II L1.'r O"tCll"1 l.'>-tl a,f,'1° Exceptions shall be provided by regulation --1 ,1 A~ v-i;.1,,,'f .eCJ1"1II•• • or directive issued to implement this proclamation. ii DDf:;)).,l- fl;.l•IJ "t A">4.l1111 f•,.L+l.ft·l- 4/ Every medical professional authori:r.cd to rut, r'i' '111 -, r-1: ;)t•r -,,,.. , 01l+•t1 prescribe a medicine shall ensure that all t"tm.e:J>:fCD-'1 onaPJ'f• ll·}h hA required information in the prescription ,--1 \-l- .,.,_;.1, hllfl•l-1I paper is filled out. 7.1 tol..Mrl' tl,f') oaf:; )\-r- l• tl,;J•Jllj. Oh'Jf: , 5/ The amount and manner of anti-microbial ,-1 :;)t•r .,,,..,. 01l+·r ".e h1t: m.,. medicine prescription shall comply with fuh r'i hl'l"1T .,_.,C'f·l- O"tL;'f-1.m- oam ') the uniform medical service delivery A'i' ,...,C'f-1- ODtf'') hllfl-l- 11 requirements. I • Scanned with CamScanner --- --- - 6/ Unless for cmcr&fflc:y s ituations a prescrip«ion shall be given only after the patient has aot a medical record and the prescription information is sufficiently provided in the record. Mc•Ustnr dJsptnslng, and one tht copnter mrdttlon I/ Medicine shall only be dispensed by a '. 1 pharmacy professional acting within his scope of practice. 2/ Notwithstandirig to the provision of sub- article (I) of this article, the executive organ, by a directive: shall determine com-pclling circumstances when ' dispensing by other health professional categories may be appropriate. IY ..,.,'.'a>-11" UDJ:";)\•l- f"'l.;J•t.c'\m- t.t.Jra>-') 3i Every medicine dispensing shall be made llmll.,. f"7ll"r mt.+•l- mr.r f~c'\.h•l-C'th as per the paper or electronic prescription. "'""r _,,,t.•l- n+t.n 'l'.t-t -n:J= ~0>-11 /!I fll.lJ 1i-,+1t· 10-1'\-M+A' (C) ll.'i'C9" J'c'\"'lll"tf'. 4/ Notwithstanding to the provision of sub- a,t.+~· n-J:-~t+ :r-c:,c: ~cl(+ l'lc'\~llm- article (3) of this article. the executive -.,:-;)tf,:f ft"toec'\fl,}, hl'IL'l"t .. hftt\, . ~rgan_shall determine a list of over the f'OWJJ:";)t ~- ,Ic1Ir. .tm"IA 11 counter medicines to be sold in medicine retai I shops. (;/ -,-,','a,,!1" fODJ:";)t•l- IJ{\-_t ,fl')-,.(' fl!I" , SI Every pharmacy professional may dispense - - f:N/11'1 -~;)t•l- 1Ul''1fl 1'111" 111."7&-6£• , a generic medicine prescribed . using its . . 11'!7/ll.ll·l-'i ll;Hl"ta>- 9"C1 ' ;-11.f.('A. • brand, name. Special _circumstances may r.:f•I\A. II ,..,, li'f'J!- ""'IIL1tV- . ll"7.dl"1 be . determined as per a regulation or ' directive issued to implement this ~,.,. a,f,'I° ODOWJl,f A.f. 11-~;J•P,l• proclamation. J',OJ"Jfl• II 61 · While dispensing a medicine, every '!tl -,,'/01-r ,-~;,t•l- 'Ill_, .-~;)\•}, • t pharmacy professional shall ensure that 11"7.f~A.tl·l- 1.fL /11\0D~;)t•I: r'>~·l- 1 the patient is informed abolll the identity, f"7.fltn01- 'l'~r, h01"f1~1 oof.l-, ff\ll•l- use, instiuction for use, precautions, side '1'1:1'4:1 .f-)71"'7f 1-.II•}, A'i foo"flfl.+'1 effects, and other relevant information ,:J-11"7.m- -,ID~ f{\l}:fa,-") 00 afP1l• . • •-: about the dispensed medicine. I f"?"ID~ -,1.:J• hflll•},11 • Scanned with CamScanner No. J9 21• fcbN IIY 201 9 •Pll<I 11)6 ...... . N<P"' Gal. .,. Illt lHII F ,it hall be prohibited lo d',spense or scu, 7/ II s in any waY• e xpired damaged. substantt.... • ... ,,.,(11,.r. •l- • ._." ' •Ml l.0>'> f"l'? -•l-t ; f ,.., , , .,- diverted orlllegal med icin e. .t'7f'). IH •l-hhllt.' tflr ."l• ·l- Y.l. ·l·'> •l·ll ·l ·fl• fA -"I (l)J'.'r 1'1·Cll1 ,.. ""). •l- '7 I.A ' u,,,- . ~ a,i,V- ,,.,111' t •t-hllhll ),o -" 81 The phannacy pro fessional shall ensure the t l -1 ::>).·l- II 11.l,•l- r-X-:>).•l- l\;)•11"7.11>' '711"r 11"":J•'- . 111t.-l'•I: ,,,,,. legality and completeness of a pap elcaronic prescription before er' or any r ~A.h·l- C').h .,,,..r .li;,'l!t•l-'i }\(l,l.'11. dispensation. _l.K,."-1· ,,..7.1\;J·:i:a,,1 r'ft .:n ;>-\I,)•l· .,. ,-J: ";) ).•'J- ()1\- f lP' )IP' II 11/ Olll l h'1.,_,_. ,,..,,,t.,,.• ,,..,....... 9/ After dispensatio n of medicine in . ,,,... ...,. 11:J·I.I\ "~ " accordance with this article, fl.,..Je-;)t ·l· '1ll " ( a,, 'IT, fl\/. .C:.. ,-,e -~t •l· the .- ' ,,..lJf l\ll V- 'J'l"Y .,-,(J c\• 11•1·11:J 'tllt' info rmation provided under ""1 /1•fl the di,..,. r~Ah-l·Cth "YIII.C: "" - 111" 1 'A'i prescription shall be logged into a pap er or .,,,..,-,,,. r-1 :;,t-l· electronic logbook prepared for h-",. t,~:11. '7tl-l·., .'i this r'll \-ft 11- n.,. , /..C:"Yli .,_., 11<1:c lH· <f.f,A purpose, and the prescription shall be filed• lf'i -+ --r hi\11-l· 11 afte r being stamped, named, sign ed and dated by the prescriber. XI "Y'>t.'tD-V- '11 \-.f r-t :-:>).•l- 10/ Every professional shall 1't-·l- noti fy the l.t1 ')•l- A'i L9'71~·l - ll·t-,..1\h•t- l ·-,r. regional health regulator or exe cutive ,,.'i'<-') fl..fV-') a,Y ,'r l\hf lLll "'l.111" hl1A organ or health regulators at diff 1 erent llhA/1· •t--, .ni" lt a,J! ,V- tlf'- ,:Jf( f)- 1\1\• tm 'i level when he knows of defe cts •t- l,"l "lt hlJl\·l- "74'a,,), hl\ ll·l- associated with the quality, safety, 11 and efficacy of medicine. ~J. M- 1:; ,1+ ,,,,.,. Mu hr 'i -•u ,t b--"'--<I 37. Cl1sslncatlon or mtdlclnt 1nd Iii r-1 ::) t•l- mtdlul device mJ ',r ruh r'i' on "tt f I/ The classiflcatlon of any med hon~,_,a, 11"7.m>l\h•l- A'JI. 'l°C•l• icine and 'lll t med ical device shall be detenni ned A,..;.o,,- ftn.'i' •1-ltr 1.lJr1 by the "" '"l •l- ~ec utive organ based on the nature 0'7t:-l ? hil'-1'"7. h'• "· ,,c,,r. .fm"IA" prod uct and standard of the health insti of the tution. r, n,w ti,+A· '>O-fl-h'>+it (Ii) on •"l·l- t"'l.m''1 V The classifi cati on of medicin e Issu 11C11C ed in f1m ~:) t•l- hou -'\f. ,f) >, ').t."7.h•l-1\o,- accord1nce with sub-an lcle (I) /.lf 'i'A:· of this arti cle shall be as follows: V) ll\-? 11- ir ml+ ·l- na..1::)i• l- IJl\ ""·. f rt, c: a) medicin e that will be ava . ilable on the ODIPl•l- l\.fl1' f"t l·A A'i' f-0.4'•}, -Tl,.:,1 ..,, adv ice of a pharmacy professi rfl hc ml +·l- onal; 'lt\a>- fa. .l:: )t•l- :t-c ~e < without a prescription from an authoriz ed of1t9" a>-fl'I' f"t1~ I prC$Ctlber, and availab le only In au th orized med icine retail Institution; - - --- -· -- -- - Scanned with CamScanner ,,. • fcbnw ), 1019... pop I I U1 fNoro l No..,,. 0 . - No )911 on b) mcdicln~ lhat will be available only ed the prescription of an authoriz d by medical profQSional, and dispense a pharmacy professiona l; only on c) medicine that will be available ed the prescription of an authoriz d by medical professional and dispense ject a pharmacist professional, and sub ed in to the control measures pres(;rib ions acco rdan ce with the United Nat Con ven tions on narcotic drug s, illic it psychotropic substances, and opic traffic i n narcotic drug or psyc hotr substances; ce with d) medicin e clas sifie d in accordan the stan dard of health institutions, and f"J. M> 1.•fl I " ' , ' for nrc e) med icin es that will be used fl7f:J•p•':'f· '") h'lfl·l·'? f•l·tn.4'"'1. -ll'l'C: 'l'l!i:a,, dise ases or con diti ons. tJhV-t; f•"I.J'11\•11\- fM>l:;)'1.•l- , ,•.,-,.- :i·•·t J'.~Y"&-A 11 +-li .Js. Post marketing suryeillance ~~- r t;:u~-,nt r, as 1/ Eve ry manufacturer and importe Y"'i UD" f{,J ' Iii '7'1'1m-r foa ~;) 'l. •l- a,J>,Y" ftJh appropriate, shall perform periodic hV-&-':f a,J'.V- hfloa&U. 1:C:~• l- A">M'?llll- and mon itor ing of the qua lity , safe ty. a,J>,r flll"'l..ffluo,qa,- its flll"f.fM>C•t-a,- efficacy or effe ctiv ene ss of wr.r ru hr ,; M> "ttf ~., ,.,., . , manufactured or imported medicine UPf:;)'1.•l- and 1'&-·l-t L'P7f'l·l- fJJf,Y" m-m,;1. -,'l•l- flf1.fl,n> medical device. h·l- •l-A f "71 :'., .,1.;J• h II ll·l- II r, .,.,~a,,,- r-~ ;)t •l- fJJ f,r ruhll"t; _ .. ,t, 2/Every man ufac ture r, importer, or who of a med icin e or medical device lesaler shall, hfl ou ~ fJJf,'I" hh"-4-f. flhf l'-'l"'I. or hr& -l•• when required by the executive org an ,.,. f'lr lf 111,11. f\;"1111 a,J>.V- lJ~~ •f''lti7f) on its own will , perform a postma rketing V- llh'l"'i" surveillance that would enable it to L.4'1: '11'ff1'l• ou f:;) t ·l- a,f, or UD "f(, f l\f. •f'll;J•;l•f, f~t J')) •l- h·l-·l-A continuously monitor its medicine e t"'l..ll'll•ftt11-') f.('11~ 1n 1 1''i ·l- medical device; establish a vigilanc 11"71:t."I nt :>•l-'i" 1'1: system, and furnish adverse eve f"711'i'OJ'>1 fh•l-•l-A ~.,C'J•l- foullC: oth er required 1 information and hll•f'·'l-1'i t\l\ hfl Lll' l. ,n,( .JI' llh flL 'l"' t h JII• information. t"1.:r-t.-o ~I\,, )•l- hftR•l-11 ., ..!.-'.- -- -- .. .-· . . - . __ Scanned with CamScanner I 11t 1ru,u ..,_ ,.u+ .,,,.., •....: H rti-t+ u ♦, Ill.If , _,. r,.i.rtl Nepril Oum1 No 1911• hbnwy 2019 •• ,11...1I Ill 1:1 ht1.c..11-,. 11•,11. n1n.t "'· r'l'il tJDJ:-;)'l •l-'> 3/ The eKccutlve organ may periOdlttll> Cll~9" ruh9"'i' _..,t.,, 1'&-·l- A'i' ~,,.n ·l - undenake post-market survelllanet medicine and medical devices and ,. or ""'t.-'11' nr1.1Lm- rJ:-ut. ,n.t 'l''i'·l- 1•,vu. , "''Y require Its manufacturer or Importer Ola.l.11>1" A'>M"7'10- Oh9"&-li: lllf.'I" • lb appropriate, to cover the associated c flhll-ai..t11- A').\7f&.., fl..t ~C.? ,.:r•"A II • Implementation details shall OSI. be 11C11C hLJll'o.,.,.. 01.')•fl f,lllc'l'i'A 11 dctermalne by rceulation. Iii "7')"i'a,,Y- fonf:;)'t•l- a,f,9" fllhll"'i on"f(,f 4/ The manufacturer or importer of 1ny hY-t-l· UJJ'.'r hflonai_ r:c:~•l- f11mf:;~').•l- medicine or medical device shall be A'i' t111hY-'i' ,,....,1,., 1'&-·l- A'i' 1.11,~•l- -:t··u: responsible for damages caused as a ,'JC: •t-J' f,11 il"'I.I.C:11 fllY.OJ•l-11" trt fhl1A result of quality and safety problem associated with the PrOduct. 1-1'·1· ;,"'·~·l-'> .r.a,111\A, 1u:1u: llhLJIAon• I. '>11 f,Clll"l'i' A 11 Implementation details shall be detennined by regulation. ~il. U]·OIT f 091.'~\t m&p- tUh9"''i' aa"ttf 39. Prtventlon of iUegal mtdlrlne •~ 110>0>-C') /1(\aah'lflA mcdiul device drculatlon I/ Any person involved in the business of Iii "7')"i'a,,9" fltmf:;)'k,·l- Cllf,11" flllllll"'i' medicine and medical device trade '>"71: I"&- <\f. f•M"7&- {\m, ,. tlD"f{,.f shall take every precaution to ensure f"'l.111a>- tml:;)'k.•l- 1111,11" fllh9"'i' tm"tt,Ji the legality of its suppliers, use legal hU.:,'I! 119')•~ ontf),') f"7l.'111'1 11;,<e receipt, and make an immediate report f"7lfr f.(.('llf fuomtr 1. ').\11'9" 9"'>""t.f-a>- to the executive organ and other f"7l,:J·a,:,O UJf,9" ll;J'I! t1Atr). 9"'),~':f· appropriate law enforcement organ f•M')' uof:;)).•l- 1111,9" fllhll"'i' UD"f(,f •, when the illegality of the medicine and ll.r.,1'9" Cll.\.fa,,), /lht1Lll"7. Al1l\,1 ilhAA medical device is known to him. m.'i' •t-,r.11J"l(,a,, aif.9" i1hl11Jll fl'.'l';J• hl1<\•l- f"7"111:t "7S'.;J• hilfl•l-11 2/ Every medicine and medical device f./ 0U1•dl'I' oo')11: f"'l./11 tJDf:;)).•r lllf,'r found to be illegal shall be confiscated fUhll"'i' OD"fl,f 1.')M"7'111· htlLll"'l.a>- by, as appropriate, the eKccutive organ AIJA 111/,'I" fhAl'I• m.'i •t-,t, 1'1"1t or regional health regulator.

1.'),ta,C{\a,, f.t.(.:,A II r, 0,1.11 ,._.,.,.,.. 1,H,-11,.,.,.. (!O _,,,t.·r 3/ Without prejudice to the provision of f•t-111(.(1 oof:;)).•r lllf.'r fllhll"'i' UO"f(,f sub-artic.le (2) of this article, the Oh"71Jfl· fl{\uoan~ hllLll"7. Al1,\, 111f,11" executive organ or regional health fhAA m.'i' •t-.J,11J11Jtcr>- h?'lfl 11/1111- Al1A regulator together with the appropriatt ;JC flootf') f (.;J"7"1A 11 body shall ensure the appropriate disposal of confiscated medicine and medical devices. Scanned with CamScanner Ftdrnl >It.,. 0 . - No J91... F.-Yl01 9... -IIIJ9 a,,..,. flllirt; -"tt,,r h I- 4/ llle exec111ive organ or regional health 1lcr>-cr>-C.') 11·1-r"'fl . i\lll'll.l \-, hi1 i\hAA fllll.t; •1•.,_,n · 1'1· 1111.v- ~gulator shall pay a cash reward to ., 'lt,a,. II+ :J any person who gives infonnation rr.•1: A,~ ..,, "" · · 111-1111' .. '"'l1f 111,rn A A • (l,u. hl'l'- leading directly to the apprehension of hltfl• a,y,,- IIAA ,n.t; .,..,.,,,,,,w ll"T. an illegal medicine or medical device. ml.:J•m-1 J',hti:1\/.\,, !'/. :1-1:(1 ...+,- ~.e flil"ta,, M• Al'-W 40. RefurblJhtd and amanafactuad medit11) _,._C,f, ...+,- l\~fl/l -t A - - •A fUhr'i -"ft, will :J•f:fl 1'~'r l\r, r l •lwnr.+ 1'~Y- ~ .. -,,en-A At; A'Jl.1'i' Every ~furbished and remanufaaurcd ,. f"'f.a>-A -11'!1 fllhl"''i ' "?''l{.J';- , I 11>)1" medical device shall: I.I) hhl'IL.l\"7. hit,\. '-:1'1: .rn·, a) have a pennit from the executive organ; ") ·r:J •1.1'1 m,.r ,:. ..1-,. f·l•tmt,•I·" f''T.A b) contain, on its labeling. the word "refurbished or remanufactured" as 11\~ 1'"1M: A'i' r>i,n.._.,,,.. -,'>'PA .,,., J'fla,,, A'i' appropriate, and a user manual; and c) mention the length of its prior use or date ,h) J'1il1ilfFt- t»Vr f:J·l.l'lfl•l-'I 'l..l'- f"7. 1AI\' ,,.,.,., hMl·h , when it is refurbished or remanufacturcd. ,6. f11,(ll-,.ll:fl m.S: h1A7A--l- f"'l•A 111, ..,-q,e 41 : Public health pesticides ?ii ..,,'la>-r (la,, hhl'IL.l\"'1. 1i•,t1• 11>Vr I/ No person may manufacture, import, export, . wholesale, or sell public , health pesticide hhAA lll.'i .,-_,,,'l"lt.m- fofl:.t'·l- -,1,,.:n~ unless the executive organ or a regional rl'IIIC ml.+·l- 'IJ'11 i\1-fll.•Mofl 11'.'i' _ health _ regulator grants cenificate of h1A '7fl••l- f"'l.a>-A Ol.· •l-'lf. "'IV"l.·h competence. "7{1UD"1:t-1 UDl\111 .,h"-LA 111,•.,. UDlf'l' 1\f.':f-Ar,, 2/ Any person who has a cenificate of JI fllW h'>+1'· 10-fl•h 1+1'· (?i) _,,,1,,..-,. competence in accordance with the provision f,(1,4':,0 "7l.:n ~ rllhC a,l.+·l- of sub-anicle (I) of this anicle shall keep f ,,.(lmm- "7')'la,-Y" (la,. J'm>l.•,.111-'1'1 and transmit relevant record with regard to J'{IUD"ICD-11 J'h"-Llla>-1 a,f,S,- ffl,na>' ) ' i\1-0l.•f-fl,(I m.'i' h1A'7fl.••l- f~.a,.A Ol.· the public health pesticide it manufactures, ,,-IJf, fl,,-m>flh•,- m>l.1' 11D f11'i imports, distributes, or sales to the executive (ll\{ILll"'I. hlli\· a,f.r ilhAA tn.'i organ or regional health regulator. •f<.f,"1"1''1a>- 6;rC•l- "71:l.'7 hilfl•l-11 3/ Any person who gets a cenificate of I!/ i\1-0l.•N'l-fl m.'i h1A '7fl.•·l- f"7.a,.A Ol.· competence in accordance with this .,-qy, f"7.;Nf1o>-I f"7.l\l\ll111'1 f"7.h-,:fo>- provision shall be responsible for a,f,Y" f"7.l'l~IA11>' fll'IP'1•1 flA'Jl'l'l·l-'i monitoring and ensure every public health flh'l'lll . l\f, ti.l 1.c~ f"'P.li\,•l-1 h1.,? pesticide is packaged, transponcd, stored, •-•nil n"'l.111':f·A 1H:J· UDll'}'' or distributed with the least possible risk to fuoh;J·,,-A ;)l\,.~-l- OILtJ h1+1'' human. animal, and the environment. . "",,,1,,.,-,. r-0:J'·l- -,1,,.;,11 rt1hc CJJ~+•r f •l·f1tnlD' fla,, ~o>: 11 . . Scanned with CamScanner IiU _:"-'~r,u.:.\:-"' ::~~--:1:.;♦n:~•~•~r"~~~:..; , ... .. Ne pri l °"""" llo,J9U'F.i.-r201t........ll'41 U~-t,~l;l.~Il~'·"";.;r.1,-:4/u,;;°n 'llt - U~!fl~ i_/ n'"1 fll .·'" "f l ,n.<; n, r"'tel>'A ,,- ,-, :,, .., - winu The ma uffac tdtur W;e,;,tl'I -iIISnnpo ;jrt.ioSlo ii:" i~ar~~ rate Ol.· ......,.. ,- -1 .-f'a>-1 r-t of every public he&II h ·• ·• .. :s' lu .., ., r" 'th '7 :fel>' , pestIcIde &ball i,. L ,,, ,., .. r -tl'lmll>' hi\ stifCg&tion ftom other prod .11-:f ,-c-,.':f •t- t.r ,.,. ucts. .. -t r, 111\IH·• • f.l -,7-,:CI>',- ot.~ M SI The labellng of ~f J', '7l'l1.J' _,,. f'/ public health ~ ,-,-1• .,,,.~: ,11-,c-,: :t ,: t, r"7.ll'I: shall at least be In Amha ,- ,...u.rc ric language. Of f(f '7 l\l\ll-l- 1I 'f,I h fll .ll "l 11111\, A<; r hA A m.<; 61 The executive orpn •t-.f." l' 'll,.a>- l\1 ill .•M shall work Wit h ~ ·O m.<; h1 A •111•· appropriate bodies r"tjl)-1\, 01.- •M r, l· to ensure tlit ,,, .., .,-, '7: S: \111 '711'7:f•l-• 11,n; <H "'i manufactu re, transport, ha i.'.11 1: storage, IISe, "Id hf l- A t,-,. 11 1ill. •M disposal of public healt II· m. ,; I\J'. 'l-.ll h pesticide does ~ 11'7.rfllt·l -A tH ;.I · - ·l- li't111).') l\"71..?1'1 ' pose a threat to public h"11J11 ,,,..Cl>' 111,A health. :,c 11•.,&- , .fl &-A 11 , ~ P:t\+ r..a+ -mttt, re+ §e st lop Tw o c01metlq ,r. "' ➔ " " n, n. r ., ,. ,.,_.,.A ..,.,,,-..,.,. re11-n•l- - mnt t 42. General rc •l- Every cosmetic product pla O·M lt ,., .., . H•t-1 \-1 . ced on the 11\arQt h ,n ;+ r shall no t harm hu 0"11111\1:0•l- man health when 111-l-•l- fl{lo,- used 11\'i' "' · 'l-.11 ·l- ordinarily or as intende f" 'U '1.Cil -i n fl\O d. •l-V-1I ~r.. n,f .. n t -m n tt re+ ,., .t- ~ + ,-.,,-,q 43. Re gls trp tlo p of tn de ins tit ut io n ..,,','111-r re11-n•l- mn<1:1 r c •l- hr &- 09 ':f·, Every manufacturer, im h fl -" l A'i' hh porter, an d distributor f.f ..r . of Ohfl.C..ll"'l hf11\. cosmetic shal I be reg -- 11 1- 0 hl\O-l-11 istered by the execu ti~ t organ. ~§ . r..o+ -mn:tt re+ tlf \" -mn:tt re+ t,a+ 71 n A£ , ..n+ « .Coxmetic Notification an d lg 61 ..,.,,,.a,-,. r111-n •l- outntl<l!I rc fla ,- •l- gR 4i en ts .. ,, .l ·l- a, y,, - l\')"11: 1/ No one may manufac a,1. V1C "7(I01Jt1J•l- ture or import to trade a f"'l.~l\111- fa,,fl•l- ou cosmetic product unles mO<f!fa,,') 11C11C A' s a list of the cosmctk i' and related infOfflla ,,..J'J'' fr -l 1 f hil.C..ll tion is submitted in "'t 111,11. O"tJ'll.:>l!'.111- accordance with the opera hi lt-c ODW l•l- c\.ftlm- tional procedure or -l- -<1:J= )m-, 1 the executive organ. f/ "7 ~m -r fa,-0-l- ou m O tJ ' re + f•l-hl\hl\ 2/ A cosmetic m ay not contain any prohib J', 11-l- m.r.r ·t'-.ll" U-l- IJ/1111- ou fl.C.C·l- ingredi~nts or any ited ou wl -l- h-tl.+1. ingredient above the M 'l' l-)1C J'.11-l- OD maximum level estab ,n' ) lished by an applicable 01\J', I\.'t{.a ,, hJ',1'11" 11 i:egut,•.ory requi rement. .l. Scanned with CamScanner JJ"-Jf'J i,J..U. ,~+ .!111."I •,-c: fll! f'i-t-l- lfl +l lltU 't.f" f«l,nl lwpril Gaunc No. )921'FcbNa,y2019... .,.,.111•1 " Cl fflm-') m.'i' i\m>mCI~ hflL'l"'I. hl1t\, fa>-Cl•l· 3/ Whenever it is necessary to protect public m>mrlcf!f 9"C·l- .e,ll•l-') ·CD.f.V" fm-O•l- health, the . executive organ may ban a oumrH:J'') ,,.:r,.,. I\Y. 1'">~f.a,,f.\ lt.hllh/.\ cosmetic product or its ingredie.nt.

1.':f•l\/.\t1 #I "7'J'i'a,,r fa,,fl-}• Ol>ffi(l,tf V"C.-l· hrt-l· 4/ Every manufacturer or importer shall be dlJ',V" hilDD'Ll_ .t!"C.~-l· hll"C.•'1 ~U')H• ':f·"IC: responsible for any damage caused as a result :>C •l·.f.f.lt l\"7,J:.Cfl '1--"-l· ~l\.l,H• hl\lH•11 of the cosmet.ic it manufactured or imported. ~?;. rm-n~ ,,.mfltt re+ 1111-,rt;+, 45. Manufacturing, storage, transport, and 'sale l'll\'"7h'"7:f+, l'li\'"7~~1f'i" l'lt\DD1f'J' or cosmetk /ii "?'}'i'm-r rm-n•l- -mnct.t V"C•l- >irt-':f· • . I/ Every manufacturer of a cosmetic product f"7•.fm>C•t-m- fm-O+ ODfflrl<l!.f 'J"C:·l- shall make sure that its product is produced ftm/.\119" .. htmt-l.·l- PC'¼·r') IH·IH·I\ i11. accordance with applicable good tm/.\h, ODOD{.•I:') "7l.,.711' hllfl·l-,1 manufacturing practices. t .,, ~/ "7')7j=a,,9" fm-O•l- onmOcf!f 9"C·l- hrt-':f•1 2/ The manufacturer, imponer, distributor, or hl'ltm'Ll_t hh<f.of.,e a,f,9"· :ft;;i:t, ll"C•I: retailer of every cosmetic shall ensure the .RU'}H:'} 0"7f~.J!-A onl\:h, i'"79"l·h safety of the product during storJge, ~"-\ • f"7h"7:f-•l-t f"7::S::S11 tD.f.9" fmilfT ~"'· ., .,. , t.ransport, and sale. hllll·l-t I 1:1 J',111 h'I'~ mvr It.I\ •t-.l.Jl"Y. f411'1'C 3/ It shall be prohibited to manufacture, impon, oofl.l.C,f-°:(-') f"7f".'ll\ fa,,0-}• ODtnfl<l:J' ,9'"C-l• store, distribut.e, t~sport or sell any a,Vr ra,,n+ -mn-t.t rc•l· 1'1!. 1>:t> cosmetic or cosmetic raw material that is not "79"t.-l•1 '1IIOD"),l-1 "7h"7:f-l·1 "7h"-"-At in compliance wi~ this proclamation or "7::s::s,, mvr -n,. r•l-hl\hl\ 'ta>-•, oth.er applicable regulatory requirements. 4/ Every storage and transpon equipment, §I h"71'i'c&r fa,,O•l- oumfl<l!f 9"C•r ,?C having direct contact with the cosmetic '>hh. f"'l.. 'it.m- '1h"7;J= 1''i .'"7::S::S'lf l>? product, shall not cause chemical, physical, ,1ru'i'm- r.,.mn+ lf'i' rc•r,, l\"71'i'm-r and microbiological contamination. tL"'l..ftl\'et htil\'l! tDf.'r . "7hC'flf.A-1C1tA •fltll\+ f"7.f,.7/.\1' ODIi") hllfl•l-11 l>ARTFIVE h~A >.rflt rtr11tr "" .,.,,)fr rc+J: 1111+~1.c TOBACCO AND RELATED PRODUCTS ADMINISTRATION !7X. 11n +rqir re+ Af. 1.J>1: lt'i ttt)fr 46. Tobacco product special license and related products rc+':f 1/ No person may manufacture, import, 61 'f'}'i'm-r (Im- "hhfl4'.'lai h'11\- f·r9"fllf wholesale, or distribute any tobacco 9"C·l- Af. 1,.?1: "'"~ f•r9"fllf ~C•r') products without having a special license "7rt.+• tDI. IJ'IC m-fl'I' "7l'l'lfl•l- tDf.9" from the executive organ. n~rl\ "7h4'-/..A f•l'hllhl\ .,,,,. ' ' Scanned with CamScanner r. ., .i ,.. .., . o -i • 110. J9 21 • r,.......,. JOlt.... ... .11142 'llt !f•~ l.l~ f!:_ fl 1- J.# ,. t" +~ _ ~_ ;: :: .~ ;:♦. _... ;;.C;•;•~r•;1 -1:~+~r~f~t;,~•~ll;Jl~ ,. r; Kl rM h + ~ h \l•i:" n ~ _. .,1 ,/ 'l a>f,... = ,~2)mIt~ ~sh ::l: be > - ,. ~; pr:o:h:ib::lt:ed~: lo~.m:anu~fact:1e1,' .,c 1 distrib ute, 11Cll. or offer: 1,- ?C •,._ ,, AA a •., . rl l'l r- tl l'i fl wh oles& c, . to sell Or IV \ he\; , • im pa •- de an . ,-c+ CD1. tn C o>-M' {I.,-, '} t\. , -,(1'111-l·• rt to ..... y Electronic Nicotine t: . Sy ste m or other related cisarcu -,,-t.-l·• -,,~'-"'' itJ'-1." -,~l.◄ I O lf. 'r D e1,very e " bi' resem in g tech no logy product. .,.lf1' r-t·hllhfl ~a>-•• . I'! ..,,~,,..,- t- l- rl 'ld J> J/ Every tobacco ' h-11 f, fl lf ,, r h rt -' :f· grower and manufac turer shall . o "'-,-I'll! have the obligation (1111' -,-11-tA 111f, V- to prevent and tonl!Q ... -, rl •l - I rh 'l /·l- 4\ f. potential harms caused (lw t,.•r-lt=!: >.'i' ,u,tirtll. on the h Ith f • ea o its M .1 .t. tl' l 1-~·l- em pl oy ~ or the en r- h "h A 'i' funcf,' vironment as a result 'ltnC of tobacco growing or '"'lf.:J • >-.ttO-l- 1' manufacturing. nn + rl ll l' re~ -lJ "l:f O"""' ...... '-11{ "" °' ". ,. n f "'i t,tt+'f \, f•l"ltfthft 47 , Tobacco produc ·t/ No on e may man ts co ntent an d dlglos1t5 ufacture, import, wh ,.1 1:t- fftll:t-') olesale, f ·r? "l \t f .,-c:t- ., sell, or offer to 11 t ~I ,. l·l- I Oll.lMC o>-fl se ... ..- A ..,._...., ,v. ..1.• - ,,. ... .., .;u. -,n,11-l-1 n~ r1 1 'l" containing prohib -,114-t..A • -i i'l " ited ingredient by ,o>f,V" the fl' itf -t. • -,~l ◄l f . executive organ. ·t-hl \h l\ 'to>- •• ' ' !{/ f·l-9"'1\11 rc •l- >-.rt,.':f a> f,'l" hnunt.1. 21 Every tobacco m9!1uf~ I ll·l- rr tt f V"C-l- o> ret or im ~ -tl1' /~ 1 f, tl •l-i shall maintain and, >.'i' .,- f fi r ,-~t-" A-,.+ upon request, provide .1°·1 O•t-unfth•r- information about -1 11 /1\0:t- una ingredients used in lhe IJ"r O hl ll. 1 'l" 'l h tl\- manufacture of ea c\ m ft -a o > -1 f ch of their tobac ao tlm ·l- -iY.:J · hc\{l 11 product, its emis co , f,I } 1:1:n. n •l- sion, or any Ol "' ta ro + o>~·l - information about hcr CDf,9"' hll..,..~o>- h r~ :i l the product to the c\hflL'l"'l executive organ. h 1lc\· If the executive Mc\mo>- ova tU"'I 1'{1? M-< lmo>- receives legally prot ected trade ~ du organ f1 -, ~ -T./11'C htf't implementation of ring >.'i' f,,-ID- (lr,•a,-~ this sub-article and h·Mc\1'/\:t- M LJ l" : manufacturer or im the 'l ht il\, r1 -i t: "'l porter declared the fo um O ~ -iY.:J· hc il1 "~ 1 in writing, th e exec same \O-l- 11 utive organ shall ha . the duty to protect its ve confidentiality. 3/ No pcTSon shall manufacture. impo ... wholesale, distribut rt. e, sell, or offer for sale 11) "'Tlf1./o>- a, f. any tobacco produc 'r 1""1" ,_..,.._ t that: •h Q .- , l, a) has a characteriz "169"' 1.11\1\m- l\. ing navor, whether .f' .,. l\h ·l·r 11 .r -l or not lh -l -r the product. packag A f. nJ6V- .f'(la,-1 ing indicates th at lhe c\) n rc •I: h~ A product has a charac o>-ll'l" o>f,V- OV terizing navor, -C•I: b) contains a navo "f fl 1. ft -m ~ c\ f ring in any of its c >.'i' ~ I\ h? -C·I: :, om~~ c or the packaging. wr 1hlL llc\a>- 't1C o\j'. f ·l -r'll !1 "ll apping or any technica ;J• feature of th e produc l a>f,9"' "169"' f" t< t allowing modifica l'f ,f: -, "J L "' l ff tiOII ll i of the smell or taste of the product; Scanned with CamScanner c) contains one or more · additives with . propenies associated or likely to be associated with energy or vitality, a health ~nefit, or reduced health risk, such as but , not limited to, amino acids, caffeine, tauriac , ,or other stimulants, vitamins, and minerals, or Is represc~ted ,or suggested as containing any such additives or as having such properties; I • l ( f·H"'lU' 61~{1, f ...,_+ ,,,,, a,f,V- ,.r. .,••v,., • d) contains a colorant to change the colOI' of • · tobacco smo~e; or IP) flJ\l'ILJl-,,CD- "'''A f·ta11'1) l\.o\ r-l•,-1111 e) docs not conform to other tobacco product f,11-l- -ALt:-l•'> M.r-:to\ r:l·r'IIT ~uiremen ts adopted by the executive V-C-l•')' -,,-t:t•, 111'- ll'IC a,.fl1' organ. "~" -Jl1'1 -,ti4.'-A I , .,1'11'1-l-1 ,.,..,. -=Fr.=r-c f•M1AhA )p,, I • ~r+~,--;::q:'a,~-:,-~C9:+~l1-.....:-Y:.!.!!m.~ll_Af!:S'L...:-!!lmn:+tr~ 48. Prohibition of smoklng, ■nd tobacco use In llA'"lhAhAn+ 11;1: public places Iii -,-,\'.,.,- f111> hOC -Al'I '11\ l\111Ml ti,:,l• ,1 II_No_pcrson may smoke or use tobacco products ntr't .,,\'ID1I" fl:"• hnc -An .· qi\ In any ... part of ah indoor workplaces, all indoor public places. on all means of public transport, -,,\'0>r f pi,, fl;.f•t o-,.11\.,- fUll-fl -=s""' A'i n.,1,, --rt, n.+ n-,,,..,. and in all common areas within condominium housings. f .,1,,_,1>.11 fl;f• "'· .,!IQ./) .,..,. -l-rfltn -111-tr f-thAhA )11>11 . I . .,£Q.h '' • It rur.u l\'>+A' '>O-ll•h'><f'A' (Ii) _,,.t+ 'JJ No person may smoke or use tobacco In any a,1,,--l•r'ltn -m+r R-thl\hl\Q:fo,- I outdoor space 'that is within ten meters of hOC -Afl 111\o 1\1111-R tK:+ flln, . P:J•,.'f- ' any doorway, operable window, or air intake mechanism of any public place or workplace 1''i , ,..1,, fl:1'1'°f M/MC -i+c '""' ID'h1' -,a,, nc, "91111-l- ,.,,,. t-rc ,.,. ·, provided under sub-article (l)ofthisarticle. 'IA .. fHt'r' A.fft'ICl ~lA i\o\ 11::" O>h1' .,Ah ... • 'l • ' f-thAhA )fll'I I , 3/ Notwithstanding to sub-article (2) of this fl rt1.11 1-'>+A' ,o-ti->-'>+A' ll) Cl-rcr n-,.,,.,.,. ,m,.. -tttr, ,_.,.,,...., ,• , article. s~ng in any outdoor part of healthcare • , facilities, ~ government ,t-tt,-, M'it•l- AU~,;'-l- 1''i" 1'~-ia,, h~6. ' ' . institutions, facilities including schools . ,-+ R;l-f Aln ,l,Do l\1A-,A-+ MID'A. • Scanned with CamScanner r 11t Fodenl N,pril• o-n, _No. l9 2.l._ , . _ ;,20(9 .,._111'4 Jl:ll:rl~':'~'-':r:~~t=:u:+~.,._=..::..:..-c.::.:••~r~lt-t+~~g:1;,~~,_:•-:llI::":J;:-::,.::",.::;:-::CT-::-'"7"°"'.'ii;;i;.:;;iedn;;';i;;iy°"foi:'ciiJi<i'~~'yc;1~~i:::, ... ' . ' . intended mall)IY for children ·or Youth IJftA.:: ·l-9'"UC•l- 11.·l-1 1,t; h~•t-'i' f•l-v."tJ .C'r. .._ •~-,·l-1 6Ull'"C' -,-,~a>-9'" ,\.I\ {IIJ1l1I . , ... the age off I,. high~r .education instltutl11o1 • --.. • youth centers, amusement parks, and ...., h~+ nir, l'l:J- l\.e, 0111"1•1- -,t,I,A• -·, 1 • other places.as detetmlned by the executive n-,1'i''1 ;rct, 1,t; /VI tlh/14.~"7. h 11\: mf,9'" OhAA m.t; .,-,r.n11'1tal- O"'l.au'l') .,,.~,~rgan .or regional .health regulators shall be - .. pr~hibited.. ..,:: ; , , hOC .,,..,_. 'I/\ I\.<\ (l;J· 1.'i' :,,.,.c "71\. a>-111' .,~II mf,V- •l-V-lltf onm4'Y" r•H1M11\ ·)o,, 11 •• f • .. ' • !'IJ1. 111\ +r•ur re+ 7ft~ • } • '\: • '

49. Tobacco·proctuds sale . . . .... f IiI 1, l:"'1 o>- h?iIi ttun•l- n;J·l· l\tf) . l'lm- ' If The sell of tobacco produc~ by and to any • ~ • t.· .. ~. • lf) O·t-119"1't f•l-Y"'ltf Y"C •l-") person under the age of 21 shall be ' on7f1' mvr htili 'Jon•l- O;J•l· lllf) l'IID- : .' . l,' ,. • prohibited·. 1 ~ ·:i;•'",.. .' • t. !.. 1' • • - ft o,w h'f'~ ODU-~•l-. ·l-ll'"lllf .,IAfl ' .. ,. 1,<;. ·' ~· .. 2/ It ~all be. prohibited to sell tobacco ~ onm-,.r O·t-hl\hf'I.IJ:fa,. (l;J•P'":f· :,,:"F--,n. , , "! •·, p~~ucts. wit,hin -~~ndred meters of the (1)-(l'f' t'," n-,')',"a,,r rm.~ ":t-~_v-1 ; ••~ pre_mise ..of ~ ~lth_.,institutions, schools, +rue+ f\.•l- r.,..-,-,,,..,}, -,.,tr 1,,; fa,"J ·l- . •:.ii, ~d yout_h. ce~~e~ : where. smoking and . .,6h'l·l- &f •"'l•l-c· ll't.r •: •l-9"'11f,,._7 f1' .. ( ....t?bacco _use is . prohibited under this \.. .1 \ ' • •- • ,.;-\ . , . ' "' r...hl\hl\ to>- II - 1. '·• .:'.. .. - .. proclBIJlatiOQ. ' .• • .. ., 4 • l - . • t• r, -,:,1','o,-r flo,- rh., -1-c1.•h r :r11;J•' i,; '· 1 3/"No person: shall sell or lmlnge for tobacco fTl\.l•"'l.tlL7f') 7f.r•~') '1.l.Y"C' ,r~ ·1 1,,;· • •:,: produc,ts to ~ .s~l.d or ·enable or facilitate 1lfr nhtiA n..;~1'i'"f.fH· nr1r •r'¼J.~)·l- • • . such sale1 by any other m~s, including via l\.'I ,,,., +in~.. ffi-V-1111 9'"C•l-, OD7f'J'I I L. the internet,' mail t~i«:ommunication or or

1.'>~1fT .,ll~A . m.er i1~u '«i,;t:1,1 ·1 1: " through any means by which the pun:hasa' 7f.f~ -,ou;J=:J!."f- f •t-h(lhl\ )0>-11 ' , ' ' r, '< , • ~d sel,ler are n.ot· in . the same physical location. •· ' •· · · • 6 ., • ' s \'. «.. •• • . ., . ' •• I 't ,/ , .. ,. '! \ • .,J_l-"\:' .• -' • -,,,:o,,r ..:t-9'"'111. f".t7f.1Jla>- 'I.f {\.;,~pilj'> .•.• 4{._:roba~co prpducts !llay only be sold in inlJCI ·, n.r11 'IA+h4.-,. ;,·n·l- m.er Ohfl~:",.· • , •. packages ; ntaini~~ 20 -~i~k~ or consisting : ~ hti/1- ' 0':"l.a>fl') f·l-9.:"lllf <111'C, .a>_J}~· :I ·•')I,of~~-socc\fi~ ·weight\ ~~ ~rescribed by the 1 , I. 1• . ~. ,,, 1\(,,, > ., I ~ ·. h-01.-l- ouwl·l- )0>-11 .,. , II°,, ,, . • ., exec11tive organ. • • •· •t • , .,, t •J 1 ,,• ' •• ) '{;t . rlf..'I' re+? .,r~•l-i· mt. o1cJ- a>-flT I SI It shall be Pf9hibitcd to ~facture , import. .,fl,11."f-1 .,h.,:f•l-1 .,h4-LA 1• II\ 7f.r-t.~. • ·: • I Slore, ~hoJF5!l{e. di~rib!J,te, sell, or offer to .,..,.~"" (J)~'/9 ODlf'J' f•t-hl\hl\ tlD', I .. sell-any shisha product. " . ..• A tradeaet'IVI't·y that I ' if.'f'),- If) .,')~a,.'}9'" 'J~)•l- f•}~lllf , ,, .1 ,is intended ", ·to, provi' de a P1ace· &-.,or smok'ang of rc•l- l\.,flili.11 ' m~r l\.,llm.,.r .1 . shisha or other tnobac · ·, · . . ' • ._,,, . f"'l.11;,~ · r,-,.,_.. Pt- ·r•N11\hl\ )m-, ~ •••, . , • prohibited. · •• \ "" ~, • r • co producis shall be • ·• l • • i I 11 4'., • .... Hf♦, •• I • :• ~" if ,. l \ ' • . ' . • ' ... • , • I t ', II I " I• Scanned with CamScanner

50. Duty to enforce tobacco-fr tt provisions I/ It shall be the duty of the owner or another appropriate person in charge of the management of the public place or public conveyance for which tobacco smoking, use or sale is prohibited to ensure that no one smoke, use, or sale any tobacco product. and to ban the placement of an ashtray or other comparable devices intended for tobacco use in such plac'i. !U ,\tl'l • ril h't:•l- flT', •' · P.,, (D U "" ~., -,:,.•~"If 11 The owner or another responsible person of the 'I,\ 1111. ·l- tDJ', 'I° ·/\.'\ ;:)'\l,'1•} .f'llfl·l- flm- public place or conveyance, or, in the case of a r workplace. the employer or another a,J'.'/° r ~..~ fl;J•") fl•,-Cll>,\I,·,- hflt mY,' appropriate person, shall post clear and A.'\ 11·1<111 .f',\a>- l'la,. n·,-Au f"'l.:J •J'. ·l-r'l lf ") prominent notices regarding the prohibition of "7u.l./l tDJ.','I° Ul>tn+'I° f ·f-11,\h,\ tn>tf~ tobacco smoking and use a.long with its f ''t1A J\' "7til 'lll.f ' h'l'l, \-,.,\ 'r 'rAh ·J: corresponding "no-smokingn sign. f U1>,\t n'i: ..,Y.;J· h,\fl •l- 1I SI. Prot! (lion against tobac-co Indus try !Ui. r+r'IIT be'J+ il-l-6 lflA ~ 1:9'1-l·l fl,\- h'\hA Inter feren ce I/ Interactions between any government organ /ii f,n.' i 7"1\.il. 11"'1•.f'W"I "'i 11"'1.li'IL~·r "'i' 0 fl ·l-'r' ltf h.").11./l •l-t responsible for the adoption of public foo" )-,p •l- 1tt1A ODIJ hA f"7..1.l..., -,•,,;=a,,,,. , ,..,..,.,. health policy and the tobacco industry shall be Jimited to only those strictly •l-r< 1ir1 n11-,<111• tiuo.f."lm c 1ti'IL'\1. nir·, necessary for effective regulation of the . of):,: ',a,. I I tobacco industry or tobacco products. _,.,1.;r, 2/ Any interaction made in accor dance with J./ t11u, h 1+~· 'JO-i'l•h">+~· (Ii) sub-article (I) of this article, and whenever f oY.1.l ."'I -,")' fH· (Dr, 'r -,"),; ta,,'/° h·l·'l° 'llf >i.,~11 +t ;,c ,..,_,.1.-, .,., 1"'ir .,,,.H· the tobacco industry contacts the government to initiate an interaction of '7Alt'1-l- .fl\fl -l• If'{' A1 1. ,l\'7'111' OM ~ any kind, the appropriate government ae.f11 r,t;'C fl;:J•A 11 official shall ensure full transparency of • the interaction and of the contact, and it l shall be appropriately documented. 3/ No person having financial or other interest in the tobacco industry may panicipate in tobacco control training, workshop, or related events unless in accordance with an invitation by the relevant health regulator. Scanned with CamScanner 'llt lJIU 'l!t l 4'. u. t.¥ + x1 tte flif r•1-tt lfli ~, fll.U , .,- ~/ -,'lfa>-1" fm,')-,..,.,.} "'' A A'J 4/ No 11ovemtrtent orgart or .\1H''' ll1n.'i" an omcia1 ?'I I.I\ "-'· f"t.'1&- ,,, .,, .,,. ,,} worklna In ~he area of health pol tP& ,•I ·~ icy should h •rr 'lt r >i.. ,~ 11 ~t ,.. ,_l'IT receiv e any financial or ,,. ,•.,,r ,,. in-kind ,.,, .., ,,111-0 11,n:J•"> -+ oA contribution from the tobacco r1111•rr•, industry. A ,_ -,- ,,, ,.)- hl1 A h·l·ll"''ltr 11ovemment organ h..' }~ ll• rt fll1 may r~i vt h.t:&--,·l- lltn :J• contribution from the tobacco ,,.,+IIA f"'f.1•11(11- fllllJ industry in h "}+ 1,· '}0-11 h.,.,.,.. (F.) .,.,,.,~-l- ',(II- 11 accordance with sub-anicle (5) of Ibis article. f;J fl·l-Sl"'ltr h.' }~ /l• rt SI Any financial or in-kind cha I'll-, h.t:&--,·l- 'Jl\ "'l' t ritable or any "" -" "T')';a>-119 ·l' I J'°'fr ·M 'lC : other related contribution by f"'l.1.t.•1 a tobacco r1111-o w.r.r r•t.r.H· .t::>'i: M·h" "" industry shall be prohibited. jf. O-l-rfltr re + I\~ -t~ "T ? 1-flC llfl 09"1A 52. Tobacco tax A'," .lt1·CD1' ')7 .t:1 ll"oahl\h ation, and prevention and A't lll\ 09f"l ,nC , control of Illicit tra de in tobacc Iii -,,flC "unt1JA IIA''I'} f , l'(l o products ,nt:D- fun '}-, .l" ·r 1/ Th e federal government organ respons h 11A O'J/1119 fm S 1:C ible ~·r 0(Jl•1Ja>- At; for initiating the c:ounlry's lax h.·l -l" k f '11.1.+1·0>- f ·rll "''l tr -IIT policy shall TC levy a tax on tobacco produc t•·>n·nn un i»t .•r 11-rr 'lt r rc ·l- "'· ~itti the World Health ts consistent ·hl ."T t -,-{JC fun")A ;:)I Organization \,,.,.,. hl\ ll•r • I Framework Convention on Tobacco Contro l which Ethiopia has "'ti JU flA~r> f•Nlm11> fun')-,.,.., .} "''A ll'MSI" 2/ The responsible spo . ficd. nsible government rm .,; .t:c ~• l- f(Jl''Jll)o'} A't >..•rr-A-1 sponsiblc government organ IJ1.1..4'1-a>- shall control f ·l-ll"'IJtr <ll1'1'C 1•10:1 illicit trade in tobacco 7f'J products in oawt.+, f ·H "IJtr ll"'Cf-:f• U1 ·rD 1' '}- ,f:" }', accordance with the Wo rld Health 11rD-ai-C") fou ~ 11JmC ;:)'I,.',•r hl\O•l- 11 Organization Framework Co nvention on h~ A ll.t:ll-l- Tob acc o Co ntrol which Ethiopia has ra1ifitd . 1r \~ ~0 ,~ I "71f'l.f 1 -,/1 PA RT S]X ,f-a,4!/1 TC''f""lf") A', ilZ:'>(lC -i n A'i hA h'l f'J LABELINC. PACKAGING. ADVERTISEMENT 1 PROMOTION. AND PROHIBI Jt. m~'l'I TIO NS

53. General It! mw h'P)!- ou 1»t. •l- <II TT C f"'1.1.t . m•l- 0 I/ Any product regulated ...,.> 'l; a>-'/" 'l"C ·l-:- proclamation: under this ll) llh"IIJO• f :Nf1 "t; 11•,- .,.~°7. "'li f'l, fm- a) shall be appropriately packed and contain t\Y, 1'1·L" ~·u-1: fl\l D' :• labeling on its primary packag ing; I\) "'11i'l.frD- 1"C·l•'J f"7 b) its packaging material f ,fl hA ', h"IIJ-fl shall not 1)1\a>- }ilJA fCD'IJrD-1 l.lJC contaminate the product and J'":t'II Ac; comply t wit'- standar d issued by the appropriate body;and Scanned with CamScanner and · c) its labeling shall not be misleading contain information that is inaccurate. 2/ The primary packaging of a pack ed food and ,m, nfl- l:f or cosmetic shall have a label in Amharic llh"7c:~ English language. The executive organ may by a directive determine labeling or requirement different from Amharic g. Eng'li.sh language, or the primary packag.in that is 1 3/ The insert iabeling of medicine e included in the national essential medicin l list or widely circulated in the market shal the be in Amharic and in English. If is intended distribution of the medicine l limited to one region, its insen labeling shal be, at least, in English and the regi on's f /"& . *')* J',lf'iA :i working language. ' this Cll" !ii fll,t l h ,_,.,_. 10-11-h .,_,.,_. (!:) 1:•1:,1, IL'i' 4/ Notwithstanding to sub-article (3) of J1>1\h•l- article, the executive organ by a directive shall hilLJl"'L hl11\, 11.11•':f· 9"C-f":f•'} fl"Y,t r untJ' determine different labcling requirement othe f·l'l lf f1".,_.. ,_,.,.-.: ooflLC·l- IJun medicine and medical d~ ices. Y.CDil'iA II use of ttf SI No person may import or place into F.! "71,..0J-SI" DDl:;)).•l- a,J', 9" f1JJl9"'i oo" any medicine or medical device unless its a,,_ ,nr . m-il1' f"t1'1CD- ,,,,..,. ll"7'}~o>-1"' . labe.lling contains a barcode. fur>l\f -11 1: 1'-H'° "" 11.a>-A f'"I. ":f•lla,, 11 9"Ah•l- f fll hlf) 111 )co- 6/ EVCTy manufacturer or importer shall provide fOl-ll·l- 'i,t "71 'rfm -r h'/°&.":f· a,r,'I° hfluoa.a. the labeling of its cosmetic when making •I: "f• ""'tnR-f:11 O"'Lfltm-:t-ll·l- ID:,,.-,. ll9"C notification to the executive organ. f"t 'i ~a,,') ""'i." ,_,.,.-.: 1 {11\llLJl"'L 1' 11\, "71\m:t- 1\{IR•l- 11 7/ The manufacturer or importer of a med icine '!,/ "7'),..a,-11" fOD.(°~\•'J- 1\9"&-'f IDf, 'r 1\(IDDal, in shall, affix the medicine · retail price, -1: ~\• '1 1 0, "" • h""'l'I\• o,..,-. ~ C ~~ 'I'-, f11J'1t•l1 ""1 flff Ethiopian currency, on its labelling befo re fm,.(";)\•I:'> f-i• ;, • placing the product on the market. l·l- II 1111·'1 09"C•IJ "71f'l.1 "" OD{ \,n~ hllf Scanned with CamScanner Ftdonl Ncpr11 Outn• No 39 ll._ Febnlary l019. ..Pl..ll 141 !4, Food peckaglng .nd lpbtllng .H. fll\ M-0 -,1'1.f'i 11\'l" 3:!t~ Iii 011.11 h<i:A >un.+11.e 1:, :n. f ·1'4'"" m- f11\"L• Wilhout prejudice to general ltbelina A'U-~ DD/1'-C.f".f· 1,1,:•t•mtl,fl lf)o>-:• provisions provided under this part: V) 11-,12,Ca►S"' f/11\01 S"'"/.fl "71''1,I l\f, a) Fortified food labeling shall contain f""lfl· OS"', 'Jf.~•l- '>'l'l·S"'•/-fl description about the type of micronutrient used to enrich the fOOd; >.,t.01\l\1 f"t1Al\' l\'Cl''i: ffio,.1 . b) Labcling, description, or advertisement of I\) IJ"7~1 119"/'11 l\f, f"'l.l.l."I 11\"1• K'1J,li:1 any food supplement shall not rCl)rescn1 _"11\"'i A'i 1111:J•mtl htr) fc'lcr>-') 1171:J• AtmMlcA• l\.,hr mr.r 11-,w, to be used in disease prevention, 1.,1.•'Y.d"A . r-,F,1Al\' UJf,S"" r,mf.'~).•H·l· 1rca1ment, or cure, or in any way characlcrize as a medicine; • 11116.f. 1.,'Ml\o► f'"I f,'1Al\', . c) A food containing genetically modified ,I,) (llll.-unA 9"tJ'}f.'ll'i f·l·llmm S"' MI 0 clement may only be placed on the market tnn f\"}"J.f: f"7.+cna► A'>t.;J·JS1 ll''i' if it is packaged and its ·label ~tains 11te 11\"1.• l\'&.4- ·nut.-ouA f•l'l\mm•, "flnt.- phrase "genetically modified" "genetically unA 9"tJ')1:ll'i f·l'llmm• f'"I.A a,f,S"" ,,. •i-)'l'l~ cm"l{\""i .flier► • modi.tied organism" or other comparable description. un) O•hQ.l.l. f?"?•fl "'TlitJ' l\f. flt. '11\"1.• d) Labeling of irradiated food shall contain ,J. l\'1M: hll'~ ·r•""'-'-'-" wvr ?"?II· the phrase "irradiated" or the Ohf>'> '-"16 "1.l.6- f:J·h°" 1mlf)- )0 ·' internationally accepted radura symbol , f""l.J'Dl>flh-l· .,-""'<l<lf. .+A. f·l'Y.lll·l· · • · indicating a food product has been tf'i O•h,1.l.t. 9""/fl 11\~ l\'1M: hm1fl irradiated with ionizing radiation may be 'M?" h+~ &D-:,O'i J'flo,, f"1.l.6- hC"'I placed besides the labeling. wvr 6-~6- rA.h·l- J'flo,, 1 ,..,) hh'>4il\A1 hwl·-l- rc-l-'i •l''l'i·1-, o/c'i e) If the food product contains milk and milk f'IUC ?"7flt ll'>Y.1 1fl/lt t.¥1\").1 hl~t products, fish and shellfish, wheat, barley, h•l'C 1.'i m,(IA, h11tic-l•1 ws>,r 1\.1\ peanuts, soybean,, and other food /l0>H•'} 11.J'llf,"1 wvr hflc)( allergenic . its labeling_ shall clearly 11..fllh-l·A h""l.;fA fll"?fl 'J.f,H• A'i describe its content. f.U') fsi9"/ofl 'Jf.H• A'},: ?fl'1-l· f"'l.tn+V- hll'~ ll?At> OV-"/11- 11\•1• l)IJ-~ ,,,. f•1''1M ODlf'} hfln-l• 11 Scanned with CamScanner --- : SS. Labeling of plcohol drinks I/ The label of every alcoholic drink prepared at , a factory level and provided for public use shall contain its alcoholic volume and a warning that. alcohol. _consumption may .,• • cause health ,probl_C!"~ \~ ~omen should not drink alco~?lic ..drink~ duri~g pregnancy • because of the risk of birth defect. ' . , r 2/ The label of .every alcoholic drink prepared at a , fact~ry level with a volume of less than J0"/4 . I I \ t • ~· ,. I , \ .. shall contain the product's expiration date. • ,,. • • ' UI ' i' ,\ • •\ ••. \ "' 'l,1 of , ' •"\ mrdicine apd .. ..

56. Packaging and labellng medical device . 0 ' 1111.11 h'i:A }un:J><\f, 1:");,1, f·l•-l>1n>m, , Without prejudice to general latielir4l provisions ~·1M: unllLC:.,.':f• A')~·f•,nlJ-1: tf~o,-:'- . , :-, ; provided under this part: , " , shall contain the phrase "for'medical use". •.• I !' 1 2/ •Where•the medicine or medical device is ~I -1::)).•I: llV-C9"CI (Df,V- ' ruhV-'i /l•l-ll"tJC:•l-t 1n>"tl,J'a>- /ltJhV-t; ~ .,,;.h'&- intendtd1 for. research,.:education, clinical . ·.•• tria!, o~ any ,other_comparable non-medical IJ)f.')9" llfl.4' 1,~'i a>-.,_. ntr~ ~,t-,11.:.-,. l~. ., • use, !a~ling shall contai!1 the purpose for f"'l.o>-A Inn ll/1"7.a>-AIJ·l- 'Jll"7 f"t'JA!r ~ich it is intended to be used. • j • • • .,,_•'•I ~ \. - .. \ .1<\"f.~ ~:o-,;: It.'iI.a>- f, 1'1A 11 I · ')/ The ' labeling of radiop~aceuticals and e1 ~I.C h'i:<\<l: . UD,t:':)).•l- A'i fllhll"'i I • , radiation emitting • medicaf' device shall UD"t(,J' f'"'l.ll +m-·t Q.1./.C fllll,1 ;1-ti"ta>'>'i ,, contain information sufficient for the patient ·f-m:J>-...,.a,-•t h"-"I.C oo,"Jfl'f' f"'lMhAfl·l- and , use!5 , to identify radiation protection llY.1 h"l'l◄l'l•l- ffl./lo>-1' ,J;m?+V- f"7'f'4-•l- method, ,inappropriate use, . and possible IIY. . A,~.,..,. IJUD"tl,J'6" •f-M 1.11. l\hl'l-ll I . risks associated wilh the installa;ion ~f the r"'I.':fll• . .' 1;1.:,r':f·'> llll_.,..,ll f"'l'fAI\' , . ~ product, as appropriate. ·~ ' .. ·' --- J Scanned with CamScanner 11t Ullrn 1-U,.A )-"'+-· ...... •~c ,11 flttt SI ~, Ill.II , .,. ftdffll Ntpril OoJ,nt No. 39 U' fabnwy 2019, . P'llfj l,o JI. r+,-111, rct rm.5 "tllm1.,.tt• l\ll-t'lflM S7. Tobl£CO produce, ht■lth ~,111~ A'i 11\~ ~o-~ PICk11ln1, 1nd l1be11n1 ~ Iii -,,,;,.,,.,- t •l-r'ltf rc:•l- tm-•L• "711'1.f I/ The packaalng ·of any tobacco product lhali hc'l.l.ll"l hl1t\, fl"tfOlnla>- ur,fl.l.C:·l- contain rotating health warnings and me..,•• ' --ii~ that are comprised of combined images llld ,,..,,,l.·l- >.'i fl'l,11. .,.,,..C t"'f..,.ffC; ftlL'i full-color pictures In accordance With -,(l,n')4',f:,r K'IM: >.'i '11\<1'11119 'l"flA requirements set by the executive organ. llh'>X- <\.f. -111 h/lO•l-11 Kl n,u, ".,.,.K. ')(),fl-h ')4'K' (Ii) or>tPl,•l- 2/ The health warnings and messages l'Cquiltd hc'ILll"t "'''"· t"'l.ltJJ''la>- -11'-c•l- rm.'i ln accordance with sub-article (I) or this "71'1,n'}-,.4:,ra,-') t\anhll·fl f"Y.11>-t\11>-'J (l:J• article shall be displayed on no less lhai, ... ,.£1J.rC ll·l-r'ltf '/"C•I: ta>--S.• "711'1,f 70% of the front and back side of each n>.r>-'1'1'5- fJ,•l- ,...,. r:\I\ 1K· hit um,-,. principal display area of its packaging and labeling, not counting the space taken up by ,rl\M (l;J• fif.l.} uotf') ht\ll•h 1 any border surrounding the health warning. et ll"'7"1~m-9" f•l-'J"IJII' '/"C•l- fa>-•L" "7117,.1' 3/ Any misleading statement or presentation on "'· ,..,..,.DD'I' K·1M: A'i ""'t-l.•11 rrc•lr'} the outside packaging and labeling of tobacco products with Ille likely effect IO IJU61 tn.'i ""· f"Y.lllh•l-t\m- -:r--,c, ,1--'l·r create an erroneous impression about the tJJf.'J" A.4>·1:'> fl"Y,ont\b·l- f·I•.-..-..,. .hl.-'1~ product's characteristics, health effects, 11"'1.L'l'C ur,')7.(- lllf.'I" h'JX- f•l-?"'111' hazards or emissions. or any expression or '• presentation purporting to signify one 9"C•l- ht\.'\ f·l-9"'11' 9"C•l- .fM -,.,1\,} tobacco product has lesser harm compared >.'1-'lt\o>- hX-C1 --,AK' f·,.ht\111\ ~,,,. .. to other tobacco product shall be prohibited. !I fl"'7'J'?o>-'/" f•l-9"'111' 9"C•l- '\f, h}(l,,.i,t 4/ Any tei:m, descriptor, trademark, figurative, ;J•C1 +-tA.1 fl"II"' +'\At 1'.hc'l·l-t-1 .hA·l-t- color, or other sign of any kind that direotlyor lllf.'I" ,,._,.,,.,,. h1'\Mtl•'> /loom.,.?" wf.'r ' indirecily creates or i; likely to create the false impression that a particular tobacco product is f')?X- 9"'Ah·l-')1 P'l>A ')1 +t\9"1 J.r,V" 1\,1\ ,,.uu,.,,.,f. OD'}'J.(-') flonm+ir' f·l-9"'111 ' less harmful than others, including the tenns "low tar", "light", "ultra light", or "mild", rc-1: .f}i'I .,,-'l·l- >.'>-'It\• n+T:J·r 1:,,.., "e,ctra", and "ultra" and- similar terms or n,,.,,.,.,.t ...,.,t\x· r•,.ht\ht\ }.,,., , expressions shall be prohibited._

58. Advertising and promotion • Iii n,u, h'I'~ DDIP/.·l- <ll'l''l'C f"Y.~t.·lll·l- I/ The, content _of every advertisement and "7'}','lo>-9" re,.,. "'lll:J·m-1:.r · mf.'I" , pro!"otion of a _r:egulated product shall not TC''l"'if') h"'7ll''h·l- f"Y:Mt\tj: uot.Jf be false and mi~leading, be appropriate and ·l-hht\,;'1 J'A•,..1'11 •Mfl. >.'i l'l}-r-,IJc'} ethical, and ·comply with requirements of rmn+ ll''i n,w ,..,,~ >.c, h?IJ-0 'l't:fm- this proclamation and other applicable Jaws. 1'1.A•'f U1:f· f·,.+-m- -l'ILC-,.'f") "?hflC: ht\fl•l-11 Scanned with CamScanner 20 J9. .... ... lfU I .- No J921"-Fe" -'Y F...._. Ntpnl G sement media and adverti 2/ Every mass ply ve the duty to com disseminator shall ha with ued in accordance with a directive iss this proclamation. tor vertisement dissemina 3{ The advertiser and ad bje cl is uct, and if the su of any regulated prod rso n butor or another pe promotion, lhe distri y distribution of an who caused the es promotional mate rials wl\icb includ otion ag en t, device prom medicine and medical ibil ities d several rcspons shall have joint an this compliance with with regard to er applicable laws. proclamation and oth through ay not be advertised 41 Infant fonnula m any advertisement • •dissemination mea ns g on the product. except for the labelin g an d iu l device advertisin !Iii. 1111 -1:;,,t~ ,,,,.,. llf lt1 hr r; -••U,f 59. Medici ne an d prom otio n m ed TC'1"7f, under a '711:tarl;,f A'i' exceptions defined I/ Unless su bj ca to it 'dl~ the executive organ, Iii IJAf. 11-1:J• l\.•M directive issued by IJunq t, tJ' h"'I.OlM0>- advertise any med icine A/11.Jl"t Allfl. shall be illegal to "'ll'lt.OOi ment '1 0"7 fl:J•tJJ-1:J' ns of advertise 0/1•,-.,.C ..,.,.(- ;)) . ·l- through a mea ,:,. f·N11\11fl ~a,,11 dissemination. ua'11/l.':t• '7 /l·t-'l'a ion made rtisement or promot U? • 21 Any direct adve flm.'i 'I ll - I M f1 A t" 'I. h professional shall be Kl '7 '1'1 t1 1-r in-person to a healt .Jl"t vice l,f-'l'a,:,. ~P t,. t"tll'ia,)a,, 011111 through a medici ne or medical de f. .,f fl m • ,- ~ :, t.·1' m f. r promotei- who is duly authoriztd by the 11•111, 1.:1>,: O·t- · c; D D "l tl 1" C'1"7f, 01l1A 11 -, tf fH executive organ. f d it ,r -a, ;)t.•l )tD -11 - ,,, ,.. ,. ' fl lh r' i - " lt l OttL',' 3/ Unless it falls un gift or giving as der the maximum all defined by a dire owable ctive l~I OD.(- , it "1"•l - 11-,,:1.-, /l m 'i t this proclamation \ 'I ll - I ,_ -, 1, ~H · TC issued to implemen 't li l to otra- or give, di rectly tD - 04 >1 ':'''1° ,- ., ., O•N W f' t t1 shall be prohibited 'l fl -l or t, ~ / 1 f •t-114- J> A dif_ ;,- ,..,,, or indirectly, any financial, in-kind J•i nal to a health professio . (l( Jl; O" T,a>"I - - t l OD IP (.• l- comparable benefit -,111 .,..,. alth "" ~ 11 promotion to he liffl:J' -m , 0111, a,J'.r in reslation to h "t l. + 1 : f' ff .) •l- professionals. -n m •l - -,,r"",,- 'f f,) •l- 11.-, 1 'W •.,. ,.,.hflhfl )a,,, , a,1,r ,v,..11m·l- "",....,.., Scanned with CamScanner - tt !lilllUI 4U-A i_,t+ -"'"' •-re i i rti~ tri ♦'t lrt.U .,_,- Fedrrol Neprii 0.-. No 39l&.. Febnllly2019. . Ptll111J 2 4/ It shall be Illegal to advertise medicine 'lid of flm.'i -~.,·l- f"'l~l.'1- f"".('~t ·l- 1JJf.'I" 0 medical de~ices or promote within health ruhr'i UD"ftJ' -,11;J·m-l!J' h1M J'IU· fJ\l'l'-ll"'t. J\111\,1 mf,'18 fh/.\"· m.'i institution unless the appropriate e,t......., -...,v, organ grants pennisslon to the .,-,r.niniu,-1 .(.:1-.(' 'IJ'1~ -,11,,-.,•m:J, u,f,'I" advertisement. • ·rC:'l"·l- -,1:1.•1 r-t·h"h" ~111-11

60. Akohollc drink 1dvertislng and oromol!!n ~- fhAl>A DDtnT {)".,iltt'CD~ h'i' TC''f"-l- 0 il/1.., f; l.., Iii "71'lfco-'I" fJ\/.\1 1/.\ ""IO'l' .,fl:hD<l:.1' I/ Any advertisement o~ an _alcoholic product h.('"'1.J'TII>' htili ')tlD•} 11:J•':f· tun, (tp•':f· shall contain a warning. as appropriate in writing or sound, that it Is illegal to sell it to ,m'IS'J' A1~11.1111·} n-,il:hn+.f(l)o 'If, a person under the age of 18. ll'P-/.\11 ll·N''- ~-.,.'I: mf,?"' h'H~h•/'111• fl.('r~· uo111~· hMl·l- 11 !U "7°}'tf11>-'J?"' fJ\Al•A onm'J' 11111MI 2/ It shall be prohibited to directly or indirectly ua(l,(ll'tlt.f''i ""1/.\1.1' fl:J•1 llil;rc:•l- advertise alcoholic drinks in places of public -,11111-•l-tJ't fl}',,n,&-, 1~'," ,\.(',I (l;J(r gathering and sportina: street. condominium uoc;tf o.-,.-:r. h'i' flll.l\•1· fl;J•J1>1· 1111,11 and other places'by unreasonably decreasing .. h'l'~ '"''"l.·l- f"?.mf:i»'l ftn.'i the size of the warning. "'film ·1+-1:1 11+'1':J·r .r.,v, i1•Ml'l''I't 11"7'1~11 "7il·t-'l'w:i» hAhA ~m-, 1 !~/ "7'~7,lm-r fhAl•A J'.IMJ h:i. o""-,. lll\f, 3/ Any manufacturer, importer or distributor ;f r,n hAl 1A hV-6-1·1 1111-cu. 11,r.r alcoholic drinks whose volume is more than l'lh4-4-f. f011fl'i r-1-,,,..,_ ll't'l·l- A'i' IO¾ shall not directly 'or indirectly sponsor fl-11"'1 1 r·1-,,: •l-c•t:t-1 r11;,-c,.-,. public and government holiday, exhibition. •J:J:c1, f·l-V"IIC·l- O,•} 11?~•}'} A'i' ft.I\•°:(· m''l:t- f"7.'l•f+fl·l-·J h-~·l- ll+'l':J·'I"' sports event, school event and other related If} fl·Nl'PoJt 117'.}(IC "7J:t.•J youth-centered events. ' ~/ fl"71'11f)o?" }\J',1•/.\?"11 fhAl•A 'l"'C·l- flflC'J:111'1·} 41 advertising any alcoholic drink through board h"7li~}·l- "711·,..,m:,O f•Mlllhll. ~111-11 J',~J hAh'I Is prohibited. This restriction shall be applicable on any direct or indirect -,·1,;tm-1r fhAl•A rc•l- filt-'JJ: ilri hc:-,1 r·)?J::' 'l"'Ah•l-1 fJ:C~•l- hC"7t r·,:,,: unflf . advertisement that connects a brand name.. . . al emblem • trademark, 1ogo, orgamzauon wvr 11.4' .,.J'J''ir unl\f1 fhAl•A Y"C:•l- embalm, or any other distinctive feature of '1Atr~ 1\.1\•1· v-c,r.-:r-, wvr J\1A ?l\•.,.1•1 alcohol Prod.uct with non-alcoholic • ·1-P,1'-':f· .'JC fl"7 J'J'11 wf.'r flll.'1 oo•>,,: -1:c; 1 .-,. products, services, or matters h'JP,'l=t:a>- 11"7.J'tii. :"111:J•a,+,f 'IJ'. ·1·4.'1"7. J',IT'i'A1 I • • Scanned with CamScanner r F<denl Ntp,. G-.. No. 39 21• f cbn,a,y 2Gl9. .papJ 11'3 5/ It shall be prohibited to advertise alcoholic drink by associating it with any lottery system or through billboard. Details shall be determined by regulation or directive issued to implement this proclamalion. 6/ Additional restriction regarding the time, place, and manner of alcohol advertisement and promotion may be determined by a regulation issued to implement this proclamation. s&. r+rrur re+ , "l/l:J.a,:,., Te1"-l - A'i" 6 I. Tob1« 9 produd s advertising, promotion, ft?"">llC -,,:1.- , Iii , ..,., h'l'~ t'\"7/lL JI,,. fl"7.CD'IJ UDtm{,J' and sponsorship . I/ Unless it is legitimate expression as defined uni.,,(. •rt•t-L•I:,. ant.Jt l1Atr) 1111·1·.,.c. by a directive issued to implement this ..,.,,,.(I)<·,,,. f•l-Y"'ltf ,,.,:-1-·, ""'"':J''I° If) proclamation, all direct or indirect tobacco · n•t-ll'f'P6 "lll·t-'fm~1 'l'r.''l°•r mvr prodllCIS advertising. promoti on or 117..tllC: "71:t.•J f •t-ht'\ht\ tm-11 sponsorship shall be prohibit!'(!. !U fll.U h')-,.t.• ')tHl·h'J-,.t.• (Ii) hm?•\J', 2/ Without prejudice to sub-article (1) of this article, no peison may h1"f\t .• A11.•t-mll+ lf'i· ll) -,•)','(l)<')Y" f•l-9'.''ltf '/°C.•l- -,11,M'cJJ-l-1 a) initiate any tobacco products promotion, or ,·r.-'l°•r .,1:1.-, "'"',. nr,flr.71'.,. advertising. sponsorship; "7~•'1'1~' b) produce, publish, distribute, or make I\) f •l-9"'1Jtf') Y"C:•l-' ) I\.J'll•~o,-:,. Ill/,,,. accessible any tobacco products 1'C''l°•l- l\.f f _.., A · ,.r,-, .,...·~, )1C') advertising. promotion, or ""''"'ll >'Y" un·nt: -,.,-r, "7/j•t-9"t sponsorship content; or ,,. ,. .,_7f "7 f: (.-, I . ,(I(,,"-&,·l- ,,, f,,,. ,..,. ,-,ft;N D4:f• ,•i:-,,-·l- "71:t.7.I A'i f{t;r')f lC:i'l'; t' CID1A1.f') "7/j•t-9"' (DJ',,,. c) engage or participate in any tobacco •t-1.lr'lf "71:l.'I• A'i ,,. l►H· tiaw1':f•1 :"9'4! products advertising, promotion, or ,h) A,,_-t-tJ' a, f. ,,,,,,,. . . I\.'\ •t-1'1:J•,l,1 "7'1 'i't»-9"' sponsorship as media or event (la,, ·organizer, celebrity or other ,flclr: 1' tun;J• .,--,.qf, "'",,. f{t;," ftlf.J'UO:rf• f.1\1\ participant. as a recipient of any "').\'1 <Jf,)•11') (11":J' ~ sponsorship contribution, or as an n-,,r"",,. t ·r'l°'llf re• intermediary that facilitates any such n-" ' •re.,.·l- -,,:1.-, "''·,,. = contribution. 'ffl;}•tJ J4!f' .,,,lj,,-~ , ,r-hl\hl\ )0>-11 11r,flcif.•1· "" Scanned with CamScanner tt nun, 1JJ.A t.N+ .,.,.. ttc •• t1tt-t u ♦, ru• ,_ ,. r, o'fc~ ~.fl- o,,11,. -l-r'lir --t-,. 3/ Toblc:co products in retail ,bops lhalJ be a,r,,- -1.c1.c /t\O-r 1f"7'1i o+T:1" OAJI: plKCd behind or under die COU111er so 11111 t\./)t1a,, a,r,,- O'fr,'t- t\.-Mt•hP- any customer may not directly grasp or let the product. 0"7.r.':r•AO-l- o-~;J• -ir, 11110-r• • II. hAho\~l- 62. Pro bi bltlons 011.0 11'1'~ A'i 01\.t\•l· ·1-L'I-T.H• '111:fa,, Without pn!judlc:e to other prohibitions defined o-tl· _,,,l-l- r•r-+-m- hAh'l?'l· >.11.•l-mO<fl under this proclamation and other &pprorxiae tr)a,, A'>1. A'7'111- Mh•l-t\••l- •M'lt-·l- laws, the following acts are prohibited: r•t-11t\l1tl• 'i:fa>-11 lit -ft'M'C 1'-Ul'70:J-'> rc•l- -11M11 I/ The doing of any act ~ilich causes 1 rM•l-'IOt'7 1-1:1\•r 111.IS.'l'la>- '71:l'7• regulated product to be adu~ Ar1-flfl• -flt-·l- A'i 1.aa,-, atVr misbranded, counterfeited. and substandazd; -nLC•fJ'} l''Tf"lo\ A'>.IS.tr'} '71:l'7• I/ Ofla,, m.'i o\r, ,-,v,- f"t/1.Cfl 'lllJ!' )1C 2/ poisoning I food by mixing any substance that is deleterious to human health; o-+'l+A r-7,0'} --l'll• r, r-r-hM11 1.a1 ""1~11 rtr), 11n-nfl• 3/ The trading of or provision to the public of l'•N\t-'} A'i l'hll•l-'IOt'7 '1-1:tl·l- J't\O•l-'} any adulterated, sub-standard, .misbnnded, V-C•l- 1'71: a,,fl1' 'TM'l·l- atVI" and counterfeit prod~ 0"7')','a,-,- DD'}1f: 111-0l•h'til h1A'7fl•·l- ).').IS,a,,A '71:l'71 §1 r.,-hfll'l1 1.l,t) l''Tl~o\1 hfloaflfl• 4/ The receipt to trade a regulated prochK:t that f·Nl&-11 rhflT1f1f'7 1-1:tl ·l- I 1111-l-'> is adulterated, sub-standard, -mislnnded, rc:i- '>'71: o,,11,. A"Tfl111+ -+nA, counterfeit, and the delivery or proff'eRd delivery thereof for pay or otherwise; ~ '7&-1~ air,r 11"7&-1~ aa+OA I ~I 011.11 h'I'~ """'l-1- f""f.1.l'71 •1'1'C A'i 51 The refusal or obstruction of inspection and .,-I' J''ir r•1'1'C P'&- MLo\'J.a,,'} .)-{l{IC related activities as authorized under this hfl-,1:l'7• "71.'i+~ aif,,- f\')(l.,-i,t -.Ml proclamation; It fODf::)1•1- A'i l'uh,-r; -"U,J' ·1-1+<1.4-il 61 Mobile sale of medicines and medical ill~ 'Ttitt:-1 1.'i devices; and . '!.I f.U'}'} h'P~ A'i" h'PJf.'} l\"7flL,_,- f-T.e11m- 71 Conducting trade in regulated products in

1.'}fl':f'· '}1 --611'':f'-1 e11r.r 11.fl•l· contravention to regulations, directives or U't':f'-'} (IOD"J{I "11''1'C ,.,_,.l'7'1:fa,-'} otber laws issued to implement this rc+l- ,.,1: .,tiix- e11f.r a-,,i,ca,-9'" nrnrl•--·= r • -"' -•i.a,uOI\. -111: t\h1A '7fl-·l- -,:»,t{I f·l-htlht\ )a,-1 Scanned with CamScanner , -- I I

63. Power and nsp onslhil itln I an or regional An inspector of the executive org health regulator, subject to the responsibilities of the agency whe power and re he works, I I shall have the power and duties to: ' 1/ enter, during working hours, in institution which holds any regulate · and conduct investigation and any licensed d product order its d product to I temporary clo,urc; orde r " ttgulate be kept separately until laborato ry result is r !he storage • known; to detain and scile, or orde ration of, any product or without removal or alte . another thing related to the product; re the regulated 2/ lfth e institution or place whe by the product is held is not registered regulator, executive organ or regional health take legal enter with a court order and measures; r means of 3/ 10 stop any vehicle or othe tran spo rt in which -the insp ector knows It products, carries non-complying regulated of the and open, search, take sample uct: product, and detain or se[ze the prod 0 raw materials • 41 inspect regulated products and at ports of.entry and exist; l measures. SI enter, inspect and take lega licensed without court order, into a rs and any institution during its off work hou products other place if it held a regulated ' . rcAson to which the inspector has sufficient lth and believe that it endangers public hea likely to the product or o.ther evidence is d. and disappear, · be altered. or co =lc oflaw; notify such action to a nearby court - - -- -- - - Scanned with CamScanner -- • ,..,_, N,p,11 0 . - !lo. Jt 21• Ft"'-lft hit . - • . ·......11,11 'l,t tl1-at1' rr.•l-'> """'11: cr>-!I.A a1r.r 6/ to examine, open, or res• 1 fl,a>-A l'.':f•'tA ◄JI\• f"")fl,}-') rrt:,.,. equipment, roots. materials. or an~ lnspectot reasonably believes Is IISed .. .,.,.(.:1 Ut>"f/,J'I ,ft4'4?1) rJJJ.'•'/9 .,')',fa,,').,. capable of being used ror llllclt trade bi " ·1--4'4'.r. )1C r--r.-r.1 r,mt,L•l- A'i reaulated producr; " fonL•l-7f • 7/ to examine and make copies or or floni '!,/ ,-h'>J':J•f! lllf) ,,-i:J• 11.'J'f:)•l-'> l'l.,l..''11' II) documenrs, nores, files, lncludlna e l ~ f"'I.J'lll·A rmt.JI' fl.J.',11 J.')f•IIA -f•fl• files, or other records the • ~ J'on)ll·l-'> ,ft'f''f't: fl"Y,J:l.-,ll·l- -1-,t,- reasonably believes mlaflt COlllala a>-ll'I' J'l'l•·l-'> · ..,,i:rm-r l'l)P.l·• informallon relevant to detcnniaiia .,n:J·m'/f1"1·1 J:t.fl'lfl·• on111fll·1 compliance wilh the law: tab lllftples er "-11.h•l-r.-th ,,.,,nfll·'> aiY.r /1.l'l•l· component of a product, m ~ ,,., ••.,....,-., &.1.1.,-c- r,,.,,.,c,,.,<: A'i t•·1: . pholographs, and video of a ~ ,.,,:1.-,, 'i-'i a,f,r r,-<:•/1") J.',ll•l-1 product; AIL·l- funa,,flf:• f~-f'?&-'i: a,J.',r ii.~I" ,-nA tM 11"'1.L:,.J:a,, h-,IJ◄I 1m11>t.•l- f tmO,,(I.(" I tl ·MtA!l.At 11'711-flA •l-flC:;t:A.1 11'1-cJJ'l' ~m- 8/ to order laboratory examination through the a,f,,- 1'11 ◄11.•h'III- ,n.<; hJ:'1,;r ~a,, executive organ or regional hcallfl·reaui- fl.J'llilA f"Y.l·A h4'.,~ 114! rh'>.l'•l- of any product the inspector reasonably 1\'ir. .,'),;ta,,'),- ,-c•l- llhhL.ll"'la> hftA u,r,,- fhAl'I, ,n.<; •1-.J"l"lt M◄•&--ft believes might be adulterated, eounlerfcit, .,.r.-&- .,f:l.'? hllL't'l. (\,If") rc-&-m- noncompliant or olflerwisc dangerous IO "')-'!,l1Y.X-fl-l• f.,1111 A'i' A'l-'!-11 'tr.H1') public health and, until the laboratory resut rc:t- M◄l&--r-t O>IIL~ AnlL;J•a,:,. f:t.11 is known, quarantine such i ~ fot a r,1n1 h1'~ 1'1.,IILP,,- ll"'I.OJ''1 J:'l◄I period of time as defined by regulllion -•Pt.•l- 1'1•1-a,fl) 1.1&. A'l-'!..r11 a,r,r A')-'!.;}--,,: ,.,,,,, I issued to implement this proclamation; P.I -l:1'1'C f"Ul.-,IJ:fcr>- ,-r,-,.":(, fh'JA-,fl••l- 9/ inspect the proper disposal of rqulaled '1.1&..f:fa,, 1\.1'11~ OJVI" IIIW h'I'~ products when they expire or when they an t UDIP{.•l- .,...,..,. 'tJ', f'7J',a,,(\,• lf)a,, ,\ 'Jr confinncd to be unfit for 11$C in accordanCC M-,1111- ""C11'1-'l:f11>-•1 h'?IJ◄I t1f1a,. 11.'t with this proclamation; and r-·1.,.,....,- hf1A :,c fUD.f"JmC, A'i' II •h1"'llf '"J&.1.1.II OlVI° -m+r fl·l-hl'lhl'lll•l- 10/ to enter any time in any public plac:e where l\lJ1111 h'i::t- lllf) '"J'lr.'11>-9" fl;J• tobacco smoking or use is prohibited. -' 11'"7'>'i'a>9" fl't·l- ftm'?IJ•l-t 11.,... &- fl;J• A'i' during working hour in · any ~ 11011◄1 DD:}:}"lf" A'i' 111\./\•l· fl;J•sr>l· IIJ'»&- public conveyance and other places where l'l'J:t- foa-,IJ•l-1 ,,,,,,,,,crmc A'i' IJ.'J'f! tobacco smoking and use is prohibited Ac.,,r r-11>-flX-11 conduct inspections and take legal measure- Scanned with CamScanner

64. RNpon~lbllltl~ or ln,ptclO!l Every inspector: I/ before conducting any inspection activity, shall present his identification card or credential, and introduce his identity and organization, the reason for the visit and legal power to enter and inspect regulated products and institutions. t 2/ shall recognize, co11ect and present admissible evidence including sample, measurement, a copy of a document, photograph, video recording and a copy of records to support an appropriate legal measure on the institution. 31 shall, while exercising his powers and responsibilities, take due care to act within , the legal limit, in accordance with applicable laws and codes of ethics, and in a reasonable manner to achieve the purpose of this proclamation. 41 sha11 report to the executive organ or regional Q/ fh'l'~'}'i fi.l\•l- f"7fll.O"'l.f 11H···~ health regulator any non-compliance known on"Jft') 1'1..fa>-:,, A'>~h '71111· l\hl'll.l\"'L· to him with this proclamation and other laws hlll\• tDY.'1° l\hAA 11\.'i .,-.r,i,j,qto,- t,?'C•l- f"71:l..'7 "IY.:J• hl\Cl•l-11 • .' issued to implement the proclamation. 51 shall respect orders , fromI higher official and g/ rl •l-;,•l-1 f);J•"71~•l-t fl'l''J.4'4: A'i fl•l-:fll discharge responsibilities ~th the necessary 'i!'l'~:r,. pt-a>-'> uol,.09° A'i f(lllf, 11111.') ' care, diligence. honesty, and timeliness. ·h)1111 (1"7t,IIC fOP/'l~·l- "IJ!.:J• hl\tl•r• I 6/ sha11 maintain the confidentiality of every 'ii (lp,t-a>- rti1.r:r- r"'Ll'l'fa>-'J ..,.,~a>-'>r information and document he gets due to his uot._'lf tD f, ,;a (I~,: fl"'Lfl'l'C f ::'?111:J- responsibility. · '?Y.:J• hl\fl.'h I 7/ sha11 observe new work procedure that is 'j,/ hfll.l\"'L hltl\• wf.'/" fhAA m.'i' adopted by the executive organ or regional .,-.r,,q1qt,a>- 1111"1 f•l'l\lllll>''l 11111,H· fM•:Fll health regulator and Intended to implement ·,. ,n~, 1,•t-4.:f·A fl"'Lf""'IJcP- its power and responsibilities efficiently. 'i!'l'h' UD4P .,., ._,1\-4.l'I fhl\6-C l"C'J-f:f•'J •t·4'11J',H' fl\tr" n tt,{Jfl- f t/D'-09'° '7/.;J' 1,1\fl,l•ll . . Scanned with CamScanner r fo4ffll NfJlrit 0ucnt No. J92a• Fctini.,y 2019....pepll Ill · PARTEIGHT hi,~- t'1~1t ADMINISTRATIVE MEASURE ANJ! ill\ Ail:t'l'lt.t 11Cd''\ fa,'>JA .f-"lt PENALTY g~. l\n.,.-'l1.t-t 11c,-x 6S. Admlnlstrallve measure, Iii -tr1'1'C f"T.1.l"'lfl-l• rc·l- a,f,9" rr1n11 I/ Where a regulated product or a holder or , 1 rnhc ml.,.·'1-• r"1:l'·l- "'1l:n"l rntll: certificate of registration, certiflcate of ml-,.·'1- mJ'.'r I\.'\ L:J'f: f Ill fla>- .r.1rn competence or other license Is found In h.,,~ mvr ,..,., ·, h.,,1: I\..,n,.,..,. any way to be in violation of this f"T.mm- 11.11•1· 1111·'> 'l'i' h•Mi· flhil'-'l"Y. proclamation or other applicable laws, the hl11\, a,J',V- RhAA ITL'i' •l·,f,"l"ll,o>- fill.II executive organ or regional health regulator shall take, depending on the h -,-,.,.. .l"C f•r-,flll~•·l- hil·l'.ll 1.t-'P. severity of the non-compliance, one or 'AC9"'1fP'l· f,(ll(lf:11:J·A,, more of the admi~istrative measuru defined under this article. Ill ..,,,..,,,.r flcn- r,un h'f''J': mf.r h'f'11'.1 2/ A warning letter may be issued to any l\"7flL1.9"' fm"I') II.I\ u-, [\uo'f.untJ' 1.11. person who unintentionally violates the 1Jt11(11 fll-, UD•Mftf•') f .<,1,uo,n, If') ilft• provision of this proclamation or other Jaw issued to implement this proclamation for l1Atf) A'i" fl(la,, ITL'i"l hltA mf,'r l!f,111•'1- the first time, and the ' non-compliance I\J', 9"'111" 1--'l·l- f J'l\flh•l•ft htr> does not cause any harm to human health, fl"7flm"J.,-4!f 1."1'111. il.:J•fl'i: J',l•I\A,, f . body, or life. Cl "11'1'C f"U~l"'lfl•l- "'1'Jt;:a,,r flo>- f .<,1,ona,, ., 31 If the non-compliance committed by any fll"I UD•l'I\I\~ flflo>- ITL'i'l • hl1A a,f,9" regulated person would cause minor harm, IIJ',a,•l- I\J', il.filh·l-A f"'l.':f·l\a>- 1--'l•l-. f,11'1 h'f'~ il"?il.C.1.11" ll"'l.Ol"I uounl,f ~l»l•'l- as defined by a directive to implement this h}il•l't;: f"'l.'IA htr> fil.4'·l- "7l·.-,.,~ proclamation, its registration cenificate, fll"ilhc a,1.,-,.,1, a,f,9" fll"C·l'. fll"11'1'1 certificate of competence, or other license S"'llhc a,t.,-,1, a,J'.r 1\.1\ rilhc a,t.,.·l- may be suspended, and it may be revoked "" fA'I~ Acri il.CDflf: f"'l.l·A tf'i flfla,, if the violation would cause major harm to l\f, h'i:,r,s;: flTL'i' CDf,9" fhl1A ':f·"IC a,J',9" 'l"·l- f"'l.J'ilh·l-A htr> fil.4'·l- "7l.'J'l""i human health, body,or life., rrilhc a,t.,.,1, ml.'.<r rrc•l- rr1n11 rilhc ml4'•1: il.fll11 J',1•1\A It .. • I • '· l • 9.1 -ll1'1'C f"Y.1.l"lfl·l- 9"C·l- ·1'4'.'l"YJ·l- 4/ Where any regulat~~ product is suspected 11\r-a,,•J f"11'1'C uoilLC,f,':f• i\.'l'il f"Y.':f-A :ro violate applicable requirements and ilftuotf"), rtOJ':J·'P. 'l'C"I&. 11/1 IIV-C•/: there exist a reasonable ground to doubt 'i'-'i' I\Y, Milt-,f,t rcuot- a,J',9" 1\.1\ the non-compliance, it may be detained rc-t- 1'illL'1i1: X-lil il.J>11 ,.':f-1\A " · until laboratory or other examination is I p.rfonned on the sample• Scanned with CamScanner ed pr od uc t is coofinned SI Where any !TgUlat rtgUlatOI}' to violate applicable , as appropriate, req uirements it may be or di sposed or seized. confiscated, try of origin at thc returned to its coun owner's cost. this to sub-article (S ) of 6/ Notwithstanding pr od uc t in appropriate ar ticle, the ddained at owner's circumstances, may be time if relabcling. cxpen.sc until such ilar other corrective rcpaclcaging. or sim ce the pr od lld in measures would pla proclamation. compliance with this product is in 7/ Where a regubted e cable laws and, the us e:ontravcntion of appli duct will hllj·e advcnc or exposure to this pro ath or would result in de health cooscqucnces n shall be ~ to the responsible perso products and to recall their marketed tnl>ution. t immediately cease dis , ,'f•1jA11 I A11{.J',f>Y" t\.:1'1111 1Tg1Jlated product tha t is 8/ The import of a f"7.1'1 1'1 'C . f"'1.l.l.?11• l- OJI. '11<: a>-111' found to be freqll ffltly non-complying t l 4: tl~ •l- ~ m f.Y " l\. h• 'f h'7'1- or ochcr applicable Y"C.·} J', tJ ')' ) h 'I' with this proclamation ,-1..?;,..,. 1'/\ I\ -n rr .•i: ' laws may be tempo rarily or permanently .fi \:f m -') u'>l· 11, 'f1<: ll•l'OJIU 1.1, m l. barred. 11111\<t;J·m- t,f ,Y " due .1."I f.° f•lj/i\ 1 1 criminally convicted a>/11' A')~Y,1'1 t\.1 j 9/ When a person is in tly related to works • flJ f.Y " fh A A tn.'i" to ac t that is direc this 'l" t hl lll • services unde r II! h llL 'I- 4:'M'C r.gulated products or f'~ _ ,.,~- ,,-,,.,q,qtm, fill.II h' an or executive org ,-,r, proclamation, th e t1"7~1."lll·l- rc .•l - a, r, r h1 A ?h •·l - regional health regula tor may debar such .1: 11,•l- '1 .f•l- 11~:r 11-,.,,;1, ll "t 1'i"~ p t- rh Ila>- 1'4-•r-i:= person from engaging in such works. 1' "-•,-","H, r -r-t.:n m 1 p t- "" 111:.7"7. h tl•,.' l/l tl•l- r c •l- gan anil regional healt 11 I 0/ The executive or 1, "f ljA ce with a regulation A ')~ f, llt - t\. f "I I: "'1.tD"l ,.1.,,n regulator, in accordao ..: 11 "7fl'-,.,- 11.,. uo,,, •.,. x, ,.,n, ., nt this proclanwion or A,,.,<;.- issued to impleme I\. '\ h"IIJ-(1 111 \0J' tn.'i" ,r fh A A , may take a civil tJJJ',Y- hf lL 'l" f. "' '"· ,.::~1.t-'t :1: f '}t f,( J :,.1 1. cr K ;, c 11 ,}- j (t.1'A o~ er appropriate law ...Y. or tog penalty lndependch.~ etlier with ,,- ,f" l"l ta >- fll l,/ j . 1 .·, another administratm , measure. a,J1,V- ll•K m A · J1,°:f•i\l\. I I Scanned with CamScanner r ., Fednal N-•, 0 - - No, 39 21._ Fal,nwy 2019,. ....... IIIO I ~6.Comp 1• 1nton •dmlnlstntlve measure 11 A complaint . handling organ shall be established by the executive organ Or regional health regulator to handle complaints when a regulated PC'l'Son Who believes that any administrative measllrt that was taken on its product, institution o, itself, or the denial o( a legitimate SCrvict under this proclamation inappropriate, not proponional or illegal. JI -,-,7:"a,,y- :,.1.;1• h:,.t-lL fllW n ...,.,.,.. 2/ The complainant shall have the right to be on•,,t.•l- O"'l.itit-a,, r:,.1.;1• 1'1"7. "'''A heard by the complaint handling or&an r-1'1-,·l- tJDofl•l- f/1111- IT'i :J.t..;J•tr1-') establ.ishcd in accordance with this article, rlA·o•t~ ti.1+c-a1 "lflt.R f&.l<l'l:•111 and may lodge a written compl11in1, proffer evidence, respond to answer, and request f onA{l onA{l 11.1'11' A'i f a>-•U ',l>~ copy of decision. 11.m.f.,l> f',l·'IA 11 r., Oll1J "'"'"' tJDIPt,•l- f"7.+C:•fl :,.1.;1• J/ Any complaint to be made in accordance with fhll.C.,r"'t hfi/1, a,f,'r 11.hAA tlL'i this anicle shall be lodged within 30 working •1-.f"J"Jl,(D, f pt- Y~•}- :)J\I, fOD"-t{.?i° days fr om the date of final decision by the process owner of the executive organ or 0>-•U, hr1mrl·l- a,1,,r Cll-'°11'.a>- /lhflL7"7. regional health regulator or from the dale of

111.'i ·1-.f11J 11J4 frl'IY. "''": ID/.','r fhA/1, confinnation of the decision by the higher :)'Id, +ell ho~+IH· ,.,.., :l!rC' 0~ f ~"t- official of !he executive organ or regional +,;=,. a,,{11 on:)i-t,,fl hl\O•l- 11 If',•,:, fll'l.f. :)'\La>- n~ r Pt- +'i·l- CJJ:'°llr. J'Al'lm 1111' 1 .. health regulator. The complaint, however, may ' be directly brought before the complaint · O+'f':J• l\:,.t..;1- l'l°'I. hf11\, on:)i-t,,n . handling organ, if the higher official of the /!,l--tA, t executive organ or regional health regulator doesn't decide it within S working days. !/ a,u, h1+t. 10-fl•h1+t. (Ii) tJDtut,-}, :,.1.:J•') 4/ The complaint handling organ that received r++al\ r:,.1.;1• l'l"'l "'•A :,.1.;1•0,-•1 a complaint in accordance with subarticle h•1-+flAO-l· 4'') 'J!V"C: 'll\,-l• ?; f Pt- +'i•l· (I) of this article shall render its decision •fl-r •'Ill on/lm·l· .f".'iCll:J·A, • within 60 working · days from the date it [;/ OILIJ ,..,.,.,.. UPIP(.,.,. fJil-t.;J• ""'- hltA receives a complete complaint f"7.fl1' fODl,Q,t,,i' ID-'°llr, 'IJ.', h'7'1-fl W.111\a,, SI A final decision rendered by the complaint 'i!C:J': fL·l- .f."l'llf l\.'IAll·l- f,l•'IA 11 handling orgln in accordance with this article may be appealed to the appropriate cout. oflaw. Scanned with CamScanner , ,..J' •d IJ.#. t.-,,.+ ~"' • 'l'f: tli I I ,:--:~:;:------..::..__' !11.IIJ;f- •¼+ lrJ ♦l llr,If ...ll J. :r.--:- ' l', - - - -----~:;:edn-al::;~N~epn1= '·" F ·:Gucllo:~No=-~J9~1=1•~-f•:bnlM)'::~I0:19~..~--P':P:l~l 6:I_ fiI ""I'>\"D'l-9" c"lm- <f:1'1'C f"'I 1. 67. Penalty o...._ • t.·JO•l-"J v-c:,.._ 1.lJl°(I)-') J'Am11.,. w,., , r ,/ Any person who, by sub-standardizing,

1.')Jl'a•t.m- 0"71:t. • J'fl.,.l'f'li? .,.X°l\•l- . misbranding. or counterfeiting a regulated -, mr.,-. flt11>flt-•l- J'unt.,,., m1. • 1\(1,m(I{\• product, manufactures, . import, store. 1h""l:fI 11~9"1\ II ,1 lht: 11),{l'l' J'fl1•1t wholesale or sell it in retail; or provide or fif,n fllf,9" O"'l')l'I t,-.t,i\ CDf,•ta .,- Hl·r.~r.- distribute for use by the public shall be I ffl-$"" 111>')11: 1\1-:tlt.·h'dl· flh1A '?l\••l- ,..,.~ punishable by simple imprisonment for not n, A')~r'lt.-i.• exceeding three years and a fine not ~11.tf'I hV'/l•l- . 'Jun.._ •r 11-, o rl• f l.t.1 exceeding Birr two hundred thousand. If the Mlt-·l- "'i h◄lr.• .,. .._ ,m,r. ,., ''-l\ ·r _ _,.,... f,-,.")Aa .1'9"C:•I: f'l.t.)I' ii' AT +'IA • 11-,J',IIA'l' product's defect would cause grave harm to 1 1-iA•'I- human health or life, he shall be punishable rlr'lm- tll.'i (Df,S"" .,,_ o .._ by imprisonmen1,not exceeding seven vears ...,,-,m•r 'IJ', h'l:.,-i;: .,.-'l·r , AJ'ilh·l-A f"'l.l·A 'Sf.',,.._ and a fine not exceeding Birr five hundred ' .,.. 1111' 1 lu'l'l·r •t,m•l- fl"'lf,flAT 6't- Afl-' .,_ thousand . .,..,. Ac; h-llC' h?"fl·l- unf. i'I'. 11-,J',fll\ 'l' ,,,,.,. .., • ' J:',.,."Ii:'< ' ' ~/ llllll h').,_,_. ')1'rfl-h't+1.· .(Ii) O•M/\~cr,, 2/ If, due to the action described 'Under sub- 1:r.1.-l- rh·t.r+:- article (I) of this article, 11) fh'lm- "''A IIIJ',?" m.'i' I\J'• .,.-'1 ·l- f~l.c'I a) harm is caused on the body or health of any person, he shall be punishable by A'}1.tf'I ~"M: hc't'l·r ')on•l- Aflh imprisonment from seven years to fifteen ,..,,.,t- h'l"fl•l- ')on•l- l\"). All&-·r A'i' h-flr. '/ J' 11'. hflh ◄IC V'fl·r m,,f 11' . years, and a fine from Birr twenty thousand to Birr three hundred thousand. or,.,.,.. f,tf'iAII b) any person died, he shall be punishable by I\) Oi'la,, l\f, 'f"•}, J'flh-1•1\ A'Jl.tl'~ hhP'C ,--r Anh '/, ,_.,. ,..). imprisonment from 1en years to twenty years, and a fine from Birr thirty Aflt-•l- A'i' h-Or. Mte 11'. Aflh -nc thousand to Birr four hundred thousand. ht-·l- _.,. 11'. _.,.,... J'.lf'iAII 3/ If the person commits the crime described I~/ llllll h'>+t.• 'JO-fl h'>4'1l' (Ii) A'i' (!() under sub-article (I) and (2) of this article f •Ml\1.IP- co'JJ!A r,,.,L1,0DIP' ti:fA·l'~~-'1- negligently, he shaH be punished by A'Jl.tf'I ~"'·•= Aflh v-t1·r 1-·r r"'t~cn imprisonment for not exceeding three years +'lA >.flt--l- A'i Atlh -flC '/,-ti 11'. and with fine not exceeding Birr fifty f"tl.Cfl _.,.,... f.tf'i'A II thousand. 4/ Ariy person who, without a registration, §I ill\ '1'71." L~f: >.'i' ,-11111 111\.1\ 11"1 marketing authorization, certificate of f•l'l.~1111> A'Jl.•l:tnfl_,.. lf'j -,-,i;c,,,.,- l\o,, competence or other authorization as 011,U h'l'~ A'i' f,tn'J h'l'~ fl"Tlll.r.r required under this pt'OClamation and other ft"'ta>"l 11"1 .,,,wl;r• ,-111111 f1'1f l.ft'l:1 - Scanned with CamScanner Fecknl Ncpril Quell• No 39 21• hbnu,y 2019 1't 'Ill' !/ill.US~ '-u.A t-"+ ~"' •-Pc <Iii rlJ-t·'I- lrf ♦l Ill.Iii ,.r 11111,1 law issued to Implement this procl ~• r-n:N· -,1.:,1~ rr11tu: 1J1t..,,·l· 1111.r 11.'I or using a falsified document, manuf~- IOQ, L?I: .-,,1~ 111f,Y- tUl·l·t;'I 1UI: IJun'l/.\'1/.\ . -•urcs, ,flffC f"Y.1.l.?11·1·1 rc:·l· yun/.•l· u,vr import, store, wholesale or sale it in 'Clail· a,,: 1nc: a>-ll1' ,rll11'11 Yh'"7'1:1 11~?"'1 or provide or distribute for use by the Ptibr • fl•"Lfl 011.r nl·<::fc-: ri'fm IJIJ.','I" shall have its product confiscated and ~ • 11"71'i'a>-II" ,mnl: fl1-fll.•1'1'1II· f\h'l/.\ "lfl•·l- punishable by imprisonment from three J'o/'l.111 A"}~(lt-•1• f1.l.'l 1'')1.lf'I -liTTC: years to five years and with a fine frotn f""f.1./.'7-fH• rc:•1· ,ma,-1.fl A'tl.·1-tnll-,, tf'i Birr five thousand to Birr one h d Un fed hYll·l · 'J,m•l· hflh h'l"fl·l· 'J,m•l· 11"'1.1.C:fl thousand. If the crime provided under SUb- Aflt-·l · A'i h-flC: h<rfl·l· 7i. Allh -Ill: h 'H': anicle (I) and (2) of this an· I . ICC IS _.,. i'i. 11"1.1.Cfl ,n,.,,,... J',-l• 1A 11 f-fl•.P•l· 11 committed without a certificate or "71.:n""l frllh<: u,t..,,·l· '°lf.'iC: a1f.'I" competence or using a falsified dOCurnent l11H·t;'I (I'll: 11""'1/.\'JA -1:TTC f"Y.1.l."/11-l• 'J the penalty of this article shall be ¥"C·l· Olltl h'H•t.· 'Jh.fl h't-,,t.· (Ii) A'i (m additionally applicable. f ·tm.,.l'la>-"} ·1·'7'1C: Lt.·.,. I\11 fltll ·n,.r, ,..,.,,,.. ;i,,I),}• 0 •1·1.t-ll~·l· ·l·t.it•'Y. J',tf'iA.1 I f;! "7'J'1m-'l° (ta,- 1111.U h'I',: A'i' Y.11'}'1 5/ Any person who has a registration certificate marketing authorization, . certificate of . h1',: ll"7ll'-1.'1° fl"'I.ID"I .,., ODIP/.•} "11'TC fl"U~l.?IH· 'rC·} IH•ooflh·t- competence or• other license under this J'1't"a,-'} f'/°1l1'11 f10.f' '-:J>Y:i f11:J>·} proclamation and other law issued to "71.:)'l"'i f'l°l'lhC ID/..,,•} ID/,'/° "'" implement this 'proclamation and transfers '-:J'Y: llv>fl·t-'1 ID'l't hfl·MAf.: fl'tm the same to a third person, or anyone who IDf,'/° A'III.IJ'} l't'IF-1• {loo-t>flA oo-f)•} received such document illegitimately shall be punishable by imprisonment from one llf.<,•t.a,- r-,..-,.flll'i' f •f-1/l'lllfl•} A'}~lf'I year to five years and with a fine from Birr hA1Y.- '-Joo•~ Aflh h'J"l'l·} 'i®•} l\'). ten thousand to Birr one hundred thousand. Ailt.·} A'i h-OC hP'C if, Aflh -<IC h 1 ,r.- ""-,. i'I'. O"'l~C{) --,,,.... ,.,,.,.,,,A 11 'i,/ "'l'J'1m-'l° l'tm- ""·" h'I',: ODl.b/,.,}, ftn.'i' .,.-,.,,,,,,t f•t-l'tmm-'} l'IA«l'}t; •r-OJ()C 6/ Any perso~ who, in any way, prevents c< impedes the WQrk of inspector as assigned A')~.f.'-1.':r' ll"?Y.-l.•1 0"71'1-fl fl;)Y.A~ under this proclamation, or in any way 011.r lllJ','/° ~ fl"71i:'a>-'/° OD')1Y;- fhMtll 1 .obstruct inspectors from getting evidence or "7111.)f ID.f,'l° 'iao.'j' A')~o ..,.._ ....w...... .f'~/.11 ' hide or conceal such evidence from "7111.Jf .f'm ,t. A1.tlm-t. .f'J'..I. 1 • a,/.'.'I" inspectors, give false statement or ?"Coot, ll"?~'i'+~: tll't•r-'1 °?hi..,.. docum ents d unng · their work, or attempts to " a, y.,,.. 00 o.-.-. • , • 1.)f Ooortm•} ~,:•·· 1 "}~If', t·,~.,,-:. . do th e preceding acts shall be punishable 11•),:J• hh1Y: '-Jun,}- Arth h'J"l'l•l- '-Jun,} with imprisonment Iirom one year to ti\'C years. If it causes hann to .the person, body• Scanned with CamScanner pector assigned under or possession of an ins who is on duly shall this proclamation and sonment from three be punishable by impri years lo fiflttn years. al sales medicine, medic 7/ Any person who cts without having device or related produ ation, or causes the the necessary qualific of such product by sale or offer for sale ll be punishable from unqualified person sha ars and a fine from three years 10 seven ye Birr one hundred Birr ten thousand to thousand. ibes, sales, dispenses, 81 Any person who prescr thout prescription or r.wn h'l''J: fl..,,,,_,.,;- or gives medicine wi ;!JI .r.,n h' i'J : A'i prescription in unauthorized /l<mJlt.C r-,11-ir (11/.-,.,}- with ll"'/.(11''1 11? clamation and other •L· ni n contrnention lo this pro mJ'.'I" h•l·J..<l'f.tD- tD- nt this proclamation la"!s issued to impleme f" 7l l'l f wt.+•} un Je-'ft·l- f1fm1 ffl m 1 imprisonrrcnt from sha ll be punishable by •1,::tD -'r fltD- IIJt ·1, : , and with fine fro m J' f.11 a> J'.'r J'111/ -, one year 10 five years ll ,..). '}m >•}- Allh hV "ll•l- '}tJD,} - tl"T.f.C Birr five tho usa nd to Bi rr fifty thousand. ll· l- If. Allh •or. All&-·} A' i hi lC hr 91 Any inspector wh o, in relation 10 his '/¥"It if. 11"'1.f.C:ll uo.,.,..,J'."'''lA " authority under this pro clamation, h·t-C IIIW 1''1''/: h·M mtD- 10 report substantive ill "7'1'/;<1>'r h.'1f1•1.· a) intentionally fails ction findings lo facts, evidence, or inspe fl A "n 'i ·l· ?' IC .w: tH ·J'J'I/:• regional health tJJJ',¥" fhAl1- IIL'i the executive Ofl!3ll or IJ) l\{IJ..11,•'Y,tD- "' 'A ult, a person's .,. ,,, ,,, "'" r1 .c r·l - 1. r.r Jf uo tD -fl f: regulator, and as a res r.1 uot.X aiJ',9'" rmed, shall be f"'U'fl':flla>-'} ~: t, ~1 health or body is ha n,MILa>- '1.11 "7 /lt .Jf tf'1 -Ofl• punishable with imprison ment from one "" "'" ,..,,..m-;r. a, r, r 11r,flT n- :,. 1.-1: . 7-.ll•l- ft. t.f l year to three years and with a fine. >ifiA tJJJ'.'1° 11L'i 'If inspection findings to l,h '}f : '}U D• } Afltl Y'fl·l- b) ma de false rep ort A'}f.tf~ regional health 11"'1.f.CII ,..). Afl&-•l- A' i the executive organ or '}u o•} - e the appropriate regulator, or did not tak (luo_,.,.., J'.+"IA • • mstance that measure in a circu f1J..ll,"'/.a>- /\f/A II) ,h fl, J•<t;f t,; rC •l- ll1' guarantees adminis1111tiv c measure, or .,..,.ITJIIU, ,,. ,.t .ll• r measure 1ha1 is a, r,' r /111AII· IIL 'i' unjustifiably took a mino ·t-'7'1C 'IJ'.J..1t.'V" the magnitude of the uoJ..,.,,_ f"'l..1'111>'-, llO I proportional 10 IL11>' 11->,;J· punishable with f-,.t. A'}f .tf t tJJJ'.¥'° ll•M noncomplillllCC shall be .-7 "'" 'lf .1D llf : f-,.t. A-,,_in, ar 10 three year "r imprisonment from one ye tD f,'/ " n , I Y'fl·l- 'J- ·l- 111 ' '1Y: '}< JD • l- ,., . , _j Scanned with CamScanner .. .. F«lml N•J•ric Ou•n• No. 39 21._ Ftbnl,ny 2019•.. P•III I J6l and with line from Birr live tho11••- O"tl.CII •Ml\ >.11&-·l- >.'i' h-OC. --•d to Birr twenty thousand; hV"ll·l- 1t >.1'111 -tlC. 'IJ' if, fl"tl.CII m) fllW 11►1'1 h1+1.' ·I-&- l,l.l\ (II) >.'i' c) where the crime defined under th·i SSub. (ft) r•MMICD- 1:c:1.·l- n:f-A•tr.«)·l- article (a) and (b) is com , lllltled f•tl.1.0D t11f) hll.t:ll·l- CJIC >.llh negligently, it shall be punish~bl e by imprisonment from six months to one year. J',.,,IIJl\ 11 on) ftn.'i' •l·.f,''l"IW flll,11 ')0·11 h1•1'1.' d) where the inspector under (a) and (b) of (II) A'i' (I\) f•Ml\1.CD-1 1:C?:I:"} this sub article commits the crime With r.t.1.on1P- lit-"- mvr ll1\.1\ r'IIP' the intention to benefit himself or 1':,,Y'° l\"71111"·l- fl"7r'l1l >.11.lf) another person, the appropriate anti- h-, '11U ·l- .rI\ CD- f,,... ll'i' fJl '})! A corruption provision shall be .t:'),'.>7. ,,.J.ll"t J.'.lf'i'A II applicable . II hr-,-t1 :,c .,,1'.,-i;: -,•>"f.H· J'l\1.1>- '"t-•1•i;: I0/ Any person who contravenes the fm.'i' 9"Con&- 1t.r1.c•1 >.'i' ftn.'i' f9"ilhC: provision that requires health ml+·l- ltJ','i l1.1>- f1P&- A11.lf) mY,9" examination and health certificate of ftn.'i' '/°Coo&- J'l\l.l1 A'i' ftn.'i' '!°llhc. employees having direct contact with wl-,.·l- fl\.l\o>-') w&-,,-~ hr•111 ;,c: food preparation shall be punishable by imprisonment not less three months t1'·l-i;: :"11°1-)•l- '11\m- o-t;J• A')-".l\&- and with a fine from Birr twenty J'T..l1 "7'}?;=m-9" r'lm- hY'll·l- CJJC: 11"7J")II thousand to Birr fifty thousand. . +'IA All&-•}, A'i' h1lC: 'IJ if. >.llh 1lC '/9"'1 if. f"tl.Cil on+,.., f,4' 1'1A 11 !/ii "71i;:1.1>-9" l\a>- -ll1'1'C f"Y.l.l-,fl·} 11/ Any regulated person who, directly or oo.(-~).-},i fllh9"'i' DD"t/,J' A'i' .,-yJ'"ir indirectly, give, offer to give, or promise rc•l- fltn.'i' flfloo-JJPl· A')-'t;J•1111 ,""7.t:l-, mf.9" 9"C•I,'} ll"711·l-'l'OJ:,, lltn. 'i' any financial, in-kind, or any gift to any 'lfloo-J' O-l>-r;J·9" f.tJ-'} fl·l-ll'l''l't f11ll1h health professional with the intent to mJ.W" "71'/;a>-V" '}f.)·1- ll(ll;J• fl\m cause the health professional to prescribe mf,9" J'4'llh mf.9" flm,llm·} mf,V" medicine, medical device, or related ll"'l:,,l-tl :l'A f1'1· A11.lf) hY'll·} '}m,,}, product shall be punishable with Allh r'lfl•}, '}cm•} fl"tl.Cll 1.'). -,..,..,t-:r, A'i' hoflC: h.,._.,C if. Ar'lh -OC 11-fl•}, cm,f, imprisonment from three years to seven if. fl"T.I.Cll _.,.""' ,.,,.,."IA 11 years and a fine from Birr ten thousand to Birr two hundred thousand. J.P.! "7'}?jfo>-9" l\o>- n,w h'I'~ A'i' h'l')l:'J 12/ Any person who condu~ mobile sale of ll"'IIIL'AV- f"t(Jl"Jo>-'} 11'1 fltm•l-l\ll~ medicine, medical devices, or related Scanned with CamScanner I.U-11 t .:>,I+ ·"'-"I .,.ct!ij ''•·t+ If tmX:; )\•h .,1 If +l 111', U , ... r ut111•r, ~ •1•1-,,1).,J,'/f • =~N .,,,,., •;~~~~:-r.....•:dml t,y >.,; ·l·J.' .l'°lfr :::Gumt :tpn1 =~N =~2: U:••~r:•brwl :•~l~ y 01:9_.:"":..•~11~~:s- Y"C·,• contravention this to " i'i.r-i.• J.'I products in hh1X. - n""•l • 1-ifll1 h119{l ,) , 'J IY.t, 1-.")t.tr ) proclamation or other laws issued to -,. 'IA >..-"t-·l· >.,; 1111c; """C- if·l· ll'"U.c:fl implement this proclamation shall be h '}~ 111>f. 1i, ll"Y.t.c:{l ,,.,.,.,••.' • 1-iflh •fie punishable with imprisonment from one J:',.,.,,./:'\I I year to five years and a fine from Birr ten .' thousand to Birr one hundred thousand. 13/ Any person who, with the intent to materially profit himself or another person, gives or cause another person to give blood shall be punishable by simple imprisonment not exceeding three years and with a fine not exceeding Birr fifty thousand. If the person commits this act as his daily engag~ment and benefit out of other peoples need, shall be punishable by imprisonment from three years to ten years, and with a fine from Birr ten thousand to Birr on~ hundred thousand. !'.!ii 1.'/° A'i f 1.Y" •l•Cf't.•'- 11"71\IJ(MI ·l-•11JC: 14/ Any person who violates the provision 'If. f·l-1'1"7&- "71l'i'a>SI" l\a> •r-4-~"T.H· regarding blood and blood products and sub-standardizes the collection, testing, '1'1:fm- fcf:1'1'C un/14.Cf.':f• ODll>l,•r l.'r IJl\tmMll\11·1 processing. screening, pooling and A'i . f 1.'/° •1-'l't.''-a>') irradiation of blood and blood products '11\ununC:un<,1 '11\"74''i'll<•1 1111-1\MII shall be punishable with imprisonment 'll\"79'1J~1 111\"7~t.<-1 '11\CIDh"7:f•lt not exceeding one year and a fine from lllf.Y" i\.'I •l-=1\1\f. .,--,qc IJl\"7h'i'CJJ'l- Birr twenty thousand to fifty thousand. (11.Y" A'i fll.'/° .,..,.,..,_,,,. ft.t.11 ?-1:l\•l- A'J"-'i'l.o>- fl.l.1 A'tl.tr~ llh1X" ')uu•l- fl"7f.flA1' 1\1..,&-•r 'A'i h-flC 'If ii'. >.flh -flC 'IV-I\ if, 11"'1.1.C(I on+,.., f,4'11JA" ISI Any person who in violation of this f X/ ..,.,.,,m-r (lo>- , .,,., h'I'~ fluu•M M: ,,,..,_.. f ihhSl"'i' proclamation, conduct clinical trial .. " without being authorized by the hhfll. 'l''7. h 111\· 7'0,-:,,'i' • f ihhl"''i' c,o,h6-a>- J executive organ; perfonn any activity -h&- flt'/,/ . I I 16- •re,fl•A o,f,9" CJJl°I'> beyond the scope of the clinical trial h•l-l.4'1./l•l- r- "t A f'lflf protocol; use invcstigational medicine or ere 'JI\., r "" ftJhSl"'i' m-'"L~ f(l~I Ill"' 'medical device without authorization by t:Pt• r a,f,r .(.:f>t: f 1\,/IP ") uo 7'0,-:,,'i' ,,,..,_.. the executive organ; or give <11>"ttf"> l1hfl4-~"'L ttlil\· Scanned with CamScanner j Fed<ral Ncprit G....,. No )9 28• F,b<wty 2019. Pla<II l61, unauthorized financial, in-kin,d or other comparable gifts to any (Person 10 participate in the _clinical stu,dy shall be punishable with imprisonment from one yeat to ten years and a fine from Birr twenty thousand_to Birr one hundred thousand. 16/ Any manufacturer, importer, exporter, or .i:'!d -,1 71m:,y- fl"'111'1 Sl"flh<: u,t..,,·} - wholesaler with a registration certificate, f·Nltnm- funf:;)l•} hl"'t,.l·s hfluntJ.J.1 with the exception of a person having 'II~ (JJJ',l"' ~l"''I i'i•L• h"l'1-fl IJllm- fh'}f: one-time purchase permit, that sells .,.,,. -,">fr J.:J'f: llfl·I·.,,<: fil:l'·"l- "7t.:n ..J. medicine to unlicensed pe.rson shall be l"'llht; mt.4'·'1- 1111.110>- ilm- ,mf:;)t•'l- punishable with rigorous imprisonment from five years to seven years and a 111ttn hhSl"fl·l- 'Jon•l- Aflh fl'l·l- 'Jm••l· fine from Birr five thousand to Birr one fl"'l.f.Cfl ,>). 1,.,»t,.•l- J.<i hilC: '/l"'ti If. hundred thousand. J.flh •IIC: 111>,f if, 11"'1,f.C:ll un•N~• ,.,,.,.,qA I 17/ Any person who fails to report to the l'!,! llhhL'l"'I. ,.,,.... mvr fl>IAA 111.'i' executive organ or regional health ·t•,f,11/•'lta>- 1111"7 f"Y.tnf,}, f.rmf:;)l•l•'h regulator any adverse event caused by fllhSl"S' OD"fl,f1 Wf.SI" ft\.'! V"C•l·1 1~ medicine, medical devise, or other product f 'lot 1.J'm4' a,f.'r "7a,lJ, AJ'flO•l· t,;rc•l• as required under the law; fails to make /'lf.t.11 . t\.'I IH·wl't)- ·1,11.f•l· f"tf.t.•n periodic report; or falsify, conceal, t:rc+ J''lf.l.11 flll't·t·~ 1,;rr.•l· 11.t.11 deceive, or perform related activities in the ff.'14'• 1-£-nt.nt. wvr uul'tA - •1·'7'1&.•l··, report shall be punishable with simple nt:rc-l· .,.,, rLl\DD A11.tr) IIY'fl•l· me: imprisonment with not less t:han three n-,11i'I 4''1A A.»>t,:,. ",: h-tle: >tP.C 71'. months and a fine from Birr ten thousand to Birr fifty thousand. Aflt1 ilC 'll"'ti if. 0"'1.f.Cfl un,N,. J',+'f//.\ 1 18/ Any person w~vcnes the provisions ltl .f.01 h'l'~ /loo•Mll<t: f"7fl:J·m4!J'• of this proclamation ~egarding prohibitlon fTt!''l"7f1 mvr f(l7..MCI\'.T tmflLC:-f:Y··, or limitations on .advertising, promotion, f-l•ooflh•lz 1:1;.,7,p,:y.•, f''lil "7')'i"ID'Y" (1(1)- and sponsorship . activities sha.11 be hY'fl·l· aic O"'IJ"M -l''IA 1,.,»t,.•l· J.<i hilC: punishable by imprisonment for not less M" if. Al'lh -OC >.11: un,r. it, ll"'l.1.Cfl than three months and a fine from Birr ,_,.,.. .J'.4'"1A i th irty th0usand to Birr one hundred thousand. 19/ Any person who prepares, publishes, Xf!I flll.lJ h"I'~ Ar; f,IJ11 NI',:. ll"?fll.'A'l° . transmits, o r ·in any way participates in (1"7. fJJ"l IJ'7 ODIJ.Il, ,.,. "7fl '1-'l'(JJ:,. I 1'C' 'I°,.,. illegal or unauthorized advertisement Scanned with CamScanner , tobacco products in 20/ Any person who sell tobaa:o prohibited places where smoke, use,or sell is prohibited shall punishable with simple be eending six imprisonment not exc eeding Birr months and a fine not exc who smokes five thousand. Any person in prohibited or use tobacco products e with a ftne ~laces shall be punishabl usand. not exceeding Birr one tho ., sale alcohol in 21/ Any person who punishable prohibited places shall be not less than with simple imprisonment exceeding six months or a fine not Birr five thousand . r of public places, 22/ Any person in charge workplaces, and conveyances who post the "n<>- violated the requirement to with its smoking" notice along ed to take the corresponding sign, or fail smoking or required measures when lation of the tobacco use occurred in vio law shall be punishable with imprisonment not less tha n three months e thousand to and with fine from Birr on Birr ten thousand. Scanned with CamScanner - 111' U 'lf.'1 Kt ~ t.>'+ ,,_. , .,,c itll rtii:-'1- trl Fcdcnl t,1, prit Gou n• No, 39 21._ F, bNl, y 2019,.,,P lloll +l llf.l l 't,,- 161 1)/,1/ ,,,,,"fa,-<r ita,- r •l•hl\111\ 23/ Any person, who manufactures, J',1/•l · J'I\IJJ"") irnl>Ons -l·9"'ltf' a>f.9" n,n a>1' ua nt: r1' ' wholesale, distributes, stores, or in l, <rC·l ·• • lily 7Pf a>J',<r r~l \.h •N :'th tl•· way sales tobacco product with prohibite t:' unf l"'i d _.. ,1,y , a>J',<r "-" 111\.?t,- :,c: ·l•o ingredient. any tobacco product whic n•VIY. h is rtf''t 1\tl•·t:' illicit, shisha. or electronic ni•~ a,,( l""if"'f.J'11\? A M: 11•,I\•)( •· rc- l· .r-t .·I· • a>'- (}1C a>-fl1' J'M 'l 1 deli very system or other related ci&a rcuc ""'"" y h-t.'-fl• J'h -,:r: a>J',<r f ff,n A,, _.,. resemb ling technology product shal , IIY'fl•l· l be a>C Aflh V-fl-l• 'l-·l· 11"7. '-C punishable by simple imprisonment fl Aflt,-•l· A'i frorn hilC h, 1: lf. Allh 11-1\ ·l· three months to three years, and a un+ lf. •ill: fine from Birr one thousand to two hund red thousand. /'.!ii f-l·<r'llf rc·l·, a>Y .r r>.Al•A ou, 24/ Any person, who sells, furnishe n-r·, ?iii s, or in •J-·l· ,,A 'l"<l a>- (ta, , 1'71,n I A'),t,n., anyways gives tobacco product a>f .'/'" fil, n o-, ,r,f l .,,~arr .?'" J' 1.1.1 (la, , hv' fl•l· a,,: alcoholic product to a person under the or age Aflt-·l· a>J','I'" hil t: h ')1: if. 'hfl ll of 21 shall be punishabl.e by impriso nment -OC · Y'fl-l• if, 11"7.'-Cfl un. ,.,.. for not less than three months, or by Y."'"IA 11 a fine from Birr one thousan d to three thousand t.' f. I "7 '>'1CD-'/'" . f ·l-?'"'ltr 9"C ·l- h?'" t,-":j,1 25/ Any tobacco man ufacturer, importer, hf1 uu~. a,J'. ?'" hhf .f.J '. 1111,11 h'I '~ A'i wholesaler, or distributor who viol ates h'r ~') i\"7llL1.9" 11"'1.fll'IJ ,. , ., UDll'/. •l· the provisions req uiri ng disc losure of f•l- "li\ tl·l- 1 f ·l-?'"'ltr ?'"C·l- J'.ll •l-'J A'i tobacc o product content, furnishing of ·l·.f.f'f r unl .Jf' ) J'.4- related in formation to the executi f"7 Y:l . / 1 0 ve llhl lL'l "'I. CD- hl1A c\mf->- fuo organ, and the provision which rest llm ·l- A'i ricts ' "IA ? A')~J'. 1'1 f ·f-<ll\L A'Jl:.tr~ hh'1Y: 'Jou•} f ·f-'IJI\O •l-1 ?J!.:J· tobacco industry inte rferences shal l be Allh Y'/l•l· punishable with imprisonment from 'Jou •} 11"'1.1.C/I +<lA A/1?-• one year to three years, and fine r 2''i h-flC not '/9"fa 11'. 0"7 f')f l OD.,.,... J>,4•tl)t,. II less than Birr fifty thousand. 'Ii'!.! OII.U h'l4'1.' ,1»C f•,-unllh•I: Y:C 'l:f' :f· 261 When any crime define d under this f ;,.- , llm-~ •r O·f-l'lmm- 1:C ~·l- f ·,-L1.un proclamation is com mitted by a legal c\tf') 111~?'1-flH: 1:C ~·I: A1. ent ity. the court ma r as approp -;.;J•1Y:1 riate, A'l"-11:> a,y .r A1.-:.Lc/l ·l·t.U."7t may order the clos ure, suspension ,)111,r , or l\ai/1') ,::r•<lA 11 dissolving of the entity. Scanned with CamScanner F<4<n1 N• sa,;,. Oaun.c No 39 21• f.tbruary 2019. pa~II 169 PART NINE MISCELLANEOUS 68 · Ha nd · · hng and disposal of produds 1/ The handling of any regulated product under this proclamation and lhat is expired, unusable, or unfit for use for any reason shall not be in a manner that could contaminate other products. 21 Any product that is segregaled in accordance with sub-article {I) ?f this article shall be disposed with due care to the health of human, animal and the environment, and the _cost shall be covered by its owner or another wJW" ·rhAA 111.c. _.,• .,,,,1,,,t appropriate person. 3/ The executive organ or regional health onu•t.•} l'lfl•f•a>11, 9"C·} regulator, upon request by the appropriate fl"'I.UD ii h·l•ffl- "''1A ll.mr-l> person, shall give the necessary infonnation y.(1111 A .: , regarding produ':ts ~isposed of in Sf!. aot.1f {l(\aof1f accordance with this provision. ft! fllLtJ h'P~ ODIi>~•.,. 'l:'J''J'C f"Y,1,t.•lfl·} 69. lnform atio~ handling 1/ Every manufacturer, importer, distributor, or 9"C·} 1'9"t-':'f•1 hflooQ.l..1 M,~.,S.f. :fc1t retailer of a regulated , product under this ,,, f, 9" hilUD al. 1:C ]!,•} 9"C·I: t\ ,m(A;li'f proclamation shall have a system that enables to ,,.m:J'"'l.a>- >illh"'l.i.Cll 1:t.l'I ft\a>-1 show the .condition and ' process of its filC~·} o-t;J· >i'i 'li.·l- il.fflf, tl"'i.1·A .. distribution chain u~tfl it reaches the end O-t;J• ootJt (loof11 f"'i.fl11•&\ fhilt-C consumer. ,1»C'J·l- .,...,'lt-'f "71: l..., ht\fl .'h I J./ "J')~a>-9" fllLU h'l'J!- nowt.•l· -ll'J''J'C 2/ Every manufacturer, importer, or distributor ofa f"ti.l."/0:J· rc:J· h9"t-':f•i hiltftJ"-l.' IDY.9" regulated product under this proclamation shall hh"-<S-~l ,:c~:J· llll"'i.f""C•hJH , ~ have the responsibility to handle, report. and furnish, upon request, to the executive organ or regional health regulator any information regarding the quality, safety, ~ffectiveness of the product, and other i:etated matters. Scanned with CamScanner

70. Rep ul and ln1 ppl lnb le laws I/ With respect to matters provided for by this Proclamation, Proclamation No. 661/2009 •,.7f,!;:A 11 is hereby repealed . !!.I rh.,.J': .,:1'C: ?:l!ll/111.lt!i }\').,.,.. ;C(? 2/ Article 8(5) of Proclamation No. 7S9 ;) n,w /2012 is ""' ~ .,.7ft::A 11 here by repealed. Cl fllLU h'f' ~ h·,.l.~11- 1-'l f-l• ,'.JC: 3/ No law, regulation. directive or V"'l. :"C ) practice shall ..,,~111-11" tJ?I A.. ,1: a>f.'/D in so far as it is inconsistent with this hflt-C: .,.t.,"7.H· hf.'il.CD-11"1 I proclamation, be applicable with resp ect to matters provided for by this proclamatio n. if/i. .J.'H J'i --1,n . flft-To,."1-l- 71. Pow er to lss1 e implementing law s Iii ,.. ,,, ""' ~ t\"7 ilt., .,,. f"Y.)./l•l-C!' J/ The Council of Ministers may issu e regulations :f· rh c n.-l- 1.1-11 fl.J'm"I ,::t•'IA necessary for the implementation - 11 Proclamation. of lhis ,., hil4 '.'l"' l. """ · IIILU h'f' ~ 1.'i n,w 2/ The executive organ may issu e directives "',. ,.,.. ')O-il-h,.,., .. (!'i) ODIJl{.•l- necessary for the implementation of this t\"'l.lD"l J. ')-fl "7(14'.""'/.J' ODU r>l, f proclamation and · regulations issued I\.J'a>"l f.l• 'IA 11 pursuant to sub-article (I) of this Arti cle. C:f. llt\- t'IQ l. IIA "11 AS: -M9t-+

72. Tra nsf erre d pow er and mp ons lbll itla Iii t\Af. ftn. 'i ·t-lt"7-l- ffl:J>-l• "Tl..?1" 1/ Regulatory functions under Article '1 ll"ll hc s 3(2) (c), . CDl..,.·l· DD/lm-l·'> 1.'i ou.f,11JmC')1 f"T t,-rf . ftn. 'i IJt\.,.,.J'P'l·"J 0000 nn-t anm 'J 3(2) (e), 4(2), 4(16), 46 and 47 of Proc No. 661/2009 which deals with registra lamation 111-11 A'i tion and f-. J' ffl:J>-l- "7t..'..11"'1 9"/ licensing of insufficiently availab lhc a,t.+•l· le health DDiltn-l-') 1,'}~IJ-9" ill\ 'IU'l'J!i professionals, the issuance of a cert .,.,_ ;,;,, , ificate of CDl,'r h., t-'l " fUh ?"'i 'It\ - J' t.:J> ¥: A'i competence and regulation of spec ial health h1A?c\--l• OD/1""1 fl;J• f"'I.ODflh·t-m - fh'l 'J': institution, and professional and prem ise license <f:TC ll8 1il litf h1+1t r.(l) (,lt) i r.(f) (w) i for traditional medicine and alternat ive and !(f) 1 !(!1 )1 ~i A'i ~% 1:1-'?.P '°;f· OhA A complementary medicine shall be perf rm.'i -t.f,"J"lt, f"'l .h'iCD'> 1,11c;A ormed by 11 regional health regulators. lT -- lii lM i.. ... ,_ __ Scanned with CamScanner t# l..,U.•A \ .?t.+ _,11."l rs'1 •,.r: 1111 " I ~/ 011. lJ1r.• It➔• lrl! +1 111.lli , ,. . dl-(11' .. ,pqcll l71 h.'IS"':l"· 'If. r...,, ao-,,l.f' A'i' , Fcdcr,J ll<prii 0..... . lla.J9 2a"Fd nuy20 19 __: ~~== ~= =- • IY.~ ·> r,:.\t.' )•t:') , .,."""m;::•"'1~2ii ::::~:. i::::rlatory 21 Regu functions under Articles 3(2)(g), 117f:J• s,>l- "11' 1' • ,. It')·'· '- ('111,·""f\11,t•m- r".,.,.,·l•I\A.,., .,,.:fl..,u.,-. 11,1( ,.!!1.? I\ I '. · 4(14) and4 (IS) of Proclamation No. 661/2009 ,·)\• l.(11' ,_. •l:'f'<; wh'ich deals with quarantine and regulation of .. . 1 ;ry.. (" ) . .,, .,. , .n..~ ../! (-~"£) Y:') • ., ! 1•0··) ""• ii(' .. .... communicable disease at ports of entry and ")'> ....... rl'-A- tn.'i" It. ')il•l:•l-f. •l- l'"J.h'i' OI') ;•U'c-r11ll·N'l11 exits shall be performed by the Ethiopian Public · • ' A" Health Institute. ), 3/ Regulatory functions under Articles 3(2)(1 3(2)(h), and . 4(21) of Proclamation No. 661/2009 which deals with enforcement of hygiene and environmental health requirements by federal government owned health-felated controllable institutions and trans-regional health-related institutions shall be performed by 11,11.'i' the Ministry. f,h', ' CD'i'A I I - 4/ The Ministry shall monitor comp~ance with uo"J•/1 ...-,. #I f tn.c; legal requirements by health institutions owned Ulll\O,•l-'1·l- f'"l..fl'l•l •>l.f:~:i:m- fm.c; ·t-t"7·-,. by the federal government. •l·.t' l"'I, unfl .t<: -f1•') "7"l 'l;J·:fm-') f,h;J .,,.'IA I I 51 Articles 45 of Proclama,tion No. 661/2009 which ?';/ {I/) , llll'l'fl .,-,.;1;JJ, Olf.'I"' h"76--I.~ deals with registration of traditional medicine ~ and alternative and complementary medicine un.( ":)t• l- V"1111J f''t""flh•f•m- fh1' shall be carried o~t by the executive organ. 41'1'C. IY.~!i!Kif.K h 14-l\' !'it; nhll"-~"'-111'

73. Provlslon1I clause The Health Professional Ethics Committee established by the Council of Ministers Regulation No. 299/2013 shall remain operational until such time another body is established by law to take over its respon,sibility, and regulatory functions under Articles 3(2)(d) and 4(16) of Proclamation No. which deals with registration and 66112009 licensing of alternative and complementary medicine practi tioners and other health professionals coming from abroad shall be performed by the Ministry. Scanned with CamScanner •1'C ,lfJ f l,tt Si ♦7 fir.Ii 't.,- 11t IIUll:I 4U-A t_,..+ _.,,.,.

74. EfTCCIIYI date tt• t,1'¥ r-u,,;n+ 1.n. "'"' I/ This Proclamation slu!ll enter Into ro11:e on the -· Iii ~II 1\1'~ fll..'-~A 11).?t-l- f' . , fl.+o,)W-l- _,., "¥.rt: -,..c.ll-t ~lf'iA11 dale ofpubllcallon In the Federal NegarltOazette. 2/ Noiwlthstandlng lo sub-anicle (I) of this anictc, f{I tlltJ h ,.,.,.. 10-ll•h">+r.• (/i) A1'-•l·mll4' If~ ,_.(-;)).•l· A'i' fllh~ UP"f{,.f 14'.... ,.• .,.'i, anicle 53 (3), (5) and (7) of this ptoclatnation 11 ,.,,.,c,.. ,.., ,..nit,,,.. ,t1,t, ,-tiJ' rAh·l· requiring labellng of medicine and medical device Jo be In Amharlc and •English. requiring 1111"111_,._,,. 'A'i' tl-r.~,: '1:1 flll"1fl4'tn•'f' barc:odc and placing or retail price requirement f"t'->-,>crt- th'l''lt 1t·1+1t· !W (I!)• (/;) A'i shall come into effect at the eighteenth month (X) .,_., ,..,~ 110,..,. ,,,.,,,~ 11r·H· u1~•l· from the date of ~~ption ~fthl,"proclamatlon. 11:\4' •l·L'l"'I. J',lf'i'A 11 3/ Notwithstanding to sub-article (I) or this aniclc, 1:1 r,w 1,1+r.· 10-fl•h'J+r.· (Ii) A1 ~;l·mll+ .1 article • 57 sub-articles •• • ( I•3) 1regarding health lf'i f·l•9"Qlf rr.•l· fllL'i "7flm'}-,.4!J' warning and packaging on to!>&e<x> products shall -llM:-r::r-1 f"Y.uuflh·l;cr>- h ,.,.,.. Y'.l.(/i-1:) r.il h I •t • ' come· into effed at the twelve month from the . .. ,..,~ ,,,.,..,. hhll~ 11•1\-l· IJJ~•l· 11:\'1 ·l·Lll"?. dai; of adoptio~ of this p~lamation. J',lf'i A I I . r ·, J 4/ Notwithstanding to sub-article (I) of this !/I fll.tl 1,•1-,.1,· '}(),/1 article, article 55 , of this proclamation .,.,.,,.,,.11111+ lf'i • t •• , . requiring health .w:iming on alcohol products "711m1.,.4!J' ,n,flLC•f':I'· f'"l.uuhflh·l·cr>- >.•H•1.• yr, J',11 . h'l'l': ho,..,.~,.,. h-rc: • tit .,.., ii7i.l.l ' ~ 0 . shall . come into effect 'after six months, and ,• 'J.r h/1.(-11-l· CD~•l· 11:\'I A'1.ll.1n1• hAl•A ') .. articie 60 banning the advertisement of alcohol through broadcast and billboard shall come tlilt:J!'f1/l-l• A'i OILAflC:J!' h"Jf1~H· into effect after three months from the date "7/l•M'ID~ f"'J.uuflh·l•OJ- h'1+-,_. 8 .f.11 h'Pl': ,.. of adoption of this proclamation the s"' day ho,..,.11-l· hv·,H· m~•l· fl:\11 =5. •1-4'.ll"Y.· ! 1: ofFebruray2019. \ ;_ .'•· · .f.lf'iA11 t Dane at Addis Ababa on this 2.81lt day-of Fcbruray 2019 • • • • •• • t SAHLEWOR!(_ZE:WDE , • , , . . ' PRESIDENT OF THE FEDERAL DEtv{OCRATIC \ • · REPUBLIC O.f ETHIOPIA • r., '. , J ·, I I • I .t " ' /. . . Scanned with CamScanner