\ J\ I.~,I'

X..

1'.L\~.

...

--..

...

' ~..

~.~.~

/1,~f1\.:"f"kl ~1.t."CC JllfPht.f\ICC ~TlIft.h

~Yo~1A ";JtT ;JtLlIJFEDERAL NEGARIT GAZETA

OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA

h 9" h.,.;;: ~oPT cJ!1'C ;S

hJlh h(lflll~ tt'l .,.'} liif.jli

5thYear No. 60ADDIS ABABA - 29th June, 1999(lh.TV-A-I AoJ.'..t.I\C£ JllfPht.l1.1C£ tT-oA.h

f ib1l-o "'lDt}V-~ 9"tJc o.T mflct~T flDII)

lP/lD-6fi,CONTENTS

Proclamation No. 176/1999hCP~ <k1'Clif.(fi!Iiinli ~'9'" Drug Administration and Control

foP.('~~T hh.,..«;1.C'i cJ!1'1'ChCP~ : 1Jt liitlif.~ Proclamation Page 1105

htp~ <k1'C lif.(fi!Iiifjlii"\oP.('~~T hh.,..«;1.C'i cJ!1'1'C flDII) htp~

IIL'i /\ib1'-o f.,.1.1\1./\ ibJ?,lDT'i 9"C:l"'7~T oPIPl.T

oPlf~ ,}'i 011.('~~ T9" (l IlL'i h 1/.\ ..,tr>T m-h1' 1/\m-') .('ci'f

l\ ') Jlo-9" IIL'i /\l\ '}hit T 9"CT'i 9"C:l"'7~T -otr>9" /\01 t-l:

h.\'1cr"7. f"7..fh1"fm-'} m"'",!:" (loP1'}"-oI

foP.('~~T 1.tJ'}~T. LCP1i~T'i 1't.T 1IWJ1.;J11''i

rC-I:,). P'C'T'-I:,}' hm:P"'OO-'} P'C~T 11711111(lllWJhL/\.,..I

f'ic\'1-th'i PfJ?,\'1TC'-ch i7P.('~~"'~,) ib1lD1' 9"CT.

P'C'T'T'i h m:J''''9'' oP"':"T (l1lWJhL/\.,...

/\It.tJ9'' hhTIIWJIl'/~ flr~ foP.('~~T hh.,..«;1.C'i cJ!1'1'C

P'C~T oP"C;JT hhLI\'llfcr (loP1"f-l:'

(lh.TV-kl AoJ.'..t.I\'e JllfPht.l1.1C£ tTof1A.h ib1oP')

"'P'T h,}"'Jt ~W(li) oPIPl.T f"7.h.,./\m- :"m-~/.\==

h lj:/.\ Iim:"I\I\

Ii' h~C C()h

PROCLAMATION NO. 176/1999A PROCLAMATION TO PROVIDE FOR DRUG

ADMINISTRATION AND CONTROL

WHEREAS, realizing the significant role of health insecuring proper life and productivity of the people andrecognizing that drug shares a vital role in the health service,as well as in animal fertility and productivity and economicdevelopment of the country;

WHEREAS, it is found necessary to ensure the safety,efficacy and quality of a drug and so to maintain the properproduction, distribution and use;

WHEREAS, it is found necessary to deter the iliicitproduction, traffic and use of narcotic drugs and psychotropicsubstances;

WHEREAS, to achieve these ends, it is found necessaryto establish an effective system of drug administration andcontrol;

NOW, THEREFORE, in accordance with Article 55 (1)of the Constitution of the Federal Democratic Republic ofEthiopia, it is hereby proclaimed as follows:

PART ONEGeneral

foil hCP~ «foP.('~~T hh.,..«;1.C'i cJ!1'1'Chtp~ cJ!1'C 1. Short Tide

lif(fi!Iiifjli» .,.-0/\" A.m.,.h J?,~I\/.\== This Proclamation may be cited as the "Drug Adminis-

I' TC~"'!tration and Control Proclamation No. 176/1999."

2. Definitionsf:P1\- h1'1-o "'1\ TC""9" f"7.111Il\m- t}/.\If~ (lh.,..,.C In this Procl31I\.ation, unless the context provides(llt.tJ hCP~ m-h1" otherwise:

n.rs. ";1 4'40Unit Price

.,;1~+ ;1ILII) 7"...,.41. itif.!i

Negarit G.P.O.Box 80,001

.,~' ii;(ii~:'; ~Y..t,1A ~:J/..} ;JILt" 'h'l't: ~i(a~r;~ .,., Iilf.:iii ~,,.., Federal Negarit Gazeta - No. 60 29°' June, 1999-Page 1106

ji' «uP.f.::~~.}.» IIII/\'}' f(aCD'11Of,9° f~'i\I}""" n7i:J"l\uPrlPCuPC: l\"'It19u : 1\1II/i\:"1i\ lOf,tJO l\uPhl\hA

ftPJ..f11\..,A IIIn~:cD'9u 1'1'~ "1C lOf,tJO f''I'~"1{~...t. lO'U1.' (}.I"'} ft,'Ctl";h'i VIf,\1""r.--Ch 00 1::}

~'Y:'}"': f~1i\1}.}. t'lDfj "'1:"r.-:-"'1: OOC,'"f,: "tJO'i

ff.9° ."tp""J.9",}"'}: i-ih(},'f:}"1: (L1,9':Y'1: ~~C1',r~I\-,= rIP.l~::~~'Y':}"'}: tli\'�P";\1':.}"1: fl}~ "'1, 1''''~

'Y:'}"'}: ft"hh9uri rlDp'l,.f9"'}"1 ~r.' fihhtJO'i OO1A1

.f9"'}"1 ~ 1.&tV.9u "lIIn~''=1O'9u trCe;: 1'11A ..,,,...,..

ftPJ,(I)'''' O~ ,,'IIf, rIP.l~':~~''':-'"'1 f,~tJO t,A:

«fliC\1.,;h uP.,::~~.}.» "'11\"'" it. ""'r-k.r n.,..,.n

1\:}',1O' f""ln",.}' uP' °''''' :1-"" f'iC\1-th 00 1::}

~.y.:}'. -h"''I'C i\9°9u",}, uPlP~"'" 'l1\9°1'1.,.e;: <k'l''I'C

fOlJ.'l~1:(H' oo.f.':~~'}' (},If1 III\""AII)~ f'iC\1-th

rIPJ~::~~"'" 11". ftPJ.(}.e.uPlO'1tJO f,~tJOt.A:

«fl}f,\1..,..c--Ch OO1.':~~""» tPJl\"'" it...,..r-kl n.,..,.n1\:}"Cf).f""ln","" 001°,,...:1-"'" fl}f,""'r.--Ch OO1::}~.Y.:t. -h'l''I'C i\9°9u.,,,,, uPlP~"'" 'll\tJ01'1"'tt: <k'l''I'C

flll/.f,~o'n"'" oo1.':~~'}' (}..r1 II"""AII)~ fl}f,\1"'"(~":h uP.(-~~"'" 1)1\. ftPJ.(}f,uPlO'1tJO f,~tJOt.A:«uPc'tr» tPJl\"'" n1'1.,i\.,.;;: uPm1 ""1O(}1: n(}lD-:n~'}i\I}"" (h')C)'P""''i n1'1illln. "U1.,,,,,, I\f, 1'1";1

ftPJ..fi\h""A "'I1;;:1O'1tJO 1'1'~ "1C "lD-:«01. ,,'IIf, oo1::}~""'» "'11\"'" "'I';;:lD-1tJO .,.qf,

l\uPhl\hA: l\uPef>lI)mC: lOf,tJO "tPJ'I'4-"'" fOt.r1

1\°'/,\ .,.~tPJl, 1'1'~"1C lO'U1: lOf,tJO. ihf,lO"'".r I\CD' "1C "1O':«\1 i\~'l:h» "'I" .}. (}1O'"""11\0,Yt"";"'" I I\tPJef>1~""':

f,9oo"I'}' l\uP(,lJ.uPC ntPJ.A lOf,tJO f1'1ilA1 :"CYt"'i

1'1''''(..,,''} 1}f,+f,C """."" l\uP.,.fC n11\ I\f,

ftPJ.f,I.°, "'I1;;:CD'9u ,,,o(E-"'" ""If1 fef>"; :,.qof"f1:

""'lifj:}'..} : 'Ii.Y.9"'}"'}: fh1.tC .,.l\qp:Y'1: f'lf,1'i

f ,(..}, 1II/ef>1~ '"or~",Y:'}'" : 7i9u":9'"f11 f"''''CI , .U?~''''''I..f9'"f1: fml.1 uP.,.fl,.r 1''''~of"f1 I I}oo-

'iSJI"}"1 ~'i 1\~"'lU '"o':E-of"f uP,...l,.r fOtlD-I\-

1'1'1. "1C'':.}''1 f,t.lJ.9u (..A:«fl}~.,.1, 1,o':E-'}'» 111/1\"" f(}lO''i f~ ,i\I}"""

'''''ihr.' ~1.&tV'9u fn.'}''i flO'i\'" 'Yt"U'i' I\oom

n-t.f ftPJ..r11\0'A 1II/1;;:lO'tJO 1''''~'''' ""If':rJ':'}"'1: :1-9°;":}"1: f,,'Ci\ 1Yt"ih'i oomn<t.r 1''''~'Y':}"'}: fl\.n rIP9um6619':Y'1: .&t"'C~'of"f1f,c.r.}.9u(..A::

«f,,"hh9°'i OOVlI,.f» 111/""', f(}lO' lOf,tJO f~'i\I}"""

n'1i:" "uPuPCuPC c')f,9u ""'IhtJO ntiJ.i\'I' lOf,tJOnCf).6f.1'1'1ilA I\f, ',':"9u I\f, ftPJ.lD-A UlJ1;;:lD-tJO

uPVlI,.f ""lr1 f"'I\.rf. fOOOOCOOI,.rI fl\Pt.ofl, :f.,. J'. 'r1'i'i f,,'Ci\ ihhtJO'i OOVlI,I9'"f1f,(,1J.9° t.A::

«f ihhr'i OO1A 1.f» "'11\"'" f(}lD- lOf,tJO f~ ,i\I}"""

("Ii:" I\OOOOCOOC 1Of,9° I\UlJhtJO nlD-ta'l' lOf,tJO

nlO'6f.1' 1'1ilA I\f, ',':"tJO I\f, ftPJ.lD-A UlJ1;;:lD-tJOuP1A1.f : f<ki\/.\ rJP,...,{..rhc-"f, : ",,1,1)!"f1 I

rJPCA..9':Y'1: -$,7": "0'" : 'I''I''i OO(}A 1''''~of"f1:1'1C.,;,(."'iA "'C{\:}"'}: h.Otil"":Y'1'i ,{.A'l""f1f,(,Y.9u t,A:

«frJP.f.':~~"'" '}o'.f.' ,...1..» "'I""" OO1::}~of"f

"'I9u I..}o: '"I11oorIJ.}. rJPI\h: n:E-tJOI\'i n"fc:FC'"'Ih4-,(./.\ ""lr1 ,,'t..}. OOOOCOOCI I}f, 11}ce flc-

"'I**tJO'i UlJil~1.' ~'i n'..,1: lOh.A""'" 00,...1.."""f,c.r.}.9°t.A:

~,

i:'

!!'

?;,

?;,

'it,

~~,

u'

!,

1) "Drug" means any substance or mixture ofsubstances used in the diagnosis, treatment,mitigation or prevention of a disease in man oranimal. This shall include narcotic drugs andpsychotropic substances, pesticides, animal foodadditives, poisons, blood and blood products,vaccine, sera, radio active pharmaceuticals, cos-metics and sanitary items, medical instruments andmedical supplies;

2) "Narcotic Drug" means any drug subject tocontrol according to Narcotic Drugs Conventionsof the United Nations ratified by Ethiopia. Thisshall also include a drug that is categorized asnarcotic drug by the Authority;

3) "Psychotropic Substance" means any substancesubject to control according to psychotropic Subs-tances Convention of the United Nations ratified byEthiopia. This shall also included a substance that iscategorized as psychotropic substance by theAuthority;

4) "Poison" means any substance that may causedanger to man, animal, plant and environmentwhen taken in a small quantity;

5) "Pesticide" means any chemical, mixture, com-pound or living organism used to prevent, controlor destroy pests;

6) "Cosmetic" means any preparation intended to beapplied to the human body for cleansing,beautifying, promoting attractiveness or alteringthe appearance without affecting the body's struc-ture or functions. This includes products such asskin creams, lotions, perfumes, lipsticks, finger nailpolishes, eye and facial makeup preparations,shampoos, permanent waves, hair colors, de-odorant, medicated soaps and any ingredient inten-ded for preparing these products;

7) "Sanitary Item" means any preparation used in themaintenance of cleanliness of man, animal andhousehold. This includes pads, tampons den-tifrices, sweat-bands, detergents;

8) "Medical Instrument" means any instrument thatmay be used on the inner or outer part of the bodyfor diagnosis or treatment of a disease in man oranimal. This includes various diagnostic,laboratory, surgery & dental medical instruments;

9) "Medical Supply" means any article that may beused on the inner or outer part of the body fordiagnosis or treatment of a disease in man oranimal. This includes, suturing materials,syringes & needles, bandages, gauze, cotton &other similar articles, artificial teeth, chemicalsand x-ray films;

10) "Drug Trade" means production, import, export,wholesale and retail of drugs, This shall includeperformance of quality control, establish and ranscientific offices and act as a comtnission agent,

ut i!ff.U~ ~Y..t./.\ ~:Jt,,,, ..m,1I)'I:'PCt. M~r;~ +, Iv.fjl! q.9'". Federal Negarit Gazeta - No. 60 29tl1June, 1999 - Page 1107

Hi' «f-f1.cJ>"" 117/.;J16IiJ. f9"i\tJC CD/."''-''» 117/\'-" noo.(-~~.-,. ,..,.(- "., I.. /\ OtIPII7 I.. "CD- "., (..CD-' /\ 117tt'l'(-

fll7..ri\'f.A 1'''':E-'-''C)' .(-c:E-:t"C£ 11.4>'-" 1/\CD- oolf)'

f .,../.;J 1m n'-" f 9" i\ tJ C CD/..,..-,. 'ICD-I

II{' «1I71i't.r» 117/\'-" oo,f.::"~"" nCD-i\m' /\0000-1\'-" CD~9"

/\ootJ"..-,. CD~9" /\oom:"/\A fOt,r1/\..,A fII/,'?/CD-9"

oor1f "'-I" hoo,f..'~~-I:;1C "''1'.'" .."j.'1'-" .rl\TCD-'

oor1f9'~' /\oom:,./\.r fOt.r1/\..,1\-- ib/\o~ /I.4>9'~'

~'1.1.9° (..A:

If.' «11\~ R'lI-tj:» 117/\'-" i\/\it,.(- oo.(-~~.-,. iti\"'I\'tCD-'

oo/.~ fOt1AR' nfll/1i't.rCD- I\~ fOt:t".,..9" CD~9"

fOt/\mtj: R'lI-tj: ".I" nll71i't.rCD- CD-i\'I' nit'l~'1'-"

fll7.h'''''''CD-' OOO'/\6IiJ.R'lI-tj: ~~1.9" (..Ai

IP.' «iti\ooi\/\o 117:"/.11» fII//\'-" fit'.(-' it9"t.~ fOO.(-

:"~'-" 1171i't.r CD~9" oo/\,r: f'..,.(- 9"AtJ.-,.I f'..,.(-

i\9" CD~9" 117'~:CD"9" l}~'1'-" A~ 9"AtJ'-" l/\it9°(..:~ ~.:PY.' noom"'9° oo'(-~~-I: nhCD-'1""'?/CD-

it 90I.:'}" h' Y..,..oo/,'I' t,i\ooi\/\o 117:"/.11 'lCD-I

I?;' «ooh/\i\» 117/\'-" nit'.f.: oo.(-~~.-,. ~1I'-" I\~ ibl\ '11Cnoo,I.1.OOC CD~9" ~1I1:' nh~A CD~9" 00-1\--noo-I\--

nibl\ '11C noo.,..I1"" CD~9" n""1n.CD- 00'1.(-

n,R','hC)' 'l/\oooo/.-I:C)' 'l/\oo.rtf- htM'(- '11C ;JC

h'Jt'11111 117.(-/..., '1CD-:

rk. «f,'htJ9"C)' oo-h(..» 117/\"" fit'.(-' oo.(-~~.-,. L'P7i

'1'-"C)'Y.U''1'-'' /\117/.;11'1' nh,i\",'-" CD~9" n"9'~ I\~fOtY./..., foo'(-~~"" oo'h(.. '1CD-f

I~' «foo,f:~~'-" 'l/\oo-.r» "'//\.-,. 4.CII7",-i\'-" I .(-(..'ti\'-":f4.CtII,". 'f:tJ~7i.r, ".If' fh,i\",'-" mS oo-.r.,..,?/,9"~'1.1.9° ('.A:

I~' «fh,i\","" mS oo-.r'I'~:» "'//\.-,. nfJ.'./.~CD- fOt"

m CD" fh' i\ ",..,. ,'htJ 9"C)' '-"9" UC.-,. .,..h:t"'-" f\o

oo..rCD" /\oo.,..°l(lC fll7_.ri\~/\CD- Jt ..,~: JtT/\ofIII

CD~9° "C1:~~'-" .r/\CD' "CD- 'lCD-I

iil. «f ,'htJ9"C)' '1/\00' r» "'//\.-,. ,'hOO9".,..'?/CD-' noooo~.- .cooc fn7i:t"CD-' l}~'1"" fOt/\~C)' noo.(-~~'-" CD~9"

itl1A' noo:"J.'.y.' fll7..rtJ9" f"CD- CD~9" fh,i\",chh.9° CD~9" h 'IIlll-~' '''''''1( ,. h 'JtfhC)'CD-' f.,..L

.,. J.'./\"" "CD- '1CD':

?}. «foo .f..':"~'-" "'/II"1f» 01'/\.-,. L.4>'(- 'l/\CD- f ,'htJ9"C)''l/\oo..r '''R't:: /\,'hIID.o.,'fOt"'I' foo'(-~~'-" /If.l\

""/11'1' '1CD':?}Ii' «h' i\ "'.-,.» "'/

/\..,. f 11...,.C)'f ~C h' i\ "'.-,. "'-If), f'l,'hC

h,i\",,""C)' '1n9" ~'I.1.9"('.AI?}I{. «"CD'» "'//\.-,. f"'~.'I'c.' "CD- CD~9" n,'h'" f"CD-'1'-"

001H. f"""mCD' it I1A '1CD-::

hr,:A !!fOD.e,,;~~.'J-J.1I4'.l:f.Cr,- 4lTTC fMP'AflJ11

1I1tU?!I:!l:r

f.' 00**9"

Ii' fooY::"~"" iti\"'P'Y.CC)' <h'l''I'C 'l/\".,AII)'. h'lUn~\1\ «'l/\""AII)~.» noo'lA fOt:t"CD:" (lIlU it'P:E-.,..* <h":l. A ::

I{. '1/\"" t.\ 11)). ""ml. '1'1: /\m:"1\~ Ot~i\'-"?- ~1fC)'t.\::'PC)'00"" I..r 11.'-"

f'l/\".,t.\II)). 'PC)'oo""l..r 11.'-"itJti\ itn'llfli h'J.'.iti\"'I\

.t'1-1: n"'/C)'TCD-9" ".,tj:(.. :"C,6liJ.tj: 00"" ~.r 11.'-"/\. Ii /.CD-~~I\A::

P.'

11) "Certificate of Competence" means a certificateshowing the fulfillment of organizationalrequirements and preparedness by a person to carryout drug trade;

12) "Packing Material" means any article that may beused for filling, inserting or wrapping or packingdrugs; and this includes immediate container andother materials for wrapping the immediate con-tainer;

13) "Label" means any material which is printed oraffixed to a packing material which provides thenecessary information about a drug and this in-cludes an insert;

14) "Counterfeiting" means using in any way, thepacking material or indentification or any<trademark,trade name or any special mark thereonof an authentic product of a manufacturer withoutthe permission of the manufacturer and presentingsuch falsely labelled and packed drug as if it ismanufactured by the genuine manufacturer.

15) "Adulteration" means reducing the quality of adrug by adding to its content a substance other thanits content, or by substituting its content in whole orin part by such other substance, or by storing ormanufacturing it under unsanitary conditionswhereby it may have been contaminated with anyother foreign matter;

16) "Clinical Trial" means testing a drug on human oranimal subjects to prove its efficacy and safety.

17) "Pharmacy Personnel" means a pharmacist, drug-gist or pharmacy technician and it also includesveterinary health personnel;

18),'Veterinary Health Personnel" means a person

trained in veterinary medicine, that enables him/herto carry out his/her profession, at a Degree,Diploma or Certificate level.

19) "Medical Practitioner" means a medical doctor,surgeon veterinarian or other health personnel whois licensed to Examine and diagnose the disease ofhumans or animals and treat them by drug orsurgical operations;

20) "Prescription" means any order for drug written orsigned by a duly licensed or authorized medicalpractitioner issued to a patient in order to collectdrug from dispensing unit;

21),'Animals" means domestic and wild anima~sand

also include sea animals and bees.22) "Person" means any physical or juridical person.

PART TWOEstablishment of Drug

Administration and ControlAuthority

3. Establishment1) The Drug Administration and Control Authority,

hereinafter referred to as "the Authority" is herebyestablished by this proclamation.

2) The Authority shall be accountable to the PrimeMinister.

4. Head Office

The head office of the Authority shall be in Addis Ababaand it may have branch offices elesewhere as necessary.

"~. ?ii't:?iY.~'; ~..J!../..A ~:Jt.} :Jltl" '~'rL: ~; I\~ r;~ <1'1!v.tiii q.9". Federal Negarit Gazeta - No. 60 291hJune, 1999-Page 1108

?i' ql\OII

f'It\P'Af'J)./~I\tIIJ oo.V:lh'i.":'}" .V.tJ'}'1:":':CD': 00.~'1,}'1:"

:':CD.I,' 'I,/..:J':':CD' f'hn(1<I: uDlrr,:':CD,,}ci U"o,'10' ,,':"9°

I\f, fIfJCPl\:':CD''} tllJl.:)"'I' fJI1'I,'A::

~. f'It\P'Af'n. P'AJ'n'i .,.0,I1C

')t\/vAf'J',. flll/.h.,.t\.:,. p'Aflnr, .,.o,I1c.-:Y.f,e:~:"A:

?i' foo.V::~'i.'}' f.'n'1'}: 11fJ.~"n'1""r, "'/,. tllJl.;J11i51.

flfJflfJtI~',=tp"f'ltI:J"}P,C,~'1 ,ftl;J~ A: U0000 tI;;:CD'

flfJ"'I.'} flfJlJ./..:J':':(I).'} f,~flJcn/..A:

~ UflfJ.V::~'i.'}' '}o,.V: P'/.. t\III/..ptllJ~ J?:c"f:,,.',f. NLcj>""

""11.7,61'-1. flfJflfJtI;;:tp'.}'. ,ftl;J~ A: NLcj>"" tIIJ1.;J11i51.

f9"tlhC (f)I.""} ,fJ(tflJA: f,~flJcn/..A: 9°tlhC

(f)I.""':'} .fo,P,A: f,1J'CI'A: 00:"1~ '} CDf,S'"flfJIJII. ,'''} t\ 111/.00t\tl'l' Cf).h f':A UCD:"'1: ,f tI:rcD':J> A:

i:' fW'/-":'} fOO,V:O'i.:" fIfJIIC1'C ,fll;J~A: Uoo"C1'~f".I}.,..,:,}.'} 00 .V::~'i.":'}" Uf.l.~ f,oo .r.-I1A: ootlC

1'~"} h '} f." tltlA '.. '1'1: f,hAl'tA:ii. fO',/.": foo.~':~'i.:" tlCf': ffll/.oo/..U""'} Tt\.1'1.

,foo'16''-I.A: I.c~:" Ih"""}" ,f";J~A! t\00'}..,P'''''

t\(D'l't}. .f4'C'IA:

?i' fflfJ.~':~'i.'} '}o,.~. P'/.. flll/.tl4--4--U"",}r,ffll/.cnr,hc

U""'} flfJ'}1.~' .fllfJfJ:fJ:A: Utlc4. f"'lPtIIJ~""'}

f,I.,(~A: .fUI.:":J'A:

'k t\oo .~':~'i.'}' 9°C'}' flll/.cIJ.t\. "'10 iJ:J>tp'f'}r, ffll/1i't.f

iJ:J'tp'.}'.'} 'I'/...}' f,4'>flJcn/..A:

'k f'iCt\";hc,' l'tfJt':f'(~"J;h 00 .r.-~'i.",:Y''} "00/..1."":

"'/tlUDflJ.}.: IIfJI\h: /VC61!"}'r, "cn.cj>4'S"',} f,h:t'

"'I\A: f,4'>flJcn/..A:

:j;. fW,I.(t.U 00 .~':~'i."'''}'',} y.tJ'}'1"": 00 .r.-1'}'1""r,

'1'/.':" flfJoo,,;;:tp'.}'.'} .f";J~ A: fl\(l/...y./.r, fht\.

'i.1}/p''I,ci"::;',} f,',ooo,tllJA: UmS "1A..,i\""" CD-tl'I'

'1'(1-1'(1)' '1':"9" I\f, ~,,}P'.(I).t\. f,L:"P,A:

Ii' oo.~':~'i..r."}"'} UIII/.oot\h"" fool.~ tllJiJhA Ire:

f,1J'/..A: h,}f.t,tltl.l\'..'1": ool.}ftp'f'} i\CJt\oo-.ftp'.}'.li i\'Hll..,.(tn' J.tI"'I\A~A: t\.i\"'f ool.~ ffll/.,f

tI','I\A4. (ttp',}'. flll/..ftl"'I\A4."",} ool.~ CD:":t'1f

'1:"',' '}hht\ ;;:'1.}. J'I.,,)O,flJA:

X' foo .~':~'i.'}' m:f':'} i\OI/cn'ihcr, i\tllJtl4--4--"" n01C

(f).tI'I",' U(I).61!' fOl/.,V.I.'" t,P,P"tI l'tf, ') l'tlf ..,~.y.'f'}

Uooh:J""A t\01/.": UtIIJ.cn:"S'" o-~:t. n",,,,'IC "f.

~,'}P'.(I)'A .ff.C;JA:

I?i' foo.V::~'i.'}' IID'h/.. 'I"fcf:tp'.}'.'} hfool.OOI. f.L:"P,A:

'I.f.'I:'} f.h:""'I\A: (D'm. .,: '}9° f.1oo..,fII/ A:

t\W,/.": nlll/.cn:t'9" tJ.~:,. 'I':"S'" I\f. h'}P"CD-l\-

f,tl.:t'P,A:

X~' Uoo.~':~'i.'}' 00001.11 i\1II/.f.CtI flfP.}. CDf.S'"fen. ,}'1""flfJ:Jocf)h flfJ'}tlt" flr'1(1).'} '}'I'I. '11C A~ A~

'i 11D"itp:Y.'} n 00'" UA fIfJC9°c.- 9°'} 'I:t':t:CD-'} ,f I.;J

",f'JA: flfJc':'}'cI"Cf).'}9" f,cnchOl/A:

Ii:' i\P'/..(D' "tltlA'.. fin..}''} f9°Coo/.. I\(l/...y./.tp:Y.

.ff./..~A:

:(!~. t\OI/.(tcnCD' "',Ad,i\":,' hC':.f .ftlhfi:I\A:

Hi' f').UI.'}' 11i\n,:,. f.11'r,A: (I)'A f.CPCPl\A: n/ tiS'"

,ehtll'tA: f,h(tl'tA:

n;. I~I\OI/(I)'') i\0I/tltl.'A9" flll/.I.P,. t\.i\":Y' ",,,,'Ic.-'f'}.fh'i'(I).r,A::

5. Objectives

The objective of the Authority shall be to ensure thesafety, efficacy, quality and proper use of drugs.

6. Powers and Duties of the Authority

The Authority shall have the powers and duties to:1) set standards of quality, safety and efficacy of drugs

and ensure their observance;2) set standards of competence for organizations to be

involved in drug trade. It shall issue a certificate ofcompetence, control compliance with the stan-dards, renew, suspend, and revoke the certificate ofcompetence; and inform same to the concernedauthority;

3) prepare list of drugs for the country, structure thedrugs in the list into different categories, revise the

list whenever necessary;4) formulate policy governing the sector; prepare draft

legislation and present it for the approval of thegovernment;

5) create favorable conditions for the promotion andexpansion of drug trade and shall encourage andprovide support to those who are involved in thetrade;

6) control the quality of raw materials and packing

materials used for the production of drugs;7) monitor domestic or foreign new scientific

achievements in the drug sector in order to adapt

them to the country's condition thereby promotingand strengthening the sector;

8) prepare standards of safety, efficacy and quality of

traditional medicines; and shall evaluate laboratoryand clinical studies in order to ensure the safety,efficacy and quality oftraditional medicine; it shall

issue license in order to use traditional medicine inthe health service;

9) serve as Drug Information Center and control drug

information to be distributed to professionals and

the public; it shall also disseminate current andunbiased information;

10) make follow-up on domestic and foreign new

scientific achievements on drug sector and shall putmaximum effort for their implementation so as topromote and expand the sector;

11) issue license for conducting clinical trial; monitor

the process; evaluate the results and authorize theuse of the result in such a way that it benefits thecountry;

12) identify ingredients that caused death or ill health

due to dry poisoning and forward possible remediesby conducting investigation on sample ingredients;

13) organize quality control laboratory needed to carry

out its duty;14) collect service fee;15) own property, enter into contracts, sue and be sued

in its own name;16) perform other lawful activities as may be necessary

for the attainment of its objectives.

.,~. lii\:?iY.il 4..J!0/'.&\'.,;1t-1' :J/l.fI' c~'rc ~~(a); ?)!{.,., nltili q.9'". Federal Negarit Gazeta - No. 60 29tllJune, 1999-Page 1109

1:' f'lftP"A")'l. "*9u'lftP"A"J'1.:

?i'" ",. Y: (1G~':!{. "".f.: tpr, P"/'. 1',ith..f:~ "hr, ",.Y: ~h""A P'/'.

"it h..f:~: "h,..ItV.9uI:' "ittt.l\'I.CD' "../,.,f.1f-:". ~Ci~:J-A::

f(1CY: 1',fJI\""

(1C.p,. nOO')"'p''''' f"7."(1'{/O.(}f)o)' "fll\"" ~Ci~;J-A::

~,

ji' f(1CP,. P'A")')r, ''''''fIG

(1GP,. f"7.h.f.ft...,. P'A")')',' 'f''''fIG ~Ci~;J-A:

fi' f)ftP'AIIJ'l." nnl\~',.} ~OO/'.A: ~~lIJm/'.A;!(, foo.t'::~~"" '.'n.,.),: 'JP.f..,.,,..,..,.Cj 'P/'."" "71.;116fi}.

ooooU;;:sP~'" ooG9uC: .f~~':J'A;

f.' flJ"lkf:" foo.f.'~~'r ooUC1fC ,f?tY::J'A:!!, f"tp:~:" "tt.~?t9u (""oo"h'" f"7."'Co- :"t..;J-sP'f,.

ooC9ur.- CD.lt~ ~(}II)A:

?i' fflftP'AIIJ.,." fP'/'. Tr ,/'.~r, l.<t:" n1:""

,f?t.f p A: tt.'" .f.'~ np' /,. I\~ ootp tt-,. ,f 1.;J

"'")A::

I' f(1GP,. it,n(}fl

?i' (1C,P" nv-it"" mc "')~' 'I.IL ~(}(I(}fIA:: IrCi~

1',ittt.l\'l.lrCi (}:l:~ n(},nltO.CD' "'(, n"7r,TCD-~ 'UI.~() n () flA::

!{. ()(1C,p" it.n(}fl I\Y, 1',.nt'~:sP:t: "fl1\"" h"'11- ~A~'"'l.f)l~, ~Ir'.' A::

;=. f(1CP,. CD.lt~ fOIl.'" 1\"tt.CD' nito(l(}'ICD- n"'11-

"f)t\.:,)". n"o(ltf~:CD' .t':9ub ~lrr,A:: IrCi~ Y:~1\

"hh.A ""h h.A f.f'htt.ft ",. Y.lr., (}... lto.CD- CDlt:t;

.f.'9u" ,eli l.'PA::!!, f'lU 1',')"'1\' .r:') :J'I.sP"}"'"h"'."'mn~ Ir.,CD'; (1C'p"

f /,.(}.') fit'O(}fl p,., P'G~"" ,., It.,fCDIIJ f,'fl\A::

it" f)ftp' A II)',. tp'.. P' /,. 1',it h.,fJ:

fi' ff)"p'AIIJ.,. tpr, P'/', "ith..fJ: n(1CP,. ,,:,./,.0."""

n,JP')"'p"} ~"(I'Ul/A::

!(, tp'.' P'/'. "ith..fl1: fflftP'AIIJ.,. P'/,. "it"-~O'/.

nooll'" ffl"P'AIIJ'l.') P'/'.sP'f f,OO/'.A: .fit.,..c;

~'/'.A::

f.' f'lU 1',""'?t. ,.O.it """'1\ (li) "m:J'I\f, "";J1C"h,.,..f'tJln.,. IrCi: tp'i P'/,. "ith.,f~:

lJ) UllU "tp)?: 1',')"'?t. ~ f.,.oo"h.,.CD-" ffJ"P'A1I)'l.') P'A")')',' 'f''''fIC P'/,. I\f, ,fCD-I\A::

,,) f tC.,Yo/'.Af(}. itA (}cii.it hoO'/.7i,.,. 00U'1.:J-'e,JPCU nootl'f'A ffl"P'A")"''' U'/,..,.1f'f

YA"I'/,.A: J' it 'f'P'.f.' /'.A:ch) ffJ"P'A")',.') f P'/,. Tr.-"It..~r, l.<t:" n:~""

1',U;J:~'" "(1G,P" ,f"'CfIA:: (}.tt.'"Y:9u np' /,.I\~ .fCD'I\A:

00) "fJ "P'A") 'l. (H' tt."". "..,. n:~""r, fP'/'.

Tr.-"1t..9u OOlJ'(.')' 1,.,10(1 CD",1.,fY.C;JA;

II') flftP'AIIJ'l. hv-it,t.;;: CD1Ci~' ;JC n"7.,fY.C:):f:CD'""...,...",:.}'. v-ft. fl"P'A")"''' f,CDhl\A;

(.) itftfl"P'A")',. fP'/'. "h":"it,.pfl. ft(1C'p"t.;rc,). ,f"'CfIA::

!!, tp'iCD' P'/,. "ittl,r:~ "flftP'AIIJ'l. fP'/'. :"A'PlJ:r,n"7.,rittt.A'" ClP{Jl') P'AIIJ"r, 'f''''fl~'' nhtt.A

"flftP' A")'l. 9uh'}A P' /,. 1',ith..fJ:r, "t\."o'f

1J.'/,..f.1f-:'''nCD.t,A',' It.,fit'f'I\AlJ: f,~'I\A::

Hi'

7. Organization of the Authority

The Authority shall have:I) a Board,2) a General Manager and Deputy General Manager,3) the necessary staff.

8. Members of the Board

The Board shall have seven members to be appointed bythe government.

9. Powers and Duties of the Board

The Board shall have the powers and duties to:I) direct and supervise the Authority;2) approve standards of safety, efficacy and quality of

drugs;3) approve the list of drugs for the country;4) decide on compliants raised in the implementation of

this proclamation;5) approve the plan of action and budget of the

Authority and also ensure its implementation.

10. Meetings of the Board

I) The Board shall meet once in three months and onsuch occasions as the chairperson may decide.

2) There shall be a quorum where the majority of themembers of the Board are present.

3) Decisions of the Board shall be passed by majorityvote and in case of a tie the chairperson shall have acasting vote.

4) Without prejudice to the provisions of this Article,the Board may issue its own rules of procedures.

11. General Manager of the Authority

I) The General Manager of the Authority shall beappointed by the government upon recommendationof the Board.

2) The General Manager shall be the chief executiveofficer of the Authority and shall direct and adminis-ter the activities of the Authority.

3) Without prejudice to the general provisions of SubArticle (1) of this Article the General Manger shall:(a) exercise the powers and duties of the

Authority specified under Article 6 of thisProclamation;

(b) employ and administer personnel of the

Authority following the basic principles of thefederal civil service laws;

(c) prepare and sumit to the Board the annual plan

and budget of the Authority and implementsame upon approval;

(d) effect payments in accordance with theapproved budget and work programmes of theAuthority;

(e) represent the Authority in all its dealings with

third parties;(f) submit periodical reports to the Board.

4) The General Manager may delegate part of hispowers and duties to the Deputy General Managerand employees of the Authority to the extentnecessary for the efficient performance of itsactivities.

'IJt li1f.nI toY-..t./A ~:JtT ;JlLllJ <h'l'C ~ IU~ ?)~4>1Iitf1(i 'J.,...

II'

Federal Negarit Gazeta - No. 60 29th June, 1999-Page .1110 -

Ir'

fl1t\P'Aff}). 01:""

f 11t\P' A ff}). 01:"" howz'h"'~"" f "'ID-ff}ff} f,IfCj A I

Ii' OOO,}"'P''''' hOWZ,001.1101:""t

I' hOWZ,{HI(aOID-f4.:J>f: !ft..1A..,tto"" htt:l= 'hCj

r' h",1\ 9"'}1if!>h0WZ,1~10.11

11t\ 'l. Pf 11 00 If ..,11""

Ii' 11t\P' A ff}). f.,. ".7.1\Cj ..,.h h t\ ~ f If ~ f'l. Pf11oot'..,11"" f,f,t'AII

I' ft)t\P'Aff})' f'l.Pf11 OOIf..,11""Cj 1,}"11 ~h (a~f."f

0 tpCjID- l>.Jl"'C m f,9" tpCjID- l>.Jl"'C 0 OWZ,(af,OOID-

l>.Jl"'C OfqOOi: f,OOl.oot.~11

11t\"'",ff) ff}&sP"f

Ii' f,U'} t\tp1:-Cj f,U'} t..tp1:- t\O?ll4.1.9" fOWZ,mm1.'}p"fCj OOOO&lsP"f ooh()&'TID-'} t\ooh;l-.,.ACj

t\0?1.;J11' 11t\P'Aff}). foof:~t"" I1t\OO-lsP"f'}

O"'",ff}ff}&~"" f,oo f:I1AII

I' mLU t..,}"'1\ '}o-l1 t..,}"'1\ (Ii) 0011'1."" f.,.oo1.O

"'",ff} ff}& fOWZ,h.,. t\1D- P' A ff}'}Cj .,..., t)C f,lj I. tp A I

u) Ooof:~t"" '}..,f: P't. f"'IPO?~ f:C1:-.,."f'}=

fmS f:c1:-.,."f'}Cj foo"'o.l h.l\sP"f'} htt:""

n OWZ,1f).n""nO?CjTID-9" (aq..,. 000'" t)"" t\ 00",ff}IIlCI

t\) oof:~t"" ~h flr~ 0?'}~1D-'}9" &ttCf:= 117""'-mf,9" 1P~f: t\OOOOAh""Cj t..ll4.I\1. Iflj ""'1'f 1D-9" c:.,. tt-c .,. 1.C'''' 'h '}Jl(a1ll1D- t\0? f:1."'I

m) '1t\P'Aff}). nOWZ"fmff}1D-fCjOO-Cj t..ml}(af:OOOO&,f 0011'1."" h"'OOI.i: mf,9" hlD-lif!>

hoom OOf:~t"'"f I\f, t\0?111.~~"" fOWZ,11

t\ .., ~ Cjoo-CjsP"f'} t\ OOID-(af:I

(0) f"'ht\h~: f.,.nl\ n:= f"'Iif!>OI.O~= f"'Oh~

mf,9" OO?CjTID-9" "'1\ 9"h'},,,,,

0"'111

:P OWZ,ID-I\,e. ,..t;..,. ,f 1.C l}~ .,.11 t\ ID- 0 "'111

1.1Il~ OOf:~t"'"f I\f, fl\Pt."'& 9"Coot.

'h '} JlI1 ~f: t\ 117f: I...,Cj 1D-(f1.i: 'h 11h OWZ,;l-m:"

Y:1.119" nt..1 A.., ""..,. I\,e. 'h '}.t;f,1D-~ ;l-7i 11D-

'h '}Jl",(! t\O?ff1t:

11') OOf:~t"'"f ft..1A..,"""" ffooCjTID- "",0....m,e.9" n'LU t..tp1:- 0011'1."" 1':"9" I\f, 'h'}.t;

f,1D-~ ""m(a'} n"'10.1D- OO'}1f: 'h'}Jlm1~

t\O?f:I...,Cj (ULU t..,}"'1\ n'}o-ll ck1'C (I) (00)00 II' I."" f;l-li ,...,.') 0 II' 1\l} "'Cj"" ID-ll1' ID-l}'"'h'}JlI1"f. 0?f:1."'11

m-h A Cj llt\ 00 1111l""

11t\P'Aff}). t\P't.1D- :"A1'tj:Cj t..114.I\1. Iflj 11111D-hP'Aff}'}Cj .,...,t)~ nhLA t\hAA t..111\"" OlD-hACj00 1111l""f,"fl\ A II

I~'

I~'

h~Afl1t\OOf:~t"'"f 9"1;1t)Cjck1'1'C

9"1'111

Ii' 0?'}~1D-9" nt..1C ID-ll1' fOWZ,OOI.""mf,9" hlD-lif!>fOWZ,OOff}oof:~t"" 1.U,}~i: I OOf:1,}~i:Cj 1't.i:

"'19""'qu Of)t\P'Aff}). l},e.OOff111 nt..1A..,"""" I\f,

iLlD-A t..,e."fA9" II!{. f9"l'1'1 .,...,f)C fOWZ,hCjm~1D-f,U'} t..tp1:- t\O?ll

4.1.9" n OWZ,mff} 1.,}11 00 II' I."" f,IfCj A II

I~' f9"111f) 9"ilhC mI."'''''

Ii' mL U t..tp1:-t..'}.,. 1\ I~ 00 II' I."" t\ "'OOff1 0 00 f:~t ..,.

t\t..9"11"" qoo"" fOWZ,I1t\..,A f9"l'1f) f9"llhcm I. .,...,. f,(a ff} A II

I?;'

12. BudgetThe budget of the Authority shall be drawn from thefollowing sources:1) budget allocated by the Government,2) license/service fees, and3) any other source.

13. Books of Accounts1) The Authority shall keep complete and accurate

books of accounts.2) The books of accounts and other financial

documents of the Authority shall be auditedannually by the Auditor General or by an auditordesignated by him.

14. Inspectors1) The Authority shall assign pharmacy personnel as

inspectors to ensure the implementation of thisProclamation, and regulations and directives to beissued pursuant to this Proclamation.

2) An Inspector assigned pursuant to Sub Arti,cle (1)of this Article shall have the power and duty to:(a) enter and inspect establishments for produc-

tion, import, wholesale, and retail trade of adrug, health institutions and port of entry orexist at any opening hours;

(b) investigate and, if necessary, retain aphotocopy of records, documents, prescrip-ti.onsand the like pertaining to drugs;

(c) take samples of drugs produced locally orimported as evidence; in accordance with thesampling procedures that shall be formulatedby the Authority;

(d) subject to quality control drugs that are adul-terated, spoiled, counterfeit, contaminated orthose suspected to be dangerous to the public,he shall be authorized to order the quarantineof such items until the results of the laboratoryare known;

(e) ensure the disposal of drugs when they expire. or when they are deemed to be unfit for use inaccordance with this Proclamation, and causethat decision be given within thirty days uponthose under quarantine pursuant to Sub-Article (2) (d) of this Article.

15. Delegation ofPowers and DutiesThe Authority may delegate part of its powers andduties to regional legal bodies to the extent andwhenever it deemed necessary for the efficient perfor-mances of its activities.

PART THREEDrug Registration and Control

16. Registration1) No drug, whether produced locally or imported,

shall be put into use unless it is'duly registered bythe Authority.

2) The registration shall be effected in accordancewith the regulations to be issued for the implemen-tation of this Procalamation.

17. Certificate of Registration1) A -registration Gertificate which remains valid for

five (5) years shall be granted for a drug registeredpursuant to Article 16 of this Proclamation.

1X' liif.lifHi 4..Yo/,.fA~:J(,"" ;JtLlIJ <h'l'C :!; IU. ?;'~ .,., IDfj{i ,.,...

~.

Federal Negarit Gazeta - No. 60 29th June, 1999-Page 1111

I;;;'

f9"hhc lDl."'~ oP.(-~t~ noP.(-~t'-" "7"""lD~9"

,fl\oP.(-~t'-" "7u'lr h'}.ltu-9" nf'-"~lD- fm.'�

.(-C~'-"'� foP.(-~t'-" rc~C: .(-C~.-,. 1.I.jf h1A

""1/\"'-"I\~ illD-A h'}1.lPf.rA "7oPAh'-" hI\O'-"::

hl\J;""I9" 9"1'111

fi' "7,) ~ lD-9" f ToP U1n oP.(- m t'-" f T(amlD- f9"1I111

f9"hhC lDl."''-'' lD~9" fh1A""I/\"'-" UoP') h"7l\<k

O.c.'-" fll'} h hoP'" 'II"''} n.c.'-" /\J;""I9" 9"11111

oP:"l.-fl hl\O'-" ::

~. 11/\r'AllJ). hJ;""I9" 9"1'1'1 "7oPAh~ ;1C oP:"l.-fl

hl\lPf.1I1TlD- oPl.jf$Pr 1'C1'C oPoPl,l IlDllJA ::

Iii' f'l'&.'-" 1.I.jf

fi' 11I\r' AllJ). 0 lPf.1lDllJlD- ~C"7tt 1:1 lD~9" n1''''nl\lD- ft\./\"r V1C:r ~C"7tt1:1 oPIPI.'-" f'l'&.'-"1.I.jf ,f 1.;1 ""IllJ A ::

~. flDllJl\'-"'} f'l'&.'-"1.l.jf f"71":1.1\ oP.(-~t'-" =- 'I'~'�

f"7'7i1.,f iJ:J> I\h1A""I/\"'-" t\.lD-A h~rA9" ::

nh1A""I/\"'-" I\f, n'P/\- oP.(-~t"'r I\~ hl\lPf.1.I.""I

h'-"'-"A

fi' Oh1A""I/\"'-" I\~ f'Pl\. oP.(-~t"'r'} 1."',}~'-" =-

oP .(-,., ') ~'-"'� 'I'&..-,.1\"71.;11'I' 11I\r' A llJ). h'-"'-"A,f1.C;1A ::

~. "7'}~lD-9"oP.(-~t'-" nh1A""If\o>'-"I\~ h'P/\ n~1\

~Cf I.'PA 1'11/\" fT1oPTlD- foP .(-,.,') (a'Ll.~'-" I1tJl,hl\oPCf?- (1.1.;11'1' W~9" flPf.lhh'-"l\lD- 1-J;'-"

hlPf.(amlD- '1':"9" hoP1.Cf (a,1~ 11/\r'AllJ)'

oP.(-~t~ 0'1':"9" I\f, h,}J;~lD-A f"71.(-'� 9"111

I1lD-'}foPIPl.1' r'AllJ'} ~CfI.'PA ::

hl\ihh9"'i" oo-h&.

fi' fihh9"'� oo-h&. n(alD- W~9" Oh'}hlt'-" I\~/\"7.(-1.""1 flPf.~/\lD- ~tJ'} h'P~ /\"7ht.?t9"OlPf.WllJlD-1.'}11 oPIPI.'-" nl1l\r'AllJ)' (a,t."''(-'�

(alD-flD- n& I\~ f ihh9"'i" oo-h&. h '}.ltt}~.(-O'-"

O~U-ii: hTh"7"7 lDf,9" h,}hlt flf~ h,}1.If~

fh'}hltlD-I1/\n.'-" t.:J>'(- hT11 h'l f~C'I fl1ihCh,) h It'-" h If). hoP'} ""Ir''-'' t.:J> .(- (I.1~ -fl~f,lr'lA::

~. ftLtJ h'}"'~ '}o-h h'}"'~ (fi) .(-'};YL n. CfC9" ;

Oh'l'fl'l ~ii:(am-C h'l"'r=- I\h:"oPhJ;9" I1A1.I.....ih?t'l'-" : Ohhl.~r : nhh9"C: ihoP9"T~r h'lfoo-h&. h.(-&''llD-I1I\OO-,f lD~9" .(-C~.-,. (a$Pr I\~

f ihh9"'� oo-h&. "7 .(-1.""1h~~A9" ::

f.' O'11\r'AllJ). T19"""Iqu ,fA?t1.'" f ihh9"'� oo-h&.

lD-m.'-"'} n"7,};;: lD-9" ih'-"oP.-,. I\~ "7lD-llJ'-" lD~9"

0"7'};;:lD-9" oP'}1.(- "7IP&.",l.'-" h~~A9" ::

9.' fihh9"'� oo-h&. hl\lPf.1.I.""II1TlD- (a$Pr flPf.1A~oPl.jf n9"r'm.c oPmn:" hl\O'-" ::

oPl.jf hl\"7hTI\I\ii:'� hl\'}""1'(- "7h;rW4:1$Pr

fi' "7'}~lD-9" (alD- oP .(-~t'-" ~h oPl.jf$Pr 1\111\00-1

$Pr9" If~ /\,.,11I.T(a(1- t\.lhTI\Aii: flPf.rl\lD-

foP I.jf $P~ '-"h h 1\;;:

~'-"'� m:J>lPf.~.-,. 011I\r' A llJ).

h f TI.;11m (I. t. .,. .(- 1\'-" ~lD- ::

t).

flfi'

fI~'

2) The certificate shall show whether the.drug is a

prescrip~ion-drug or non-prescription drug; andalso the level of the health institution or drug retailoutlet where it shall be available.

18. Re-registration

1) Any registered drug shall be presented for re-

registration at least 120 days prior to the end of thevalidity date of the registration certificate.

2) The Authority shall issue detailed guidelines

regarding the documents that should accompany anapplication for re-registration.

19. Standard of Quality

1) The Authority shall assure the quality of drugs as

per its own pharmacopoeia or the pharmacopoeia

of other countries which are recognized by it.2) No drug, raw material or packaging material which

fails to comply with its quality specifications shallbe put into use.

20. Post Marketing surveillance

1) The Authority shall carry out post marketing

surveillance in order to ensure the safety, efficacyand quality of drugs that are put into use.

2) The Authority shall have the power to ban the use,

or to revoke the registration, of a drug that was putinto use when, later on, it is proved to be ineffectiveor its risk outweighs its benefit.

21. Clinical Trial

1) A clinical trial shall be conducted only on a human

being who has given his consent in writting and on

domestic animals with the consent of the owner andon wild and sea animals when permission of theGovernment is obtained, and all of which aresubject to the authorization of the Authority inaccordance with the regulations issued for theimplementation of this proclamation.

2) Notwithstanding Sub Article (1) of this Article, a

clinical trial shall not be conducted on nursing andpregnant women, on children under the age of 18,

on prisoners, on insane persons, and on personsdependent on the investigator or on the institution.

3) No clinical trial result which has not been evaluated

and approved by the Authority shall be publishedor disseminated in any way.

4) Any identifying data about the trial subjects shall

be kept confidential.

22. Dissemination of Infonnation and Advertisement

1) No person shall disseminate any drug related

information that is meant for professionals and thepublic unless after their usefulness and correctnessis verified and approved by the Authority.

'IX- liitlifHt ~1-..t.&\ '1;M:r- :J.LIfJ <h'l'C :!; (}~ t)'!t +1 Iv.fjli 1."" Federal Negarit Gazeta - No. 60 29"1June, 1999-Page 1112

~, "7'~c&9" (tm' ilt\ ,..,f: "7il:t'CD~! fCDtI)c&' ih..,CDf,'Ju n(lt\P'AII}). fCDII}m,' oPoP(,.f .fA.,.h.,.t\CDf,'Ju n"7tjTm''Ju 1\i.\~\' ..,-n~.,.(to-' t\.!i)il""

f"7."fA oPf:~~"'" f"7.oPt\h"" f'..,f: "7il:t'CD~!n~',.h,~ CDf,9" n"7tjTC&9" oP'"f: t\.!CDtI)

1\f,:}"'A 9"::

1)f.'

,

ilt\oP~'~~"" "7if'l. fsP"ftj .,I\6J.1"K",.h.~

{i' "7'~c&9" oPf:~~"" f,V' 1\'P~ t\"7il~'la9"

n "7, CDII} 1.,-n tj oPoP (,.f oP IP ~..,. n1\"'f] 0- ttA:t'

if1tj .,I\6J.1" K",.h,(j: ttA"'1.~1n"" nil.,..,.C t\1n!

t\. .,.c:.n CDf,'Ju n"7tj:fc&9" 1\i.\~' t\.1P t.6J.1"1\f,"}"'A'Ju ::

~. "7'~:CD'9" foP ,f.::"~"" 1\'JUt."f : 1\iloP'L1. : 1\h~~f,OJf,'Ju TC:F(, Y.:c:E-"" CDf,9" fmS f:C~"" t\1\1A

",f\...1, f"7,.f"'C(lTC& oP f:~~-f"f n1\..,Qo- f :t'if.,.tj

11\lil!' K",.h-(j: f'f'1,~.,qTc& oPt1').' "7~;J11'

1\t\n""::

W9.'

hC':A !!ilt\ ,,'cf1-thtj PIf,f1""Cc'1:h oPf:~~-f"f

A¥- l-:J>1: ilt\ "7 ill-t\.,.

Ii' tjCf1'f:h oP f:~~"':}"" t\"7iloPtI)"" : t\oPI\h :t\1II/'JU~"" CDf,'Ju t\"7h~~A h(lt\P'AtI)). A¥-&Oo<J>,f: "7c&II}"" .fil&.A;JA ::

~, ftic:tl":htj fi)f,f1.1,c:'c:h oP f:~~-f"f' f"7il

oP{f}"": foPI\h : f"79"~"" : foP .f1' : CDf,9"

f"7h"7T"" A¥- *07, &,,<J>f: f"7.(tmc& foP f:~~"",..,,: P't. ~.<J>1:I\I\:':CD' (t~"f -n:F f,rrtjA ::

W?;' il t\ "7 il oP lI}""tj oP 1\h

Ii' ftjc:f1-thtj i)f,f1""Cc'"C:h oP f:~~.,."f, f"7iloP

tI)'1-r. foPI\h Af. *"7. l-:J>f: f.,.(tmc& (tc&

nf'I.ILCD' f"7iloPII}"" CDf,9" foPI\h A ¥- ~:J> f:

oPmf"" f,'iCn;J'A : n1\'f: '1.11. f"7.(tmc& A¥-&,,<J>,f.:'Juhllm'" (:~) ...') nl\f, 1\.f.,t\..,A'Ju ::

~, tjc:t\,,:h OJf,'Ju i)f,f1.1'Cc'1:h oP f:~~"'"f' n;ril:t'

n':" llJf,'Ju noPch.n IIIliloPII}"" CDf,9" oPI\h 1\f,l-.,. ,f.:'Ju ::

i:' IIIn~:m''Ju (tCD't.'c:f1,,:h OJf,9" i)f,f1""Cc'1:h oP f:~~

,':'}"") ht\.f\"~" oP y::,,~,":f' CDf,9" /J:J>~"f ;JC 1\7i''''lII/iloPtI)"" CDf,'Ju oPI\h 1\f,l-.,.f:t\""9" ::

9.' IIIn~:CD''Ju (tm. r.cf1.,:h CDf,9" i)f,f1""Cc'1:h oP f:;}~.,.',}"., (t..filoPII) llJf,'Ju l1.Ah (It\P'AII}). ilt\1\il.,.

71'11''''.fCDII}c&' oPoP(,.f oPh.,.A f,'icn:t'A ::

ilt\oP ,f.::"~'1' "711"" O)~",,":f' 1\il.,.tIll1' P'Cq..,.

Ii' r.c:t\,,:h oP ,f::"~":'}"" "7111' fOTJ,"ft\CD' noo-.fc&

},') J;.II.'t. f.f'oP"" nt.' t.\ f, &.,<J>f: f.,.(tmc& f ,."hh9"tj

(It\(JD'.f .n:F f,rrt.' t.\ ::

~, fi)f,f1""Cc'1:h oP,f.:~~"':f' f"7.:t'IIU''''' nOO-.fc&

h,J;.lPt. n.f'oPII1nr. A¥- &.,<J>f: n.,.(tmc&

f ,."hh'Jutj (It\oo'.f f,rrtjA ::

i:' "7'~:OJ'9" fihh'Jur. (It\oo-.f tjcf1-thtj i)f,f1""Cc'1:hoP ,f.::"~-f:f', t\/..(t, "7111' 1\f,"fA9" ::

!!, r.c:t\,,:hr. i)f,f1.1'Cc"c:h oP f:~~-f"f f"7.:t'IIU'''''

nAf. foPy':;}~"" 111/11""CD~"''''' -n:F f,rrr.A ::

?;, "7'~:OJ''Ju fr.C\1.,:tJ (Df,9" i)f,f1""Cc'1:h oPf:;}~""

111/"..,. OJ~"''''' 111/°,'1.1\,1',ft\n"" oPil&,C""tj 1\lPt.C

f,V') i',«p~ t\lIIlil&,'Ia'JUnOTJ,CDII}1.,.n f,OJ(ttjA ::

1!?;'

2) No person shall cause advertisement concerningdrug whether in writing or in any way which is notin compliance with law of trade advertisement, orthe directives issued by the Authority, or which ismisleading to the public as to their value or effect.

23. Packaging Materials and Label

1) No drug shall be put on the market or distributed byany means uless it is duly packed or labelled as maybe provided in the regualtions and directives thatmay be issued to enforce this Proclamation.

2) Any drug manufacturer, imp9rter, wholesaler,retailer or health institution shall ensure that alldrugs which he offers for use are duly packed andlabelled,

PART FOURNarcotic Drugs And Psychotropic

Substances

24. Special License Requisite

I) A special license issued by the Au~ority shall berequired to import, export, manufacture or dis-tribute narcotic drugs.

2) A special license to import, export, manufacture,possess or store narcotic drugs psychotropic subs-tances shall be issued only to persons having drugtrade lisence organizations.

25. Import and ExportI) Any person having a permanent special license to

import or export narcotic drugs or psychotropicsubstances shall apply for a special import or exportpermit for each consignment; such special permitshall be valid only for ninety (90) days.

2) No person shall import or export narcotic drugs orpsychotropic substances through post office or byship.

3) No person shall import or export narcotic drugs orpsychotropic substances packing them with otherdrugs or articles.

4) Any person who imports or exports narcotic drugs

or psychotropic substances shall comply withpackaging guidelines issued by the Authority.

26. Prescriptions

I) Only a medical practitioner who is registered andhave a special license shall prescribe narcotic drugs.

2) Psychotropic substances shall be prescribed by alicensed and registered medical practitioner.

3) No medical practitioner shall prescribe narcoticdrugs and psychotropic substances for himself.

4) Narcotic drugs and psychotropic substances shallonly be prescribed on a special prescription paper.

5) The management of and standard that any prescrip-

tion for narcotic drugs or psychotropic substancesshall fulfill would be set forth in the regulation to beissued pursuant to this Proclamation.

K' ~jf,~nr ~.J! {,,1A ~;Jt-'" ;JILl') -t.'I'L: t. IU.?!~4», IP.fji! q.9". Federal Negarit Gazeta - No. 60 29tl'June, 1999-Page 1113

27.fi~' ll/\h,f,fll

f'iC\'1'I:h'i I)J.'.\'1""(~'Ch oP ~~).":f'i ll/\ '1tUJ

fo<J.1AO' 1\.'}iiJ.'.(a":J" : t,\'1c~ oP,f'lr l.-o.,.~":J"-'i

fo<J lI'lr dJ I. cf>.y.":J"-~ A l"~ 'I /\ dJ- f -0 I."" I) 1''} dJ-lll' dJ J.'.'J"

(H'/\f hC~A dJ'lllf' oPcf>oPl''i ~A4,'J" n.,.4.cf>1./\""

11/\oo',f "I,:€:oP ,fll h/\ n ..,.::

llAh dJ ;11 f.'

o<J'}~dJ'9° .,.~~ fo<J,oP/\h"'dJ- {}dJ- f.,.n/ttr- i fh1A

..,/\ ,. 'ULJ'TdJ-9° ,f/\t.I1:t:dJ- i wJ.'.'J" nih1WI'~""

f"',fll' 'ic\'1-f:h WJ.'.9u I)J.'.\'1""~'ChoP ~~)..y.":J"-'}

n.,./\f 11:1' J.'.J.'.tIA : 'I/\P'AtlJ'" no<J..,fWtlJdJ- oPoPt"f

oPlPl..1'9u h'}JtW1~ ,fy'C;1A ::

fi~'

fiil' P' /,. ll/\".,* 1.1'

"",}~W'9u 4.~~ f'''{}l1lW' {}dJ- P'/',dJ-'} l1.J'*C'1'

nh:( ll/\ o<J..1'f.'I c\'1'I:h 'I I)J.'.\'1""~'Ch oP ~~)..y.":J"- i

1'\.'}iiJ.'.(a":J"-:I\./\..":J"-F.hoP'}.y.~'i OI/II'lr WI.cf>.y.":J"-11/\P'

AtlJ'" no<J,{}l1lW' oPoPt"f oP'lPl."" hllt./t1.dJ-'}

oPt,'l.9u J.'.'icn:t-A I:

t,\'1c~ h,f,fll'i t,7'c,1' hcf>/,.I.-o

o<J,}~W'9° t,~ ~ f"'{}l1ldJ- {}dJ- ll/\'ic\'1i:h WJ.'.'J"

I)J.'.\'1""~'Ch oP~~)..y.'f h1A..,/\""" 11/\P'AtlJ'" no<J..J'

wtlJw, oPoPt"f oPlPl."" t,\'1c~ oP,fll'i t,rc"" 01/:"1.-0

J.'.'icn:t'A I:

«!}.

«!}Ii'

hC~A ?;

ll/\oPCII":J"-'i'L1.I.C hlf:/tct oP~~)."'":J"-

ll/\ oPCII'.f..

Ii) 11/\P' A tlJ'" q /\ 'J" h cf>c~ oP /\ h.J'sP":J"-'} oP IPI.""

n"., ,f.:I.°' foPCI'":J"'} llCllC hdJ-I'.y./\o<J..oP/\h:t-TdJ-

U-/\. ,fl)w,:J'A I ll/\oPCI'":J"- h,f,fll i h1i7i1''i hW;J

1,f:9u oPoPt"f ,fWtlJA :1

tI'I'}~:dJ'9° {}dJ- hl1/\P'AtlJ'" A ~ t.~ ~ I),f1~oPC,,',}'.'} o<J'J"I."" : hdJ,6£b o<JlloPtlJ"" : OI/h~4.A

hJ.'."}"'A9° :1

0I1'}~:cD'9u oPCI'''}"''} fo<J"foPC"" : fo<J..,flloPtlJ wJ.'.'J"

fo<J..fhci~c~A {}dJ' 'I/\P' AfI)'" noaz.,fwtlJdJ- OPOPt,J'

oP IJ' 1..1' ll/\oPC'''''''' 'IICllC oPl.jf foP,fll'i /\'I/\P'

AfI'~, t,;rc"" fOl/:"I.,n o,!lo:r h/\n..,. II

"1I6f,}'~C J1~t}4: UO.(.:~~.,.:.t:

Ii' 11/\P'AtlJ'" nq/\9Uhcf>l"~fh.y.o<J..h1\.~C:( h.:l'}l1.

oPoPt"f oP ,,. I."" ll/\".1.I.C hlf:/tct oP ~~)..y.":J"-

1'\,f,fl1: P'C6£b,1': hlll~cf>'J"'i hW;J1~ oPoPt"f

,fClttlJAl1

,-.

e.

@!{.

~. 0I1'}~:dJ'9° {}dJ' A f, t,,4>,f: I)J.'.'i I.dJ' ".1.I.C hlf:/tct

l"1D,f,':~)..y.',}'.'} f\.J'oPc,1': f\.,flloPtlJ : f\.,fh~lj:A

mg.9° f\.jflf' hJ.'."}"'A9°1:

e. OIl'}~:dJ'9° A f. t,,4>f.' f"'{}l1lW' (}dJ- ll/\hoP/,.1.

:,.:,:w, : ll/\hiioPfI':':w, dJJ.'.'J" ll/\hh~t./tTdJ-

".1.I.C hlf:/tct oP,f,':~).'"'''''' 11/\P'AtlJ'" no<J..{}l1ldJ-

oPl"IDt"f oPlPl.,1' l"lDl.jf foP,fll'i t,rc"" fOl/~I.'"

.J'~p:" h/\(!:r',:

Storage

Narcotic drugs and psychotropic substances andinvoices, registers, and prescriptions shall be stored in alockable metal cupboard or in a special room the key ofwhich shall at all times remain in the hands of theauthorized professional.

28. Disposal

Any person shall keep damaged, expired, or seizednarcotic drugs or psychotropic substances in a separateplace and shall dispose them in accordance with thedirective to be issued by the Authority pursuant to thisProclamation.

29. Cessation of Business

Any person who is licensed pursuant to thisProclamation and who ceases to operate his business

-""shall deal with the stocks of narcotic drugs,psychotropic substances, invoices, other documents,and prescriptions related to same as directed by theAuthority.

30. Recording and Reporting

Any person who is licensed pursuant to thisProclamation shall keep records aI1dsend reports aboutnarcotic drugs or psychotropic substances in accor-dance with a directive that shall be issued by theAuthority.

31

PARTFIVEPoisons andRadiopharmaceuticals

Poisons

I) The Authority, based on international standards,shall prepare a list of poisons and communicate toall concerned bodies, and issue a detailed directiveon their storage, sale and disposal.

2) No person shall manufacture, import and distr~utepoisons unless he first have obtained a specialpermit from the Authority.

3) Any person who manufactures, imports or dis-tributes poisons, shall keep detailed records of suchpoisons in accordance with the directives that maybe issued by the Authority and reports to same.

32. Radio pharmaceuticals

I) The Authority shall issue regulations and directivesregarding the storage, distribution, use and disposalof radio pharmaceuticals in accordance with therecommendations that it may receive from theInternational Atomic Energy Agency.

2) No person shall manufacture, import, distribute orsell radio pharmaceuticals unless he first haveobtained a special permit from the Authority.

3) Any person who has a special permit pursuant to thisProclamation shall keep records and send reports ofmanufactured, imported or distributed radiophar-maceuticals, in accordance with the directives thatmay be issued by the Authority.

rut li'i'f..lifn! 4..1..t./A ~:Jt..,. ,?lLIIJ +''I'C t. {'at.?t§ +1 Iitf:ili ~.,...J

Federal Negarit Gazeta - No. 60 29th June, 1999-Page 1114

c!)c'

hr,:A ifm1:( A ~1 ;J'LJP'f-

th1W1' foP.(-~t.'t 1..,f,,-rt.

i' nW1~1\~ oP:"651 th.., fnl\m f"'l..!ll+tIJ \1Atr~

nll"'+CI "71~W-9" L:J>'(- f.,.(tmW- (tw-;u) fULtJ hCP~ h1+" I9. oPlPl.'t f"'oP1.n

"''''tlJtIJ~ "'''''1"'-1 "1'-;!h'l'w-1 "1:"4-.'tfLml hll.(-ll.'t WC n"7,e.nA1' "rt..'tw,e.9" bi1C IittJ n"7,e.nA1' oP+~ w,e.9"no-l\i:9" ,e.+tlJA==

1\) '1I\rAtIJ~.1 It,rllL:".(- L:J>J;.1n"7'1'TW-9"oP11.(- 1\f\.1\ (tw- \1ll.,.I\i\L hh1'(- qoP-rn"7,r1ll'l' hY'll-r qoP-r n"7,e.nA1'"rt.-r

"'I h-nc ?;ittJ n"7!1ll'l' h-nc t;ittJ n"7,e.nA1' oP+,I>"b ,e.+tlJA==

!l' "71<;:W-9" L:J>'(- f.,.(tmW- foP .(-~t.'t h9" {.."fI

hlloP'Ll.I 1\II. w,e.9" ~9"I\ hh4-4-,e. L:J>.(-1\f\.1\W-

(tw- oP.(-~t.'t \1h4-LI\ ho-I\-r qoP-r n"7!1ll

hh9"ll-r qoP-r n"7,e.nA1' "P't.-r "'I h-nc GittJ

n"7,r1ll'l' h"'c ?;ittJ n"7,e.nA1' oP+"'" ,e.+tlJA==C. "71<;:w-9"(tw- f11:J>-r"7l;J1651 f9"llhC wl+-r

It,e.lilW- noP.l~..~t-r f1..,.(- P't. h.,.(t"7t.hh9Dll-r qoP-r n"7,r1ll'l' h(tl1-r qoP-r n"7,e.nA1'

"P't.-r "'I h.nc ?;ittJ n"7,r1ll'l' h-nc 2ittJn"7,e.nA1' oP+,I>"b ,e.+tlJA==

9.' "71<;:W-9"f"fc;Fr: ,(-C~-r fthh9"'1 oo-! h"'l..L

:"1.W- oPm1 hllnA{O w,e.9" hlt1(8 hifm w,e.9"L:J>'(-hf\.l\w- (tw- oP.(-~t-r 11"'- \1+ln ho-I\-rqoP-r n"7,r1ll'l' hh9"ll-r qoP-r n"7,e.nA1'

"P't.-r "'I h..IC ?;ittJ n"7,r1ll'l' h-nc t;ittJn"7,e.nA1' oP+,I>"b,e."'tlJA==

?;. "71<;:W-9" (tw- oP.l~..~t-r foPhl\ll .(-C1.-r hL1aoP

w,e.9" hltlt"f 11\6£b"o-tt: noP.(-~t-r "7if1.! I\,e.

I\"'c.: w,e.9" nh'M~-r h-r.y. 11"'"1' w,e.9" 1.UW-

,rl\Ln-r oP.(-~t-r hifm w,e.9" I\h1A..,f\o-r \1'P1\

hhP'C qoP-r n"7,r1ll'l' hY! qoP-r n"7,e.nA1'

"P'(..-r "'I h"'c ?;ittJ n"7!1ll'l' h"'C 2ittJn"7,e.nA1' oP"'£I>"b,e."'tlJA==

}. flLtJ1 h'P~ '(-1;J1.sP"f w,e.9" ,e.tJ1 h'P~ l\"7ll

L1a9" fwm- 1.1f1"f'l' oPoP~!sP"f1 noP.,.I\I\tt:f oP.~~t -r 1..,.(- P' (,.1 f"'l..oP1\hi: f\.l\°"f

1'4-.y."f1 f L1aoP "71<;:w-9" (tw- ho-I\-r qoP-rn"7,e.nA1' "P'(..-r "'I h-nc Iitu n"7,e.nA1'oP"',I>"b ,e."'tIJ A ==

I\ILU h1"''' hL1a1a9DoP.(-~t-r "7l\-r f'l'C\"1i:h'l'It,e.\"1-rC''ChoP.(-~t .y."f1 h,e.g;}.9"C9"==

f'l'C\"1i:h'l' It,e.\"1-rr:'Ch oP.(-~t.y."f1 th1W1'hm:J>.,.9" f"'l..14-4- .(-C1. .y."f

"71~w-9" (tw-;

i. f'l'C\"1i:h w,e.9" flt,e.\"1-rC''Ch oP.(-;)t.y."f1

th1W1' hm:J>.,.9" l\oP14-4-.'t n"7'1'TW-9" oP11.(-\1ll.,.'Pw", w,e.9" f\.l\°"f "1Jl!ll.,.'Pw-cJ: \11.l1

w,e.9" hL"'1.;

c!)9..

PARTSIXOffenses

33. Illegal Drug TradeExcept penalizing in accordance with the penal code isstronger than the following:I) Any licensed person who:

(a) impedes the work of inspector assigned pur-suant to Article 14of this Proclamation shall bepunishable with imprisonment for not morethan six months or with a fine not exceedingten thousand Birr or with both.

(b) transfers the licenses issued to him to anyperson by way of any means shall bepunishable with imprisonment of not less thanone year and not more than three years and afine of not less than five thousand Birr and notexceeding twenty thousand Birr.

2) Any licensed drug manufacturer, importer, expor-ter or wholesaler who sales drug to a peson withouta license shall be punishable with imprisonment ofnot less than two years and not exceeding five yearsand with a fine of not less than five thousand Birrand not exceeding twenty thousand Birr.

3) Any person who trades drug without a certificate ofcompetence shall be punishable with imprisonmentfor not less than five years and not exceeding sevenyears and with a fine of not less than twentythousand Birr and not exceeding fifty thousandBirr.

.

4) Any licensed drug retailer who wholesales, ordispenses arugs in excess or less quantity than thatjustified by medical practice or purchase drugsfrom a person who is not licensed pursuant to thisproclamation shall be punishable with imprison-ment of not less than two years and not exceedingfive years and with a fine of not less than fivethousand Birr and not exceeding twenty thousandBirr.

5) Any person exercising unfair trade practice bycounterfeiting, or adulterating or affixing or en-closing mislabel to packaging material, or buyingor selling substandard or expired drugs shall bepunishable with imprisonment of not less than tenyears and not exceeding twenty years and with afine of not less than twenty thousand Birr and notexceeding fifty thousand Birr.

6) Any person who fails to comply with the provisionsof this Proclamation, or regulations and directivesissued pursuant to this Proclamation, shall bepunishable with imprisonment of not exceedingtwo years and with a fine of not exceeding tenthousand Birr.

7) For the execution of this Article drug shall meanany substance excluding narcotic drugs andpsychotropic substances.

34. Offenses Facilitating Abuse of Narcotic Drugs andPsychotropic Substances

Any person who:1) by way of any means, publishes or displays, or

causes or permits to be published or displayed anything promoting or encouraging the abuse ofnarcotic drugs or psyr.'otropic substances;

'IA"li1lifHi ~1-o~.i:\ ~;M"" ;JfLIIJ cft'1'C ~ ,.." ttl"''J Iiif:ii 'l."" Federal Negarit Gazeta - No. 60 29th June, 1999-Page 1115

I' OI1Ao.T~T tD~'r nI1A~,.:t"~T nll1tD- o.TI ..,0.

tD~'r n"7'i:ftD-'r "-1\ P:t" 'ici1i:h tD~'r lt~i1Tc."Ch 00.('~t"":f ~1 tD1' +m"+"t9»:f ~1-'l1A1~nT l11.l1 tD~'r hL+1.:

C' f'iCi1i:h tD~'r flt~i1Tc."1:h oo.('~t"":f A"7l111f"7..fit:fA L:J>1: lt~li ltD- ~1-'ltD"'~ l11.l1

tD~'J° hL+1.:

~I f'iCi1i:h tD~'r flt~i1Tc.'1:h oo.('~t"":f A"7l111L:J>.('o.liltD-'r .fAn4: 'rh11T tD~'r h+10.tD-oom1 nl\~ I1f1tH

?;. fthh."'" T~t111 f+~nlnll n~1tD1' 0011.('

f++fl= f+1.AtI tD~'r 1.H.tD-.fALOT 001f)'1~.ftD+ f'iCi1i:h tD~'r flt~i1Tc.'1:h oo.('~t

"":f1 h1('m tD~'r l1+l(h h...I1T 'OOT O"711it'i'h"Ft. "'ritT 'oPT (1"7~IA1' ~Ft'T'i h-oC~if..u O"711it'i h-fIC !litu n"7~nA1' oo+~~+IfJAII

i~' itAtD-Cit

ntLU ""';E- n"'+Jr ~C ~'i ~~ f+OOAh-J:T tD1:(A-:ff+L~oonT tD~'r htD1:(~ f+1"f 1-olT ~tDlltAII

00.('~t"":f1 n+OOAh+ itA"tL~"'" "-A-:f tD1:(A-:f

Ii' hOO.('~tT "it+.&;1.C'i 4:1'1'C Ft. ;JC n+IIt1.fFt- ooiti1:f +oo.('P f"tlPt. f001..,FTIPt..,.~ tD~'r ~1\4. oo1.AI noo+nA tD~'r

n119°.(''i tD~'J° "o"HI I1AIf~ "-1\ """f.~T ntLU

"";E-'i "":(1 A"7itL~'r n"ttDm-T 1.1P:y. h+1.'111tD.tD-1iflo :

V) fOO.('~tT ,..,.(' Ft. L:J>.(' f-n:J>TI17l;J1651 f'rithc tDl+T f"'m tD~'r

~1-'ll11' .f1.l1 m~'r .f1.'" m~'r ~1-'l:t"1.it.f1.l1 :

A) fOO.('~tT tD~1JDfOO.('~tT IJDCT A"7lJDlT

f"t.f1A..,A' 1't. ":J>9»:f1.U1~T = L"7i~T'if1't.T l.l~ "'1n.tD'1 "''r1''7 tD~1JD4:1'1'C

It.f1.C''' "1A..,i\oT I\~ ~1-'ltD-~ fL+1.(J}~IJD~1.ctt.+.(' .f1.l1 ~11.1f~ h~ ~OOT

nll7.f1itC; hI?; qOOT n"7~nA1' ~Ft'T ~'i

h.nc ~itu f"7.f1it'i h-nc !litu f"7~nA1'uP+,"" ~+IfJA:1

I' (ULU'"'+Jr 1a-it "'+Jr (Ii) f+OOAh+tD- :t-IfJTuP1.A.f nl1mtD- 'IA"'&;~ I\~IJD+t.R"t ~1f'iA II

C' fULU"'+Jr 1o-it "'+Jr (Ii) O+ooAh-J:T 1'~"":fnoot.~1JD .+..,I1C tD.it1' f+lt+t.'i ,..&;~ m1. tj:C.('

f1.T hoo:t-lf1- n4.T itA+L~OOtD- 1'~T'i itA+1111(,9»~ "t'i m*OI/. ool~ i\"'ml1m- ftj:TU "ttitof:C

fULU ~.., OOlPlT hit ~1.&;~00IPlTnT A.11.C..,

~":J"I\A II

t!)1'

t!)~.

htj:A ~A ~ A ~ .('1 ;J1.9»:f

ool~ itA"7it+I\Afi:

foo .('~tT ,..,.(' Ft. L:J>.(' f"tl1m- "..,11-0 11\:ftD-

"I1I\T itA"'m-T'i itl\1.r'1-T fOO.('~tT ,..,.(' Ft.L:J>.(' AI1AFAIfJ). ool~ f"7it+I\Atj: ..,1..:t"

"AI1:ftD-1I

2) is an owner or occupier of a house, a compound orany place, causes or permits there the ~buse ofnarcotic drugs or psychotropic substances;

3) administers or causes or permits to be administerednarcotic drugs or psychotropic substances withouthaving a license to prescribe;

4) without sufficient reason or above the standarddose, prescribes narcotic drugs or psychotropicsubstances, even if he has a license;

5) sells or supplies narcotic drugs or psychotropicsubstances on presentation of a prescription, wherehe knows that the prescription is forged, unlawfullyaltered, cancelled or expired, shall be punishablewith imprisonment of not less than 7 years and notexceeding 15 years and with a fine of not less thanthirty thousand Birr and not exeeding fiftythousand Birr.

35. Confiscation

All properties used to or derived from the Commissionof the offenses mentioned in Articles 33 and 34 of thisProclamation shall be confiscated.

36. Qther Offenses Related to Drug1) Any civil servant or official assigned to perform

duties related to Drug Administration and Controlactivities who by taking bribes or through nepotismor favoritism or other illegal relationships byviolating the Proclamation and regulations to beissued pursuant to this Proclamation:(a) issues and renews a certificate of drug trade

competence and certificate of professionalregistration or mislead others to do so;

(b) authorizes the use of drugs and raw materialswithout making adequate evaluation or inves-tigation of their quality, safety and efficacy ormislead others to do so;shall be punished with imprisonment of not'less than ten years and not exceeding fifteeny,earsand with a fine not less than Birr thirtythousand and not exceeding Birr fiftythousand.

2) The penalty provided for under Sub Article (1) ofthis Article shall also be applicable to a person whohas given bribe.

3) When the offen~e provided for under'Sub-Article(1) of this Article is committed by more than oneperson, if one of them first give adequate infor-mation 'on the commission of the offense and therole of the major role player(s) before the case wasseen by court, Ministry of Justice may free theperson from criminal liability .

PART SEVENMiscellaneous

37. Submission of Infonnation

Legally delegated and authorized bodies should submitcurrent report, regarding Drug Trade License theyissued or renewed, to the Authority.

~lin:U!i 4..1.I,-/A ~;J":" ;JtLIIJ cf11'C~ (a~?;I+' !Dfjji ,.,-. Federal Negarit Gazeta - No. 60 29thJune, 1999-Page 1116

41. Powers to Issue Regulations and DirectivesI) The Council of Ministers shall issue regulations

necessary for the effective implementation of thisProclamation.

2) The Authority shall issue directives necessary forthe effective implementation of this Proclamation.

42. Effective Date

~CP:(.fO"J~«;n""1.IL This Proclamation shall enter into force as of. the 29thday of June, 1999.

~U ~CP:E-h(\~ tJl"" Iur.:ili q.9" 1.9"r: f~'i ~1f'i1A :1

~~. foo"if;J1{"I1:');J1.

~U ~'P:E- hoofD-lI)-f: n4."" f"'(\m fl1:Jt"" '''It;J1-'

f9"hhe lDl."''''' (lIlU ~CP:E- OOIPI."" "')1."'(\m

.,..,..-r: lULU~CP:E-«; ~U') ~CP:E-A"'litUt;o n"tlDm""

1.')(1'f'i ooOO{".ftp'f OOIPI."" ~"'~1.t-1A 81

c!)u' hlAhit

".,')~m-')9" foo1:~t"" ')..,1: ",t- .fAoo1:~t"" I1A

oo..f ""i1~1: ~~:FIA9" ::

f"'7i~ :I11'f

Ii' f"th.,.f\o"" lULU ~CP:E-.,.1iI.CPIA;

V) foo 1:~t"" ~"'''''OO9'''i "(\11),,- f4-C"7f11:1

1:');J1. ck..-e ii/Iii'-';A) f4-e"'lft. 1.')11 ck..-e !Uit~/Iii'-!li nflU

hCP:E-n.,."ifL). 1-~f"'f It~ "'L~"t~"" ~~':'

I.fD-9"II

I'. ~U1 h'P:E- f"t:J>I.') "'l'iTfD-9" :11..,. 1.111lD~9"oooo{".f HllU ~'P:E- fD-it..- f"'OOAh-f: 1-~f"'f')

n"tooAh"" "'L~"t~"" ~~':' 1.fD-9"81

~.

~Ii- 1.,)11'i oooo{,,1 f"'lfD-II)"" ",1A1I)')

Ii- f"'l.tit""r:'f 9"he 0."" ~U') hCP:E- A"'litUtr

f"t.fitLIA1- 1.')(1'f') A..fmll) ~'fitlA II

I- I1A",IAII)). ~U1 ~CP:E- A"'litL~9" f"t!itLIA1-

oooo{".ftp'f') A..flDlI) ~'fitlA II

~I'

h.ctit hn'1 (\~ tJl .,.') Iiir.:ili q.9".

?-/e ~;J(t 1.~~

fho ""f"k.f tf.-s.'..t-Itce .ct'fOht-ft.lce {"Tl1A.h

T ("Il~')""

38 Transitory Provision

The certificate of competence issued prior to the cominginto force of this Proclamation shall be deemed to havebeen issued under this Proclamation and be subject to theprovisions of this Proclamation and to regulations anddirectives issued pursuant to this Proclamation.

39. ProhibitionRunning Drug trade in the absence of a professionalPharmacy Personnel shall be prohibited.

40. Repeal1) The following are hereby repealed:

(a) Decree No. 9/1947 relating to the Phar-macopoeia for the Maintenance and Adminis-tration of Medicine.

(b) The Pharmacy Regulations Legal Notice No.288/64, with respect to matters covered in thisProclamation.

2) Any law, regulations, directives or practices whichare inconsistent with the provisions of thisProclamation shall not apply with respect tomatters provided for in this Proclamation.

Done at Addis Ababa, this 29thday of June, 1999.

NEGASO GIDADA (DR.)PRESIDENT OF THE FEDERAL

DEMOCRATIC REPUBLIC OF ETHIOPIA

.ncn'i" M9" ",.,."tl .(-c:E-"";1-"'00BERHANENASEL.,\MPRINTINGENTERPRISE