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4o~t-A ";1&:'" ;Jttt1l FEDERAL NEGARIT GAZETTE
OF THE FEDERAL DEMOCRATIC REPUllLlC OF ETHIOPIA ..... ------_ .. _-,
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CONTENTS Regulation No ,299/2013
Food, Medicine and Health Care Administration and Control Council of Ministers Regulation ............. ........ ... ... Page 71.83,
COUNCIL OF MINISTERS REGULA TlON No.29911013
COUNCIL OF MINISTERS REGULATIONS TO PROVIDE FOR FOOD. MEDICINE AND HEALTH
CARE ADMINISTRATION AND CONTROL
This Regulation is issued by the Council of Ministers pursuant to Article 5 of the Definition of Powers and Duties of the Executive Organs of the Federal Democratic RepUblic of Ethiopia Proclamation No. 69 112010 and Article 55(1) of the Food. Medicine and Health Care Administration and Control Proclamation No. 661 t:!009.
I. Short Title
PART ONE
GENERAL
This Regulation may be cited as the <;Food, M~dicine and Health Care Administration and Control Council of Ministers Regulation No. 299/2013".
2. Definitions
In this Regulation unless the context otherwise requires:
1/ "Proclamat ion" means the Food, Medicine and Health Care Administration and Control Proclamation No. 661 /2009;
21 "food" means, without prejudice to the definition provided under Article 2 (I) of the Proclamation. a product that is produced by food manufacturer for more than one regional state or foreign markets.
31 "food manufacturer" means a manufac turer producing food intended to sale for marc than one reg ional stille or foreign markets, excluding micro and small enterprises en gaged in the preparation of traditional foods;
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41 l~ fGod sa fety" means the proo r , ~:l d control o f
food that is safe for use in the process of
delivering food to the consumer Ihrough proper
manufacturing, preparation, handl ing, storage
and transportation;
51 "food irradiation" means the process of
exposing. food to radkuion energy to kill
harmful bacteria and other organisms to extend
shelf-life;
61 "potentially hazardous food" mcans food
exposed 10 or capable of support ing the growth
of disease-causing microorg3nisms or the
production of toxins ;
71 "pre-packed food" means food ,hat was already
packed by the manufacturer before reaching the
seller;
81 "food supplement" means a type of food' that
supplement the normal diet and which is a
concentrated source of vitamin, mineral or other
substance with a nutritional or physiological
effect, alone or in ' combination, designed to be
taken in measured small quantities and is
prepared in capsule. pill , powder, liquid, drops
or any other similar forms;
91 "infant formula" means milk or milk-like
product of animal or vegetable origin
formulated industrially in accordance with the
appropriate standard for infant formula and
intended to satisfy the nutritional requirements
of infants starting from birth and during the first
six months;
101 "follow-up formula" means a milk or milk-like
product of animal or vegetable origin
formulated industrially in accordance with the
appropriate standard for follow-up formula and
marketed or otherwise represented as suitable
for feeding infants and young children older
than six months of age;
II I "complementary food" means any food
processed in du~trially. sui table as a complement
to breast milk. infant formula or follow-up
formula when it become insufficient to satisfy
the nutritional requirement of the infant.
121 "genetically modified food" means meat and edible plants modified through genetic engineering;
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Federal NcgaritGazene No.!l 24th January, 2014 P:Igc 7185
13/ "alcoholic beverage" means any beverage
containing alcohol, whatever its strength;
141 "sell" means to offer, advertise, keep, store.
display, or deliver for sale or to exchange "food,
medicine or tobacco product in any manner for
consideration;
151 "certificate of pharmaceutical product" means a
document issued by the Authority or the
manufacturer country regulatory body
confirming that the medicine is manufactured
by a licensed manufacturer;
161 "good manufacturing practice" means the basic
principles which any food or medicine
manufacturer should consistently comply with
in manufacturing safe and quality food or safe,
efficacious and quality medicine;
171 "complimentary or alternative medicine" means
a raw or partially or fully processed product
which is neither indigenous traditional medicine
nor associated with modem medicine;
181 "dangerous chemical" means a chemical that
can cause severe injury to human health if not
cautiously kept or utilized and categorized as
dangerous by the Authority;
191 "hazardous waste" means any waste deleterious
to human health and that cannot be recycled;
201 "recyclable waste" means liquid waste that
could be treated to avoid injury to human health
or waste that could be transformed into usable
thing through various mechanisms;
211 "frontier port" means· international airport,
controlling station at border or dry port
designated by the competent body;
221 "communicable disease" means disease that can
cause major epidemics by spreading rapidly;
231 "quarantine" means separation of persons who
are suspected to be exposed or infected with
emergent communicable disease until the
infection is confirmed;
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Federal Ncgarit G<l.7.ctte No. II 2-l'h bUlJJr~'. ~0 14 Pat:l.: 7 J lS6
241 " isolation" means scp;::.ration o f;J person who is
infected with communic;)ble di sease for certain
period so that he may not tr:m smit the di':;cJsc-to other persons;
25/ "conveyance 9Pcrator" means airplane or trai;l
captain or the driver of any other operator of
conveyance;
261 "health professiona l" means a person registered
as a health professional by the appropriate
organ to protect human health or provide health
services and includes complementary or
alternative medicine practitioner;
271 "health service" means a service provided by a
health professional as per the type and scope of
practice permitted by law:
28/ "insumciently available health professionals"
means health professionals regarded as
insumciently available by the Ministry of
Health where the national demand remains
unfulfilled;
29/ lIimpairment" means a mental or physical
condition which reduces the competence or
judgment of a health professional in performing
his professional duties;
30/ "mental disorder" means a disorder of thought.
perception, feeling or behaviour that seriously
impairs a person's Judgment. capacity to
recognise reality, ability to associate with others
or ability to meet the ordinary demands of life,
in respect of which treatment is advisable;
311 "unprofessional conduct" means the conduct of
a health professional contrary .to professional
ethics or obligations stipulated in the
Proclamation, this Regulation or other relevant
law or standards;
32/ "client" means a patient or user who establishes
contractual or otherwise relationship with a
health professional to obtain health service for
himself or for a third party;
33/ "inst itution" means health or complementary or
altemat ive medicine service institution or food
establ ishment;
34/ "food establishment" means all estab lishment
undenaking food trade in accordance with
Ankle 2(2) of the Proclamat ion. but does not
include food retail trade;
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Federal Ncgarit GJzette No, I I 24'j, Janu:1ry , 20 1:t PJ.ge 7187
351 "food handler" means any person involved in
food manu facture, import or export trade
activity having contact with the food;
361 "food forti fication" means (he addi tion of one
or more micronutrients to a food to prevent or
correct a demonstrated de fic iency o'f one or
more nutrients in the general population or.
specific population group;
371 "health"' means a state of complete physical,
social, mental wellbeing and not merely the
absence of disease or infirmity;
381 "life saving emergency treatment" means a
service provided by any person or trained
professional 10 a patient who has encountered
imminent and life threatening disease or injury
until Ihe palient has got access to regular health
care services;
39/ "emergency medical treatment" means a
medical treatment provided in health institution
by a health professional to a patient who has
encountered disease or injury which could
result in imminent and life threatening or
pennanent health problem;
401 "tissue"' means collection of cells typical in
structure, composition and function that are
taken from organs excluding reproductive
organs such as male and female reproductive
organs, testosterone and progesterone, fetus and
blood or blood products taken during blood
donation;
411 "transplantation" means substituting, through
surgery, a patient' s infected organ or tissue or
that which is unable to perfonn its normal
function by donated organ or tissue from a
living or dead person;
421 "artificial reproduction service" means the
introduction of semen into a female's vagina or oviduct for the purpose
of fertilization by means other than the natural
way and includes uniting spenn and egg cells
externally with a view to introduce the fenilized
sperm and egg into such female's reproduclive
organ;
431 "distributor" means a person who distributes
food or medicine products in more than one
regional state;
IJ~'" INI7-
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h?d~'ra! NcgaritUazcltc No. I I 2·1'10 J;mu;w-,", ~(il 4 Page 71!S8
44i "Authori ty" means the I:lhiopinll Food,
Medi::ine and I-Iealth C:!re ;\dmin j~lrat ion and Conlrol Authority;
45/ other definitions provided under Artide 2 of the Proclamat ion shall be "pp lic;'h l ~.
PART TWO FOOD AND MEf>IClNE
ADMINISTRATION AND CONTORL
CHAPTFRONE
FOOD SAFETY AND OUALITY
"'I'i'l'arr lim,'; '/'1)0'1"'1. YtllJ'~ (lJg.9" '/-7fl.ar')
V.I'. v'n')'" '1' t·')· .1'.01 Y tlmtH 9""I·fl il.no/.'l· ;
3, General
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1111.r.·f:'l ilUDIX\,OOC I UD ... h·'l
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If~ on·n, Oon-n· uU,I'.'lI'lT r 'I-hI'lhn ~ar::
"'I'I'i' ar ')9" 1'9""'1'0 "'I7i'/,! I ooM i I"l"'l.l':
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O'har~'/''i'ar 119"':·':(· 'h'l.r.-tool.·1· fl"'lilooiltl
m,{'.?" 1'9""I0''l 'l'':. ')'" .I'.V'l~·)· M.I'.'(r
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No food unfit for human consumption or not
complying with appropriate safely and quality
standards may be manufactured. imported. exported,
stored, distributed, transported or made available for
sale or use to Ihe public.
Food Manufacturing
II No food manufacturer may, wilhout registration
and pemlit rrom the Authority, sale food
product intended for distribmion in more Ihan
one regional state. or for export market, or
change the type and production process of the
food.
2/ The Authority shall register or issue a permit in
accordance with sub-anicle (I) of this Anicle
upon ascenaining the fultilment of good
manufacturing practices, food safety and quality
laboratory test and other necessary
requirements.
3/ Without prejudice to the provision of sub-anicle (!) of this Anicle the Authority shall adopt
directive determining the kinds of foods that shall be registered.
Food Adulteration and Counterfeiting
II It shall be prohibited to add or mix any
substance to any food so as to increase its bulk
or weight, or make it appear bettcr or for any
other similar purpose.
2/ It shall be prohibited to partially or completely
embed in any food anything hannful to human
health or that can affect the safety and quality of
the food.
3/ It shall be prohibited to present any food as if it
is produced by the real manufacturer or
affecting quality and safety by imitating its
package, identification, trade mark, trade name
or any mark.
n' i.7i.Iif-irilt .. f.t·1.\ t'kl' .7!Lr11 'i~'T'C X,~ '1'C .~· X ."') ~i'i.X ~.~. Federal Ncgaril Gaz('ttc No. II 241b JanuaJ)',2014 I'ilgc 7189
======~======================= I 6. food Stor.az~TrRn50ortation and Disolav
!il "'I'g'oH" \'7"~J-fl M " t. :1" , 1111. ' M1""(,I;',
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11M')' n"'lf ,?A'l' avAh· o-oU"} MO')'::
!.'I "'I1'i'm·"?" 7'''7 ·n h'~nht'l 9""I'0 ! h9""Ill "'·C<j:6·P hODC1" 1· )t hlf;" ~?C'f ! hh'){) ft,)· Ol)'.9" Ilt>(o°',f· OilY. 'I?C'-:;' ;JC "'Ih"'l
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h1'~lI' (ti) opu'l.t h1.<t01\l\,"1 r'rllf r"l-n1
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tlSlo>· Y.7CJA::
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ru,e;tt') ou{)&'c,H') n"'l.)"',!1 ouAh' .<t~y,'}
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oullt'l'l' rtln}9"::
I I Any food manufacturer. exporter, importeJ or
distributor shall store, display. pack or transport
perishable food at appropriatc tempt'rature or
cold chain.
21 AllY food manufacrurer, exporter. importer or
distributor transporting food on or in any part of
a vehicle may only be possible where that part
has been cleaned to such an extent that
chemical. physical or microbiological
contamination of the food is prevented.
31 It shall be prohibited to store, load or transport
any food together with contaminated food,
waste food, poison. any hannful substance,
animal or any .other contaminant.
7 . . Food Fortification
11 For the purpose of protection of public health
the Authority may order any food manufacturer
to fortify food with different minerals and
vitamin .
21 Any food establishment may only manufacture, import, distribute or sale any food identified for fortification in accordance with sub·artic\e (I )
of this Article where slleh food is enriched in accordance with requirements adopted by the Authority.
31 The labelling of fortified food shall contain the
phrase stipulating with what mineral or vitamin
the food is fortified .
8. Food Irradiation
II A food irradiation establishment shall be
designed (0 meet the requirements of safety and
good hygienic practices.
21 The radio nuclei remain in any food may not
exceed the acceptable limit.
/I. r"l1l 0>1. MC M .... ,\h
O>-{)'l' M"'IIl7CJ=,/''j' (J}!'. o>-~ 9. Food Import and Export
\ [il "'I1'i'0>·r flo>- tlVlll.1't'I·n h1A"}ft-')
r"'l.o>-t\ 9°'1111 0>1. ,,7C o>-fl'l' "'I1l7/j.). f"'l:NI(J}' /j1'lP'tllTJ'r \'9""10,' Y.vntc; 'l't·')- il"'ll,:>7'r c'l.J.~.£: ",lfC;t\::
II Any person may only import food for public
consumption upon obtaining permit issued by
the Authority after ascertaining the safety and
quality of the food.
17t' :~o.tirl t.,~',(;,C\ ~.7t} ?IV'l 1:'1'C Iti 't'c n .,.-, MTLl Ii.?". Federal Negarit Gazetle No. II 2·I,h .lall uary , '.' 014 Page 7190
-"""""'========""""""===;~==,,,=------.-.-.--'=~- - -'1f1P't\f'l'r hm'''1i> MC 1'1'1 9'''']'0 )'.tJJH:<J 21 Where the Authority ,!Scemin, that imported V-I 'l',H: YA'I'mO '~ ",,[J'~-') Ill,:J7m h"l'111 food is not safe and is of poor quality. it may
(U:O)' ~oj'}I>'.· h '}JtiD?~' m,£.9" ro~ oofTlO")' order its appropriate disposal or may cause to
h1C ),Vtaollfl Yfl)'.C;;tI:: be returned to the country of origin.
L'I '111P'C'.fTJ'r :wu"l'r, "'h.m· '1'9:9" ItmN> P9"C'/O 1'I\·I1&'-I'·t 9"Co<>&. f9 D ilhC (1)<'.4")"
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I. M:t..Q;I, "'I t it <J tlor'!' ",yor 9""l(l'f
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"'1'l'i'ar9" oor htlA -t-'li;;t l'iD''1 h:t-cM· h1A,,/I\·')· avflm')' l''''I.ifflor M (Jl-'/or '.tJ'l~')·<J
'!' t- ,). hIl flp' A ffI 'r "'Il?1 ""I. c'I. om or 111 ~ or ::
Ir. Mhtl/lt\ 71r"L'
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o 1If. 1''''1.0 t- "L' ; II or "L" h 1 C 10J' fl7iY"L'
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l'),tI/lA oom'!' h"l'l'O ,I'flor h!JtI ,I'lDfflorJ
J(l:q \'°'l.,1'''lll ODU") MM·::
3/ The Authority shall, when requested by the
exporter, issue a certificute of lab~ratory
analysis, a certificate of authorization to sale the
product at the local market or health certificate.
10. Food Supplement and Genetically Modified
Foods
I I Any person may only sale food supplements
upon the registration and .. permit of the
Authority.
21 No person may sell a food supplement unless in
pre-packed form and its labelling contains the
phrase "food supplement".
31 No labeiling. presentation or advertisement of a
food supplement may describe that a balanced
and varied diet cannot provide appropriate
quantities of nutrients or attribute to the food
supplement the property of preventing or
treating a human disease.
41 Special pernlit of the Authority shall be
required to manufacture. import, export or
distribute genetically modified foods.
51 No person may sell genetically modified food
unless in pre-packed fonn and its labelling
contains the phrase "genetically modified
food",
11. Infant and Follow up Formula and Comple
mentary Food
II Special permit of the Authority shall be
required to manufacture, import, export or
distribute any infant and follow up formula or
complementary food.
21 The Authority shall adopt specific requirements regarding the marketing of breast-milk substitute.
12. Trans-Regional Water Supply
Any person may only carry out trans-regional water
supp ly services upon the approval of safety and
quality of water by the Authority.
13. Sale of Alcohol
I I Any alcoholic beverage produced at industry
level for distribution in more than one region or
for export market or imponed for local
consumption shall comply with the standards
prescribed by the competent organ.
•
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Federal Ncg.arjtGazl:lI~ Nn. l\ 24\h J:"lnuarY,2.01-l Pag~ 7 19 1
2/ Alcoholic b~vcragc supplied to mnrkl'l pursu3m
to sub-art icle ( I) of this Article hovin, less than
ten per cent of alcoholic content sh:11! state it s
expiry date on its label.
31 The Authority shall issue directivt: regarding
regulation of alcoholic beverage.
CHAPTER TWO
MEDICINE ADMINISTRATION AND CONTIWL
14. Gener:"
No medicine the quality, sofety and efficacy of
which is not ascertained may be m;mufactured,
imported. exported. stored, distributed . transported
or made available for sale or usc to the public.
15. Manufacturing and Certificate of R('.gistration of
Medicine
11 AllY medicine manufac.turcr or an agent may
only manufacture or import a med icine that i's
included under the nationa l drug li st.
Notwithstanding sub-article (I) of this Article,
domestic medicine producer may produce
medicine not included in the national drug li st
and have it registered in a special circumslance
to sell it to foreign market.
No medicine that is not included in the national
drug list and not having certificate of
registration may be supplied to market.
41 The Authority shall issue a certificate of
registration of medicine market authorization
afler:
a) assuring the medicine mnnufacturer's
compliance to good manufacturing
practice;
b) the medicine dossier is evaluated and found
to fulfil safety, quality and efficacy ·
requirements; and
c) the medicine fulfil laboratory qllality test
requirements.
51 Any medicine manufacturer may change any
information submitted during application for cenificate of registration of a medicine after
issuance of the certificate only upon written notification to and approval orthe Authority.
-=--:';/ 41'rg:m·?" tmx:;"I'1:1· fflulJll'/O ),9"/,·:-",
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IIlf~ A"J'lll '1i'\ar oo'11Y: ~, 'IP,,(1)l$': ro,!'.9" roy. au<l\n-)' ~,lC h'J.'I,OD(\{) .l'M'.C:>(.I::
61 Any manuracturer who h,,, 'l.OI regis tered
medicine shall submi t J!l application to the"
Authority for the renewal 01' th" certificate of
rcgistrution of the merlicinc s ix months before
the expiry o f the per iod stipulated under An iclc
13(3) of the Proclamat.ion.
16. Storage, Transportation and Oistrihuiion of
Mc!lieiD~
II Any medicine manu factu rer, exporter, imp0l1er
or distributor shall store, transport or distribute
medicine at appropriate temperature or cold
chain.
21 Any m~dicine manufacturer, exponer, importer
or distributor may transport medicine by any
conveyance only where the compartment of the
conveyance that has link with the medicine has
been cle.aned to the extent Ihat chemical,
physical or microbiological contamination of
the medicine is prevented.
17. Medicine Ad"lIcration and Counterfeiting
1/ It shall be prohibited to add or mix any foreign
substance to any medicine so as to change its
amount, content or weight, or to make il appear
better or for any other similar purpose.
2/ It shall be prohibited to partially or completely
embed in any medicine anything harm ful to
human health or that can affeci the quality,
safety and efficacy of the medicine.
3/ It shall be prohibiled to present any medicine as
if it is produced by the real manufacturer by
imitating its package, identification, Irade mark,
trade name or any special mark or present it by
altering its content and nature.
18. Importation of Medicine
11 Any person may import medicine upon
obtaining pre-import permit and a penn it of
entry from the Authority at a port of entry.
2/ The Authority shall calise the disposal or the
return to the country of origin of imported
medicine, as may be appropriate, when its
safety, quality or efficacy are not up to Ihe
standard.
•
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r~deral Ncgarit Gazette No. II 24lb January. 20 14 I'ilge 719}
31 The Authority shall issue appropriate evidence
for the disposed medicine when requested by
medicine importer.
19. Raw Material and Pacldng of M('dicine
II
21
Any person may only produce. imp0l!, export.
distribute or store raw materio.!s and packaging
of medicine after obtaining permil from the'
Authority.
The Authority shall issue detailed directive
regarding raw material and packaging of .
medicine.
It. fAt"""10 uu~·2'1.,r Ol!: h1' orllT 11.111 20. Import orMedidne Not Registered OO"'l.TMt !J:'l.;J'
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6.:1'Y: '1.'1 fl.il·l· Mt.1\7. MF.:V) "'Irl.lI Mil')' : :
The AUlhority may, on anyone of the following
grounds, grant a special PCOllit for th(' import of
medicine not registered :
II for clinical trials or any other scientific
investigations; .
21 for personal use of a patient. when prescribed
by physician;
31 for conducting laboratory quality test for registration purpose;
41 for natural or man-made disaster or similar
emergency aid;
51 for use of diplomatic missions; or
61 for medicine lacking motivation of importers or for medicine used for the treatment of diseases not given adequate attention.
21. Poisons and Radioactive Pharmaceuticals
No person may manufacture, import. export,
distribute, store or possess poisons or radioactive
pharmaceuticals without obtaining a certificate of
competence from the Authority.
22. Clinical Trial
I I Clinical trial on human subjects may be authorized by the Authority after the research proposal is being evaluated and accepted from scientific, legal and ethical perspectives.
21 Any researcher applying for authorization in accordance with sub-article (I) of this Allicle
shall submit to the Authority the research proposal, relevant information about himself
and his associates , the medicine for the trial, permit from Clinical Trial Ethics Committee and other necessary documents.
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Fc.eeraJ Ncgarit Gazelle No. II 2·)'-" January,20 14 Page 7194
= 31 The Authority shall regulate the progress of an
authorized clinical trial regularly in accordance
with good medical procedure, suspend or stop
the clinical trial where necessary. ev"llIate the
results and authorin' the usc ()f the result In
such a way that it benents the pllblic,
tir. I'mlll''''' -lit· ..... ~-9'''7IlC n°'l.1; -t-4'tTJtTJt 23. Clinical Trial Ethics Committee Sunervisorv
I'LlJI>\ Body
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I I The Authority shall establish a Clinical Trial
Ethics Committees Supervisory Body.
21 The Clinical Trial Ethics Commitlees
Supervisory Body shall be responsible for
recognizing and monitoring clinical trial ethics
commitlees established at different levels and,
where necessary, for establishing them.
31 The Director General of the Authority shall be
the Chairperson of the Clin ical Trial Ethics
Commiltee Supervisory Body,
41 The Clinical Trial Elhics Committee
Supervisory Body shall issue directive
necessary for discharging its responsibilities.
24. Obligations of the Researcher
II The researcher of the clinical trial may not
disseminate the result of the research without
notifying to and getling approval from Ihe
Authority.
21 The researcher of the clinicallrial shall have the
duty to allow access to and cooperate with the
Authority in inspecting the place of the trial
and the trial documents,
31 Except covering reasonable costs incurred in
the clinical trial, the researcher of clinical trial
may not make any payment, in cash or in kind,
to the person subjeclto the clinical triaL
25. Clinical Trials on Pregnant Women, Nursing
Mothers, Minors or Foctus
Clinical trial on pregnant women, nursing mothers,
minors or foctus may only be carried out in
accordance with Article 15(4) of the Proclamation
upon ascertaining the fulfilment of the following
conditions:
"""."
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Feoeral Ncgaril Gazette No. ! 1 24th January,2014 PlIgc 7195
II scient ific evidence is produced proving Ihal the
medicinal product is intended to diagnose.
prevent or cure diseases in pregnant women,
nursing mothers, minors or foetus;
21 clinical trial carried on persons olher than
pregnant women, nursing mothers, minors or
foetus cannot be expected to produce
satisfactory test results according to scientific or
medical knowledge;
31 in the case of a clinical trial on nursing mother,
the amount of medicine passing into breaSI milk
may not cause harm to (he breast fed infant;
41 in the case of a clinical trial on a pregnant
woman or nursing mother, the informed consent
of the pregnant woman or nursing mother and
the father of the minor or the foetus or, in
absence of the latter, the consent of the pregnant
woman or nursing mother is obtained after
being briefed about the clinical trial;
51 in the case of a clinical trial on minors;wilhout
prejud ice to the interest of the minor, the
informed consent of his father and molher or in
absence or one. the informed consent of the
other parent or in case of an orphan minor. ·the
infomled consent of his guardian is obtained;
61 in the case of a clinical trial on foetus, it is
confirmed thai the trial may not cause harm to
the foetus, and the informed consent of his
molher and father or in absence of the latter, the
consent of his mother is obtained.
~~, ObbP"r:' ihuoP"1''l'x 11£ M"'I u., rihbp"'i . 26. Clinical Trial on Persons with Mental Disorder
~
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l''''I.h'I'fI·.'f· II''!.;!'?''!'' aD"" 1I;1''fm· lI.L;J1'l'
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f(7U·ht· 01'1ll,')' "'IY""]')' h')Y.",?;ftl
"Y,')I\P, IOY,9" 1','hh9"" au':}l aD.ft:n·: 1.'1
Clinical trial on persons with mental disorder may
only be carried out in accordance with Anicle 15(4)
of the Proclamation upon ascenaining the fulfilment
of Ihe following conditions:
II the purpose of the clinical trial is to diagnose,
prevent or cure mental disorder;
21 clinical trial carried on persons other than those
with mental disorders cannot be expecte-d to
produce Silt is factory test results according to
scientific or medical knowledge; and
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Fl!d('rul Ncg:J.rit Gazette No. \1 2·1 '~ Janu:lry, ~ Q 14 Page 71 96
----- - ------ ---,.-.-_.,------_.,- --- -31 the informed consent of the person with mental
disorJcr is obtaintd if h(' is capJbl l.! to give his consent o r, where he is not c<lpab!c to give his
consent, the consent or his guardian is obtained afte r being br iefed about the cl i n i~al tria l.
27. Clinical Tri al on Prisoners
II Clinical trial on prisoners may only be carried
out in accordance with Article 15(4) of the
Proclamation upon a, ccrtaining the fulfilment
oflhe fo llowing condilion,:
a) the clinical Irial is to diagnose. prevent or
treat a disease th :lt may particularly affect
prisoners; and
b) the prisoner pal1icipaling in the clinical
trial can make decision whether to
participate in the trial free of any undue
influence.
21 The concerned prison administration shall h~ve
the righl 10 be made aware of. and have Ihe
respons ibility to provide Ihe necessary
cooperation for, the conducting of clinica l trial
on a prisoner pursuanl to sub-article (I) of this
Article.
28. Withdrawal from Clinical Trial
Any person, who has given his consent for a clinical
trial to be conducted on him. may wilhdraw from
the clinical trial at any lime.
CHAPTER THREE
TRADITIONAL AND COMPLEMENTARY
OR AL TERNA TIVE MEDICINE
ADMINISTRATION AND CONTROL
29. Registration orTr"dition.I Medicine
II Any person may apply 10 Ihe Authority for Ihe
registration of trad itional medicine by
submitting information with regard to the
source and use of Ihe medicine and other
necessary information.
21 The Authority shall issue certificate of
registration upon ascertaining the efficacy,
safety and qua lity of the traditional medicine.
31 The Authority shall ensure lhe confidentiality of
the information obtained in accordance with
sub-article (I ) of this Article.
30. Rcvistration of Complementary or Altrrnative Medicine
The provisions of Article 15(2) of this Regulation stipulating on the registration of medicines shall, mutatis mutandis, be applicable for registration of complementary or alternative medicine.
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Feder;ll Negarit GalCtlc No. 11 241h JallU <.\ I)I. 20 14 Page 7197
CHAPTER FOUR
POST MARK ETING SI:RVF.ll.l.ANCF.,
FOOt) ANt) MEDICINE SEIZURE ANt) DISPOSAL
31. Post M:lri{ctilH' Surveillance
1/ 11,e Authority shall underlake post marketing
surveillance on food or medicine supplied for
sale, and based on the results, take necessary
measures against non compliance with the relevant requirements.
21 Any food establishment shall have the duties to:
a) inform the Authority where there is
unprecedented problem in food safety and
quality ;
b) refrain ITom distributing unsafe and low
quality food for human consumption;
c) collect and dispose, in accordance with the
directive issued by thc Authority, the food,
he offered for sale if it is found unsafe and
low quality,
31 Any health institution shall have the duties to:
a) reporl to the Authority on unprecedented
adverse drug reaction, product safety
update or complaint on the safety, efficacy
and quality of medicine; and
b) refrain from distributing any medicine that
the Authority has notified as having safety,
efficacy or quality defect.
41 Any food establishment or health institution
shall coop,rate wilh the Authority in
undertaking post marketing surveillance,
51 Where the Authority orders the rccall of any
medicine in accordance with sub-arlicle (3)(b)
of this Arlic l., the medicine manufacturer or its
agent shall have the duty to recall and dispose
the medicine.
6/ Any medicine manufac turer, importer or
distributor shall be respons ible to establish a
pharmacovigilance system for continuously
monitoring the safety of the medicines for
which it has obtained market authorization and
to take corrective measures in case of
irregularities.
1,! "'I'Fi'm'9" I'mS ~Iluo,y I''''IS ;>'l'uom"
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1-"IC "'lilh''''''' h'i 1I .~1'\H" f"'l.1AlI' If~'
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1''<;-}- y~1l uolf~" 1''''I.'ltI)\' uolf, I'IIO'r9"::
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FI:(kral Ncg.:u ;t Ga7.c!tc N(1. 11 24!~ January. 201·\ Pugt.: 7198
71 Any health professional shall immediately
inform the Authority any adverse drug effect as
well as problems that he encounters with
respect to the efficacy or quality of medicine.
32. Food or l\1(~dicinc Seizure and Oispo~al
I I The appropriaTe organ may seize food or
medicine and order disposal or sending back to
the country of its origin where the food or
medicine:
a) does not have market authorisation;
b) is counterfeit;
c) has expired;
d) is of deteriorated quality;
e) is stored, distributed, alTered for dispensing
or dispensed by a person without certificate
of competence issued in accordance with
this Regulation; or
f) used in unauthorised clinical trial.
21 The appropriate organ shall issue a certificate to
the owner or possessor of the food or medicine
disposed in accordance with sub-article (I) of
this Article upon request.
PART THREE
CONTROL OF TOBACCO PRODUCTS
33, Requisite of Permit
No person may import, distribute or sell a tobacco
product except with the permit of the Authority
upon confirmation of the product's compliance with
requirements .
34. Protection of Minors from Tobacco Product
No person may directly or indirectly sell to or create
temptation upon a minor to use tobacco products.
35. Packaging and Labelling of Tobacco Product
11 The labelling of any tobacco product shall
describe the characteristics of the product and
the health problem and hazard it causes, and
may not directly or indirectly create the
impression that it is less harmful than any other
tobacco products.
21 The label of any unit packet, package and
outside packaging of tobacco products shall:
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Federal Ncgarit GazCtlc No_ !! 24~1 January. 2() 14 Page 7199
a) bear hea lth warning dc, cribing the harmful
effects of tobacco lise which slJall constitute 30 % or more of the principal
display areas;
b) descr ibe the health warnings in .words or
picture that smoking causes cancer, cnrdiac
or bronchitis diseases or immature death or'
serious health problems caused as a result of tobacco use;
c) be written in Amharic or English in large,
visible, legible and irremovable manner;
and
d) contain infonnation on the maj or
const ituents and main hazardous constituents fou nd in the emissions of the
tobacco products.
31 For the purposes of this Art ic le, the term "outside packaging 01 in relation to tobacco products applies to any packaging used in the retail of the product.
36. Places Prohibited for Smoking
II No person may smoke tobacco in a place for
public gathering or use.
21 Places for public gathering or use shall include the fo llowing:
a) rooms ofhealth institution;
b) class rooms of educat ional institution;
c) public conveyances;
d) dining places like hotels and restaurants; and
e) such other places prohibited for smoking. as may be dctennined by the appropriate organ.
31 Notwithstanding the provisions of sub·article
( I) of this Article, smoking in places for public
gathering or use identified by the Authori!» may
be allowed at a designated smoking areas.
I'A RT FOUR ,
HYGIENE, ENVIRONMENTAL HEALTH AND
COMMUNICABLE DISEASES CONTROL
37. Dangerous Chemical
I I The production, import, storage, transportation.
distribution, sale or use of any dangerous
chemical shall comply with the requirements set
by the Authori!» to prevent any hazard to public health.
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Federal NegarilGazctll! No. II 24!ti Jan uarY,2014 Page 7200
21 In case of violation of the requirements
,prescribed pursuant to sub-artic le (I) of this
Artkle, the appropriate organ mJY seize or
recall from market and order the disposal of the
dangerous chem ical or scndi'1g it bac-k to its country of origin and take other necessq,ry
measures.
38. Transportation and Disposal of Dead Bodies
1/ It shall be prohibited to bring into the country
or send abroad a dead body or human remains
unless otherwise permitted in accordance with
the requirements set by the Authority.
21 No dead body may be exhumed before seven
years from the date of burial except by the order
of a court or where burial place is required for
public purpose in accordance with the relevant
law.
31 The provisions of sub-article (I) of this Article
may not be applicable with respect to the
transportation of human remains for
archaeological or tourism purpose.
iii h"'llJ{I' filar hilA fI.e&.;PJ:' ouC~"'I flf'r 39. Wast. Handling and Disposal
:1.
(j)J?,jI" 07i;l' t'tfil'l·ftA9· r"'l.i·lI· 4I'ij'ij?,:-".,) II It shall be prohibited to burn or dispose by any
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other means a poisonous or contagious wastes
without obtaining permit from (he appropriate
organ.
21 No person may engage in recycling or disposal
of poisonous or contagious wastes without
obtaining permit from the appropriate organ
upon fulfilling requirements set by the
Authority.
3/ The appropriate organ shall, prior to the
designation of a place for disposal or recycling
of waste, confirm that the disposal or recycling
of waste at such place may not cause damage to
public health.
41 No person may discharge liquid waste to the
environment unless treated in accordance with
standards to be issued by the appropriate organ.
40. Institutions Subject to Health Related Control
The appropri ate organ shall ensure that institutions
subject to health related control satisfy the necessaty
hygienic and environmental health protections
requirements and take necessary measures thereof.
-
Federal Negarit Gazette No. 11 24th January, 2014 Page 7201
!'i/i, f1:'I"'1;e; J:,M'J; '!1i,II'f._ 141.
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Sound and Air Pollution
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OJf!,9" 1''''1.1'1 "'1'):;'01'9" "'01' nav'1n.Y'i' avm·"'. hA 'I),'. \'mS hlll'IO'''' ·/:'!"rc f}),'.J'.L "10')''1 f}),'.&..,. y.'I'I.). oD"]'1')' my,?" avm·'Tj·)· h),'.:r·t\.9"::
Any person shall comply with the requirements for
the prevention of sound and air pollulion set by Ihe
Authority for the protection of public health.
42. Toilet of Pu blic Facility
Any toilet of a public facility shall fulfil the requirements set by the Authority,
43. Vaccination of International Passengers
II Vaccination of international passengers shall be
given at health institutions designated by the Authority,
21 Any conveyance operator who has brought a
person not allowed to enter into the country in accordance with Article 26(2) of the Proclamation shall be obliged to return the person to the countty of his departure covering
the expenses of his stay,
44. Conveyance and Consignments Control at
Frontier Port
II Any conveyance entering into or transiting Ihe country may not bring or dump any waste or remains of waste in Ethiopian territory except in accordance with accepted manner.
21 Notwithstanding the provision of sub-article (I) of this Article. any person may import recyclable waste or by-product upon the
permission of the Authority,
31 If any conveyance or consignment entering or leaving the country is suspected of transmitting
communicable disease, it shall enter or leave
the country after undergoing the necessary
sanitization including spraying and permit from
the Authority.
41 Importing or exporting blood. blood products,
human tissue or organ, urine or stool may only
be allowed by obtaining permit from the
AUlharily.
51 Any conveyance operator who has brought a consignment not allowed to enter the country or
waste shall be obliged to return same to the country of shipment at his own and the owner's cost.
45. Individuals Crossing Boarder on Foot
Any person entering or leaving the country on foot
at the time of epidemic and public health emergency may not enter or leave the country without undergoing health inspection and obtaining permission at a frontier port.
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Federal Negari r G,IlI:U,' No. 1\ 24\~ January, 20 l ,1 Pag,· n02
46. Suspertcd Person a nd Dnl,. to Re po rt
11 An)' international entry passenger shall be •
obliged to respond to quarantine inspection
through verbal or written request for protection
of pub I ic health,
21 In the cOllrse of trave l, if an)' passen'ger is
suspected to be infected with any
comm unicable disease, the conveyance operator
shall inform the head of the nearest or
destination rrontier port about the type of the
disease, principal symptoms and any other
relevant information.
3/ The head of the fTontier port receiving
information in accordance with sub article (2)
of this Article shall immediately report the
in formation to the inspector at the port .
4/ For the purpose of this Article "head of rrontier port" means the head of the rronticr' port aviation or Revenue and Customs Authority
station.
47. Quarantine and Isola tion
11 Suspected person shall be quarantined
immediate ly. The Authority shall immediately
send the suspected person to the public health
emergency management body for quarant ine .
21 The Authority shall ensure that any suspected
person upon confirmation of his infection be
transferred to an isolation room in a health
instirution and provided with the necessary
curative and rehabilitative treatment.
3/ The public heal th emergency management body
shall organize quarantine centres in the main
rrontier ports or designate the nearest health
instirutions as isolation centres,
48. Measures taken to Control Communicable '
Diseases
II The Authority may take the following measures
to control communicable disease:
aj ordering the closure of schools and other
public places for a certain period;
bj establishing temporary controlling posts in
any part of the country; and
cj taking any other necessary measures.
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Federal Ncgarit Gazette 1\n II 241h January,2014 Page 7203
2/ Th~ relevRnt bodies shall cooperate 'with the
Authority at frontier ports to effectively
undertake control of communicable diseases.
PART FIVE
HEALTH CARE
CHAPTER ONE
HEALTH CARE SERVICE
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"I?,J-p"'h' rh:f.hg"iVh.1:1l 9"trc 49. Vaccination Obligation and HlV/AIDS
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Counselling Service
II Any health institution and health professional
employed by the institution shall, based on the
medical standard and the service provided, have
the obligation to give vaccination and access to
HIV I AIDS counselling service to maternal and
pregnant women,
21 Parents or guardians shall have the obligation to
vaccinate children in accordance with the
directive to be issued for the implementation of
the Proclamation and this Regulation,
50. Health Education
Any health institution shall, based on the services
provided by it, have the obligation to provide health
education and current infonnation to clients.
51. Curative and Rehabilitative Medical Service
II governmental health institution shall provide
medical service in accordance with the referral
system and its capacity.
21 Medical service may be provided at a health
institution, at a work place, at the patient's
home, at the place of accident. in an ambulance
or at any other similar place according to the
standards to be issued by the appropriate organ,
52. Patient's Informed Consent
II Medical service may not be provided without
obtaining the patient's informed consent.
21 Notwithstanding .the provision of sub-article (I)
of this Article, medical service may be provided
to a patient without obtaining his consent when:
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oulll'}' 1''''I.mON1·)·') r Y:')H'i' l'ih)]V"<; ?'1A"}I\")' I'ooilm')' "}i!.;J- MO')'::
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Federal NcgaritGazclfc No. 11 24 110 January,20 14 Page 7204
a) the patient is unable to give his consent and
such consent is given by:
(I) a person authorized by the patient 'in
writing to give consent on his behalf;
(2) in the absence of a person authorized
to give such consent, th~ spouse.
child, parent, brother or sister of the
patient;or
(3) a person authorized to give such
consent in accordance with the law or
a court order;
b) failure to treat the patient, may result in a
serious risk to public health;
c) the patient has not expressly or in any other
way refused to get the medical service and
any delay in the provision of medical
service could result in irreversible damage
on his health.
31 Any health professional shall make
reasonable effort to obtain the patient's
informed consent.
41 The health professional shall explain to the
patient who refused to get medical service.
Ihe possible risks of his refusal 011 his hcallh
and shall record same in writing.
51 A consent given under this Article shall be
valid when it is obtained tram the patient or
any other third party in writing, unless it is
permitted by directives to be expressed orally
or through conduct with respect to specific
types of medical services.
53. Emervenev Medical Service
If Any health inst itution shall have the ' obligation to provide life saving emergency
treatment.
2/ Any health institution shall have the obligation to provide emergency medical treatment in accordance with applicable
standards of health institutions.
3/ Emergency medical treatment may be provided in all emergency and epidemic cites in collaboration with lhe relevant organs.
•
. !I!i. I'mll?"" M."l'l' o/·1l11t't> TI. p'c'}t
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Federal Ncgarit Gazette No_ II 24th January. 2014 Page 720S
= 54. Referral System
Ii Any health institution shall have the obligation
to provide medical services :n accordance with
health service standard to be issued by the
appropriate organ.
21 Where any health institution is unable to provide
the proper examination or treatment to a patient,
it shall refer the patient to the appropriate health institution where he can get the proper service in accordance with the referral system.
31 Any health institution shall have the obligation
to admit a patient sent to it in accordance with the referral system and give fced back to the
sending health institution.
41 The referring health institution shall, before
referring a patient for emergency treatment, have the obligation to make sure that the receiving health institution can admit the patient .
. 51 Any person shall have the obligation to observe the directive on the implementation of referral system.
55. Death and Post-Mortem Examination
1/ Death shall be ascertained :-vhen there is no sign
of life as approved by a competent health
professional based on examination of functions
of brain, heart and breathing organs.
21 Post-mortem examination may be conducted
only where the spouse, child, who attains
majority age, parent or guardian of the deceased
or the appropriate organ requests to know the
calise of death.
3/ Examination to detennine cause of death may be carried out by a competent health institution.
41 Notwithstanding the provisions of sub·article (2) of this Article post mortem examination for education or research purposes may be carried out where the deceased has given his written
consent during his lifetime or where the deceased has not prohibited such donation during his lifetime and the consent of his family has been obtained. 'lX. I' mll'l"" 9"11 h C (JlUr
"'1'}'i'ar'l" I'mS '1".1:9" r J'1l r ihh'l"" 'l"l1hC
1''''l.II'/·II'')-·) 00t.:<lP')'- 56. Medical Certificate rDt.4'"r t1;:"'I"'l. fl.tI'!' Every health institution shall issue medical
.£'.1'1t1:-/il 1';t"11"'1.ar'i fI'I"; 0.1'.''''1.'' h.l'."6·7\! IJ./ I''I''C 00 II· (1)0 ') ar rn. 'r" t1;t-1J "'l. (1)0 r-t .l'.t.1f1
."I.') ,hll'l"" h<; ,.),S!. t"">;t"(I}o I'·rllmro·'j
ot.<j":·)·" rncJ': !D'<'I~> I
certificate to a patient containing the following infonnation: I I naI11e, age and address of the patient; 21 examination result and medical treatment
provided to the patient and, as the case may be, sick leave and board decision;
-
- ---
1:1 \' ,MI?"'; "'1(,0:(1)' \"1' (\11\0 ')") 'I"ll J !if ·1·t1;J' ;!';', ",),7"'0 MU?M,t'l" '~' f;i'lI"'l,tD·')
O)~';/,T fmS IFI.;/' I 'he;
<il fl.t'l- i" hflt,/I?, \'If'I' uul)lp-'i',,)::
n. (\M~M:-'1L3''I'Al',~\h?"e;
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'hl;?" 'he; inS Ilt'lUD'Y (lm' f\t·7i \"/,'Ptlf,
a,ll?"" uofllll')' .\";':"61::
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m:r."'"T'j ';"ll{:'il"n :fI)\) :mC /I f,:}'·t\9 1J::
j1°M-50i:1'l-1'
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Feder;:!l Ncgallt G.rlClte No. I I 2401, January, 201-4 Page 7206
= 3/ date of the issuance orthe med ical t.:'ertificatc;
41 whether periodic medical treatment is nccc~sary and the patient's current s ituation; and
51 other necessary information .
57 Artificial Reproduction
1/ Artiftc il1 l reproduction service may be provided
by a health institlltiOl; and health professional
authorized by the appropriate organ.
21 letting or hiring of womb I(>r the purpose of artificial reproduction shall be prohibited.
31 No person or research instilute may engage in
the technology of cloning of human being.
CHAPTER TWO
'DONATION OF BLOOD AND BLOOD
PRODUCTS AND DONATION AND
TRANSPLANTA TION OF ORGANS AND
TISSUES
,
~I 1'1.7"'0 \'.1'.7" "''PM, tl1<'1 i "'IMl'\lI'O .56. Donation of Blood and Blood Products
I'P'C"lC" )' P't·flJi' 00llq'f~')' OOClfP-'1·· II Blood and blood produCIS donation, collcction 'If!., ,~uuftC ,/'tD· aoh'OtD') 1.1\1l;fCf~:: and distribution shall be done based on
r.1 \'c'\(!l- Ilf!.,Cfl') ·') /1"'1-'11 ,,1t1 "llI-'r mJ.'.?" MJ.'.1<\'f ?"C?"C 1''''I.(!l-tI .I:?" CflK,?" I'.I:?"
'/''I'}, M;>i'i'9" If~ " '<j>fll! 1''1111'0 '!':J>?"
I''''I.YM''i uulf') I'M') '?";:
1'.1 "'I')'i'(!l-1r' r 1.9"'1 r 1.?" 'I''/'}' /IN' flr.
fl.1'\'!' r"'l.i't'lCfl' f.U1~'"'' ,!"I--/, fl.l;>?'!'
~Cfl'::
!III, ft111.lltI hlj:lI-'1''1 rUlIt.-tJ'I'<\'} A1<\'1 1:"/1 1'M
uuClfP-''f
/il f1.'IA )1fj:1\-1''J UlI{.-U'P<\'r 1:"1\ 'rM
"'Ih~-tD'} 1''''I.fl\(!l- 1"/'4'<]1(1 UJ.'.Cfl')·
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(\,II 1'1·7i1\ 1."'It·~ uu'}1Y: I''''IM'1 uul1''r
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Uy.Cfl '" 'l(l.(. 0".'1 I'n1ttl lllj:lI-'1''J UlIl
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Illf1 /I.7ic J.',i,,,tI::
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n'}</'{) (i:) ".IPl. ')· f'lil. 'h'i.l'.If~ '/'t'l;Jo'
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11"/ /.').'tllt.t'l(!l- uum\'~' K::'j"'ItI::
-~-; ... ---",-:, ~-- .. '~,: ~---
principles of humanity.
21 Blood and blood products used for the purpose of saving life or scientific research may not benefit both the donor and recipient financi ally.
31 Blood and blood products may only be given to
a recipient after their safety and quality are
tested,
59, Organ and Ti>suc Donation and Transplanta tion
Principles
II Transplantation of organs or tissues may only
be carried out if there is no other better means
of preserving the life or physical integrity of the
recipient as proved by a medical board.
21 Any person may donate or prohibit the removal
of his organs or lissues in any other way while
alive or after his death.
31 A person may, at any time. revoke the act by
which he has promised to donate his organs or
tissues while alive or after his death.
41 Where a person who has promised to donate his
organs or tissues revokes his promise, pursuant
to sub-article (3) of this Article. in bad faith. the
recipient shall be enlitled to be indemnified for
the expenses which he has incu(\'ed due to such
•
f;1 r"'l.h"·I1··}·1 rmt:NI" NMhII !!,If'OA:-
V) f'>lliA n<j:l\oi'<; tHIl- U<P<\,l ' ')"11:
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til) fil'IA lI'}:n-)'-'O U-fll-U<P,'I-}-1 <j:"'H
CD.f!.9° ~'-fC(l'l- "'1M-POI'} I
federal Negarit Gazette No . 11 24th January,2014 Page 7207
51 The following acts shall be prohibited:
a) trading in human organ or tissue;
b) receiving, giving or promising ·to give
monetary or non-monetary benefit for
organ or tissue donation;
c) advertising demand or supply of organ or
tissues;
on) f7'}M')-1 I'hl]A 11'i:/'\-i-'i' u-fll-u<P<\')- d) using animal organ or tissue for the punpose
lin(/}- 1'1-11 '1-11''1 "'1'1'£\:: of transplanting it to human.
~.. U,eCD-I> I]IIL flO)- I'hll.1\ tl'i":II·:r-'O u-fll-u<P<\-}-1 60. Organs and Tissues Collection from Deceased
ilfloofl-flfl-fl Person
fil h,}1: (\(J)- nU,eCD'}- n~nlo'l' CD'1-')' fh'IA
11<j:/,\-'I"}'O V-fll-U'i'<\'''1 nonf\1i1 h-/-il"'l"'l
ffl(J)-fCD- u,eCD·I- il.fM: 1I'}q.n "-M
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0011111\1\ M',:)'- A?"::
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U'ffl1' Mil1 ou'}:;r.."; h,l'.)··I1-?"::
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fmS '111""'f>"1- hll-fl·)· J'''~fI' ""If') ~'i' • '};r.n-'I'h'!CD-1 h"'l.flJ'l.-'!.'I- I'II\S (tn
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I I Where a person has consented to donate his
organs or tissues upon his death, the organs and
tissues that can be used for transplantation may
be collected upon his death,
21 No health institution may collect organ, and
tissues pursuant to sub-article (I) of this Article
without obtaining special license from the
Authority .
31 Where there is no wrinen evidence showing
express prohibition of donation made by the
deceased, while alive, and where the spouse,
children or parents or siblings of the deceased,
in the order of their list, agree with the
donation, organs and tissues that can be used for
transplantation may be collected from the
deceased.
41 Where the individual, listed under sub-article (3) of this Article are suspected of crime for the death of the deceased, they may not have the right to give consent with respect to donation of organs and tissues of the deceased for transplantation.
51 Unless the donor ordered a particular recipient
as beneficiary in accordance with provisions of
transplantation, selection of organs and tissues
recipients shall be based on compelling medical
reasons and the principles of justice and equity.
61 Health professionals who declare the faCI of ·
death of the donor may not be less than two;
and be different from , and have no monetary relationship with, those who conduct the
transplantation,
-
',-' ,
Federal Negarit Gazette No, II 1.41/1 }wlUary. 20 14 Pa!;c n08 ~=======================r====~ = t./i. OUr.lDo}· .lJfl oor fhll" . h'/:{\:'1S'JJjJt:IJ'f.'I.:r1 61. Organs or Tissues Collection frolll Li \' ing
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Person_~
II Collection of organ or ti ssue from a living
person may be carried O,Ul where competent
health professionals believe removal Qf organ or
tissue from the donor does not pose any serious
and pennanent danger to his health or life and
where:
a) the donor has capacity to give consent and
enter in to juridical acts, and agrees in
writing. based on infonned consent, in the
presence of two witnesses; and
b) it is established by the National Transplantation Committee referred to in Article 62 of this Regulation that:
(I) there is spousal bondage or relation by
consanguinity or affinity between the
donor and the recipient; or
(2) in the absence of spousal bondage or
relation by consanguinity or affinity,
there is no monetary relationship
between the donor and the recipient.
21 Notwithstandi ng paragraph (aJ of sub-article (I)
of this Article. bone marrow tissue may be
collected from a minor upon the consent of his
guardian.
2i No health institution Illay collect organs and
tissues pursuant . to this Article without
obtaining special license from the Authority:
62. Transplantation .
II No health institution may transplant organs and
tissues without obtaining special license from
the Authority.
21 The Authority shall establish National
Transplantation Committee with a view to
ensuring that organ or tissue collection and
transplantation is being carried out in
accordance with professional ethics.
31 Any transplantation may not be perfonned
unless the National Transplantation Committee
approved the transplantation request; provided,
however. that the National Committee may,
where necessary. give delegation of power to a
transplantation committee established at
regional level.
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Federal Ncg..tril Gazclh: No, 11 24'h Janu:lry, 201 4 Page 7209 ----.----~~
PART SIX
HEALTH PROFESSIONALS
CHAPTER ONE
PROFESSIONAL LICENSING AND REGULATION
63. Designation of Health Profesliions and Requisite of Professional License
II The Authority shall designate, register and
license health professionals and set Iheir scope
of practice.
21 No health profess ional with professionalliccnse
may provide health services beyond the scope
of practice of his profession unless with special
decision of the appropriate organ in exceptiona!
compelling circumstances.
31 Any person qualified with more than one health
profession shall be entitled to a professional'
license to practice all of his health profess ions
so far as he satisfies the necessary requirements.
64. Health Professionals Register
\I The Authority shall have a register for
registering every health professional practicing
in Ethiopia comprising his name, nationality,
principal residence and place of business and such other necessary particulars.
21 Any higher education institution shall send its
graduate lists in health profession to the
Authority and appropriate organ.
31 The register to be kept in accordance with subarticle (I) of this Article shall be open 10 the
public as may be necessary.
65. Issuance of Professional License
II Any health professional shall be granted with
health professional license upon fulfilling the
requiremenls set by the Authority for hea lth
profess ionals.
21 The appropriate organ may issue restricted
professional license, as may be appropriate, for
impaired health professional.
31 . No health pro ressional may in any manner
transfer or rent his professional license to lhird
party.
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Federal Negarit tiazcltc No. II 24'ft January,2014 Page '/110
66. Renowal of ProfessionAl Lieense
I I In applying for renewal of professional license
in accordance with Article 33(2) of the
Proclamation any health professional shall
present:
a) certificate of completion of the required continuing professional development in his
profession; and
b) medical certificate proving his fitness to
practice the profession.
21 For the purpose of this Article "continuing professional development" mean$ a training periodically anended by a health profe~sional
during his practice to maintain his professional knowledge and skills and enhance his professional competence in accordance with the directive to be issued by the Authority.
67. Inactive Slatus
II Any health professional who did not practice
his profession for more than two years for any
reason shall notify the appropriate organ prior
to resumption of practicing his profession.
21 The appropriate organ may authorize the professional referred to in sub·article (1) of this
Article to practice his profession upon requiring him to produce evidence of completion of
continuing professional development or causing
him to anend training, or to work under the
snpervision of a competent hcalth professional
working in a health institution chosen by the Authority.
31 If a health professional who did not practice his profession for more than two years engages in practicing without notifying the appropriate organ, he shall be deemed as practicing without professional license.
68. Health Professional Trained in Foreign Country
11 Without prejudice to the provisions of Article 65( 1) of this Regulation, any person with a duly recognized foreign educational background applying for professional license shall:
a) produce evidence of equivalence of qualification issued by the competent body;
b) complete from six months to a yearlong
intemship program at assigned health institution by the appropriate organ where he did n<?t practice his profession in any foreign country for more than two years.
Federal NcgaritGazettt No:'1 24lb January. 20 14 Page 72lJ
~~~~~~~~~~~~~=========== I]) I'II.U 1,1'~)1; ·}D·h 1,"'/')\' (Ii) J:1:n fiSC?" 21 Notwithstanding the provisions of sub-artic le
=
hll·/I·)· <}oo')' O'lY. (lCO·"!." h1C Y1I11/1 I'mS (I) of this Article, a health professional with
fl/lOD'J' 1'·""'Il.fl')· coy.?" I'M·fl·)· h'IC more th"n two years of professional practice in
I'flo;.!· p'C"l."·)· hlt,')'l'k,l' fflO;.l' P'C"l."·)- any foreign country shall complete internship
.?C 1''''1.e''l''l?'' hln 'l1\P'A"I~ fl"'1.coll)ro' program as detennined by the Authority if the f'flJttL')' \'n.~H·C·i?i.T TC"lt.?'U U'fmc;'I'~' disease pattem of the country of his training or
Practice is incompatible with Ethiopia's disease j?<;'CO;.l'A::
pattern.
1:1 1'1I.1I h14>)\' '10·11 h1,~)1; (ii) h<; (lI) 31 Notwithstanding the provisions of sub-article
t:·'.n?':-': fi.':'<,?" <I11P'N']'" hco-"l." h1C (I) and (2) of this Artic'e, the Authority may
IIh"l."C 7.tt fl"'1.·P.\'. I'hClI;.I' Ilt· i 11M • .? 7.t1. issue temporary professional license for a health
1'(\11<}'l? hell;/, coy,?" (iflIlI"A"I'" fl"'1.cofl'" professional with foreign educational lIt..tr:f. I'mS 1,1A"III'.r,:I: 11"'1.0011\' background, where the professional intends to
provide health services in short tenn charitable CJlloo-J'?':f 7.llJ''l? 't_.r Ilt- /..:I't: II.fl'l' activity, emergency humanitarian crisis or other
j?'f·I\A:: health services to be determined by the Authority.
iii fillS Q/lun',I'co"} O?lt,l''f'n· ,l'lloo"lco'
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41 The institution which brought the health
professional on temporary basis shall:
a) upon the completion of the professional's mission, notify the Authority and ensure the surrender of the temporary professional license;
b) bear civil responsibility for any damages caused by the health service provided by the professional.
69. Surrender of Professional License
Any health professional shall have the obligation to
slU'Iender his professional license where his license
is suspended or revoked or he completes his mission
or relinquishes practicing his profession.
CHAPTER TWO
HEALTH PROFESSIONAL CODE OF CONDUCT
70. General Principles
Any health professional:
II may not practice his profession in any manner that violate the Proclamation, this Regulation or any other relevant law;
21 shall provide health services to the client
without any discrimination;
3/ shall give the utmost consideration for the health and need of the client.
71. Health Proressional Ethics Committee
1/ A Health Professional Ethics Committee (hereinafter the "Committee") is hereby established.
21 Members of the Committee shall be professionals drawn from the relevant institutions and be designated by the Minister, and their number shall be determined as
necessary.
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72. Powers and Duties orth. Committee
The Committee:
11 shall examine, investigate and propose
appropriate administrative measure to the
Authority on complaints made with respect to
substandard health services and incompetent
and unethical health professionals;
21 shall, where il proves availability of sufficient
evidence to support the complaint, send
summon to the health professional or institution
against whom a complaint is lodged with the
notification to respond within 30 days;
31 may, where appropriate, assign an independent
researcher in consultation with the Authority to
investigate the complaint;
41 may propose suspension of license or certificate
of competence to the Authority until the
appropriate decision is passed on the complaint;
51 shall, upon identifying the root causes of
frequently lodged complaints and grievances,
propose policy directions intended to provide
sustainable solutions to the problems;
61 shall perform such other duties that may be
assigned to it by the Authority.
73. Meetings of the Committee
II The Committee shall meet as frequently as its
functions requires. 21 The presence of more than half of the members
at any meeting of the Commi"ee shall
constitute a quorum.
31 Decisions of the Committee shall be passed by
majority votes; in case of a tie, the Chairperson
shall have a casting vote.
41 Without prejudice to the provisions of this
Article, the Committee may adopt its own rules
of procedure.
74. Main Responsibilities of Health Professionals
Any health professional shall:
II be accountable for the health services he provides and for his decisions as per his assigned duty;
21 obtain informed consent from a patient, in accordance with the relevant law, before rendering a service;
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31 provide genuine and
during profess ional
colleagues and clients;
adequate information
communication with
41 respect patient confidentiality. privacy. choices
and dignity;
5/ maint3in the highest standards of personai
conduct and integrity;
61 discharge his professional duty in a team work
respecting the contribution of other health
professional ;
71 provide appropriate counselling service to the
client;
81 update his professional knowledge and skills to
new medical technologies and innovations;
9/ maintain proper and effective communication
with his patients and other health professionals;
101 register and keep accurate client records;
111 avail himself and provide professional service
in his working place during assigned duty
hours;
12/ ensure public participation and acceptance in
designing and implementing public health
programs;
13/ comply with any lawful instructions and
procedures of the appropriate organ with
respect to his profession.
75. Fees and Commission
Any health professional may not:
i l accept commission or any benefit apart from
service charge from a person or another healih
professional or institution in return for the
services he renders;
21 pay commission or offer benefits to any person
for recommending patients~
3/ offer or accept any payment or benefit which is
intended to induce to act or not to act in a
particular way not professionally indicated or to
over-charge patients;
•
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Fcd\!r.l1 NegantGazctlc No. 11 24th Jm~u:lr)', 201 4 Pllge 72 14
4/ charge or receive fees for services not rendered
personally or by his employee or pallner or
substiiute;
51 receive payment or allY bellefll for
recommending or referring patients to another
health professional, for treatment or· for
participation in clinical trials or other research;
61 provide health service, for his benefit, thai docs
nol serve the needs of his palien!.
76. Practicing with other Health Pro["ssionals
II A health profess ional shall employ a health
professional who is licensed by the appropriate
organ.
21 Unless for training purposes, a health
profess ional may not work with or give any
kind of professional support to another health
profess ional not licensed by the appropriate
organ.
77. Profession.1 Confidentiality
II A health professional may not disclose, verbally
or in writing, information regarding a patient
unless the appropriate organ believed that there
is a prominent health risk 10 Ihe public
demanding to do so, it is ordered by a court, he
gets writte n consent from the patient or the
patient's guardian or it is permitted by law .
21 A health professiona ' may release or transfer
information regarding palients for the purpose
of conducting scientific research or studies
where the information released is in such a
manner that it does not identify directly or
indirectly any individual palient.
31 A health professional shall encourage a patient
with communicable diseases to disclose his
status to individuals with potential exposure to
the infection.
78. Preferential Treatment and Referral of Clients
II Any health professional shall render the same
level of care to his clients in ilinerant and
resident practice.
21 Any heallh profess ional may not provide any
preferential treatment to a client by considering
the relationship established with him in another
health inslitution where the same professional
works.
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Federal NcgarilGaz¢ttc No. 11 24111 January, 20 14 Page 72 15
31 A health professional may not refer a patient to
another health institution where he works unless
for services unavailable and necess itadng
referral upon declaring the vested inkrest of the
professional in the referred health institut ion.
41 For the purpose of sub-article (1) of this Article,
" resident practice" means a practice which a
health professional conducts on full time basis
regularly while "itinerant practice" means a
practice which a health professional conducts
other than the resident practice.
79. Prohibition of Secret Remedies
1/ No health professional may use secret remedies.
21 Every health professional shall, in the conduct
of his practice, use only an apparatus or health
technology or intervention whiCh is proved
upon investigation to be capable of fulfilling the
claims made in regard to it
31 For the purpose of this Article "secret remedy"
means a medication or treatment that cures a
disease or disorder or relieves its symptoms that
is known by only a few people or professionals
and intentionally withheld from general
knowledge.
80. Advertisement of Profession and Service
I I Any health professional may not advertise:
a) his services if the advertisement IS
unprofessional, untruthful or misleading;
b) his services unless otherwise he is
authorized by the appropriate government
organ;
.c) in a manner that directly or indirectly
encourages the unnecessary use of health
services;
d) his services in a manner that affects or undermines the services of other health professionals;
e) his services by drawing anention 10 his personal qualities and superior knowledge;
..
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Federal Ncgaril Gaz.cUC No. II 241" Jauuary,20l<l Pa~c 7216
f) his services in a manner that promises a
gift, discount or other inducement to attract
a person to use the service.
21 Any health professional shall ensure the advertisement of a health institution whose certificate of competence is issued in his name respect the provisions of sub-article (I) of this
Article.
81, Medicine and Medical Instrument Advertisement
I I A health professional may not advertise medicine or medical instrument unless he is a direct employee of the manufacturer or distributor and authorized to do so by the appropriate government organ.
21 A health professional may not, in consideration of the benefit he may derive, advocate the preferential use of any medicine or medical instrument that would not be clinically appropriate or cost-effective to the client,
82, Research Participation
A health professional may only participate in
research performed on human subject if the research
has wri"en approval after appropriate ethical
evaluation and is being performed in accordance
with the approved research protocol.
83, Requesting and Providing Professional Support
or Consultation
II
21
In case of any doubt or difficulty and need of supplementary or higher level of care, a health professional shall request support or consultation from any other professionaJ colleague for the benefit of the client,
A health professional consulted by a colleague shall provide the required professional advice and service as per the standard of his
profession.
84. Obligation to Serve Despite Belief
A health professional may not refuse on grounds of
personal belief to provide services such as
contraceptive, legal abortion and blood transfusion.
85. ]ssuance of Official Documents
11 A health professionaJ shall sign official documents relating to patient care such as laboratory and other diagnostic requests and results, prescriptions. certificates, patient records, hospital and other reports after "Tiling
his full name.
1l'C :ill.Un ~trl:\ ~.?M· ?IL'~ 'll'T'C Iii 'l'C !~ "'./ ru '1.1"'. Feder:ll Negarit Gazette No. II 24" Janua,y. 2014 Page 7217
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O"'lf,l'A ro.e?" OM.I'.' "7iT I'TJ't\') liar I'07iT 11'''T'1 071;1-1))' 1''''I.,rllh'}lIar') ())om,.). tlTlJ"'I.lI)·
Maul ,:J ,:J .}. T lJ "'I. ())o UO')lC Oau')!,.lI
t-lI'') MIlt\ 1I/'r lIOU~ .eu')') ODl~ I'ITII"'I.o>- 'l.-,.Mt /oIl1\')'
111' tlS1C J?'fl\t\::
2/ A hcalrh professional shall issue genuine and
complete sick leave or certificate of illness.
86. Prescriptions and 1\1cdirine Dispensing
1/ No health professional may prescribe medicine
or fonnulations about which he has no
knowledge about its composition atld
pharmacological action.
2/ A prescription on which a health professional prescribe shall be standardized and prepared in accordance with the standard of the institution and type of the profession .
3/ Any health professional shall prescribe
medicine registered in the nation'al drug list
unless for compelling reason.
4/ Any professional dispenser of medicine may
not dispense or keep any medicine obtained
through illegal channel.
87. Waste Disposal and Disease Prevention
1/ Any health professional shall dispose of disposable healthcare wastes in an appropriate
. manner for the sake of himsetf. the client and the public health . .
2/ Any health professional shall respect safety
provisions that ensure the non transmission of
diseases from himself to client, from clienl to
client or from c1ienl to health professional.
88. Disclosing Prognosis
1/ A health professional shall explain the nature
and possible outcome of the terminal or sever
illness to the patient or, in case of a minor or
mentally ill person, to the guardian.
2/ Notwithstanding the provisions of sub-article
(I) of this Article, a health professional may
only communicate the nature and possible
outcome of the terminal or sever illness to
family members of the patient where he
believes that the patient may haon himself due
to emotiona1 instability.
'ltll. 1.11 t\ ') 1. 'l uo-J' 'I: J'to. If ~ -I' "lIlC,) • 1''''1 ~ l "I "I Y.;t-
tTCT 89. Reporting of Impairment and Unprofessional
Conduct
"'I')'i'(O'?" \'m,C; Ill'lau·,r 1''''I.h·/'I\--)-·) h"lll·n
1\1I11~ hilA t?'C')' o~Y:l'7 MIl')':-Any health professional shall report the following to
the appropriate organ:
fil MltI 1'1''1'';1·tI l1t'1- ,l'UD~Il')") I't'lA I'm,'; flt'lolJ·.n I.tltl i
~I I''''L,I'aH'(/)' (/)f,9" 11.1',4. I.'M.,!'(/)·:Y 1"/·.I'.l1
htf'/ (/).1',9" n'hlllmlar I.hll· 9"h1,1'1'
Ort· 'I bll.Ln'J, ·/·10.W··) j'; :>~: 1.·}-'l.m,l'.:Y
9"IIC 1'·I·t'\'JOm· h tf~ I't·O··) I.lltI:
U I'OD·J' /'.:Jo.l'.' I't'I.t'I(D. mf,9" 1'00',1' t.:I'-'\.
I' ;1'11'.0')' (/)f,9" Nc'llllfl'l' c'lar I'mS
/'1t1"11l'+ I.I'c'lm ootf',·') I 1.'i
§I 1'11.0'1 flt\oo·.n O?'g'ar9" -,I''f ,l'tltf~ I"~
9""I'lC)::
h'f:tI Mr
M·t-1!"'Ir
j. !1M2'''' "'ll2-'1~U."()[email protected]'±
Federal Negarit Gazette No. 11 24th January, 2014 Page 7218
11 an impairment in another health professional if
he is convinced that such professional is
impaired;
2/ his own impainnent if he is aware of it or has been publicly infonned, or he has been advised by colleagues to obtain help in view of an alleged impainnent;
3/ the provision of health service by a person without professional license or whose
professional license has been suspended or
revoked; and
4/ any unprofessional conduct of another health
professional.
PART SEVEN
INSTITUTIONS
iii "'I')';'m'9" t\(/)' 1'11:1'1' "'Il:>1"~
(/) L 4' 1- /'''1'111 l-jt\ lD- /, l-j tI <'1,1"1'1
9"fltlC 90. Certificate of Competence
M:4!'1" fit· 'IJ', ooO"'l?-')' /'J','ftl9"::
~I II"'1')'i'(/)'9" '1-:1:9" Nt\m 1'11:1'1- "'Il,n~
9"flhC (/)L4'1' Ol',}oo'" oo:N.fI M01-::
rl "'I1'i'ar9" r*9n 1'11:1"[' "'Il:>7~ 9"flhC
(/)l.,,')· O(/)t\.I'.I11- oofiotC')' 170M'''' fI?-lD-1
"'I h 'ian J',';' C n:1' tI : :
21 /'''Ifll1 ,l't\(/). /'l-JtI 1'11:1")' "'Il:>1"i. 9"flhC
(/)l4")' oa'l.I~'1'n-l· (/).1',9" 1l"'L,I'.~fIn1- tl1.
I'9"C1:1 (/)J!,9" I'h1t1"11l-1:1 '}J',~1'i
hoo&·l')· i M1Jl:P:')' i hhoo;f'f1- 1.'i 1l.1l-'f
Mot"1. I'tf'1- !W"C'I: roJ',9" hh1t1"lll·'"
'1'&")''i !,.U1~')· pC I"/-,!',I'll- "'I'i'flD-19"
'}J',~')' IJ-'!.;I·?Jf1 1.11. .,.*- "I$!.:1' 11.,1' fI.,,9"'1' J', 'f'l tI : :
(;1 1'11:1'1' "'IlP7"i. 9"flhC rol"")'1 /'''Ifll1
Ij II lD- /, Ij tI ot:l' !': lD-al, 11"'11'i'lD-9" 00 till
II{l M' 'i' (/)71 "'I fI.,."" <j: /, J',;f tl9": :
'Ii. 1'.11-"±-_"'llZL·''I..2''1JIlc...JIJ.l.tl.L1I11ap ooilfi
"'IW (/).9" 1'11:1'1- "'Il P 1 ~ 9" flhC (/)l4' 1-
1':1'1.1'.l1r 1 I'-/-lPllIll')' roM" 1.!':"Ir r'/'hllh
IIllr roM· 1"?-(/)'1 f*lm "'*9" 1'11:1'T
"'Il P 1 ~ 9"11 h C ro t.4' 1: 1 /'''11)11 ""lD- /, IjA
0000l1li MO'r::
jl. MI)II-,I'?J'f I'm.'i 9"Coot-
iii "'1')';'(/)'9" '''*9" h·/··/A.'JJ', ;JC "I·n·~·)·
,l'lIar I'm. .. '11100'.1'1 (/)J',9" 9""1·11 Mp~1
11',.*9" (/)·fI'1' hoo4'm<;. Ilt.·.,. 1.1-'1.U·9"
111''100'" . hl1.1'./'J',.1l.!lb.l':II IlM'~C I'm.'i
9"Coot· .,.')-'l.fY.C"I "'I!':l"l Mil')'::
-"'~- ---"'" .,..,..,
1/ No person may establish and run institution
without obtaining a certificate of competence
from the appropriate organ.
2/ A certificate of competence issued to any
institution shall be renewed annually.
3/ Any institution shall undertake its business in
accordance with the requirements on the basis of which its celtificate of competence issued.
41 The appropriate organ may issue or renew a
certificate of competence subject to restrictions
on the type of the product or service, means of
production, processing, storing and any other
necessary conditions relating to the quality and
safety of the product or service.
5/ It is prohibited to transfer in any manner a
certificate of competence to a third party
without the penn iss ion of the appropriate organ.
91. Surrender of Certificate of Competence
Any institution whose certificate of competence is
revoked, cancelled or denied renewal or which has
ceased operation shall surrender its certificate of
competence to the appropriate organ.
92. Professionals Health Examination
11 Any institution shall make health professional
or food handler who has contact with clients to
undertake pre-employment and annual medical
examination'-except for HIV / AIDS.
!l.1 "'1'I'i'ro'9" rills 'ltloo'J' OIl.U n'HK' '1M' h 14'lI' (~) oow I. 'l' t\t,(r rills 9"Cou{"
"'1Y:I.'1 hj'A'tl9"::
t:1 "'1'I'i'IJI-9" 9"'111 nll;l)';
n71;t' n"'1.J'1/Il'l· '/.11.
.e'i'cn;t'tI::
n9" '111 0 "'l.1' ... tI <i:
(\01-*00' "'111'CDP
fJJ "'1'}'i'IJI-9" r9"'111 1'*9" n9"'1'o n"'1.1' ... tI<i:
R7i;t' r·t-J'I! oolf~' r;t'cD4'1 r9"'111 M1:>;t>;
07i;hD' r"'lY,.f· ... tI'i:o·l · 1,1.:<1 Mh.I.CfI Y:l.fI
h9"'111 :>C 1hh. '1''I'J'1JI- flt.?''T ?,'I-'I. 7t1t1
"'IY:I.'1 Mn'l'::
al I]tlp'N'1~' h·r7t1;J.!.'. :>C '1TH'). J'tl1JI-1
rills ~tI-J' roy.9" \'9"'111 Ml?»: 9"Coot.
Il.J'.I',C"lO·). M"'l. 71]1JI- rn71.r nj.'. ~-).
n-/,outlll-I' llCllC ououtJ' J'CD"!tI::
11:. M1'*9" ",,{lloCf.'f'i htlM?''f
iiI "'I-I';'IJI-9" -1'<':9" f''''I.tlJi''J'1JI- 1 7-:tt 1'l'1.
~7r: ')' '1 .jI7i7i?' ';f (\ un.jl "!Ill C IJI- fI"! 'l! r .jI7i 7i
hYY'lf'1 h01:>7Y: P'C~"'- (\.<;'I.IJI- ,I'.1l]tI::
II "'11'i'CD'9" -f'*9" hlJl-~ MC 9"'11l'l CDj.'.9"
ouY::>'d-1 n"'l{lou"!-)- M'l';t' CD~ t\A MC
t\au ... h /II] t\P' A "!.,. A r. 4. Ji' Y: "'1"11').
Mn-).::
1'.1 "'11';'01'9" -"'1;9" NMM (]lj.'.9" I'MtI"I(\o-).
7.1\.1JI- J't\lon-)· 9"'1·(n CDj.'.9" 001::>'1.-).'1
"'I{lao"l')" noY'l' w,e9" "'II'lt,lXl.-}· h.e '):tl9": :
ij,/ "'11';'01'9· Mou(.T.l, roy.9" )';9·... hhM.y.
'1'*9" i'11Ji'-)' "'11.?7"'L 9"{lhC CDI.4'-)·
M. fl IJI- 1'1 IJI- 9""l1l'l m .e 9" 001::> 'I. .) •. ) "'I M.
loA h.e'ftl9"::
(;1 "'11'i' IJI-9" r . 1'"1'1 C tl9" 9" I: 1'1 "'l. J'f.C'1 '1' "'1 t i' Ill. '1 n 7 A '1 (\0 ·l· ?, 1-'1.1'1 'l' r.t 4' ~ i' Ill. '1 '1' *9"
1''''I{'ro· O;t","'I.w· ... y. fl"'l.J'.I',CfllJl- '1-.<1-).
:>II.1.H' J'.'~CO;J,tI::
h<i:A il9"')·).
Af. Af. 1:1?1?''f
~!i. "",,;II i'oo{lm-r '19.;t'
iiI "'11'i'01·9· i'1ll.'1 I]flou·f n"/lJl1 I]fllJl- n"A
O"'l'1:far9" 7.tL rno' ,!' fit· &,Ji'-,\- ' ) ?,1-'1.,!' ... .e
Wj.'.9" rt.fl·1 mj.'.9" \'1\,<'\ lJt\uo'f -J''f
?")i'fI,4>(~ 1''''I.fllY. uul:<1 h')-'l.f4'Cll 1l.1ll1'i'
l'au'I'I]OC "I$'.;}. MO')'::
Federal Negarit G37.ctle No.1 J 24\h January,2014 P<1ge 7219
21 No health professional may undertake medical
examination for himself in accordance with
sub·article (I) of this Anicle.
31 Any food handler shall notity the institution
where he is infected by food borne ·
communicable disease. Any food estoblishment
shall screen a food handler infected by food
borne communicable disease.
4/ Any food establishment shall remove any food
handler who is infected by food borne
communicabJe diseflse from activities involving
contact with food until the disease becomes non
communicable.
51 The Authority shan issue directive on the type
of medical examinations that a health
professional or food handler who has contact
with clients shan undenake.
93. Institution Requirements a nd Prohibitions
1/ Any institution shall develop intemal waste
management system to manage its hazardous
substances and wastes.
2/ An exporter institution shan obtain special
permit from the Authority for transiting
medicine or food from foreign country to
another country.
3/ No institution may impon, keep or distribute
prohibited or expired food or medicine.
41 No wholesale or impon institution may
distribute food or medicine for a person with no
cenificate of competence.
5/ Any health institution which permits a student
on practical training to provide health service
shan be responsible for any damage the student
may cause to a patient.
PART SEVEN
MISCELLANEOUS PROVISIONS
94. Duty to Furnishing Information
11 Any health professional shan cooperate with the
appropriate organ whenever requesred to show
his professional license or provide information
about his professional performance or that of
others.
_ .. -
fl fJl'I?'tllTJ~' fllLU h14'7i 1frll h14'7i (Ii) ov!pd' J'11or1 ovG>: nu"? I-ttl1't.4'1.
nll'~"'c O"'l.il'l'C <fOmf1:r Mn7'"
'Ii, "Tc'l' 1''''11;1.'1 '71'.;1'
jil "'I1'i'or9" {lco' h'}Y: 1'/1\,'1 Ilil-J' 1'/1\,'1
1I''I.;t-or 'n-/< 1''''I,J'1.C?or Muvlf'r1 COM"
ov'J''!! ytlU"/ ?'~ Y""IfJC ovt.1.uv·'>
lJov~O '}' h"ll]lI 'I(leD' hlltl 1''''I<'IeD1> "I~;t
Mn'}'::
11/ OILU h'lo/>\' ')frll h')4'>\' (Ii) UOIPG'/' h"lfJlI
'I(lor Itl-ttl n:r'i tI(l'l uol.Jl I'l'Im {lor nu"?
1'mJ'<t hJ!,lf')Y"::
n. l!~.:'IkT_t!<j:J'
"'11>;' co-9"
"'I G :n "'I. 1'1"'1<'11.111
9"llhC
{lCO' I'tID.J' fit· t.JI>Y: CO~Y" NIJ1>7'
9" II h C CO I. H· 1'1"'1 or 1TJ7' CO J!, 9"
ouY:;:"I;l'1 {l"'lllau1l?'n aJJ!,9" t\il-l'
aJl.N·)'·')'I MtI"II'I·,H1 (I"'I"I1r
nov1"1?'-l' n1..I'.o/' ,,'au'> tID{ll.')' h"lfJlI 'Il'Ior
h!JtI I' h?tI "1(1")' h<J:, f!,h<J:'ItI::
Federal Ncgari( Gazette No. 11 24lh January, 2014 Page 7220
2J The appropriate organ shall keep the
confidentiality of information obtained in
accordance with sub-article (1) of this Article
unless otherwise permitted by Jaw.
95, Duty to Report
1/ Any person who believes that a health
professional is unfit to practice or commils
unprofessional conduct shall notify the
appropriate organ.
21 Any person who in good faith nolifies the
appropriate organ in accordance with sub-article
(1) of this Article may not be legally liable.
96. Service Fees
Every person shall pay service fees to the
appropriate organ at the rate approved by
. government for obtaining or renewing professional -
license or certificate of competence, registering
medicine or receiving other certificates and services.
U. I1I1T7i<;-'I Tt.Il"'Ur flII"'If.<;6-Tor u1l' 97. Repealed and Inapplicable Laws
/il l''''I.h-l'(I--)· ntl.U .I'.'HI '~7il.'I'tI:- 1/ The following are hereby repealed:
Il} I'/I\,~' h7t1"lt'I- ,l' '''*9'' t.JI>Y: MITJ'l''I a) the Licensing and Supervision of Health
of:'l''l'C 1''''I.'LIl')·C:''''· 9"hC o.r .I'.1'n Service Institut ions Council of Ministers
"''l'C H~!!IIi!!ii'l! h'l Regulation No.I74/1994; and
II) rn.-rl"fI'Y illS fJlI-Y?Jr oo"'lhcr
1'Cl't "'1**"'1.,1' r"'l. 'I.1l·h:l' 9"hC o.r
.l'.1-(] 4!'l'C ~!ilIiir'.l!i::
r.1 J!,Ul .1'.111 1''''I.JI>G1 "'I,'i'or9" .f.111!
oouot:J' aJJ!,9" I'hIJJ6-C tl9"Y: flIl.u .f.111
(lI'll'l' I'TOD(lh1> ?·.II1"1'-1 n"'l.ovllh+ Tt.
''''I.~,r hJ!,<;l.aJ·~u: :
,1:. oouo_?Lf~ITJ:Le~~ 1l(l?'tllTJ~' J!,U1 .1'.111 11"'111&.1.9" 1''''I..,IlUNI
auov? J' ?J:j:1 lI.'aJlTJ f. 1'-'ItI::
7/1. .1'.111- I''''I..K'IOr 'I.!l.
f.U .1':111 n.l...r,t·tI ~;JM' ;J11.1TJ ;t-,)-qu haJlTJn')'
""1 ~Y"C' 1'1.'1 Y,lf'itl::
Mil MfJ 'l'C J.~ 4'') f71~ 't.9"
;:. J!.II"'I c J'9" .1'.1\ II ~
1'n.'}·I"A·' .I...I'.6-II'/! )(. quht-fl.J',/!
"Tl1l1.h m'l''IJ!. "'I.. 'I.llrC
b) the Ethiopian Health Professionals Council
Establishment Council of Ministers
Regulation NO.76/2002 .
21 No regulation. directive or customary practice
shall. in so far as it is inconsistent with this
Regulation, be applicable with respect to
maners provided for by this Regulation,
98, Power to Issue Directives
The Authority may issue directives necessary for the
implementation of Ihis Regulation.
99. Effective Date
This Regulation shall enter into force on the date of publication in the Federal Negarit Gazene,
Done at Addis Ababa, this 24'~ day of January, 2014.
HAILEMARIAM DESSALEGN
PRIME MINISTER OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA
-
