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የאድ٪ኒُ ፈንድን እና የאድ٪ኒُ አቅץቦُ ኤጀንגהּהּד תያ Drug Fund and Pharmaceuticals Supply Agency
דፅደשּׂያ አዋጅ…. ገጽ 3¹þ9)#9 Establishment Proclamation …. Page 3939
ይֱ አዋጅ “የאድ٪ኒُ ፈንድን እና የאድ٪ This Proclamation may be cited as the “Drug Fund
and Pharmaceuticals Supply Agency Establishment
ኒُ አቅץቦُ ኤጀንגהּהּד תያ አዋጅ שּׁጥץ
Proclamation No. 553/2007.”
5)$3/09)(9” ـብֹ ֵጠשׂስ ይ٤ֶָ፡፡
2. Definitions
2. ُץጓה
In this proclamation, unless the context otherwise
የቃִ አገוֹብ ֶַ ُץጉ וየגያרጠው ካֲָነ requires:-
በስ ץשׂـበዚֱ አዋጅ ውስጥ፣
2/ “የሕክוና אገָገያ” ֳُד በֹּٍלን 2/ “medical supplies” means any Article that may
ֳ ץאץאאወይדֳ וከ וበውስጥ ወይו be used on the inner or outer part of the human
body for diagnosis or treatment of disease, and
በውጭ የרውነُ አካָ ጥቅֶ וይ የגውָ
includes suturing materials, syringes, needles,
דንኛውא וገָገያ ֲתን፣ የשּׁስָ אስፊያ
bandages, gauze, cotton and similar products,
ክצ٤ን፣ עתንጆ٤ን፣ ץאፌዎ٤ን፣ ፋָך፣
chemicals and x-ray films;
ጐዝ፣ ጥጥና ָרא ዝግጅِ٤ን፣
ኬגካֹ٤ንና ፊָז٤ን ይጨָףו፤
3/ “medical instrument” means any instrument
3/ “የሕክוና עכאያ” ֳُד በֹּٍלን that may be used on the inner or other part of
ֳ ץאץאאወይדֳ וከ וበውስጥ ወይו the human body for diagnosis or treatment of a
በውጭ የרውነُ አካָ ጥቅֶ וይ የגውָ disease, and includes various diagnostic,
דንኛውו עכאያ ֲתን የֳـያዩ laboratory, surgery and dental instruments:
የעאץאאያ፣ የֶቦץِף፣ የשׂዶ ጥገናና
የጥץስ ሕክוና עכאያዎ٤ን ይጨָףו፤
4/ “የאንግ ُםየጤና ֳُד ”והּـበፌዴָף 4/ “public health institution” means a health service
ወይו በክָָ אንግُם ֳוֹቤُነُ rendering institution owned by the Federal or a
የـגዳደ ץየጤና አገָግֹُ የרגጥ והּـ Regional State;
ነው፤
5/ “regional state” means any state referred to in
5/ “ክָָ” ֳُד በኢُዮጵያ ፌዴֶףዊ
Article 47(1) of the Constitution of the Federal
ዴזክתףያዊ עፐብֵክ ሕገאንግُם
Democratic Republic of Ethiopia, and includes
አንשׂጽ #7/1/ የـጠרשׂው דንኛው וክָָ the Addis Ababa and Dire Dawa city
ֲתን የአዲስ አበוֹና የድפዳዋ ከדـ administrations.
አስـዳደצ٤ን וይጨָףו፤
6/ “appropriate body” means a body responsible
6/ “አግוֹብ ያֳው አካָ” ֳُדየጤና ُדהּـን body to regulate the competency of health
ብቃُና የאድ٪ኒُን ደֱንነُ፣ ፈዋֹּלነُና service institutions and pharmaceuticals safety,
ጥנדֳ ُףጋገጥ ָםጣን የרـጠው አካָ efficacy and quality;
ነው፣
gA 3¹þ9)$1 ØÁ‰L ነU¶T Uz¤È qÜ_R ^4 ነּሴ @9 qN 09)(9 ›.M Federal Negarit Gazeta No. 64 4th September, ነ 2007… page 3941
7/ “גኒስَ ”ץእና “גኒስُ ֳُד ”ץእንደቅ 7/ “Ministry” and “Minister” means the Ministry
ደـוከ ִـየጤና ጥበቃ גኒስَ ץእና and Minister of health, respectively.
גኒስُ ץነው፤
3. Establishment
3. והּהּא
የאድ٪ኒُ ፈንድ /ከዚֱ በኋֶ “ፈንድ” እየـ The Drug Fund (hereinafter referred as the
ֳוֹየגጠף/ በዚֱ አዋጅ ָחשּׁהּـ፡፡ “Fund”) is hereby established.
ፈንዱ የגከו ִُـንጮ٤ ይኖָٍס፣ The Fund shall have the following sources.
1/ በዚֱ አዋጅ ُנטאከאድ٪ኒُ አቅץቦُ 1/ net income generated from the supply of
ከגገኝ የـጣ ףገתּ፣ pharmaceuticals pursuant to this Proclamation;
5. የፈንዱ አጠቃושׂ
5. Utilization of the Fund
ፈንዱ የד ףםስኬጃ ወጪዎ٤ን እንዲ₪ፍን
The Fund shall, after covering all overhead costs,
ከـደנገ በኋֶ ָאـሶ በדዟዟאֳ ץድ٪ኒُ
in turn expend for the procurement of
ግ™ እና ֳאድ٪ኒُ አገָግֹُ דስፋፊያና pharmaceuticals and the expansion and
דጠናከעያ እንዲውָ ይደנጋָ፡፡ strengthening of pharmaceutical services.
ክፍָ מስُ
የאድ٪ኒُ አቅ תּףኤጀንת PART THREE
THE PHARMCEUTICALS SUPPLY AGENCY
6. והּהּא
6. Establishment
1/ የאድ٪ኒُ አቅ תּףኤጀን ת/ከዚֱ በኋֶ
“ኤጀን ”תእየ ֳוֹـየגጠף/ የֱግ רውነُ 1/ The Pharmaceutical Supply Agency (hereinafter
ያֳው שףን የ٢ֳ የፌዴא ָףንግُם referred as “the Agency”) is hereby established
עםאያ ቤُ ֲኖ በዚֱ አዋጅ ָחשּׁהּـ፡፡ as an autonomous federal organ having its own
legal personality;
2/ ኤጀንתው ـጠעነً ֳגኒስَ סይֲናָ፡፡
2/ The Agency shall be accountable to the Ministry.
7. ዋና עםאያ ቤُ
7/ Head Office
የኤጀንתው ዋና עםאያ ቤُ በአዲስ አበֲ וֹኖ፣ The Agency shall have its head office in Addis
እንደአስፈֶጊነً በדናْውם וፍ ףቅץንጫ Ababa and may have branch offices elsewhere as
ፎ٤ ֵኖ ُסይ٤ֶָ፡፡ may be necessary.
ኤጀንתው የגከ ִُـዓֶדዎ٤ ይኖָٍס፣ The Agency shall have the following objectives:-
gA 3¹þ9)$2 ØÁ‰L ነU¶T Uz¤È qÜ_R ^4 ነּሴ @9 qN 09)(9 ›.M Federal Negarit Gazeta No. 64 4th September, ነ 2007… page 3942
ኤጀንתው የגከָם ִُـጣንና ـግُףוֹ The Agency shall have the powers and duties to:
ይኖָٍס፣
3/ የክו٤ُና የץםጭُ አውٍצ٤ን ፍُ٪ 3/ expand and strengthen storage and distribution
outlets based on equity and effectiveness;
ዊና ውጤٍ דበֲነ ָאኩ ያስፋፋָ፣
ያጠናክָף፤
4/ supply essential pharmaceutical of quality,
4/ አግוֹብ ֳוֹው አካָ ደֱንነٍْው፣ ፈዋֹּלነ safety and efficacy approved by the
ٍْውና ጥٍْףው የנـጋገጠ אድ٪ appropriate body to all public health
ኒِ٤ን ֳאንግ ُםየጤና ُדהּـያץשׂ institutions; where appropriate and in
ָוֹ፣ አግוֹብ ֲኖ תገኝ በበא שּׂጠን ֵשׂ accordance with directives of the Board,
שּץያָ٢ִ የנאـጡ אድ٪ኒِ٤ን supply to private and non governmental
ቦץዱ በגያወጣው עאאያ א ُנטאን health institutions selected pharmaceuticals
ግٍםዊ ֲֶָነና ֳግָ የጤና ُדבּـ which are not adequately available;
ያָוֹץשׂ፤
7/ የአጭץ፣ የאካከֳኛና የנጅ וጊዜ የግ™፣ 7/ prepare and implement short, medium and
የስץጭُ፣ የדከُْדና የדጓጓዝ ዕቅድ long-term plan for procurement, storage and
በדዘጋጀُ ይـገብָף፣ አፈፃፀבንו distribution, and monitor its implementation;
ይገאግָד፣
8/ provide consultancy and training services in
8/ በגያከናውናْው የ ףםዘץፎ٤ ֶይ
its field of operation;
בያዊ የוክ ץአገָግֹُና ָםጠና
ይרጣָ፣
9/ where necessary, establish committees, guide
9/ አስፈֶጊ ֲኖ תያገኘው አדካ עኮَגዎ and coordinate their activities;
٤ን ያָדשּׁהּ፣ ْףםውን ይָףא፣
ያስוֹـብָף፤
0/ ֳרגጠው አገָግֹُ ቦץዱ በגያወጣው 10/ collect service charges pursuant to the
עאאያ ُנטאክፍያ ያስከፍֶָ፤ directives of the board;
01/ የንብֳוֹ ُנቤُ ይֲናָ፣ ውָ ይዋዋֶָ፣ 11/ own property, enter into contracts and sue
በ שףስ וይከሳָ፣ ይከרሳָ፤ and be sued in its own name;
02/ ዓֶדውን ֳדስፈጸ וየנגዱ ַֹ٤ 12/ perform other activities to pursue its
ـግצוֹ٤ን ያከናውናָ፡፡ objectives.
0. የኤጀንתው አוהּ
10. Organization
ኤጀንתው፣ The Agency shall have:
1/ ቦץዱ רብሳתּውን ጨ צוበגኒስُס 1/ The Board shall have members, including the
አቅתּףነُ አግוֹብ ካֶْው የፌዴָף chairperson, to be designated by the Federal
אንግُם አካֶُ በאንግُם Government upon the recommendation of the
የרגየבና ከክָֹ٤ የـውጣጡ አֶُוֹ Minister and others drawn from
ይኖָٍס፡፡ representatives of Regional States.
ቦץዱ የגከִُـ ָםጣንና ـግُףוֹ The Board shall have the powers and duties to:
ይኖָٍס፣
gA 3¹þ9)$4 ØÁ‰L ነU¶T Uz¤È qÜ_R ^4 ነּሴ @9 qN 09)(9 ›.M Federal Negarit Gazeta No. 64 4th September, ነ 2007… page 3944
6/ ኤጀንתው ከוֹንክ የגበደנውን የገንዘብ 6/ decide on the amount and payment schedule
אጠንና አከፋፈִን ይወስናָ፤ of bank loans to be taken by the Agency;
8/ ዓٍאዊ የሒሳብ עፖ ُץያፀድቃָ፣ 8/ approve the annual financial reports of the
የውጪ ኦዲצـ٤ን עፖ ُץይָדר Agency; appoint external auditors; ensure
በנשׂበֳُ የኦዲُ עፖאـ ُץስِץ that adequate measures are taken in
አስፈֶጊውን የእُוץ እוץጃ accordance with audit reports, and ensure that
ይወስዳָ፣ עፖًץን וይፋ ያደץጋָ፣ the audit reports are made public;
2 በቦץዱ ስብֶ וֹרይ ሁֳُ ሶስـኛ 2/ There shall be a quorum where more than two
አ ֶُוֹከـገኙ ָוዓ ـጉוֹኤ ይֲናָ፡፡ third of the members of the Board are present
at a meeting;
gA 3¹þ9)$5 ØÁ‰L ነU¶T Uz¤È qÜ_R ^4 ነּሴ @9 qN 09)(9 ›.M Federal Negarit Gazeta No. 64 4th September, ነ 2007… page 3945
3/ የቦץዱ ውሳኔ የֳֶـגፈው በስብוֹרው 3/ Any decision of the Board shall be made by
ከـገኙ አ ֶُוֹበአብዛኛው ድוጽ תደገፍ a simple majority vote of the members
ይֲናָ፡፡ ֲኖ וድוጹ እኩָ በእኩָ present; in case of a tie, the chairperson shall
የـከፈֳ እንደֲነ רብሳתּው ወሳኝ ድוጽ have a casting vote’
ይኖנዋָ፡፡
4/ የዚֱ አንשׂጽ ድንጋጌዎ٤ እንደـጠበֲ שּׁኖ 4/ Without prejudice to the provision of this
Article, the Board may adopt its own rules of
ቦץዱ የשףን የስብם וֹרነ-ץםዓُ ደንብ
procedures.
ֵያወጣ ይ٤ֶָ፡፡
04. የዋና ዳይפክָם סـጣንና ـግץוֹ 14. Powers and Duties of the Director General
1/ የቦץዱ አጠቃֶይ አ ץףאእንደـጠበשׂ 1/ The Director General shall be the chief
ֲኖ ዋና ዳይפክ סـየኤጀንתው ዋና ףם executive officer of the Agency and shall,
አስፈጻ גበֲאን የኤጀንתውን ףםዎ٤ subject to the overall guidance of the Board,
ይָףא፣ ያስـዳድָף፡፡ direct and administer the activities of the
Agency.
2/ የዚֱ አንשׂጽ ንዑስ አንשׂጽ /1/ አጠቃֶይ
አነጋገץ እንደـጠበשׂ ֲኖ ዋና 2/ Without limiting the generality of Sub-Article
ዳይפክסـ፣ (1) of this Article the Director General shall:
ሀ/ በዚֱ አዋጅ አንשׂጽ 9 የֳאـከًُን a) exercise the powers and duties of the
የድץጅًን ָםጣንና ـግُףוֹ Agency provided for in Article 9 of this
ֶ ףםይ ያውֶָ፤ Proclamation;
ט/ ኤጀንתው ከሶስـኛ ወገኖ٤ ጋץ e) represent the Agency in all its dealings
በגያደץጋْው ግንኙነِ٤ ሁִ with third parties;
ኤጀንתውን ይወክֶָ፣
f) submit reports to the Board on the
נ/ ስֳኤጀንתው የףם እንቅስቃሴ
Activities of the Agency;
ֳቦץዱ עፖ ُץያָוֹץשׂ፣
g) perform other duties assigned to him by
ר/ ከቦץዱ የרגጡُን ַֹ٤ ـዛדጅ the Board.
ـግ ُףוֹያከናውናָ፡፡
gA 3¹þ9)$6 ØÁ‰L ነU¶T Uz¤È qÜ_R ^4 ነּሴ @9 qN 09)(9 ›.M Federal Negarit Gazeta No. 64 4th September, ነ 2007… page 3946
3/ ዋና ዳይפክסـ ֳኤጀንתው የףם 3/ The Director General may delegate part of his
ቅָጥፍና በגያስፈָግ אጠን ከָםጣንና powers and duties to the Deputy Directors
ـግ סוֹበከፊָ ֳኤጀንתው וክָُ ዋና and Employees of the Agency to the Extent
ዳይפክצـ٤ና ֳַֹ٤ ـףטኞ٤ necessary for the efficient performance of its
በውክָና ֵያስֶָـፍ ይ٤ֶָ፡፡ activities.
1/ አጠቃֶይ የאንግ ُםግዢ ֲץאዎ٤ 1/ The Agency shall, without prejudice to the
እንደـጠበֲ שּׁኖ፣ ኤጀንתው የ שףየֲነ general government procurement principles,
የግዢ עאאያ ይኖנዋָ፡፡ have its own procurement manual,
1/ የኤጀንתው በጀُ በዚֱ አዋጅ አንשׂጽ 1/ The budget of the Agency shall be covered by
05/3/ ُנטא ከרגበስበው ገתּ the revenue to be collected pursuant to
የג₪ፈን ֲኖ በቦץዱ אጽደቅ አֳበُ፡፡ Article 15 (3) of this Proclamation and shall
be approved by the Board.
2/ ኤጀንתው ካֳው ጠቅֶֶ ንብ ُנበֶይ
በዕዳ ـጠያ שּׂአይֲንו፡፡ 2/ The Agency may not be held liable beyond its
total assets.
07. የוֹንክ ሂכብ
17. Bank Accounts
በዚֱ አዋጅ አንשׂጽ 4 የـጠרשׂው ገንዘብ
The financial contributions referred to in Article 4
በኤጀንתው ስ וበـከፈ ـየוֹንክ ሂכብ of this Proclamation shall be deposited in a bank
דשׂـጭ ይֲናָ፡፡ accounts opened in the name of the Agency.
ከאድ٪ኒُ ፈንድ ገንዘብ ወጪ ֲኖ የגከ Disbursement of the Drug Fund shall only be
ፈֳው በጸደשׂው ዓٍאዊ የ ףםፕצግוףና made in accordance with the approved work plan
በቦץዱ עאאያ ُנטאይֲናָ፡፡ of the Agency and directives of the Board.
ኤጀንתው የאድ٪ኒُ ፈንዱን የִחـና The Agency shall keep complete and accurate
ُክክֳኛ የֲኑ የሂכብ אዛግብُ ይይዛُ፡፡ books of accounts of the Drug Fund.
gA 3¹þ9)$7 ØÁ‰L ነU¶T Uz¤È qÜ_R ^4 ነּሴ @9 qN 09)(9 ›.M Federal Negarit Gazeta No. 64 4th September, ነ 2007… page 3947
የኤጀንתው የሂכብ אዛግብُና ገንዘብ ነክ The books of accounts and other financial
רነዶ٤ በየዓًא በውጪ ኦዲצـ٤ documents of the Agency shall be audited
ይִףאנא፡፡ በኦዲ ץـየ סאנאـየሂכብ annually by external auditors. Audited financial
אግֳጫዎ٤ የበጀُ ዓ שֳׂוֹ ًאበአُף reports shall be submitted to the Board within
four months following the end of the budget year.
ወ ُףጊዜ ውስጥ ֳቦץዱ ይִוֹץשׂ፡፡
PART FOUR
ክፍָ አُף MISCELLANEOUS PROVISIONS
ָዩ ָዩ ድንጋጌዎ٤
21. Transfer of Rights and Obligations
!1. אብُና ግዴٍ ስֳדስֳֶـፍ
!2. ደንብና עאאያ የדውጣُ ָםጣን 22. Powers to Issue Regulations and Directives
1/ የגኒስُצ٤ וክ ץቤُ ይֱን አዋጅ 1/ The Council of Ministers may issue regulations
ֳדስፈጸ וየגያስፈָጉ ደንቦ٤ን ֵያ necessary for the proper implementation of
ወጣ ይ٤ֶָ፡፡ this Proclamation.
2/ ቦץዱ ይֱን አዋጅ ֳדስፈፀ וየגያ 2/ The Board may issue directives necessary for
the proper implementation of this
ስፈָጉ עאאያዎ٤ን ֵያወጣ ይ٤ֶָ፡፡
Proclamation.
!3. የסָךـና ـፈጻ גየדይֲኑ ሕጎ٤
23. Repealed and Inapplicable Laws
ይֱን አዋጅ የגቃנን דናْውֱ וግ፣ ደንብ፣ No law, regulations, directives or practice shall, in so
עאאያ ወይ וየአוָ ץףטድ በዚֱ አዋጅ far as they are inconsistent with this Proclamation, be
በـ₪ፈኑ ጉዳዮ٤ ֶይ ـፈጻגነُ አይኖנውו፡፡ applicable with respect to matters provided for in this
Proclamation.
@4. አዋጁ የגፀናበُ ጊዜ
24. Effective Date
ይֱ አዋጅ በፌዴ ָףነጋ ُעጋዜጣ ٍُז
This Proclamation shall come into force up on
ከወጣበُ שׂን ጀ צוየፀና ይֲናָ፡፡
Publication in the Federal Negarit Gazeta.
አዲስ አበ וֹነּሴ !9 שׂን 09)(9 ዓ.ו Done at Addis Ababa, this 4th day of Septemberነ, 2007