Council of Ministers Regulation No. 189/2010
COUNCIL OF MINISTERS REGULATION TO
ESTABLISH THE ETHIOPIAN FOOD, MEDICINE
AND HEALTH CARE ADMINISTRATION AND
This Regulation is issued by the Council of Minister pursuant to Article 5 and 34 of the Definition of Powers and Duties of the Executive Organs of the Federal Democratic Republic of Ethiopia Proclamation No. 471/2005 (as amended by Proclamation No. 603/2008) and Article 2(43) and 55(1) of the Food, Medicine and Health Care Administration and Control Proclamation No. 661/2009.
1. Short Title
This Regulation may be cited as the “Ethiopian Food, Medicine and Health Care Administration and Control Authority Establishment Council of Ministers Regulation No. 189/2010”.
In this Regulation unless the context otherwise requires;
1/ “Proclamation” means the Food, Medicine and Health Care Administration and Control Proclamation No. 661/2009;
2/ the terms “food”, “medicine”, “health professional”, “medical practitioner”, “health institution” and “Region” shall have the meanings assigned to them under Article 2 of the Proclamation;
3/ “pharmacy professional” means a pharmacist, druggist or pharmacy technician licensed by an appropriate organ;
4/ “Ministry” and “Minister” means the Ministry and Minister of Health, respectively;
5/ any expression in the masculine gender includes the feminine.
1/ The Ethiopian Food, Medicine and Health Care Administration and Control Authority (hereinafter the “Authority”) is hereby established as an autonomous government office having its own legal personality.
2/ The Authority shall be accountable to the Ministry.
4. Head Office
The Authority shall have its head office in Addis Ababa and may have branch offices elsewhere, as may be necessary.
The objectives of the Authority shall be to protect the health if consumers by ensuring:
1/ food safety and quality;
2/ The safety, efficacy, quality and proper use of medicines;
3/ competence and ethics of health professionals, medical practitioners and pharmacy professionals;
4/ the standard of health institutions; and
5/ the hygiene and environmental health protection suitability for individual and community health.
6. Powers and Duties of the Authority
1/ The Authority shall have the powers and duties to:
a) exercise the powers and duties provided under Article 4 of the Proclamation;
b) collect service fees;
c) own property, enter into contracts, sue and be sued in its own name;
d) perform other lawful activities as may be necessary for the attainment of its objectives.
2/ The Authority may, where it finds it necessary, delegate part of its powers and duties to appropriate regional organs.
7. Organization of the Authority
The Authority shall have:
1/ an Advisory Board;
2/ a Director General and two Deputy Director Generals to be appointed by the government; and
3/ the necessary staff.
8. Members of the Advisory Board
1/ Members of the Advisory Board shall be designated by the Minister upon the nomination of the Director General. Composition of the members shall be from:
a) associations of health professionals;
b) higher education institutions;
c) consumers associations; and
d) other appropriate associations, institutions and professionals.
2/ The Chairperson of the Advisory Board shall be designated form among the members.
9. Duties and Responsibilities of the Advisory Board
The Advisory Board;
1/ shall advise the Authority in respect of policy and strategic matters;
2/ may establish different technical committees as may be necessary;
3/ may adopt its own rules of procedures.
10. Powers and Duties of the Director General
1/ The Director General shall be the chief executive officer of the Authority and shall direct and administer the activities of the Authority.
2/ Without prejudice to the generality of the provisions of sub-article (1) of this Article, the Director General shall:
a) exercise the powers and duties of the Authority specified under Article 6 of this Regulation;
b) employ and administer personnel of the Authority in accordance with directives approved by the government following the basic principles of the federal civil service laws;
c) prepare, and submit to the Ministry, annual plans and budgets of the Authority, and implement the same upon approval;
d) effect payments in accordance with the approved budget and work plan of the Authority;
e) represent the Authority in all its dealings with third parties;
f) prepare and submit to the Ministry the performance and financial reports of the Authority.
3/ The Director General may delegate part of his powers and duties to the Deputy Director Generals and employees of the Authority to the extent necessary for the efficient performance of the Authority.
11. Powers and Duties of Deputy Director Generals
1/ The Deputy Director Generals shall:
a) assist the Director General in planning, organizing, directing and coordinating the activities of the Authority; and
b) perform other activities specifically assigned to them by the Director General.
2/ The Deputy Director General who is specifically delegated shall act on behalf of the Director General in his absence.
The budget of the Authority shall be allocated by the government.
13. Books of Accounts
1/ The Authority shall keep complete and accurate books of accounts.
2/ The books of accounts and other financial documents of the Authority shall be audited annually by the Auditor General or by an auditor designated by him.
14. Transfer of Rights and Obligations
The rights and obligations of the Drug Administration and Control Authority established under Proclamation No. 176/1999 are hereby transferred to the Authority.
15. Effective Date
This Regulation shall enter into force on the date of publication in the Federal Negarit Gazeta.
Done at Addis Ababa this 23rd day of August, 2010.
PRIME MINISTER OF THE FEDERAL
REPUBLIC OF ETHIOPIA