69. Borderline products
The executive organ shall issue a directive regarding the classification of a product which appears to fall into two categories and not immediately obvious to determine its regulatory status based on the nature of the product.
70. Handling and disposal of products
1) The handling of any regulated product under this proclamation and that is expired, unusable, or unfit for use for any reason shall not be in a manner that could contaminate other products.
2) Any product that is segregated in accordance with sub-article (1) of this article shall be disposed with due care to the health of human, animal and the environment, and the cost shall be covered by its owner or another appropriate person.
3) The executive organ or regional health regulator, upon request by the appropriate person, shall give the necessary information regarding products disposed of in accordance with this provision.
71. Information handling
1) Every manufacturer, importer, distributor, or retailer of a regulated product under this proclamation shall have a system that enables to show the condition and process of its distribution chain until it reaches the end consumer.
2) Every manufacturer, importer, or distributor of a regulated product under this proclamation shall have the responsibility to handle, report, and furnish, upon request, to the executive organ or regional health regulator any information regarding the quality, safety, effectiveness of the product, and other related matters.
3) Every person who has a license issued in accordance with this Proclamation shall keep and give a report, upon request, to the executive organ or regional health regulator all records about the medicines it manufactured, imported, distributed, or sold.
72. Repeal and inapplicable laws
1) With respect to matters provided for by this Proclamation, Proclamation No. 661/2009 is hereby repealed.
2) Article 8(5) of Proclamation No. 759/2012 is hereby repealed.
3) No law, regulation, directive or practice shall in so far as it is inconsistent with this proclamation, be applicable with respect to matters provided for by this proclamation.
73. Power to issue implementing laws
1) The Council of Ministers may issue regulations necessary for the implementation of this Proclamation.
2) Regions may issue proclamation, regulation, and directive to implement their respective power and responsibilities.
3) The executive organ may issue directives necessary for the implementation of this proclamation and regulations issued pursuant to sub-article (1) of this Article.
74. Transferred powers and responsibilities
1) Regulatory functions under Articles 3(2) (e), 4(2), 46 and 47 of Proclamation No. 661/2009 which deals with the issuance of a certificate of competence and regulation of special health institution, and professional and premise license for traditional medicine and alternative and complementary medicine shall be performed by regional health regulators.
2) Regulatory functions under Articles 3(2)(g), 4(14), and 4(15) of Proclamation No. 661/2009 which deals with quarantine and regulation of communicable disease at ports of entry and exits shall be performed by the Ethiopian Public Health Institute.
3) Regulatory functions under Articles 3(2)(f), 3(2)(h), and 4(21), and 4(15) of Proclamation No. 661/2009 which deals with enforcement of hygiene and environmental health requirements by federal government owned health-related controllable institutions and trans-regional health-related institutions shall be performed by the Federal Ministry of Health.
4) The Federal Ministry of Health shall monitor compliance with legal requirements by health institutions owned by the federal government.
5) Articles 45 of Proclamation No. 661/2009 which deals with registration of traditional medicine and alternative and complementary medicine shall be carried out by the executive organ.
75. Provisional clause
The Health Professional Ethics Committee established by the Council of Ministers Regulation No. 299/2013 shall remain operational until such time another body is established by law to take over its responsibility, and regulatory functions under Articles 3(2)(c), 3(2)(d), and 4(16) of Proclamation No. 661/2009 which deals with registration and licensing of certain health professionals, alternative and complementary medicine practitioners and other health professionals coming from abroad shall be performed by the Federal Ministry of Health.
76. Effective date
1) This Proclamation shall enter into force on the date of publication in the Federal Negarit Gazeta.
2) Notwithstanding to sub-article (1) of this article, article 54 sub-article (3), 54 sub-article (5) and 54 sub-article (7) of this proclamation requiring labeling of medicine and medical device to be in Amharic and English, requiring barcode and placing of retail price requirement shall come into effect at the eighteenth month from the date of adoption of this proclamation.
3) Notwithstanding to sub-article (1) of this article, article 58 sub-articles (1-3) regarding health warning and packaging on tobacco products shall come into effect at the twelve month from the date of adoption of this proclamation.
Dr. Mulatu Teshome
PRESIDENT OF THE FEDERAL
DEMOCRATIC REPUBLIC OF ETHIOPIA
Categories: Draft Laws