Draft Laws

Food and Medicine Administration Proclamation /Draft/

Food and Medicine Administration Proclamation

Draft

January 2018
Preamble
Proclamation No……../2018
A PROCLAMATION TO PROVIDE FOR FOOD and MEDICINE ADMINISTRATION

WHEREAS, it is necessary to prevent and control the public’s health from health hazards caused by unsafe food;
WHEREAS, it is necessary to prevent and control the public’s health from unsafe, inefficacious and poor quality medicines, and unsafe and ineffective medical devices;
WHEREAS, it is necessary to prevent and control the illegal distribution and use of narcotic drugs, psychotropic substances, and precursor chemicals;
WHEREAS, it is necessary to install a regulatory scheme compatible with the country’s expanding industry and manufacturing sector;
WHEREAS, it is necessary to prevent and control the public’s health from the devastating health, social, and economic consequences of tobacco products;
WHEREAS, it is necessary to adopt a national legal framework that enables to establish a coordinated food, medicine, medical device, cosmetics, and tobacco products regulatory system; and
NOW, THEREFORE, in accordance with Article 55(1) of the Constitution of the Federal Democratic Republic of Ethiopia, it is hereby proclaimed as follow:

PART ONE
GENERAL

1. Short title

This proclamation may be cited as the “Food and Medicine Administration Proclamation No……/2018”

2. Definitions

In this Proclamation, unless the context otherwise requires:
1) “food” means any substance, whether processed or semi-processed, which is intended for human consumption, and includes plants, and plant and animal products placed on the market or offered for use by the public; salt, water, alcohol, and other drink, and any substance which has been used in the manufacture or treatment of food but does not include medicine, cosmetics, and tobacco products;
2) “food safety” means the conditions and practices that preserve food is fit for human consumption during manufacturing, handling, storage, or transport;
3) “irradiation” means a deliberate exposure of food to ionizing radiation;
4) “medicine” means any substance or mixture of substance:
a) used in the diagnosis, treatment, mitigation or prevention of human disease, disorder, abnormal physical or mental state, or the symptoms thereof;
b) used in restoring, correcting or beneficial modification of organic or mental functions in human; or
c) articles other than food, intended to affect the structure or any function of the body of human;
and it includes articles intended for use as a component of any articles specified in clause (a), (b) or (c).

5) “pharmacy professional” means a pharmacist, druggist, or pharmacy technician licensed by the appropriate health professional regulatory organ;
6) “narcotic drugs” means a medicine subject to control in accordance with the Convention issued by United Nations and ratified by Ethiopia and include a drug that is categorized as narcotic drug by the executive organ;
7) “psychotropic substances” means any substance subject to control in accordance with the Convention issued by United Nations and ratified by Ethiopia and include a drug that is categorized as psychotropic substance by the executive organ;
8) “precursor chemical” means any substance or mixture of substances subject to control in accordance with the Convention issued by the United Nations and ratified by Ethiopia and include a substance that is categorized as precursor chemical by the executive organ;
9) “prescription” means a paper or electronic order for medicine that meets requirements set by the executive organ, and written and signed by a duly licensed medical professional;
10) “raw material” means the basic material from which a regulated product is made;
11) “counterfeiting” means a deliberate or fraudulent mislabeling of a product in respect of its identity and/or source including the packing material, identification or trademark, trade name, any special mark thereon of an authentic product and presenting such falsely labeled product as if it is manufactured by the genuine manufacturer;
12) “adulteration” means adding any foreign substance or ingredient or substituting the content of the product in whole or in part by such other substance so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is;
13) “pharmacopeia” means a document accepted by the appropriate organ containing the particulars of medicine preparation, physical aspects of medicine and non-medicinal substances, preoperational aspect, content, intensity and standards and criteria’s to be fulfilled related to such particulars;
14) “medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related articles and their accessories, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
a) diagnosis, prevention, monitoring, treatment or alleviation of disease or injury,
b) investigation, replacement, modification, or support of the anatomy or of a physiological process,
c) supporting or sustaining life,
d) control of conception,
e) disinfection of medical devices,
f) providing information by means of invitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
15) “clinical trial” means any systematic study on medicine or medical devices in volunteer human subjects in order to discover or verify the effects of, and/or identify any adverse reaction to the products, and or to study its absorption, distribution, metabolism, and excretion with the object of ascertaining their efficacy and safety;
16) “bioequivalence center” means the center in which two types of medicine productions are ascertained by research as to their similarity of efficacy and safety;
17) “public health pesticide” means any substance or mixture of substances used to prevent, control or destroy pests to protect human health and includes pesticide-treated mosquito net;
18) “cosmetic” means any article intended to be used by means of rubbing, pouring, steaming, sprinkling, spraying on or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance and, any article intended for use as component of a cosmetic but such articles excludes laundry soaps, articles intended for the diagnosis, treatment, mitigation or prevention of human disease, and products intended to affect the anatomy or of a physiologi¬cal process of a human;
19) “tobacco product” means a product entirely or partly made of the leaf tobacco as raw material which are manufactured to be used for smoking, sucking, chewing, or snuffing;
20) “tobacco product special regulatory license” means a permit granted by the executive organ for the purpose of tobacco manufacturing, import, wholesale, or sell but this does not include a trade license;
21) “barcode” means a machine-readable code in the form of numbers and a pattern of parallel lines printed on and identifying a product for the purpose of monitoring by the manufacturer or executive organ;
22) “means of advertisement dissemination” includes the mass media, outdoor advertisement, telecom, postal, internet website and fax services, cinema, film, video and any other related means of advertisement dissemination;
23) “regulated product” means any product administered in accordance with this proclamation and includes food, medicine, medical device, cosmetic, and tobacco products;
24) “medical professional” means a physician or other health professional who is authorized by the appropriate organ to examine and diagnose human diseases and treat them by drug, surgical operations or other related medical means;
25) “packing” means any article that may be used for filling, inserting or wrapping or packing regulated products and includes the immediate container and other wrapping materials;
26) “label “means all labels and other written, printed, or graphic material that is affixed to a regulated product or any of its container or wrapper and includes insert;
27) “repacking” means packing of any processed or semi-processed regulated products by a different manufacturer in any other way;
28) “ inspector ” means any professional authorized by the executive organ or regional health regulator to perform inspection activities pursuant to this Proclamation;
29) “institution registration” means a recognition granted to regulated institution in accordance with set requirements;
30) “product registration” means a recognition granted to regulated product in accordance with set requirements;
31) “quality control system” means a procedure intended to ensure that a regulated product meets quality and safety requirements;
32) “institution” means any establishment involved in the manufacture, export, import, wholesale, retail, or repacking of regulated products;
33) “manufacture” means all operations involved in transforming raw materials into regulated products under this proclamation including in the preparation, processing, compounding, formulating, filling, packing, packaging, and repackaging;
34) “certificate of competence” means a permit issued for a person to carry out the manufacture, import, distribute, wholesale, sale, or retail trade of regulated products under this proclamation; quality control provider, bioequivalence center, or other purposes regulated under this proclamation; however, it does not imply a trade license;
35) “executive organ” means a body which is empowered to administer this proclamation and other laws issued to implement this proclamation at the federal government level;
36) “region” means any state referred to under Article 47 of the Constitution of the Federal Democratic Republic of Ethiopia and includes the Addis Ababa and Dire Dawa City Administrations;
37) “regional health regulator” means a regional government body which is empowered to administer this proclamation and other laws issued to implement this proclamation at regional government level;
38) “appropriate body” means, as applicable, other organs that have a legitimate interest in the course of implementation of powers granted under this proclamation;
39) “person” means a natural and juridical person; and
40) any expression in the masculine gender includes the feminine.

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