LABELING, PACKAGING, ADVERTISEMENT, PROMOTION, AND PROHIBITIONS
1) Any product regulated under this proclamation:
a) shall be appropriately packed and contain labeling on its primary packaging;
b) its packaging material shall not contaminate the product and comply with standard issued by the appropriate body; and
c) its labeling shall not be misleading and contain information that is inaccurate.
2) The primary packaging of a packed food and cosmetic shall have a label in Amharic or English language. The executive organ may by a directive determine labeling requirement different from Amharic or English language, or the primary packaging.
3) The labeling of medicine and medical device that is included in the national essential medicine list or widely circulated in the market shall be in Amharic.
4) Notwithstanding to sub-article (3) of this article, the executive organ by a directive shall determine different labeling requirement other medicine and medical devices.
5) No person may import or place into use of any medicine or medical device unless its labelling contains a barcode. The executive organ, by a directive, shall provide for exceptions and detail implementation this provision.
6) Every manufacturer or importer shall provide the labeling of its cosmetic when making notification to the executive organ.
7) The manufacturer or importer of a medicine shall, affix the medicine retail price, in Ethiopian currency, on its labelling before placing the product on the market. Detail implementation shall be determined by a directive issued by the executive organ.
8) For the purpose of this part “primary packing” means the covering, wrapper, or container that has direct contact with the product intended for retail sale.
55. Food packaging and labeling
1) Without prejudice to general labeling provisions provided under this part:
a) Fortified food labeling shall contain description about the type of micro-nutrient used to enrich the food.
b) Labeling, description, or advertisement of any food supplement shall not represent to be used in disease prevention, treatment, or cure, or in any way characterize as a medicine.
c) A food containing genetically modified element may only be placed on the market if it is packaged and its label contains the phrase “genetically modified” “genetically modified organism” or other comparable description.
d) Labeling of irradiated food shall contain the phrase “irradiated” or the internationally accepted radura symbol indicating a food product has been irradiated with ionizing radiation may be placed besides the labeling.
e) If the food product contains milk and milk products, fish and shellfish, wheat, barley, peanuts, soybeans, and other food allergenic its labeling shall clearly describe its content.
2) Detail implementation of this provision shall be determined by a directive.
56. Labeling of alcohol drinks
1) The label of every alcoholic drink prepared at a factory level and provided for public use shall contain its alcoholic volume and a warning that alcohol consumption may cause health problems and women should not drink alcoholic drinks during pregnancy because of the risk of birth defect.
2) The label of every alcoholic drink with a volume of less than 10% shall contain the product’s expiration date.
3) Detail implementation of this provision shall be determined by a directive.
57. Packaging and labeling of medicine and medical device
Without prejudice to general labeling provisions provided under this part:
1) The label of every in-vitro medical device shall contain the phrase “for medical use”.
2) Where the medicine or medical device is intended for research, education, clinical trial, or any other comparable non-medical use, its labeling shall contain the purpose for which it is intended to be used.
3) The labeling of radiopharmaceuticals and radiation emitting medical devices shall contain information sufficient for the patient and users to identify radiation protection method, inappropriate use, and possible risks associated with the installation of the product, as appropriate.
4) For the purpose of this article, “in vitro medical devices” means a device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, and includes reagents, calibrators, control materials, specimen receptacles, software or related other articles.
58. Tobacco products health warning, packaging, and labeling
1) The packaging of any tobacco product shall contain rotating health warnings and messages that are comprised of combined images and full-color pictures in accordance with requirements set by the executive organ.
2) The health warnings and messages required in accordance with sub-article (1) of this article shall be displayed on no less than 70% of the front and back side of each principal display area of its packaging and labeling, not counting the space taken up by any border surrounding the health warning.
3) Any misleading statement or presentation on the outside packaging and labeling of tobacco products with the likely effect to create an erroneous impression about the product’s characteristics, health effects, hazards or emissions, or any expression or presentation purporting to signify one tobacco product has lesser harm compared to other tobacco product shall be prohibited.
4) Any term, descriptor, trademark, figurative, color, or other sign of any kind that directly or indirectly creates or is likely to create the false impression that a particular tobacco product is less harmful than others, including the terms “low tar”, “light”, “ultra light”, or “mild”, “extra”, and “ultra” and similar terms or expressions shall be prohibited.
5) Detail requirements with regard to packaging and labeling of tobacco products shall be determined by a directive issued to implement this proclamation.
59. Advertising and promotion
1) The content of every advertisement and promotion of a regulated product shall not be false and misleading, be appropriate and ethical, and comply with requirements of this proclamation and other applicable laws.
2) Every mass media and advertisement disseminator shall have the duty to comply with a directive issued in accordance with this proclamation.
3) The advertiser and advertisement disseminator of any regulated product, and if the subject is promotion, the distributor or another person who caused the distribution of any promotional materials which includes medicine and medical device promotion agent, shall have joint and several responsibilities with regard to compliance with this proclamation and other applicable laws.
4) Infant formula may not be advertised through any advertisement dissemination means except for the labeling on the product.
60. Medicine and medical device advertising and promotion
1) Unless subject to exceptions defined under a directive issued by the executive organ, it shall be illegal to advertise any medicine through a means of advertisement dissemination.
2) Any direct advertisement or promotion made in-person to a health professional shall be through a medicine or medical device promoter who is duly authorized by the executive organ.
3) Unless it falls under the maximum allowable gift or giving as defined by a directive issued to implement this proclamation, it shall be prohibited to offer or give, directly or indirectly, any financial, in-kind or comparable benefit to a health professional in relation to promotion to health professionals.
4) It shall be illegal to advertise medicine and medical devices within health institution unless the appropriate executive organ grants permission to the advertisement.
5) For the purpose of this article, “medicine or medical device promotion agent” means a person who has a special certificate of competence from the executive organ to promote medicine and medical device to health professionals.
6) Detail implementation of this article shall be determined by a directive.
61. Alcoholic drink advertising and promotion
1) Any advertisement of an alcoholic product shall contain a warning, as appropriate in writing or sound, that it is illegal to sell it to a person under the age of 18.
2) It shall be prohibited to directly or indirectly advertise alcoholic drinks in places of public gathering and sporting; street, condominium and other places by unreasonably decreasing the size of the warning.
3) Any manufacturer, importer or distributor of alcoholic drinks whose volume is more than 10% shall not directly or indirectly sponsor public and government holiday, exhibition, sports event, school event and other related youth-centered events.
4) Any television advertisement of an alcoholic product shall contain clear prohibition contained in this proclamation or other laws issued to implement this proclamation.
5) Any alcoholic drink whose volume is less than 10% may only be advertised through broadcast from 9 PM in the evening to 6 AM in the morning.
6) Additional restriction regarding the time, place, and manner of alcohol advertisement and promotion may be determined by a regulation issued to implement this proclamation.
7) Detail implementation of this article shall be determined by a directive.
62. Tobacco products advertising, promotion, and sponsorship
1) Unless it is legitimate expression as defined by a directive issued to implement this proclamation, all direct or indirect tobacco products advertising, promotion or sponsorship shall be prohibited.
2) Without prejudice to sub-article (1) of this article, no person may
a) initiate any tobacco products advertising, promotion, or sponsorship;
b) produce, publish, distribute, or make accessible any tobacco products advertising, promotion, or sponsorship content; or
c) engage or participate in any tobacco products advertising, promotion, or sponsorship as media or event organizer, celebrity or other participant, as a recipient of any sponsorship contribution, or as an intermediary that facilitates any such contribution.
3) Tobacco products in retail shops shall be placed behind or under the counter so that any customer may not directly grasp or see the product.
4) For the purpose of this article, “tobacco advertising and promotion” means any form of commercial communication, recommendation or action with the aim, effect or likely effect of promoting a tobacco product or tobacco use either directly or indirectly.
5) For the purpose of this article, “tobacco sponsorship” means any form of contribution to any event, activity or individual with the aim, effect or likely effect of promoting a tobacco product or tobacco use either directly or indirectly.
Without prejudice to other prohibitions defined under this proclamation and other appropriate laws, the following acts are prohibited:
1) The doing of any act which causes a regulated product to be adulterated, misbranded, counterfeited, and substandard;
2) poisoning a food by mixing any substance that is deleterious to human health;
3) The trading of or provision to the public of any adulterated, sub-standard, misbranded, and counterfeit product;
4) The receipt to trade a regulated product that is adulterated, sub-standard, misbranded, counterfeit, and the delivery or proffered delivery thereof for pay or otherwise;
5) The refusal or obstruction of inspection and related activities as authorized under this proclamation;
6) Mobile sale of medicines and medical devices; and
7) Conducting trade in regulated products in contravention to regulations, directives or other laws issued to implement this proclamation.
Categories: Draft Laws