Draft Laws

Food and Medicine Administration Proclamation /Draft/

PART SEVEN
POWER, FUNCTION, AND RESPONSIBILITY OF INSPECTOR S

64. Power and responsibilities

An inspector of the executive organ or regional health regulator, subject to the power and responsibilities of the agency where he works, shall have the powers and duties to:
1) enter, during working hours, in any licensed institution which holds any regulated product and conduct investigation and order its temporary closure; order a regulated product to be kept separately until laboratory result is known; to detain and seize, or order the storage without removal or alteration of, any product or another thing related to the product;
2) If the institution or place where the regulated product is held is not registered by the executive organ or regional health regulator, enter with a court order and take legal measures;
3) to stop any vehicle or other means of transport in which the inspector knows it carries non-complying regulated products, and open, search, take sample of the product, and detain or seize the product;
4) inspect regulated products and raw materials at ports of entry and exist;
5) enter, inspect and take legal measures, without court order, into a licensed institution during its off work hours and any other place if it held a regulated products which the inspector has sufficient reason to believe that it endangers public health and the product or other evidence is likely to disappear, be altered, or concealed, and notify such action to a nearby court of law;
6) to examine, open, or test a product, equipment, tools, materials, or anything the inspector reasonably believes is used or capable of being used for illicit trade in the regulated product;
7) to examine and make copies of or from any documents, notes, files, including electronic files, or other records the inspector reasonably believes might contain information relevant to determining compliance with the law; take samples or component of a product, measurements, photographs, and video of a regulated product;
8) to order laboratory examination through the executive organ or regional health regulator of any product the inspector reasonably believes might be adulterated, counterfeit, noncompliant or otherwise dangerous to public health and, until the laboratory result is known, quarantine such items for a period of time as defined by regulation issued to implement this proclamation;
9) inspect the proper disposal of regulated products when they expire or when they are confirmed to be unfit for use in accordance with this proclamation; and
10) to enter any time in any public place where tobacco smoking or use is prohibited, and during working hour in any workplace, public conveyance and other places where tobacco smoking and use is prohibited conduct inspections and take legal measure.
65. Responsibilities of inspectors
Every inspector:
1) before conducting any inspection activity, shall present his identification card or credential, and introduce his identity and organization, the reason for the visit and legal power to enter and inspect regulated products and institutions.
2) shall recognize, collect and present admissible evidence including sample, measurement, a copy of a document, photograph, video recording and a copy of records to support an appropriate legal measure on the institution.
3) shall, while exercising his powers and responsibilities, take due care to act within the legal limit, in accordance with applicable laws and codes of ethics, and in a reasonable manner to achieve the purpose of this proclamation.
4) shall report to the executive organ or regional health regulator any noncompliance known to him with this proclamation and other laws issued to implement the proclamation.
5) shall respect orders from higher official and discharge responsibilities with the necessary care, diligence, honesty, and timeliness.
6) shall maintain the confidentiality of every information and document he gets due to his responsibility.
7) shall observe new work procedure that is adopted by the executive organ or regional health regulator and intended to implement its powers and responsibilities efficiently.
8) Detail implementation of this article shall be determined by regulation issued to implement this proclamation.
PART EIGHT
ADMINISTRATIVE MEASURE AND PENALTY

66. Administrative measures
1) Where a regulated product or a holder of a certificate of registration, certificate of competence or other license is found in any way to be in violation of this proclamation or other applicable laws, the executive organ or regional health regulator shall take, depending on the severity of the non-compliance, one or more of the administrative measures defined under this article.
2) A warning letter may be issued to any person who unintentionally violates the provision of this proclamation or other law issued to implement this proclamation for the first time, and the non-compliance does not cause any harm to human health, body, or life.
3) If the non-compliance committed by any regulated person would cause minor harm, as defined by a directive to implement this proclamation, its registration certificate, certificate of competence, or other license may be suspended, and it may be revoked if the violation would cause major harm to human health, body, or life.
4) Where any regulated product is suspected to violate applicable requirements and there exist a reasonable ground to doubt the non-compliance, it may be detained until laboratory or other examination is performed on the sample.
5) Where any regulated product is confirmed to violate applicable regulatory requirements it may be, as appropriate, seized, confiscated, or disposed or returned to its country of origin at the owner’s cost.
6) Notwithstanding to sub-article (5) of this article, the product in appropriate circumstances, may be detained at owner’s expense until such time if relabeling, repackaging, or similar other corrective measures would place the product in compliance with this proclamation.
7) Where a regulated product is in contravention of applicable laws and, the use or exposure to this product will have adverse health consequences or would result in death the responsible person may be ordered to recall their marketed products and to immediately cease distribution.
8) The import of a regulated product that is found to be frequently non-complying with this proclamation or other applicable laws may be temporarily or permanently barred.
9) When a person is criminally convicted due to act that is directly related to works in regulated products under this proclamation, the executive organ or regional health regulator may debar such person from engaging in such works.
10) The executive organ and regional health regulator, in accordance with a regulation issued to implement this proclamation or other appropriate law, may take a civil penalty independently or together with another administrative measure.
67. Complaint on administrative measure
1) A complaint handling organ shall be established by the executive organ or regional health regulator to handle complaints when a regulated person who believes that any administrative measure that was taken on its product, institution or itself, or the denial of a legitimate service under this proclamation inappropriate, not proportional or illegal.
2) The complainant shall have the right to be heard by the complaint handling organ established in accordance with this article, and may lodge a written complaint, proffer evidence, respond to answer, and request copy of decision.
3) Any complaint to be made in accordance with this article shall be lodged within 30 working days from the date of final decision by the process owner of the executive organ or regional health regulator. The complainant, however, shall first confirm that the decision cannot be reversed by the higher official of the executive organ or regional health regulator.
4) The complaint handling organ that received a complaint in accordance with sub-article (1) of this article shall render its decision within 60 working days from the date it receives a complete complaint.
5) A final decision rendered by the complaint handling organ in accordance with this article may be appealed to the appropriate court of law.

68. Penalty
1) Any person who, by sub-standardizing, misbranding, or counterfeiting a regulated product, manufactures, import, store, wholesale or sell it in retail; or provide or distribute for use by the public shall be punishable by simple imprisonment for not exceeding three years and a fine not exceeding Birr two hundred thousand. If the product’s defect would cause grave harm to human health or life, he shall be punishable by imprisonment not exceeding seven years and a fine not exceeding Birr five hundred thousand.
2) If, due to the action described under sub-article (1) of this article,
a) harm is caused on the body or health of any person, he shall be punishable by imprisonment for not less than one year and not exceeding fifteen years, and a fine not less than Birr twenty thousand and not exceeding Birr three hundred thousand.
b) any person died, he shall be punishable by imprisonment for not less than ten years and not exceeding twenty years, and a fine not less than Birr thirty thousand and not exceeding Birr four hundred thousand.
3) If the person commits the crime described under sub-article (1) and (2) of this article negligently, he shall be punished by imprisonment for not exceeding three years and with fine not exceeding Birr fifty thousand.
4) Any person who, without a registration, marketing authorization, certificate of competence or other authorization as required under this proclamation and other law issued to implement this proclamation, or using a falsified document, manufactures, import, store, wholesale or sale it in retail; or provide or distribute for use by the public shall have its product confiscated and be punishable by imprisonment for not less than three years and not exceeding five years and with a fine not less than Birr five thousand and not exceeding Birr one hundred thousand. If the crime provided under sub-article (1) and (2) of this article is committed without a certificate of competence or using a falsified document the penalty of this article shall be additionally applicable.
5) Any person who has a registration certificate, marketing authorization, certificate of competence or other license under this proclamation and other law issued to implement this proclamation and transfers the same to a third person, or anyone who received such document illegitimately shall be punishable by imprisonment for not less than one year and not exceeding five years and with a fine not less than Birr ten thousand and not exceeding Birr one hundred thousand.
6) Any person who, in any way, prevents or impedes the work of inspector as assigned under this proclamation, or in any way obstruct inspectors from getting evidence or hide or conceal such evidence from inspectors, give false statement or documents during their work, or attempts to do the preceding acts shall be punishable with imprisonment for not less than one year and not exceeding five years. If it causes harm to the person, body, or possession of an inspector assigned under this proclamation and who is on duty shall be punishable by imprisonment for not less than three years and not exceeding five years.
7) Any person who sale medicine, medical device or related products without having the necessary qualification, or causes the sale or offer for sale of such product by unqualified person shall be punishable by not less than three years and not exceeding seven year and a fine not less than Birr ten thousand or not exceeding Birr one hundred thousand.
8) Any person who prescribes, sales, dispenses, or gives medicine without prescription or with unauthorized prescription in contravention to this proclamation and other laws issued to implement this proclamation shall be punishable by imprisonment with not less than one year and not exceeding five years, and with fine not less Birr five thousand and not exceeding Birr fifty thousand.
9) Any inspector who, in relation to his authority under this proclamation,
a) intentionally fails to report substantive facts, evidence, or inspection findings to the executive organ or regional health regulator, and as a result, a person’s health or body is harmed, shall be punishable with imprisonment not less than one year and not exceeding three years and with a fine.
b) made false report inspection findings to the executive organ or regional health regulator, or did not take the appropriate measure in a circumstance that guarantees administrative measure, or unjustifiably took a minor measure that is not proportional to the magnitude of the noncompliance shall be punishable with imprisonment not less than one year and not exceeding three year and with fine not less than Birr five thousand and not exceeding Birr twenty thousand;
c) where the crime defined under this sub-article (a) and (b) is committed negligently, it shall be punishable by imprisonment not less than six months and not exceeding one year.
d) where the inspector under sub-article 9 (a) and (b) commits the crime with the intention to benefit himself or another person, the appropriate anti-corruption provision shall be applicable.
10) Any person who contravenes the provision that requires health examination and health certificate of employees having direct contact with food preparation shall be punishable by imprisonment for not less three months and wit a fine not less than Birr twenty thousand and not to exceed Birr fifty thousand.
11) Any regulated person who, directly or indirectly, give, offer to give, or promise any financial, in-kind, or comparable gift to any health professional with the intent to cause the health professional to prescribe medicine, medical device, or related product shall be punishable by not less than three years and not exceeding seven years and a fine not less than Birr ten thousand and not exceeding Birr two hundred thousand.
12) Any person who conducts mobile sale of medicine, medical devices, or related products in contravention to this proclamation or other laws issued to implement this proclamation shall be punishable by not less than one years and not exceeding five years and a fine not less than Birr ten thousand and not exceeding Birr one hundred thousand.
13) Any person who, with the intent to materially profit himself or another person, gives or cause another person to give blood shall be punishable by simple imprisonment not exceeding three years and with a fine not exceeding Birr fifty thousand. If the person commits this act as his daily engagement and benefit out of other peoples need, shall be punishable by imprisonment for not less than three years and not exceeding ten years, and with a fine not less than Birr ten thousand and not exceeding Birr one hundred thousand.
14) Any person who violates the provision regarding blood and blood products and sub-standardizes the collection, testing, processing, screening, pooling and irradiation of blood and blood products shall be punishable with imprisonment not exceeding one year and a fine from Birr twenty thousand to fifty thousand.
15) Any person who sales blood by receiving money; gift, financial or in-kind promise shall be punishable by not more than three years and a fine not more than Birr thirty thousand.
16) Any person who in violation of this proclamation, conduct clinical trial without being authorized by the executive organ; perform any activity beyond the scope of the clinical trial protocol; use investigational medicine or medical device without authorization by the executive organ; or give unauthorized financial, in-kind or other comparable gifts to any person to participate in the clinical study shall be punishable with not less than one year and not exceeding ten years and a fine not less than Birr twenty thousand or not exceeding Birr one hundred thousand.
17) Any manufacturer, importer, exporter, or wholesaler with a registration certificate, with the exception of a person having one-time purchase permit, that sells medicine to unlicensed person shall be punishable by not less than five years and not exceeding seven years or a fine not less than Birr five thousand or not exceeding Birr one hundred thousand.
18) Any person who fails to report to the executive organ or regional health regulator any adverse event caused by medicine, medical devise, or other product as required under the law; fails to make periodic report; or falsify, conceal, deceive, or perform related activities in the report shall be punishable with simple imprisonment with not less than three months and a fine not less than Birr ten thousand and not exceeding Birr fifty thousand.
19) Any person who contravenes the provisions of this proclamation regarding prohibition or limitations on advertising, promotion, and sponsorship activities shall be punishable by imprisonment for not less than three months and by a fine not less than Birr thirty thousand and not exceeding Birr one hundred thousand.
20) Any person who prepares, publishes, transmits, or in any way participates in illegal or unauthorized advertisement or promotion as defined under this proclamation and other law issued to implement this proclamation shall be punishable by simple imprisonment not exceeding three years and with fine not less than Birr fifty thousand.
21) Any person who sell tobacco products in prohibited places where tobacco smoke, use, or sell is prohibited shall be punishable with simple imprisonment not less than six months and a fine not exceeding Birr five thousand. Any person who smokes or use tobacco products in prohibited places shall be punishable with a fine not exceeding Birr one thousand.
22) Any person who sale alcohol in prohibited places shall be punishable with simple imprisonment not less than six months and a fine not exceeding Birr five thousand.
23) Any person in charge of public places, workplaces, and conveyances who violated the requirement to post the “no-smoking” notice along with its corresponding sign, or failed to take the required measures when smoking or tobacco use occurred in violation of the law shall be punishable with imprisonment not less than three months and with fine not less than Birr one thousand and not exceeding Birr ten thousand.
24) Any person, who manufactures, imports, wholesale, distributes, stores, or in any way sales tobacco product with prohibited ingredient, any tobacco product which is illicit, shisha, or electronic nicotine delivery system or other related cigarette resembling technology product shall be punishable by simple imprisonment from three months to three years, and a fine from Birr one thousand to two hundred thousand.
25) Any person, who sells, furnishes, or in anyways gives tobacco product or alcoholic product to a person under the age of 18 shall be punishable by imprisonment for not less than three months, and by a fine from Birr one thousand to three thousand.
26) Any tobacco manufacturer, importer, wholesaler, or distributor who violates the provisions requiring disclosure of tobacco product content, furnishing of related information to the executive organ, and the provision which restricts tobacco industry interferences shall be punishable with imprisonment not less than one year and not exceeding three years, and fine not less than Birr fifty thousand.
27) When any crime defined under this proclamation is committed by a legal entity, the court may impose up to tenfold of the fine provided under the sub-article to which the entity is convicted. The court, as appropriate, may order the closure, suspension, or dissolving of the entity.

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Categories: Draft Laws

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