Draft Laws

Food and Medicine Administration Proclamation /Draft/

3. Scope
1) This proclamation shall be applicable in respect of food, medicine, medical device, cosmetics, and tobacco product intended to be placed on the market or offered, in any other way, for use by the public, and other products and raw materials regulated under this proclamation.
2) Without prejudice to sub-article (1) of this article, the division of regulatory power between the federal and regional state governments shall be in accordance with Articles 4 and 5 of this proclamation.

PART TWO
EXECUTIVE ORGANS
4. Power and duties of the executive organ
The executive organ shall have the powers and duties to:

1) initiate regulatory standards and implement standards issued regarding food safety; safety, efficacy, quality, and rational use of medicines; safety, quality, and effectiveness of medical devices; and other products regulated under this proclamation; adopt appropriate pharmacopeia from another country or manufacturer;
2) issue, renew, suspend or revoke a certificate of competence or take another appropriate measure of an importer, exporter or quality control service provider, bioequivalence centers, and a manufacturer or wholesaler whose product is intended to be traded in more than one region;
3) evaluate and register medicines, medical devices, food and other products that are required to be registered under this proclamation, or regulation or directive issued to implement this proclamation based on applicable requirements; issue, renew, suspend or revoke marketing authorization or take other appropriate legal measures;
4) detain, seize, confiscate, order the disposal or recall of, or take such other legal measures on a regulated product that is not in compliance with this proclamation or other law issued to implement this proclamation;
5) inspect and take the necessary administrative measures on a regulated product under the possession of a retailer or other person not certified by the executive organ but the product’s introduction into the market were authorized by the executive organ;
6) identify ingredients that caused death, sickness, disability, disorder, or other health problems due to adulteration or other illegal activities on regulated products and take appropriate legal measures by conducting investigation of sample ingredients;
7) issue import permits and, upon request, grant export certificate for regulated products, their raw materials and packaging materials;
8) prepare and, as necessary, revise list of essential medicines, notify registered foods and medicines to the public; issue national formulary, classify medicines into different categories, revise the classification whenever necessary;
9) undertake or order post-marketing surveillance to ensure food safety; safety, efficacy and quality of medicines; safety, quality, and effectiveness of medical devices; and on other regulated products and take appropriate legal measures in accordance with the findings;
10) ensure that evidence of existing and new adverse events and information about pharmacovigilance of globally monitored products are followed upon and, as appropriate take the necessary legal measure;
11) authorize the conduct of clinical trial, monitor and inspect the process as to its conduct in accordance with good medical practice, evaluate the results and authorize the use of the result in such a way that benefit the public; order the clinical trial to be suspended or stopped;
12) promote rational use of medicines and medical devices;
13) regulate the manufacture, import, export, distribution, prescribing, dispensing, use, recording and reporting of narcotic drugs, psychotropic substance and precursor chemicals, and prevent their abuse;
14) regulate the cross regional advertisement of regulated products in cooperation with the appropriate government body;
15) coordinate the implementation of the World Health Organization Framework Convention on Tobacco Control and its implementing guidelines; establish national coordinating mechanism to follow-up effective implementation of tobacco control, and work in collaboration with appropriate bodies;
16) regulate the content and product disclosure, manufacturing, packaging, labeling, design, import, storage, distribution, advertisement, promotion and sponsorship, and related aspects of tobacco products in line with the World Health Organization Framework Convention on Tobacco Control and its implementing guidelines;
17) ensure, in collaboration with appropriate bodies, proper disposal of expired and other non-complying product regulated under this proclamation;
18) appoint inspectors, and, as appropriate, order the inspection of any premises in accordance with this Proclamation;
19) determine and assess civil penalties as per regulation issued to implement this proclamation, collect civil penalties and use the same for the purpose of health regulation; and
20) collect service fees, and use the same for the purpose of health regulation.
5. Regional health regulator
A regional health regulator shall exercise all the residual powers not given to the executive
organ as per Article (4) of this proclamation, and it includes, but not limited to, the power to:
1) ensure implementation of applicable standards and regulatory requirements issued concerning food, medicine, medical device, cosmetics, tobacco products and other products regulated under this proclamation by institutions controlled by the respective regional health regulator;
2) issue, renew, suspend, revoke or take other appropriate legal measure on a certificate of competence to retailers of regulated products, and manufacturers, wholesalers, distributors and other persons whose product is intended to be traded only within the boundary of the respective region, or take other appropriate legal measure on their regulated product;
3) ensure that pharmaceutical compounding by pharmacies is undertaken in accordance with the applicable standard and regulatory requirement;
4) regulate, in collaboration with the appropriate body, outdoor advertisement and other advertisements, promotion, and sponsorship of regulated products that are limited within the respective region;
5) appoint inspector s and order inspection of institutions controlled by the regional health regulator and regulated products under their possession;
6) jointly work with the appropriate government organs to control illicit trade of regulated products;
7) regulate smoke-free public place, work place, public conveyance, and other places as per this proclamation and other laws issued to implement this proclamation; tobacco product retail sale, and other related tobacco control measures contained in the World Health Organization Framework Convention on Tobacco Control; and
8) assess and collect civil penalties as per appropriate law.

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