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Ethiopian Digital Identification Proclamation No 1284/2023
The Proclamation establishes an Ethiopian Identity System applicable to any person residing in Ethiopia.
Regulation No. 531/2023, Definition of Organization, Powers and Duties of the Ethiopian Food and Drug Authority
This regulation is issued to implement the Food and Medicine Administration Proclamation No.1112/2019. It provides the organization, powers and duties of the Ethiopian Food and Drug Authority.
Regulation No. 535/2023, Community-Based Health Insurance Council of Ministers Regulation
This regulation is issued to implement Proclamation No. 1273/2022 Community-Based Health Insurance Proclamation. It establishes the framework for managing health insurance pools and reserve funds (Sections 3-6), outlines membership and contribution procedures (Sections 7-9), and details provider payment mechanisms (Section 10). It also addresses fund management, financial deficit coverage (Sections 11-13), and miscellaneous provisions such as co-payment and data management (Sections 14-20).
Proclamation No. 1273/2022 Community-Based Health Insurance Proclamation
This Proclamation provides the legal framework for the Community Based Health Insurance System.
Proclamation No. 1263/2021, Definition of Powers and Duties of the Executive Organs Proclamation
The Proclamation 1263/2021 was enacted to provide for the definition of the powers and duties of the executive organs of the federal democratic republic of Ethiopia. It includes provisions regarding the mandate of the Ministry of Health (cf. section 35).
Ethiopia Essential Medicines List
This document provides the national list of essential medicines and other health products in Ethiopia.
Medicines and related substances regulations
These Regulations provide rules on the registration and access to the market to medicine; licensing requirements for pharmaceutical operations, manufacturers, wholesalers and dispensaries; as well as on record-keeping, import of medicines, and clinical trials, etc.
Proclamation No.1112/2019, Food and Medicine Administration Proclamation
This Proclamation is to provide for Food and Medicine Administration. It provides rules to regulate several areas including food, medicine, medical devices, cosmetics, and tobacco products.
Consumer Protection Act
The Act contains provisions to provide protection of the interests of consumers by means of investigation, prohibition and control of unfair business practices; and to provide for matters incidental thereto.
Data Protection Act
This Act regulates the protection of personal data and ensures that the privacy of individuals in relation to their personal data is maintained. It also establishes the Information and Data Protection Commission and provides for all matters incidental thereto.
National Registration (Amendment) Act
This Act amends sections 2, 6, 7, 9, 12, 14, 17, 17A, 18 and 19 of the National Registration Act of 1986.
Regulation No 370/2015, Rate of Service Fees for Food, Medicine, Health Professional and Health Institutions Registration and Licensing
This Regulation is to determine the fee payable for registration and license of food, medicine, health professional and health institutions.
National health quality standards for clinics - Management and leadership
The Botswana National Health Quality Standards for Clinics provide guidance on the topic of management and leadership in the governance of the health facility focusing on such areas as responsibilities and accountability of governing bodies; applicable laws and regulations; budgeting, reporting and auditing processes; planning of health services that correspond to the patient and population needs, etc.
National Health Quality Standards - Medical Care
The National Health Quality Standards for Hospitals provide guidelines for hospitals regarding coordination of patient care, facilities and equipment, clinical practice guidelines, assessment of patients, patient care, medication, etc.
Regulation No 299/2013 Food, Medicine and Health Care Administration and Control
This regulation is issued to implement the Food Medicine and Health Care Administration and Control Proclamation No 661/2009. and covers among other aspects of food safety and quality which includes manufacturing, storage and transportation among other aspects; sale of alcohol; medicine administration and control which includes manufacturing, registration, storage, transportation, importation ad clinical trials among others; traditional and complementary medicine administration and control; post-marketing surveillance; control of tobacco products and places prohibited for smoking among other aspects.
Public health Act
The Public Health Act repeals, re-enacts, consolidates and amends the law relating to public health in Botswana.
National Health Quality Standards - Standards and guidelines for emergency medical services
This document outlines the required standards and guidelines for delivering high-quality emergency medical services in Botswana, focusing on ensuring effective, timely, and consistent care across the healthcare system.
Medicines and related substances Act
This Act provides for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
National Health Quality Standards - Health care organizational management
The National Health Quality Standards - "Health Care Organizational Management" provide comprehensive guidelines for managing healthcare organizations in Botswana, covering areas such as governance, resource management, leadership, quality improvement, and compliance with regulatory standards to ensure effective and efficient delivery of healthcare services.
National Health Quality Standards - Diagnostic, Care and Treatment Support Services
The "National Health Quality Standards - Diagnostic, Care, and Treatment Support Services" establish guidelines and standards for the provision of diagnostic services, patient care, and treatment support in Botswana.