Health Legislation

These guidelines prescribe data, which is required to be submitted to the National Drug Authority to demonstrate the safety, efficacy and quality of vaccines being applied for market authorization. The guidelines also describe the format (CTD) in which dossiers should be presented in support of the application.

The Patient Charter is an official document by the Government of Uganda that spells out the various Patient Rights and Responsibilities for the service consumers in the national health care system.

The law sets out the fundamental principles and rules for the organization and operation of the national public health system.

The decree provides the National List of Essential Medicines.

This document provides guidelines on pharmacovigilance in the Democratic Republic of Congo.

This order, which provides for the organization and governance of health structures in the Gabonese Republic, supplements order No 1/95 of January 14, 1995, providing guidance for health policy in the Gabonese Republic.

The law regulates the manufacture and registration of medicines, the approval of medical devices, and sets out rules for pharmacies and the practice of the profession of pharmacist.

The Patients' Rights Charter outlines the fundamental rights of patients in Rwanda.

This Law establishes the Rwanda Food and Drugs Authority and determines its mission, organization and functioning. The authority has a legal personality and enjoys administrative and financial autonomy. 

The South Sudan Essential Medicines List (SSEML) is a comprehensive list of medications essential for addressing the country's public health needs, prioritizing safe, effective, and affordable treatments for the most common health conditions.

This decree sets forth the principles and regulations for health units within the National Health Service. It outlines specific statutes for these units, differentiating between those operating as public business entities and those in the public administrative sector. The decree applies to all National Health Service entities in the healthcare network, including hospitals, hospital centers, local health units, and other establishments providing care to National Health Service users, under public-private partnership agreements.

The objective of the law is to establish an institutional framework for regulating the pharmaceutical sector to ensure market approval and use of pharmaceutical products that are accessible, safe, efficient, and of appropriate quality (art.2). It notably establishes the Authority for pharmaceutical regulation (Autorité Ivoirienne de Regulation Pharmaceutique - AIRP) and addresses its mandates (chapter 1).

The Essential Medicines List of Ghana of 2017 is a comprehensive guide outlining the medicines deemed essential for addressing the primary health care needs of the population. It includes a wide range of medications selected based on their relevance to public health, evidence on efficacy and safety, and comparative cost-effectiveness, aimed at ensuring accessibility and affordability.

The decree sets out the organization and operating procedures for hospital pharmacies.

This Law establishes the rules for the efficient and safe production, distribution, use and availability, as well as quality assurance of medicines, vaccines, biological and health products for citizens.

The document contains the updated National List of Essential Medicines (Lista Nacional de Medicamentos Essenciais). It is a mandatory tool for Health Professionals to use throughout the process of searching for, acquiring, distributing and prescribing medicines within the National Health Service.

This Regulation establishes the pricing system for medicinal products. All medicines circulating in Mozambique shall be subject to the pricing system provided for in these regulations.

This document describes each level of the public health system in Rwanda in terms of the types of services offered, the description and qualifications of staff that provide the services and the equipment required to carry out the services. The health service packages support the clinical and managerial standards by which the healthcare facilities operate. The ultimate goal of this document is to provide guidance in the organization of public health service facilities to improve the quality of health care and services provided to the population of Rwanda.

This document describes for each level of care, the types of services offered, the description and qualifications of the staff that provide the services and the equipment required to carry out the services. The health service packages support the clinical and managerial standards by which the healthcare facilities operate. The ultimate goal of this document is to provide guidance in the organization of private health service facilities to improve the quality of health care and services provided to the population of Rwanda.

This Act repeals and replaces the National Pharmaceutical Procurement Unit Act, 2012 to establish the National Medical Supplies Agency as a public service agency responsible for the procurement, warehousing and distribution of drugs and medical supplies in a transparent and cost-effective manner for and on behalf of all public institutions throughout Sierra Leone.