Health Legislation

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.

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.

This Act establishes the Pharmacy and Medicines Regulatory Authority; provides for the functions and powers of the Authority; and provides for matters connected therewith and incidental thereto.

The document establishes the list of essential medicines in the Republic of Mali.

The decree revises Niger's national list of essential medicines.

The Constitution was reviewed and adopted in 2019. The Constitution contains 159 articles addressing a large number of issues such as the protection of fundamental rights and freedoms, the fundamental principles of the state and institutional arrangements (non-exhaustive list).

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 decree provides the National List of Essential Medicines.

The Constitution of Chad is the supreme law of the country and outlines the fundamental principles and framework of the government.

The Constitution of Comoros was adopted in 2001 and last amended in 2018. The Constitution contains 122 articles addressing a large number of issues as the protection of fundamental rights and freedoms, the fundamental principles of the state and institutional arrangements.

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

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 law modifies the articles 8, 135,137,139,159,160,166,195,204,226,244,250,275,292 and the title XII of the Constitution of the Republic of Mozambique. 

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 Act provides for public health, the conditions for improvement of the health and quality of life and the health care for all people in Zimbabwe, the rights, duties, powers and functions of all parties in the public health system, and the measures for administration of public health.

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.

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.