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.

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.

This Act lays down the fundamental provisions and principles and aims to give concrete form to the rights and duties of the population in matters of health. Its purpose is to ensure the prevention, protection, maintenance, restoration and promotion of people's health. It was published in the Official Journal on 29 July 2018.

The decree provides the National List of Essential Medicines.

This Law establishes the fundamental principles relating to the organization of public health in the Democratic Republic of the Congo.

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.

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.

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.

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 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.

This Act provides for the establishment of a Medicines Regulatory Authority; for the registration of medicines and medical devices; for the control of medicines and scheduled substances, and for incidental matters.