Health Legislation

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.  

The Act regulates the quality and safety of medicines and related products and connected matters.

This Act promotes and protects the health and safety of the general public through safeguarding, maintaining and enforcing the highest standards in the practice of pharmacy.

The decree creates a multi-sectoral committee to combat counterfeiting and the illicit sale of medicines and other pharmaceutical products, reporting to Niger's Minister of Public Health.

These Regulations govern the issuance of licenses for the importation, exportation, manufacture, distribution, and retail of drugs, etc.

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.

This Act makes provisions for the establishment of the Kenya Medical Supplies Authority and for connected purposes.

The decree establishes a Committee of Experts in charge of technical evaluation, whose mission is to carry out the technical evaluation of applications for registration of pharmaceutical products for human use. It also gives an opinion on the quality, safety and efficacy of pharmaceutical products for human use submitted for registration.

The decree creates the Commission Nationale du Médicament (CNM) for human use, whose mission is to validate the work of the Expert Committee responsible for the technical evaluation of applications for marketing authorization for pharmaceutical products for human use. It also gives a final opinion on marketing authorization applications; applications for renewal, extension of variation and transfer of marketing authorization; temporary suspension of marketing authorization; and proposals for definitive withdrawal of marketing authorization.

These guidelines establish an Essential Drug List of Botswana of 2012 and provide the requirements regarding the levels of availability across health care providers.

The decree establishes the pharmaceutical policy in Burkina Faso. The Pharmaceutical Policy is a national planning framework that expresses the government's vision, goals, objectives and strategic interventions for the development of the pharmaceutical sector. The policy aims to improve access to quality healthcare products, available throughout the country at a cost adapted to the population's purchasing power.

This document provides for standard treatment guidelines and the essential medicines list.

The National Public Health Act revises and consolidates the law relating to public health to prevent disease, promote, safeguard, maintain and protect the health of humans and animals and to provide for related matters.

The decree revises Niger's national list of essential medicines from 2009

This Act provides for the establishment of an independent Drug and Food Control Authority in South Sudan and provide an appropriate and effective independent regulatory mechanism to control and regulate the manufacture, supply, promotion, marketing, advertising, distribution and use of drugs, poisons, chemicals, cosmetics medical devices and food for human or animal use.

This Act regulates the conduct of clinical trials for medicinal products in Mauritius.

The Decree establishes the General Bases of the National Pharmaceutical Policy.

This Law defines the legal provisions relating to medicines, medical devices, other health products and the practice of pharmacy in the Islamic Republic of Mauritania. This Law is published in a collection of other legislative acts and can be found on page 3 of the file.

The Diploma approves the Medicines Registration Manual. The purpose of the Manual is to (a) Standardize the procedures and activities relating to the registration of medicines; (b) Clarify the doubts that professionals have encountered when interpreting the Registration Regulations; (c) Support professionals in the field in carrying out their daily activities in a standardized way; (d) Support applicants in complying with registration and post-registration procedures; (e) to make the registration process an optimized and increasingly swift process. 

The purpose of the Regulation is to define the procedures for approving pharmaceutical products for human use in the member states of the West African Economic and Monetary Union.