Health Legislation

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.

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 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.

The Decree sets out the conditions for manufacturing and importing contraceptive products into Burkina Faso.

This document establishes a National List of Essential Medicines in the Central African Republic.

This Proclamation regulates activities in respect of food, medicine, environmental health, health professionals, health and controllable health related institutions in the country.

This decree, taken in application of the provisions of article 109 of Ordinance No. 01/95/PR/MSP of January 14, 1995, sets out the procedures for the care of patients in public health facilities.

This Act amends the Medicines and Related Substances Control Act, 2003, so as to amend and delete certain definitions; provides for a period within which the Council must be appointed; provides for the appointment of chairpersons of committees established by the Council; amends provisions relating to the classification of medicines and other substances as scheduled substances; amends provisions relating to the manufacturing, packing and selling of specified Schedule 3 and specified Schedule 4 substances; deletes references to generic substitutions; substitutes references to Schedule 1, Schedule 2, Schedule 3 or Schedule 4 medicines by references to Schedule 1, Schedule 2, Schedule 3 or Schedule 4 substances; inserts provisions relating to the registration of premises engaged in the manufacturing of medicines; amends provisions relating to offences and penalties; amends provisions relating to the destruction of forfeited medicines, scheduled substances or other things; provides for the making of regulations in relation to medicines; amends provisions relating to the exclusion of medicines from the operation of the Act; amends the transitional provisions; amends provisions relating to the repeal and amendment of certain laws; and provides for matters incidental thereto.

This Act amends section 38 of the Pharmacy and Drugs Act of 2001.