Health Legislation

The diploma approves the National List of Essential Medicines. 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 Ministerial Decree regulates information and advertising of medicines and other health products.

This Ministerial decree regulates the trade of pharmaceutical products in the Democratic Republic of the Congo.

This Regulation is to determine the fee payable for registration and license of food, medicine, health professional and health institutions.

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 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.

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.

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.

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

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

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

This Decree determines the conditions for opening and operating of wholesale pharmaceutical stores in Rwanda.

The Resolution approves the Traditional medicine policy and implementation strategy.

The resolution approves the strategy for preventing and combating drugs.

This Decree regulates the production, import, marketing and dispensing of medicines and one of its objectives is to ensure that medicines in the Republic of Mozambique are safe, effective, of good quality and meet the needs of the population.

This Order provides the rules governing the advertising of medicines.