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 Constitution was promulgated by Decree No 2010-754 of 25 November 2010. It includes 185 articles addressing a wide array of issues including, among other things, human rights and duties and institutional arrangements.
The Constitution of Niger (2010) is structured into several titles, each addressing different aspects of the state's governance and the rights of its citizens. The document begins with a Preamble, followed by Title I: The State and Sovereignty, which outlines the fundamental principles of the Republic of Niger. Title II: Rights and Duties of the Human Person includes various articles on individual rights, including health rights. Title III: Executive Power details the roles and responsibilities of the President and the Government. Title IV: Legislative Power focuses on the functions of the National Assembly. Title V: Relations Between Executive and Legislative Powers describes the interaction between these branches. Title VI: Judicial Power covers the judiciary's independence and structure. Title VII: Economic, Social, and Cultural Development outlines the state's development policies. Title VIII: The Higher Council of Communication addresses media and communication regulations. Title IX: Local Authorities discusses decentralization and local governance. Title X: Treaties and International Agreements covers the process of treaty ratification. Title XI: Cooperation and Association with States focuses on international cooperation. Title XII: Revision details the process for amending the Constitution. Title XIII: Transitional Provisions and Title XIV: Final Provisions conclude the document. Articles 12 and 13 specifically refer to health rights. Article 12 states that everyone has the right to health, and Article 13 emphasizes the state's duty to create conditions ensuring access to medical services and assistance in case of illness.
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.