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Diploma Ministerial No 223/2010 Aprova o Manual de Registo de Medicamentos
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.
Constitution de de la République du Niger
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.
Règlement No 06/2010/CM/UEMOA relatif aux procédures d’homologation des produits pharmaceutiques à usage humain
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.
Constitution
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.
Décret n° 2009-720/PRES/PM/MS/MEF/MCPEA portant conditions de fabrication et d'importation des produits contraceptifs au Burkina Faso
The Decree sets out the conditions for manufacturing and importing contraceptive products into Burkina Faso.
Liste Nationale des médicaments essentiels en République Centrafricaine
This document establishes a National List of Essential Medicines in the Central African Republic.
Food, Medicine and Health Care Administration and Control Proclamation No. 661/2009
This Proclamation regulates activities in respect of food, medicine, environmental health, health professionals, health and controllable health related institutions in the country.
Medicines and Related Substances Control Amendment Act
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.
The Pharmacy and Drugs (Amendment) Act
This Act amends section 38 of the Pharmacy and Drugs Act of 2001.
Decreto-Lei No 59/2006
This decree regulates the marketing authorization, registration, manufacture, import, export, marketing, donations and advertising of medicines for human use.
Constitution
The Constitution of the Democratic Republic of the Congo was adopted in 2006 and revised by Law No 11/002 of 20 January 2011. The Constitution consists of 229 articles that are grouped into eight titles. The Constitution includes provisions on the key principles of the organization of the Republic, human rights and fundamental freedoms, organization of powers, key state organs, etc.
Liste nationale des médicaments essentiels par niveaux 2006
The document establishes the list of essential medicines in the Republic of Mali.
Constitution de la Republique du Burundi 2018
The Constitution was promulgated in 2005 and reviewed in 2018. The Constitution contains 292 articles addressing a broad range of issues as the protection of fundamental rights and freedoms, the fundamental principles of the state and institutional arrangements.
Constitution
The Constitution includes 279 articles addressing a wide array of issues including the Kingdom and its constitution, the protection and promotion of fundamental rights and freedoms, the acquisition and loss of citizenship, the directive principles of state policy, as well as institutional arrangements (the executive, the legislature, the judicature, local governments, and traditional institutions). The Constitution also addresses public services, public finance, and international relations. (non-exhaustive list).
Standard treatment guidelines and essential medicines list
The policy establishes the national list of essential medicines and treatment guidelines in Lesotho.
Ministerial Decree 12 of 2005 determining the Conditions for Opening and Operating of Wholesale Pharmaceutical Store
This Decree determines the conditions for opening and operating of wholesale pharmaceutical stores in Rwanda.
Constituição
The Constitution was promulgated in 2004 and modified in 2018. It includes 306 articles (17 titles) addressing a large number of issues as the protection of fundamental rights and freedoms, the fundamental principles of the state and institutional arrangements.
Resolução No 11/2004 Politica da Medicina treadicional e etrategia da su implmentação
The Resolution approves the Traditional medicine policy and implementation strategy.
Ley No 3/2003 de Medicamentos
The scope of application of this Law includes: medicines and health products, as well as the actions of natural and legal persons involved in the production, marketing, prescription and dispensing of pharmaceutical and health products within the national territory. This document is published as a part of a compilation of laws and decrees and this Law is located on page 2 of the file.
Resolução No 15/2003 estratégia de prevenção e combate à droga
The resolution approves the strategy for preventing and combating drugs.