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Health Legislation

Health Legislation

Results (140)

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.

Essential drug list

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 Revised Guidelines (4th edition) for Prevention of Mother-to-Child Transmission (PMTCT) of HIV and AIDS provide more detailed and effective interventions to reduce the risk of mother-to-child transmission (MTCT) than previous editions. They emphasize the early initiation of ARV prophylaxis starting at 14 weeks, highlighting the importance of early antenatal care (ANC) attendance for all women.

Drug and Food Control Authority Act, No 37

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.

Guidelines for antiretroviral therapy in Kenya

These guidelines outline standardized protocols for the initiation and management of HIV treatment, emphasizing early treatment initiation and adherence to improve health outcomes. They incorporate recommendations for monitoring treatment efficacy, managing side effects, and addressing co-infections, ensuring a patient-centered approach in diverse healthcare settings.

Clinical Trials Act

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

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

These Guidelines outline standardized protocols for voluntary testing and counselling to enhance access to HIV services, ensure informed consent, and promote client confidentiality and support.

This Guidance Framework outlines strategies and standards to ensure high-quality, client-centered HIV testing and counselling services, promoting accuracy, safety, and confidentiality in the process.

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.

Liste Nationale des médicaments essentiels en République Centrafricaine

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.

The law regulates the management and control of HIV/AIDS in the Republic of Guinea.

HIV/AIDS decentralization guidelines

These Guidelines outline a framework for transferring HIV/AIDS service delivery responsibilities from central to local levels, promoting community involvement and improving access to care.

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