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Health Legislation

Health Legislation

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The decree revises Niger's national list of essential medicines.

Guidelines for Registration of Human Vaccines

These guidelines prescribe data, which is required to be submitted to the National Drug Authority to demonstrate the safety, efficacy and quality of vaccines being applied for market authorization. The guidelines also describe the format (CTD) in which dossiers should be presented in support of the application.

The Decree creates a management body called "Caisse nationale d'assurance maladie universelle". It is placed under the technical supervision of the Ministry in charge of social protection and the financial supervision of the Ministry in charge of finance.

The decree provides the National List of Essential Medicines.

Lignes directrices sur la pharmacovigilance en République Démocratique du Congo

This document provides guidelines on pharmacovigilance in the Democratic Republic of Congo.

The law regulates the manufacture and registration of medicines, the approval of medical devices, and sets out rules for pharmacies and the practice of the profession of pharmacist.

The law creates a compulsory health insurance scheme known as the "Régime d'Assurance Maladie Universelle" (Universal Health Insurance Scheme) designed to cover the health care costs attached to sickness and maternity for insured persons and their dependent family members.

The law establishes the fundamental principles of social protection in Niger. The purpose of the present law is to guarantee social protection to people at risk of vulnerability and vulnerable people in accordance with the National Social Protection Policy.

This Law amends the Law 03/2015 of 02/03/2015 governing the Organisation of Community-Based Health Insurance Scheme.

This Law establishes the Rwanda Food and Drugs Authority and determines its mission, organization and functioning. The authority has a legal personality and enjoys administrative and financial autonomy. 

South Sudan Essential Medicines List (SSEML)

The South Sudan Essential Medicines List (SSEML) is a comprehensive list of medications essential for addressing the country's public health needs, prioritizing safe, effective, and affordable treatments for the most common health conditions.

The National Social Security Fund Act

This Act establishes the National Social Security Fund and provides for its constitution, administration and other matters related to the Fund.

The National Health Insurance Act

This Act provides for sound financing for the national health system; provides for universal access to quality insured health care services; establishes the National Health Insurance Management Authority and provides for its functions and powers; establishes the National Health Insurance Scheme and provides for its systems, procedures and operation; establishes the National Health Insurance Fund and provides for contributions to and payments from the Fund; provides for accreditation criteria and conditions in respect of insured health care services; provides for complaints and appeals processes; provides for the progressive establishment of provincial and district health offices of the Authority; and provides for matters connected with, or incidental to the foregoing.

The objective of the law is to establish an institutional framework for regulating the pharmaceutical sector to ensure market approval and use of pharmaceutical products that are accessible, safe, efficient, and of appropriate quality (art.2). It notably establishes the Authority for pharmaceutical regulation (Autorité Ivoirienne de Regulation Pharmaceutique - AIRP) and addresses its mandates (chapter 1).

The objective of this decree is to define the modalities and procedures for concluding, suspending and terminating agreements governing relations between the Health Insurance Fund (IPS-CNAM) and healthcare providers.

The objective of this decree is to define the requirements and modalities for affiliation to and registration with the general basic universal health insurance scheme (i.e. population groups covered).

Essential Medicines List

The Essential Medicines List of Ghana of 2017 is a comprehensive guide outlining the medicines deemed essential for addressing the primary health care needs of the population. It includes a wide range of medications selected based on their relevance to public health, evidence on efficacy and safety, and comparative cost-effectiveness, aimed at ensuring accessibility and affordability.

This Law establishes the rules for the efficient and safe production, distribution, use and availability, as well as quality assurance of medicines, vaccines, biological and health products for citizens.

Lista Nacional de Medicamentos Essenciais

The document contains the updated National List of Essential Medicines (Lista Nacional de Medicamentos Essenciais). 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.

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