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Health Legislation

Health Legislation

Results (143)

The document contains regulation taken by Lesotho’s government during the emergency of COVID 19.

This Law establishes the Disaster Risk Management and Reduction Legal Regime, which comprises risk reduction, disaster management, sustainable recovery for building human, infrastructural and ecosystem resilience, as well as adaptation to climate change.

The Decree approves the Organic Statute of the Autoridade Nacional Reguladora de Medicamento (The National Medicines Regulatory Authority). The purpose of this Decree is to define the rules governing the organization, management and operation, as well as the powers of its bodies.

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.

Nigeria Essential Medicine List (7th Edition)

The document establishes the national list of essential medicines in Nigeria.

This document establishes the national list of essential medicines for children in Nigeria.

Lista Nacional de Medicamentos

This document provides a second edition of the List of Essential Medicines in Sao Tome and Principe.

Medicines and related substances regulations

These Regulations provide rules on the registration and access to the market to medicine; licensing requirements for pharmaceutical operations, manufacturers, wholesalers and dispensaries; as well as on record-keeping, import of medicines, and clinical trials, etc.

This decree establishes a Center of Public Health Emergency Operation (Centre des Opérations d'Urgence de Santé Publique - COUSP) (article 2), sets its attributions (article 4), and its organizational modalities (chapter III).

This Proclamation is to provide for Food and Medicine Administration. It provides rules to regulate several areas including food, medicine, medical devices, cosmetics, and tobacco products.

Pharmacy and Medicines Regulatory Authority Act

This Act establishes the Pharmacy and Medicines Regulatory Authority; provides for the functions and powers of the Authority; and provides for matters connected therewith and incidental thereto.

The document establishes the list of essential medicines in the Republic of Mali.

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 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.

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 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).

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