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Public Health (COVID-19) Regulations 2020 - Legal Notice 38 of 2020
The document contains regulation taken by Lesotho’s government during the emergency of COVID 19.
Lei No 10/2020 Lei de Gestão e Redução do Risco de Desastres
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.
Decreto No 115/2020 Aprova o Estatuto Orgânico da Autoridade Nacional Reguladora de Medicamento
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.
Règlement No 04/2020/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.
Nigeria Essential Medicine List (7th Edition)
The document establishes the national list of essential medicines in Nigeria.
Nigeria Essential Medicines List for Children (1st Edition)
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.
Décret N°2019-292 du 3 Avril 2019 portant création, attributions, organisation et fonctionnement du centre des opérations d'urgence de santé publique
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).
Proclamation No.1112/2019, Food and Medicine Administration Proclamation
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.
Arrêté No 2019-2521/MSHP-SG fixant la liste Nationale des Médicaments Essentiels en Dénomination Commune Internationale
The document establishes the list of essential medicines in the Republic of Mali.
Arrêté No 110 MSP/SG/DGSP/MT portant révision de la Liste Nationale des Médicaments Essentiels
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.
Decreto-Lei No 33-2018 Aprova a Lista Nacional de Medicamentos Essenciais
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.
Loi 2018/024 relative aux médicaments et produits de santé et à l'exercice de la profession de pharmaciens
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.
Law No 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority and determining its mission organisation and functioning
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.
Loi N° 2017-541 du 3 août 2017 relative à la régulation du secteur pharmaceutique
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).