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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.
Loi No 29-2019 portant protection des données à caractère personnel
This law, published in the Official journal on 7 November 2019, is to put in place a system to ensure the protection of the fundamental rights and freedoms of individuals, in particular their privacy, with regard to the processing of personal data; and to ensure that information and communication technologies remain at the service of the citizen and do not infringe individual freedoms.
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.
The Data Protection Act
This Act gives effect to Article 31(c) and (d) of the Constitution; establishes the Office of the Data Protection Commissioner; makes provision for the regulation of the processing of personal data; provides for the rights of data subjects and obligations of data controllers and processors; and for connected purposes.
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.
Nigeria Data Protection Regulation: implementation framework
The document is a comprehensive Regulation on data protection in Nigeria. It is a guide to assist data controllers and data administrators/processors in understanding the controls and measures they need to introduce into their operations in order to comply with the Nigeria Data Protection Regulation.
Loi No 2019-014 du 29 Octobre 2019 relative à la protection des données à caractère personnel
The purpose of the law is to regulate the collection, processing, transmission, storage, use, and protection of personal data.
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 Data Protection and Privacy Act
This Act protects the privacy of the individual and of personal data by regulating the collection and processing of personal information; provides for the rights of the persons whose data is collected and the obligations of data collectors, data processors and data controllers; regulates the use or disclosure of personal information; and provides for related matters.
Data Protection Act
This Act regulates the protection of personal data and ensures that the privacy of individuals in relation to their personal data is maintained. It also establishes the Information and Data Protection Commission and provides for all matters incidental thereto.
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.