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Procedures for the registration, renewal, change in characteristics and extension in range of both imported and locally manufactured registered pharmaceutical products
These are the guidelines for the registration, renewal, change in characteristics and extension in range of both imported and locally manufactured registered pharmaceutical products.
Lei No 03/2016 Visa Garantir e Proteger os dados pessoais das Pessoas Singulares
This Law establishes a framework to guarantee and protect the personal data of individuals.
Lignes directrices sur l’approvisionnement en médicaments essentiels en République Démocratique du Congo
This document provides guidelines on the supply of essential medicines in the Democratic Republic of Congo.
Arrêté ministériel No 120/CAB/MIN/SP/008/CPH/OBF/2015 portant règlementation du commerce des produits pharmaceutiques en République Démocratique du Congo
This Ministerial decree regulates the trade of pharmaceutical products in the Democratic Republic of the Congo.
Regulation No 299/2013 Food, Medicine and Health Care Administration and Control
This regulation is issued to implement the Food Medicine and Health Care Administration and Control Proclamation No 661/2009. and covers among other aspects of food safety and quality which includes manufacturing, storage and transportation among other aspects; sale of alcohol; medicine administration and control which includes manufacturing, registration, storage, transportation, importation ad clinical trials among others; traditional and complementary medicine administration and control; post-marketing surveillance; control of tobacco products and places prohibited for smoking among other aspects.
Medicines and Related Products Act
The Act regulates the quality and safety of medicines and related products and connected matters.
Loi No 2014-038 sur la protection des données à caractère personnel
The purpose of this law is to protect the rights of individuals in the processing of personal data.
The National Drug Policy and Authority (Issue of Licenses) Regulations
These Regulations govern the issuance of licenses for the importation, exportation, manufacture, distribution, and retail of drugs, etc.
Medicines and related substances Act
This Act provides for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
Loi N°2013-450 du 19 Juin 2013 relative à la protection des données à caractère personnel
The objective of the law is to govern personal data protection.
Protection of personal information Act No 4 of 2013
The Act promotes the protection of personal information processed by public and private bodies; introduces certain conditions so as to establish minimum requirements for the processing of personal information; provides for the establishment of an Information Regulator to exercise certain powers and to perform certain duties and functions in terms of this Act and the Promotion of Access to Information Act, 2000; provides for the issuing of codes of conduct; provides for the rights of persons regarding unsolicited electronic communications and automated decision making; etc.
Data Protection Act, 2012 Act 843
The Data Protection Act of 2012 establishes a Data Protection Commission, to protect the privacy of the individual and personal data by regulating the processing of personal information, to provide the process to obtain, hold, use or disclose personal information and for related matters.
Lei No 22/11 Da proteção de dados pessoais
The purpose of the law is to establish the legal rules applicable to the processing of personal data with the aim of guaranteeing respect for public freedoms and the fundamental rights and guarantees of natural persons.
Data Protection Act 2011 (Act No 5 of 2012)
The Act establishes the Data Protection Commission, provide for principles for regulation of processing of personal information in order to protect and reconcile the fundamental and competing values of personal information privacy under this Act and sector-specific legislation and other related matters.
Diploma Ministerial No 223/2010 Aprova o Manual de Registo de Medicamentos
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.
Décret n° 2009-720/PRES/PM/MS/MEF/MCPEA portant conditions de fabrication et d'importation des produits contraceptifs au Burkina Faso
The Decree sets out the conditions for manufacturing and importing contraceptive products into Burkina Faso.
Information and Communications Act
The Act provides for the re-structuring, development, and regulation of the information and communication sectors in The Gambia and for matters connected therewith.
Medicines and Related Substances Control Amendment Act
This Act amends the Medicines and Related Substances Control Act, 2003, so as to amend and delete certain definitions; provides for a period within which the Council must be appointed; provides for the appointment of chairpersons of committees established by the Council; amends provisions relating to the classification of medicines and other substances as scheduled substances; amends provisions relating to the manufacturing, packing and selling of specified Schedule 3 and specified Schedule 4 substances; deletes references to generic substitutions; substitutes references to Schedule 1, Schedule 2, Schedule 3 or Schedule 4 medicines by references to Schedule 1, Schedule 2, Schedule 3 or Schedule 4 substances; inserts provisions relating to the registration of premises engaged in the manufacturing of medicines; amends provisions relating to offences and penalties; amends provisions relating to the destruction of forfeited medicines, scheduled substances or other things; provides for the making of regulations in relation to medicines; amends provisions relating to the exclusion of medicines from the operation of the Act; amends the transitional provisions; amends provisions relating to the repeal and amendment of certain laws; and provides for matters incidental thereto.
Decreto-Lei No 59/2006
This decree regulates the marketing authorization, registration, manufacture, import, export, marketing, donations and advertising of medicines for human use.
Statistics Act
This Act provides for a sustainable, effective and efficient national statistical system for The Gambia for the collection, production and dissemination of integrated, relevant, reliable, timely statistical information, establishes The Gambia Bureau of Statistics as a supervisory authority for the national statistical system.