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Drugs and Related Products Registration Regulations
The Regulation sets up rules in the registration of drugs and related products manufactured, imported, exported, advertised, sold, distributed or used in Nigeria.
Specifications for Essential Medicines Supplies
Specifications for essential medicines supplies.
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.
Lei No 12/2017 Lei de medicamento, vacinas e outros produtos biológicos para o uso humano
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.
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.
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.
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.
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.
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.
Ley No 3/2003 de Medicamentos
The scope of application of this Law includes: medicines and health products, as well as the actions of natural and legal persons involved in the production, marketing, prescription and dispensing of pharmaceutical and health products within the national territory. This document is published as a part of a compilation of laws and decrees and this Law is located on page 2 of the file.
The Tanzania Food, Drugs and Cosmetics Act
This Act provides for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and repeals the Food (Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978, and provides for related matters.
Decreto No 22/99 Aprova o Regulamento de Medicamentos
This Decree regulates the production, import, marketing and dispensing of medicines and one of its objectives is to ensure that medicines in the Republic of Mozambique are safe, effective, of good quality and meet the needs of the population.
Proclamation No 36/1993 to control drugs, medical supplies and sanitary items
This proclamation provides rules to control drugs, medical supplies and sanitary items.
The Medical Stores Department Act
This Act establishes the Medical Stores Department for the procurement, storage and distribution of medical supplies and provides for other matters connected or incidental to the establishment and management of the department.