Health Legislation

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.  

The Act regulates the quality and safety of medicines and related products and connected matters.

These Regulations govern the issuance of licenses for the importation, exportation, manufacture, distribution, and retail of drugs, etc.

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.

This Law provides for the extension of the health insurance regime as established by Ordinance No 2005-006 of 29 September 2005 to other population categories such as employees of local authorities and their public establishments; employees of projects and other administrative structures benefiting from financial autonomy; persons exercising a liberal profession; employees and pensioners of the private sector, private law associations and other civil society organizations; professional journalists and private press collaborators; independent workers.

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. 

The Decree sets out the conditions for manufacturing and importing contraceptive products into Burkina Faso.

This decree, taken in application of the provisions of articles 51 of the Constitution and 107 of Ordinance No. 0022/PR/2007 of August 21, 2007, establishes the technical operating procedures of the Compulsory Health Insurance and Social Security Scheme.

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.

The executive decree n° 06-339 of 2 Ramadhan 1427 corresponding to 25 September 2006 modifies the executive decree n° 94-187 of 26 Moharram 1415 corresponding to 6 July 1994 fixing the distribution of the rate of the social security contribution. This decree was published in the official journal of 27 September 2006 (see page 16).

This decree regulates the marketing authorization, registration, manufacture, import, export, marketing, donations and advertising of medicines for human use.

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.

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.

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.

This proclamation provides rules to control drugs, medical supplies and sanitary items.

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.

The Act provides for the registration and control of medicines and related substances for human and animal use, establishes the Medicines Control Council, and outlines its powers and responsibilities. It includes provisions for the licensing of manufacturers, distributors, and dispensers, as well as measures to ensure the availability of affordable medicines. The Act also addresses the regulation of medicine pricing, generic substitution, labeling, and procedures for appeals and re-evaluation of registered medicines.