Health Legislation

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 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.

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 establishment of a Namibia Medicines Regulatory Council; for the registration of medicines intended for human and for animal use; for the control of medicines and scheduled substances and provides for incidental matters.

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 a national drug policy and a national drug authority to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory health care and safeguarding the appropriate use of drugs.

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.

This Act is to establish a Medicines Control Authority of Zimbabwe and to confer functions on such Authority in relation to the registration of medicines; to provide for the Zimbabwe Regional Medicines Control Laboratory and for its functions; to provide for the appointment of a Director-General of the Authority and for the keeping of a Medicines Register; to provide for certain prohibitions, controls and restrictions relating to medicines and other substances; and to provide for matters connected with or incidental to the foregoing.

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.