Health Legislation

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.

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

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 Act provides for integrated and coordinated disaster management that focuses on prevention, preparedness, response, mitigation, and recovery from, disasters or emergency situations, and the management of their effects, establishes a National Disaster Management Agency and Regional, District and Village Disaster Management Committees.

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 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 Act provides for an integrated and co-ordinated disaster management policy that focuses on preventing or reducing the risk of disasters, mitigating the severity of disasters, emergency preparedness, rapid and effective response to disasters and post-disaster recovery and rehabilitation; regulates the establishment and functioning of national, provincial and municipal disaster management centres; regulates disaster management volunteers and matters incidental thereto.

The Act is to establish the Disaster Management Authority; to regulate its powers and functions and to make provision with respect to emergencies arising out of disasters including prevention, mitigation, preparedness, response and recovery measures for the protection of life and property from the effects of disasters.

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.

This Act makes provision for the co-ordination and implementation of measures to alleviate effects to disasters, the establishment of the office of Commissioner for Disaster Preparedness and Relief the establishment of a National Disaster Preparedness and Relief Committee of Malawi, and for matters incidental thereto or connected therewith.

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.