Health Legislation

The Decree approves the Organic Statute of the Autoridade Nacional Reguladora de Medicamento (The National Medicines Regulatory Authority). The purpose of this Decree is to define the rules governing the organization, management and operation, as well as the powers of its bodies.

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 document contains the updated National List of Essential Medicines (Lista Nacional de Medicamentos Essenciais). It is a mandatory tool for Health Professionals to use throughout the process of searching for, acquiring, distributing and prescribing medicines within the National Health Service.

This Regulation establishes the pricing system for medicinal products. All medicines circulating in Mozambique shall be subject to the pricing system provided for in these regulations.

The diploma approves the National List of Essential Medicines. It is a mandatory tool for Health Professionals to use throughout the process of searching for, acquiring, distributing and prescribing medicines within the National Health Service.

The Namibia Essential Medicines List acts as a guide for the level of availability and use of essential medicines based on the skills levels of health workers as well as the availability of diagnostic facilities at the various levels of the Namibian public sector healthcare system.

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. 

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 Resolution approves the Traditional medicine policy and implementation strategy.

The resolution approves the strategy for preventing and combating drugs.

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 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.