Health Legislation

This regulation establishes the rules applicable to the exercise of pharmaceutical activity, in the public and private sectors, by natural or legal persons.

The Resolution approves the Health Policy and the Strategy for its Implementation.

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.

The diploma approves the rules of Procedure of the Ministry of Health.

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 resolution approves the Organic Statute of the Ministry of Health. It defines aspects as it competencies, functions, and the functions of it organs among other aspects.

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 Decree establishes the rules for implementing Law 34/2014, of December 31, on the Right to Information. It is applicable to the bodies and institutions of the State, direct and indirect administration, representation abroad, local authorities and also to private entities which, under the Law or by contract, carry out activities of public interest or which, in their activity, benefit from public resources from any source and have in their possession information of public interest.

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 present Statute applies to the Hospitals of the National Health Service and aims to establish general rules on their organization and operation.

The Decree introduces an Identity Card for national citizens based on biometric elements. 

The resolution approves the Charter of Patients' Rights and Duties.

This Regulation establishes the legal framework applicable to the contracting of public works, and the supply of goods and services to the State, including consultancy and concessions.

The Diploma approves the general regulation of hospitals in Mozambique. The regulation applies to all hospitals in the National Health Service and to those that are managed by the private non-profit sector.

The Resolution approves the Traditional medicine policy and implementation strategy.

The resolution approves the strategy for preventing and combating drugs.

This diploma establishes the technical description of the different institutions of the National Health Service across the four levels of care, the classification and their specific functions. 

This Ministerial Diploma approves the norms of the organization of the National Health Service for the care and treatment of people living with HIV/AIDS and the Guiding Principles for the treatment of patients with HIV/AIDS Infection and the respective Technical Guides.

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.

The objective of Decree No. 21/99 is to establish the conditions, norms, and procedures for the practice of the pharmaceutical profession in Mozambique, ensuring compliance with technical, ethical, moral, and deontological principles.