Mozambique

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

The purpose of this Law is to establish mechanisms for the protection and promotion of health, the prevention and control of diseases, as well as threats and risks to public health.

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

This Law establishes the Disaster Risk Management and Reduction Legal Regime, which comprises risk reduction, disaster management, sustainable recovery for building human, infrastructural and ecosystem resilience, as well as adaptation to climate change.

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.

The law modifies the articles 8, 135,137,139,159,160,166,195,204,226,244,250,275,292 and the title XII of the Constitution of the Republic of Mozambique. 

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 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 Law establishes the Order of Nurses of Mozambique and approves its Statute. The Order of Nurses of Mozambique is a legal person governed by public law, representing nurses, and carrying out services in the public interest. Registration and recognition by the Order of Nurses are mandatory conditions for the exercise of nursing activity in Mozambique.

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 law regulates the legal framework for the exercise of private medicine.   

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.

The Law establishes the Order of Doctors of Mozambique and provides the Statute of the Order as an integral part of the law.