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 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.

These Regulations provide rules on the registration and access to the market to medicine; licensing requirements for pharmaceutical operations, manufacturers, wholesalers and dispensaries; as well as on record-keeping, import of medicines, and clinical trials, etc.

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

The Act contains provisions to provide protection of the interests of consumers by means of investigation, prohibition and control of unfair business practices; and to provide for matters incidental thereto.

This Act regulates the protection of personal data and ensures that the privacy of individuals in relation to their personal data is maintained. It also establishes the Information and Data Protection Commission and provides for all matters incidental thereto.

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 Act amends sections 2, 6, 7, 9, 12, 14, 17, 17A, 18 and 19 of the National Registration Act of 1986.

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 Botswana National Health Quality Standards for Clinics provide guidance on the topic of management and leadership in the governance of the health facility focusing on such areas as responsibilities and accountability of governing bodies; applicable laws and regulations; budgeting, reporting and auditing processes; planning of health services that correspond to the patient and population needs, etc.

The National Health Quality Standards for Hospitals provide guidelines for hospitals regarding coordination of patient care, facilities and equipment, clinical practice guidelines, assessment of patients, patient care, medication, etc.