Health Legislation

This regulation is issued to implement the Food and Medicine Administration Proclamation No.1112/2019. It provides the organization, powers and duties of the Ethiopian Food and Drug Authority.

This regulation is issued to implement Proclamation No. 1273/2022 Community-Based Health Insurance Proclamation. It establishes the framework for managing health insurance pools and reserve funds (Sections 3-6), outlines membership and contribution procedures (Sections 7-9), and details provider payment mechanisms (Section 10). It also addresses fund management, financial deficit coverage (Sections 11-13), and miscellaneous provisions such as co-payment and data management (Sections 14-20).

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.

This Regulation is to determine the fee payable for registration and license of food, medicine, health professional and health institutions.

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.

This regulation is issued to implement the Food Medicine and Health Care Administration and Control Proclamation No 661/2009. and covers among other aspects of food safety and quality which includes manufacturing, storage and transportation among other aspects; sale of alcohol; medicine administration and control which includes manufacturing, registration, storage, transportation, importation ad clinical trials among others; traditional and complementary medicine administration and control; post-marketing surveillance; control of tobacco products and places prohibited for smoking among other aspects.  

The Proclamation establishes a mandatory health insurance scheme for pensioners, employees and members of their families in Ethiopia.

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.