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 document provides the national list of essential medicines and other health products in Ethiopia. 

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 Proclamation is to provide for Food and Medicine Administration. It provides rules to regulate several areas including food, medicine, medical devices, cosmetics, and tobacco products.

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.

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

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 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 Proclamation regulates activities in respect of food, medicine, environmental health, health professionals, health and controllable health related institutions in the country.

The Resolution approves the Traditional medicine policy and implementation strategy.

The resolution approves the strategy for preventing and combating drugs.

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.