The purpose of this ordinance is to determine the rates and fees for regulatory services offered on drugs and other health products by the drug regulatory authority for Burundi (ABREMA).
The purpose of this ordinance is to organize the registration of medicines for human use and other pharmaceutical inputs in Burundi.
This regulation establishes the rules applicable to the exercise of pharmaceutical activity, in the public and private sectors, by natural or legal persons.
The law creates the Burundian Authority for the Regulation of Medicines for Human Use and Food. The authority's general aim is to protect public health by promoting the quality and safety of products such as prefabricated and ambient foods, medicines for human use, cosmetics and dietary products containing active ingredients, herbal medicines, traditional medicines, and medical devices, among others.
The decree provides for the organization and functioning of the Central Purchasing Center for Essential Medicines of Burundi [CAMEBU].
The decree regulates the establishment, organization and functioning of the National Public Health Institute of Burundi.
The Resolution approves the Health Policy and the Strategy for its Implementation.
The Decree defines the normative framework for the organization and operation of the Ministry of Public Health and the fight against AIDS.
Decreto No 115/2020 Aprova o Estatuto Orgânico da Autoridade Nacional Reguladora de Medicamento
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.