Health Legislation

This Decree amends articles 12 and 40 of Decree No 2023-409 of July 26, 2023 relating to the responsibilities, organization and operation of the regulatory authority for the health sector

This decree defines the terms and conditions for implementing the mandatory health insurance.

This Decree approves the amended statutes of the Beninese pharmaceutical regulatory agency, now named “Beninese Agency for Medicines and other Health Products”.

This decree establishes the responsibilities, organization and operation of the Health Sector Regulatory Authority. This Authority is attached to the Presidency of the Republic (art.3) and has a broad spectrum of action including among others, public and private health sector, all levels of the health pyramid, physical, mental and social health, hospitals and primary care, all age groups as well as the health of citizens and foreigners.

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

This decree establishes the responsibilities, organization and operation of the Ministry of Health.

This decree determines the conditions for the creation, approval, operation and control of reproductive health structures in application of the provisions of Article 12 paragraph 3 of Law No. 2003-04 of March 3, 2003 relating to the sexual and reproductive health.

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.

By this decree, the Government of Benin appoints the auditors of the National Health Insurance Agency.

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.

This decree establishes the Steering Committee for the implementation of the Universal Health Insurance Scheme and contains provisions concerning its composition as well as its departmental and regional structures.

This decree establishes the National Consultative Committee for Vaccination and Vaccines of Benin (CNCV-Benin), defining its composition, its responsibilities and its functioning to advise and guide the country's vaccination policies.

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.