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 Decree defines the normative framework for the organization and operation of the Ministry of Health and Public Hygiene.

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 document establishes the list of essential medicines in the Republic of Guinea.

The law authorized the extension of the state of health emergency in 2021.

The Resolution approves the Health Policy and the Strategy for its Implementation.

The Constitution of Guinea was reviewed in 2020. The Constitution contains 156 articles addressing a large number of issues as the protection of fundamental rights and freedoms, the fundamental principles of the state and institutional arrangements.

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.

This decree establishes interoperability mechanisms for synergy of action between civil registry services and health structures across all the regions of the country.

The Act sets up thematic groups, among others, to monitor the implementation of the National Health Development Plan in relation to certain themes.

The Civil Code is a document that brings together rules relating to civil law, governing topics such as the status of persons, property, as well as private relations between citizens.

The code aims to promote and guarantee children's access to the enjoyment and exercise of their rights.

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 regulates the manufacture and registration of medicines, the approval of medical devices, and sets out rules for pharmacies and the practice of the profession of pharmacist.

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.