Health Legislation

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 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 purpose of the law is to govern the protection of personal data.

The Law establishes the Order of Nurses of Mozambique and approves its Statute. The Order of Nurses of Mozambique is a legal person governed by public law, representing nurses, and carrying out services in the public interest. Registration and recognition by the Order of Nurses are mandatory conditions for the exercise of nursing activity in Mozambique.

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 law is to prevent and combat the illicit trafficking of migrants; protect the rights of migrants subject to illicit trafficking; and promote and facilitate national and international cooperation to prevent and combat the smuggling of migrants in all its forms.

The purpose of the law is to determine the fundamental principles of the control of HIV and AIDS in Niger.

This decree establishes the criteria and the modalities to prove indigent status during a judicial process

The decree creates a multi-sectoral committee to combat counterfeiting and the illicit sale of medicines and other pharmaceutical products, reporting to Niger's Minister of Public Health.

The order creates a framework for reflection and exchange between players and partners in the implementation of health research, called the "Cadre de Concertation de la Recherche en Santé" (Health Research Consultation Framework), reporting to the Minister in charge of Public Health. Its mission is to promote exchanges and build the capacities of players involved in health research.

The decree establishes a Committee of Experts in charge of technical evaluation, whose mission is to carry out the technical evaluation of applications for registration of pharmaceutical products for human use. It also gives an opinion on the quality, safety and efficacy of pharmaceutical products for human use submitted for registration.

The decree creates the Commission Nationale du Médicament (CNM) for human use, whose mission is to validate the work of the Expert Committee responsible for the technical evaluation of applications for marketing authorization for pharmaceutical products for human use. It also gives a final opinion on marketing authorization applications; applications for renewal, extension of variation and transfer of marketing authorization; temporary suspension of marketing authorization; and proposals for definitive withdrawal of marketing authorization.

The decree revises Niger's national list of essential medicines from 2009

The law sets the rules applicable to legal aid and judicial assistance and creates the National Agency for Legal Aid and Judicial Assistance, which is responsible for implementing the provisions relating to legal aid and judicial assistance.

The law creates a public administrative establishment, with legal personality and financial autonomy, called the Centre national de lutte contre le cancer (National Cancer Center).

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 Constitution was promulgated by Decree No 2010-754 of 25 November 2010. It includes 185 articles addressing a wide array of issues including, among other things, human rights and duties and institutional arrangements.