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Health Legislation

Health Legislation

Results (14)

The Decree adopts the national pharmaceutical policy. This policy sets out and prioritizes the medium- and long-term goals set by the State for the pharmaceutical sector, and defines the main strategies for achieving them. It provides a framework within which pharmaceutical sector activities are coordinated. It covers both the public and private sectors, and involves all the main players in the pharmaceutical sector. It is an integral part of national health policy.

The purpose of the Regulation is to define the procedures for approving pharmaceutical products for human use in the member states of the West African Economic and Monetary Union.

The decree revises Niger's national list of essential medicines.

These are the guidelines for the registration, renewal, change in characteristics and extension in range of both imported and locally manufactured registered pharmaceutical products.

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 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.

Clinical Trials Act

This Act regulates the conduct of clinical trials for medicinal products in Mauritius.

The purpose of the Regulation is to define the procedures for approving pharmaceutical products for human use in the member states of the West African Economic and Monetary Union.

Dangerous Drug Act

This Act provides for the regulation, control and classification of dangerous drugs.

The Ordinance provides legislation governing pharmacy. The ordinance regulates the classification of medicines, the registration of medicines, the dispensing of medicines, dietary products, cosmetics, the rules for practicing the profession of pharmacist, the dispensing of medicines by doctors and other aspects.

Proclamation No 24 of 1984 The Pharmacy Act 60/1983

This Act regulates the practice of pharmacy in the country, establishes guidelines for the licensing, operation, and conduct of pharmacies, as well as regulates the sale and manufacture of pharmaceutical products.

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