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Health Legislation

Health Legislation

Results (56)

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).

This law provides the finance law for 2024.

The purpose of this ordinance is to organize the registration of medicines for human use and other pharmaceutical inputs in Burundi.

The Essential Medicines and Health Supplies List for Uganda (EMHSLU) 2023 reflects the policy of the Ministry of Health, for the appropriate procurement of safe and efficacious essential medicines, health and laboratory supplies in public institutions.

This law modifies and completes the law n°90-14 regarding conditions for the exercise of trade union rights.

The executive Decree No 22-401 of 26 Rabie Ethani 1444 establishes the composition, organization and operation of the National Health Observatory. It was published in the Official Journal of 24 November 2022 (pages 7 -10).

The decree provides the modalities for establishing the list of essential medicines. It was published in the Official Journal of 31 May 2021 (pages 12 -13).

The purpose of this law is to regulate immigration and emigration in Burundi.

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 order of 11 Joumada El Oula 1442 corresponding to 26 December 2020 lays down the procedure for setting the prices of medicinal products by the intersectoral economic committee for medicinal products. The text of this order was published in the official journal of 27 December 2020 (see pages 33-36).

Constitution

The Constitution was adopted by referendum in November 2020 and has been promulgated by Presidential decree n°20-442. It includes 225 articles addressing a wide array of issues including Fundamental Principles for the Society, Fundamental Rights, Freedoms and Duties, and Organization and Separation of Powers (non-exhaustive list).

The law institutes a Social Protection Code in Burundi.

The legislation regulates the production, import, export, conservation, distribution, quality analysis and sale of medicines for human use, including traditional medicines, as well as all other health products, pharmaceutical practice and opticianry.

The Decree defines the normative framework for the organization and operation of the Ministry of Public Health and the fight against AIDS.

Guidelines for Registration of Human Vaccines

These guidelines prescribe data, which is required to be submitted to the National Drug Authority to demonstrate the safety, efficacy and quality of vaccines being applied for market authorization. The guidelines also describe the format (CTD) in which dossiers should be presented in support of the application.

Patient Rights and Responsibilities Charter

The Patient Charter is an official document by the Government of Uganda that spells out the various Patient Rights and Responsibilities for the service consumers in the national health care system.

The Data Protection and Privacy Act

This Act protects the privacy of the individual and of personal data by regulating the collection and processing of personal information; provides for the rights of the persons whose data is collected and the obligations of data collectors, data processors and data controllers; regulates the use or disclosure of personal information; and provides for related matters.

This Act lays down the fundamental provisions and principles and aims to give concrete form to the rights and duties of the population in matters of health. Its purpose is to ensure the prevention, protection, maintenance, restoration and promotion of people's health. It was published in the Official Journal on 29 July 2018.

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