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Arrêté No 68/MSP/DGSP/DPHLMT, portant création de la Commission Nationale du Médicament (CNM)
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.
Health Care Agency Act
This Act establishes a Health Care Agency and provides for matters connected therewith or incidental thereto.
Public Health Authority Act
This Act establishes the Public Health Authority to regulate and monitor health-related services, and establishes the Public Health Authority Board and the Appeals Board, their functions, powers and procedures and provides for matters connected therewith or incidental thereto.
Drug and Food Control Authority Act, No 37
This Act provides for the establishment of an independent Drug and Food Control Authority in South Sudan and provide an appropriate and effective independent regulatory mechanism to control and regulate the manufacture, supply, promotion, marketing, advertising, distribution and use of drugs, poisons, chemicals, cosmetics medical devices and food for human or animal use.
Health Institutions and Facilities Act,2011 Act 829
The Health Institutions and Facilities Act of 2011 provides for a Health Facilities Regulatory Agency to license facilities for the provision of public and private health care services, establishes the Mortuaries and Funeral Facilities Agency to control and regulate facilities connected with the storage and disposal of human remains, establishes an Ambulance Council to regulate the operation of ambulance services in the country in accordance with policy standards and to provide for related matters.
Diploma Ministerial No 223/2010 Aprova o Manual de Registo de Medicamentos
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.
Décret n° 2009-720/PRES/PM/MS/MEF/MCPEA portant conditions de fabrication et d'importation des produits contraceptifs au Burkina Faso
The Decree sets out the conditions for manufacturing and importing contraceptive products into Burkina Faso.
National Accreditation Board Act, 2007 Act 744
The National Accreditation Board Act of 2007 establishes the National Accreditation Board and provides for related purposes.
Medicines and Related Substances Control Amendment Act
This Act amends the Medicines and Related Substances Control Act, 2003, so as to amend and delete certain definitions; provides for a period within which the Council must be appointed; provides for the appointment of chairpersons of committees established by the Council; amends provisions relating to the classification of medicines and other substances as scheduled substances; amends provisions relating to the manufacturing, packing and selling of specified Schedule 3 and specified Schedule 4 substances; deletes references to generic substitutions; substitutes references to Schedule 1, Schedule 2, Schedule 3 or Schedule 4 medicines by references to Schedule 1, Schedule 2, Schedule 3 or Schedule 4 substances; inserts provisions relating to the registration of premises engaged in the manufacturing of medicines; amends provisions relating to offences and penalties; amends provisions relating to the destruction of forfeited medicines, scheduled substances or other things; provides for the making of regulations in relation to medicines; amends provisions relating to the exclusion of medicines from the operation of the Act; amends the transitional provisions; amends provisions relating to the repeal and amendment of certain laws; and provides for matters incidental thereto.
The Optometry Act
The Act provides for the establishment of the Council to regulate the conduct of Optometrists and Ophthalmic Opticians, the registration of Optometrists and Ophthalmic Opticians and provides for related matters.
Decreto-Lei No 59/2006
This decree regulates the marketing authorization, registration, manufacture, import, export, marketing, donations and advertising of medicines for human use.
Health Professionals Act
This Act provides the legal framework for the regulation, registration, and practice of health professionals by establishing the Health Professionals Council.
Lei No 41/VI/2004 Establece as Bases do Servico Nacional de Saude
This law sets out the foundations of the National Health Service, including the definition of health actions and services, on a permanent or occasional basis, by natural or legal persons governed by public or private law, with a view to promoting and protecting health, preventing, treating and rehabilitating illness.
Ley No 3/2003 de Medicamentos
The scope of application of this Law includes: medicines and health products, as well as the actions of natural and legal persons involved in the production, marketing, prescription and dispensing of pharmaceutical and health products within the national territory. This document is published as a part of a compilation of laws and decrees and this Law is located on page 2 of the file.
National Health Act No 61 of 2003
This Act provides a framework for a structured uniform health system within the Republic, taking into account the obligations imposed by the Constitution and other laws on the national, provincial and local governments with regard to health services; and provides for matters connected therewith.
The Tanzania Food, Drugs and Cosmetics Act
This Act provides for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and repeals the Food (Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978, and provides for related matters.
Ethiopian Health Professionals Council Establishment Council of Ministers Regulations No 76/2002
These regulations establish the Health Professionals Council. The council has, among other things, the following attributions: advise the Minister; work in collaboration with the appropriate bodies, ensure that health professional training offered in the country is of high standard; make sure that professional ethics are observed by professionals; follow up and supervise that the names of registered professionals and those who are cancelled from the registry due to various reasons are properly kept by the secretariat.
Diploma Ministerial No 127/2002 Technical description, list of specific functions, criteria and mechanisms for the classification of primary, secondary, tertiary and quaternary level institutions
This diploma establishes the technical description of the different institutions of the National Health Service across the four levels of care, the classification and their specific functions.
Health professions Act
This Act regulates and controls the practice of medicine, dentistry, pharmacy and allied health professions, and provides for matters connected and associated therewith.
Health Professions Act
This Act covers a broad array of issues pertaining to health and care profession and health facilities. It notably establishes a Health Professions Authority of Zimbabwe, a Medical and Dental Practitioners Council of Zimbabwe, an Allied Health Practitioners Council of Zimbabwe, a Natural Therapists Council of Zimbabwe, a Nurses Council of Zimbabwe, a Pharmacists Council of Zimbabwe, a Medical Laboratory and Clinical Scientists Council of Zimbabwe, an Environmental Health Practitioners Council of Zimbabwe and a Medical Rehabilitation Practitioners Council of Zimbabwe. It further provides for the composition and functions of the Authority and those councils, for the registration of persons in health professions and the issue of practising certificates to registered persons; the exercise of disciplinary powers in relation to registered persons and for the registration and control of health institutions and the regulation of services provided.