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Therapeutic Goods Act 1989
The Therapeutic Goods Act 1989 is an Act of the Commonwealth of Australia which regulates therapeutic goods. The Act is administered by the Therapeutic Goods Administration (TGA), which is part of the Commonwealth Department of Health. The statutory framework set out in the Act is supplemented by the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. The central mechanism through which therapeutic goods (being medicines, biologicals and medical devices) are regulated is the Australian Register of Therapeutic Goods (ARTG). Subject to the alternative supply/export pathways set out in the Act, all therapeutic goods must be "registered" (for prescription medicines), "listed" (for complementary and over-the-counter medicines) or "included" (for biologicals and medical devices) in the ARTG to be lawfully supplied in Australia. History In 2020, the TGA re-classified nicotine Nicotine is a natural product, naturally produced alkaloid ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Australia
Australia, officially the Commonwealth of Australia, is a Sovereign state, sovereign country comprising the mainland of the Australia (continent), Australian continent, the island of Tasmania, and numerous List of islands of Australia, smaller islands. With an area of , Australia is the largest country by area in Oceania and the world's List of countries and dependencies by area, sixth-largest country. Australia is the oldest, flattest, and driest inhabited continent, with the least fertile soils. It is a Megadiverse countries, megadiverse country, and its size gives it a wide variety of landscapes and climates, with Deserts of Australia, deserts in the centre, tropical Forests of Australia, rainforests in the north-east, and List of mountains in Australia, mountain ranges in the south-east. The ancestors of Aboriginal Australians began arriving from south east Asia approximately Early human migrations#Nearby Oceania, 65,000 years ago, during the Last Glacial Period, last i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Nicotine
Nicotine is a naturally produced alkaloid in the nightshade family of plants (most predominantly in tobacco and ''Duboisia hopwoodii'') and is widely used recreationally as a stimulant and anxiolytic. As a pharmaceutical drug, it is used for smoking cessation to relieve withdrawal symptoms. Nicotine acts as a receptor agonist at most nicotinic acetylcholine receptors (nAChRs), except at two nicotinic receptor subunits (nAChRα9 and nAChRα10) where it acts as a receptor antagonist. Nicotine constitutes approximately 0.6–3.0% of the dry weight of tobacco. Nicotine is also present at ppb-concentrations in edible plants in the family Solanaceae, including potatoes, tomatoes, and eggplants, though sources disagree on whether this has any biological significance to human consumers. It functions as an antiherbivore toxin; consequently, nicotine was widely used as an insecticide in the past, and neonicotinoids (structurally similar to nicotine), such as imidacloprid, are s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Regulation In Australia
Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness. Contemporary medicine applies biomedical sciences, biomedical research, genetics, and medical technology to diagnose, treat, and prevent injury and disease, typically through pharmaceuticals or surgery, but also through therapies as diverse as psychotherapy, external splints and traction, medical devices, biologics, and ionizing radiation, amongst others. Medicine has been practiced since prehistoric times, and for most of this time it was an art (an area of skill and knowledge), frequently having connections to the religious and philosophical beliefs of local culture. For example, a medicine man would apply herbs and say prayers for healing, or an ancie ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Law Of Australia
The legal system of Australia has multiple forms. It includes a written constitution, unwritten constitutional conventions, statutes, regulations, and the judicially determined common law system. Its legal institutions and traditions are substantially derived from that of the English legal system. Australia is a common-law jurisdiction, its court system having originated in the common law system of English law. The country's common law is the same across the states and territories (subject to augmentation by statutes).. The Australian Constitution sets out a federal system of government. There exists a national legislature, with a power to pass laws of overriding force on a number of express topics. The States are separate jurisdictions with their own system of courts and parliaments, and are vested with plenary power. Some Australian territories such as the Northern Territory and the Australian Capital Territory have been granted a regional legislature by the Commonwealth. Th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health Policy In Australia
Health, according to the World Health Organization, is "a state of complete physical, Mental health, mental and social well-being and not merely the absence of disease and infirmity".World Health Organization. (2006)''Constitution of the World Health Organization''– ''Basic Documents'', Forty-fifth edition, Supplement, October 2006. A variety of definitions have been used for different purposes over time. Health can be promoted by encouraging healthful activities, such as regular physical exercise and adequate sleep, and by reducing or avoiding unhealthful activities or situations, such as smoking or excessive Stress (biology), stress. Some factors affecting health are due to Agency (sociology), individual choices, such as whether to engage in a high-risk behavior, while others are due to Social structure, structural causes, such as whether the society is arranged in a way that makes it easier or harder for people to get necessary healthcare services. Still, other factors are be ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health Law In Australia
Health, according to the World Health Organization, is "a state of complete physical, mental and social well-being and not merely the absence of disease and infirmity".World Health Organization. (2006)''Constitution of the World Health Organization''– ''Basic Documents'', Forty-fifth edition, Supplement, October 2006. A variety of definitions have been used for different purposes over time. Health can be promoted by encouraging healthful activities, such as regular physical exercise and adequate sleep, and by reducing or avoiding unhealthful activities or situations, such as smoking or excessive stress. Some factors affecting health are due to individual choices, such as whether to engage in a high-risk behavior, while others are due to structural causes, such as whether the society is arranged in a way that makes it easier or harder for people to get necessary healthcare services. Still, other factors are beyond both individual and group choices, such as genetic disorders. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
1989 In Australia
The following lists events that happened during 1989 in Australia. Incumbents *Monarch – Elizabeth II *Governor-General – Sir Ninian Stephen (until 16 February), then Bill Hayden *Prime Minister – Bob Hawke **Deputy Prime Minister – Lionel Bowen **Opposition Leader – John Howard (until 9 May), then Andrew Peacock * Chief Justice – Sir Anthony Mason State and Territory Leaders *Premier of New South Wales – Nick Greiner **Opposition Leader – Bob Carr *Premier of Queensland – Mike Ahern (until 25 September), then Russell Cooper (until 7 December), then Wayne Goss **Opposition Leader – Wayne Goss (until 7 December), then Russell Cooper *Premier of South Australia – John Bannon **Opposition Leader – John Olsen *Premier of Tasmania – Robin Gray (until 29 June), then Michael Field **Opposition Leader – Michael Field (until 29 June), then Robin Gray *Premier of Victoria – John Cain Jr. **Opposition Leader – Jeff Kennett (until 23 May), then Ala ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Standard For The Uniform Scheduling Of Medicines And Poisons
The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is an Australian legislative instrument produced by the Therapeutic Goods Administration (TGA)., subsection 4A. Before 2010, it was known as the ''Standard for the Uniform Scheduling of Drugs and Poisons'' (''SUSDP'').. The SUSMP classifies drugs and poisons into different Schedules signifying the degree of control recommended to be exercised over their availability to the public.. , the most recent version is the ''Poisons Standard October 2022''. The Schedules are referred to under State and Territory legislation for regulatory purposes. Although each State and Territory has its own laws, the vast majority of medicines and poisons are classified according to the SUSMP to achieve uniform national regulation. Schedules Schedule 1 Schedule 1 is blank. Schedule 1 does not currently contain any medicines or poisons. Schedule 2: Pharmacy Medicine Schedule 2 (S2) drugs and poisons, otherwise known ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (F ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, or are otherwise covered by the ''Therapeutic Goods Act 1989'', the ''Therapeutic Goods Regulations 1990'', or a ministerial order, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods. Structure of the TGA and medical regulation in Australia In Australia, medical products are regulated by the TGA and, for controlled drugs such as cannabis, the Office of Drug Control (ODC). Together, the TGA and ODC form the Health Products Regulation Group within the Department of Health and Aged Care. The Health Products Regulation Group ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biological Medicinal Product
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biological medic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Over-the-counter Drug
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The rea ..., which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures. The term ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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