Australian herbal remedies being considered by the TGA to be ‘reasonably safe with less adverse reactions than conventional pharmaceutical treatments’ are allowed to enter the register at a lower level than other pharmaceuticals. Herbal products made from starting materials of pharmacopoeial standards, approved by the TGA, with claims within Advertising Code guidelines containing active ingredients…
Registered medicines are classified as high risk and low risk. The high-risk ones are assessed individually for quality, safety and efficacy and should be manufactured under GMP. The low-risk ones are listed medicines and contain ingredients permitted by the TGA for use in low-risk medicines restricted to indication and claims relating to health maintenance, health…
Therapeutic goods for human use including traditional medicines which are imported or manufactured in Australia must be included in the Australian Register of Therapeutic Goods (ARTG) in accordance with the Therapeutic Goods Act 1989. Instituted by the Common wealth Department of Health and Aged Care, the overall objective of the act is to ensure the…
The market Australia is one of the leading countries in the world with regard to practice and teaching of alternative and complementary medicine. The alternative and complementary medicine industry in Australia is growing rapidly and the current estimated market worth is over one billion dollars, with more than 20% of that market being herbal medicine…
The requirements of the licensing system in the United Kingdom are set out in Part II of the above act. Without the appropriate licence it is an offence to manufacture, sell, supply, export or import a medicine into UK, unless some exemption is provided in the act or regulations. However unprocessed plant material, without any…
The manufacture of these products is carried out by relatively few companies and, as distinct from the sale of an unprocessed herb, these preparations require a product licence for their manufacture and sale. This EC requirement was introduced in 1972 for new products and was subsequently extended to review all products irrespective of how long…
The market In Britain alone, an estimated 6,000–7,000 tonnes of herbs are extracted annually for use as ingredients of herbal remedies and for the health food market in 1983 it was estimated that the sale of herbal, homeopathic and other remedies amounted to £15M. The market for licensed herbal medicines in the UK was estimated…
Herbal product manufacturers having available the services of a Qualified Person, a resident of an EU member state, need to apply to the Medicines and Healthcare Products Regulatory Agency (MHRA) for the grant of a traditional herbal registration for every product and each must comply with the official published standards. The application should include An…
The European market has harmonized regulations for the marketing of herbal medicinal products and issued the Traditional Herbal Medicinal Products Directive (THMPD). It came into force on 30 October 2005 and requires traditional, over-the-counter herbal remedies to be made to assured standards of safety and quality and in conformity with regulations so that these are…
The market The herbal medicine tradition in some European countries remains strong, with quoted figures for herbalists being 16,000 for Germany and 4,000 for Denmark. In France as a result of legislation enacted in 1941, the marketing of herbal products passed very much under the control of pharmacists, 65% of total sales being through pharmacies.…