(2004; 109 pages)
Adverse event Any untoward medical occurence that may appear during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with the treatment (1).
Conventional medicine For the scope of this document, conventional medicine refers to the broad category of medical practice that is sometimes called Western medicine, biomedicine, allopathic medicine, scientific medicine, or modern medicine.
Complementary and alternative medicine (CAM) refers to a broad set of health-care practices that are not part of a country’s own tradition and not integrated into the dominant health care system. Other terms sometimes used to describe these health care practices include ‘natural medicine’, ‘non-conventional medicine’ and ‘holistic medicine’ (2).
Herbal Medicines include herbs, herbal materials, herbal preparations and finished herbal products:
• Herbs Herbs include crude plant material such as leaves, flowers, fruit, seed, stems, wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered.
• Herbal materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins and dry powders of herbs. In some countries, these materials may be processed by various local procedures, such as steaming, roasting, or stir-baking with honey, alcoholic beverages or other materials.
• Herbal preparations are the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures and fatty oils of herbal materials. They are produced by extraction, fractionation, purification, concentration, or other physical or biological processes. They also include preparations made by steeping or heating herbal materials in alcoholic beverages and/or honey, or in other materials.
• Finished herbal products consist of herbal preparations made from one or more herbs. If more than one herb is used, the term mixture herbal product can also be used. Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients. However, finished products or mixture products to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from herbal materials, are not considered to be herbal. (3)
Manufacturer For the purpose of these guidelines, the term manufacturer refers to the producer, importer, distributor or marketer of a finished TM/CAM medication product and, where applicable, to the holder of the marketing authorization or registration for that product in the country in question.
TM/CAM medication therapies For the scope of these guidelines, TM/CAM medication therapies include preparations commonly referred to as herbal medicines (see definition above), homeopathic remedies and dietary supplements.
TM/CAM procedure-based therapies For the scope of these guidelines, these include therapies that use various techniques primarily without the use of medication to provide health care. They include for example acupuncture and related techniques, manual therapies (e.g. massage, chiropractic, naprapathy and osteopathy, qi gong, tai ji quan), naturopathy, thermal medicine and other physical, mental, spiritual and mind-body based therapies.
TM/CAM provider refers to all persons who provide TM/CAM services to treat, diagnose or prevent any disease or disorder.
Traditional medicine (TM) This includes diverse health practices, approaches, knowledge and beliefs incorporating plant-, animal- and/or mineral-based medicines, spiritual therapies, manual techniques and exercises applied singularly or in combination to maintain well-being, as well as to treat, diagnose or prevent illness (2).