The directive establishes that herbal medicines released on the market need authorization by the national regulatory authorities of each european country and that these products must have a recognized level of safety and efficacy . The registration of herbal medicinal products needs sufficient evidence for the medicinal use of the product throughout a period of at least 30 years in the european union , at least 15 years within the eu, and 15 years elsewhere for products from outside the eu. With regard to the manufacturing of these products and their quality, products must fulfill the same requirements as applications for a marketing authorization. Information is based on the availability of modern science–based public monographs in the european pharmacopeia and their equivalents developed by the pharmaceutical industry.
In australia, for example, the self-regulated status of the profession resulted in variable standards of training, and numerous loosely-formed associations setting different educational standards. In the united kingdom, the training of herbalists is done by state funded universities offering bachelor of science degrees in herbal medicine. Standardization of purity and dosage is not mandated in the united states, but even products made to the same specification may honey milk differ as a result of biochemical variations within a species of plant. Plants have chemical defense mechanisms against predators that can have adverse or lethal effects on humans.
Examples of highly toxic herbs include poison hemlock and nightshade. They are not marketed to the public as herbs, because the risks are well known, partly due to a long and colorful history in europe, associated with “Sorcery”, “Magic” and intrigue. Although not frequent, adverse reactions have been reported for herbs in widespread use. On occasion serious untoward outcomes have been linked to herb consumption. This is particularly important in resource-limited settings, where the majority of patients consult traditional healers prior to or in addition to medical doctors. It is important to include traditional healers in efforts to expand access to arv in resource-limited settings, as they are key opinion leaders in the communities and have a significant impact on the health belief model for patients.
Herbal medicines are in widespread use and although many believe herbal medicines are safe, they are often used in combination and are drawn from plant sources with their own variability in species, growing conditions, and biologically active constituents. Herbal extracts may be contaminated, adulterated, and may contain toxic compounds. The quality control of herbal medicines has a direct impact on their safety and efficacy (ernst, schmidt, and wider 2005; ribnicky et al. 2008). In addition, there is very little research on whole herbal mixtures because the drug approval process does not accommodate undifferentiated mixtures of natural chemicals. To isolate each active ingredient from each herb would be immensely time-consuming at a high cost, making it not cost-effective for manufacturers . In some countries, formalized training and minimum education standards exist, although these are not necessarily uniform within or between countries.
The standards put forward allow not only to define the quality of products but also to eliminate harmful compounds, adulteration, and contamination. Within the eu, a number of committees were set up to attempt and standardize the information and guidelines related to herbal medicines. In canada, herbal remedies must comply with the natural health products regulations .
Furthermore, the metabolism of many components of the traditional herbal medicines may be inhibited by drugs such as ritonavir. It is possible therefore, that western medicines may be responsible for reduced clearance and heretofore unseen side effects of traditional medicines. In europe, the european directive 2004/24/ec released in 2004 by the european parliament and by the council of europe provides the guidelines for the use of herbal medicines .