- Medicine Information and Evidence for Policy > Medicines Policy
- Traditional Medicine > Traditional, Complementary and Herbal Medicine
(2005; 168 pages)
3.2 Regulatory status of herbal medicines
Member States were asked about the regulatory status or statuses that are used for herbal medicines in their regulatory frameworks. Detailed descriptions of seven possible regulatory categories for herbal medicines were given on the survey form. The options were the following: prescription medicines, over the counter medicines, self medication only, herbal medicines as a separate regulatory category, dietary supplements, health foods, functional foods and other status. These definitions are presented below.
• Prescription medicines: medicines/drugs that can only be purchased with a prescription (i.e. a physician’s order) (6).1
1 In some countries, the legal framework allows traditional practitioners to prescribe medicines.
• Over the counter medicines: medicines/drugs that can be purchased without a prescription from a physician (6).
• Self medication only: medicines/drugs permitted for self medication purposes only.
• Dietary supplements: a dietary supplement is a substance which contains, for instance, a vitamin, a mineral, a herb or other botanical or an amino acid. A dietary supplement may be intended to increase the total daily intake of a concentrate, metabolite, constituent, extract or combination of these ingredients (7).
• Health food: health foods could be products that are presented with specific health claims and therefore regulated differently from other foods (8).
• Functional foods: like health foods, functional foods may be products which are offered with specific health claims and therefore regulated differently from other foods (8).
• Other: products classified differently from the above mentioned categories.
Responses were provided by 131 Member States; as each was able to choose more than one category, the total number of responses exceeds the number of respondents. The regulatory category most often chosen was that of over the counter medicine, accounting for 97 responses (see Figure 15 below). The next most popular responses accounted for 23-38% of the total, and included the following categories: prescription medicines, dietary supplements and self medication only. A total of 23 countries indicated that there was no regulatory status established for herbal medicines.
Countries also had the option of describing other regulatory categories defined by their legislation; 13 countries provided this information. The other regulatory categories applied to herbal medicine include the following: health products, cosmetics, traditional medicines, herbal remedies, supportive medicines, homeopathic, bioactive and probiotic substances, and complementary products.
Figure 15. Regulatory status of herbal medicines