- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
Herbal medicines have been used in Turkey traditionally although today modern medical science is utilized all over the country whereas traditional methods have only a limited use. On the other hand, there is a rich flora of medicinal plants in the country, and experienced academic people in this field .
Prior to 1984, there were no regulations for herbal products. Crude drugs were sold in "Akthar" shops, where no special training was required for the persons responsible. In 1984, the Fifth Symposium on Crude Drugs, held in Ankara, was the first step for regulatory action on herbal products. A resolution of the symposium described the situation of herbal products, presented ideas for the solution of problems, and recommended a specific regulation for herbal products [100,101], which was followed by appropriate action.
A regulation was published by the Ministry of Health on 1 October 1985 and included a list of plants allowed to be sold in the Akthar shops, mainly crude herbs and their parts. The sale of poisonous plants such as Belladonna or Bulbus Scillae was not permitted. Since 11 March 1986, special permission by the Ministry of Health is required to open an Akthar shop [100,101].
On 17 January 1986, requirements for the establishment of herbal drug manufacturing premises (the GMP rules for herbal products) were published by the Ministry of Health, giving detailed instructions on personnel, equipment, starting materials, manufacturing operations, packaging and labelling, quality control, etc. . Furthermore, a regulation concerning the recall of pharmaceutical and medical preparations, substances, materials, compounds and herbal preparations was published on 15 August 1986 . A regulation on licensing herbal products which have any medicinal indication claim on the label was published 2 March 1995 .
The basic principles of these regulations are the following:
1. Each Akthar shop must be registered by the local branch of the Ministry of Health to be able to sell herbs. Promotion of these products with health claims is strictly forbidden.
2. According to the registration procedure, there are three classes of herbal products:
- products from plants without a risk potential for human health and without any health claim on the label, which are handled according to the food regulation;
- herbal products presented in pharmaceutical forms such as tablets or capsules, which must be registered by the Ministry in the same way as medicinal products, and require a complete documentation; and
- herbal teas with health claims on the label, for which registration by the Ministry is needed, but the documentation required is limited to quantitative formulae, specifications, quality control methods, summarized production method, and a sample of the package insert .
With the increasing importance of products of plant origin, the Ministry of Health decided to establish a separate commission for registration of herbal medicines, the Herbal Committee which consists of 3 pharmacognosists, 2 technologists, 1 pharmacologist and 1 toxicologist. With the authorization of the Committee, some 40 products, mostly teas with indications, were registered. These products are only available in pharmacies . The Committee prepared regulations for application dossiers for herbal medicines which were published in 1986. The information requested for a complete dossier includes the methods of analysis and the quality control, the manufacturing process, stability tests, pharmacological and toxicological information, indications, contra-indications, and the package leaflet .