Traditional herbal medicinal products

Amended by Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products. Directive 2001 /83/EC on the Community code relating to medicinal products for human use Amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use... 

They have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment. 

Advisory Committee (HMAC). This Committee would advise Ministers directly on areas for which the Committee is responsible. The remit of HMAC would be the registration scheme to be introduced under the Directive 2004/24/EC on Traditional Herbal Medicinal Products and unlicensed herbal medicines. However, CHM will be responsible for advice in relation to marketing authorizations for herbal medicines. Professor Philip Routledge has been appointed the first Chairman of HMAC, for a term of 4 years effective from 30 October 2005. 

Starting as an Ad Hoc Working Group on Herbal Medicinal Products in May 1997, there evolved a Herbal Medicinal Products Working Party (HMPWP) which had been operational as regards traditional herbal medicinal products imtil August 2004. However, Article 16h of Directive 2004/24/EC of 31 March 2004 formally established the Committee for Herbal Medicinal Products (HMPC). 

However, this simplified procedure should be used only where no marketing authorisation can be obtained through procedures for t)q)ical medicinal products. In order to promote harmonisation, Member States are expected to recognise registrations of traditional herbal medicinal products granted by another Member State based... 

The HMPC is expected to establish community herbal monographs for herbal medicinal products. These herbal remedies have their product particulars and literature. Apart from other controls, any advertisement for a medicinal product registered is required to contain the following statement Traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use. ... 

A traditional herbal medicinal product should comply with the following characteristics ... 

The simplified procedure for registration of traditional herbal medicinal products includes full administrative information and a complete pharmaceutical dossier on the assumption that the quality of the product is independent of its traditional use. Nonclinical data are not necessary where information on the traditional use proves that the product is not harmful in the specified conditions of use. However, where concerns are raised with regard to the product s safety, the competent authorities may ask for additional data necessary to assess safety. The dossier will, therefore, include a bibliographic review of safety data, and additional data where required, together with an expert report. 

The Committee for Herbal Medicinal Products (HCMP) has been given the task of preparing a list of herbal substances, herbal preparations and combinations thereof to be used in traditional herbal medicinal products. The list will contain for each substance the indication, strength, posology, route... 

The new Directive became effective on March 31, 2004 and implemention was mandatory in MS by October 30, 2005. For traditional herbal medicinal products already in the market, these new provisions become effective by March 31, 2011, thus providing a seven-year transitional period for manufacturers to comply with the minimal regulatory requirements of the Directive. 

Vitamin(s) and mineral(s), which could be ancillary substances in traditional herbal medicinal products for human use, should fulfill the requirements of the "Guideline on summary of requirements for active substances in the quality part of the dossier" (CHMP/QWP/297/97 Rev. 1 corr). 

The control tests on the finished product should allow the qualitative and quantitative determination of the composition of the active substance(s). A specification should be provided and this may include the use of markers where constituents with known therapeutic activity are unknown. In the case of herbal substances or herbal preparations with constituents of known therapeutic activity, these constituents should be specified and quantitatively determined. For traditional herbal medicinal products for human use containing vitamins and/or minerals, the vitamins and/or minerals should also be specified and quantitatively determined. 

In the case of traditional herbal medicinal products for human use containing vitamins and/or minerals, the stability of the vitamins and/or minerals should be demonstrated. 

Few herbal medicinal products are on the market as authorised medicines in the EU, fulfilling the same stringent requirements that count for conventional medicinal products. This is largely due to the limited availability of randomised controlled trials to support the quality, safety and efficacy of herbal medicinal products. More often they are licensed as traditional herbal medicinal products, following an adapted and simplified registration wherein efficacy is made plausible based on available scientific data (well-established use) or long-term historic use in the EU (traditional use). Sufficient data to underpin the safety should be available in all cases and the quality of the herbal... 

Another aspect that must not be overlooked is the nature of the intended claim. The use of clinical claims should be avoided (these could fall under the scope of the Directive 2004/24/EC for traditional herbal medicinal products, but not for health claims on foods). Claims too vague and unspecific also fall out of the consideration of the Regulation. It would be the case of energy and vitality, tonic, or detoxification, often used in plant extracts submissions. 

All other homeopathic and herbal medicines that do not qualify for simplified registration procedures will have to go through the standard authorisation procedure with supporting technical dossiers. The Committee for Herbal Medicinal Products has been charged with preparing monographs on herbal products so as to further facilitate the registration of traditional and well-established use herbal products. 

Finally, the scope of CE even extends toward purity control of traditional herbal medicines and phytopharmaceuticals. The analysis of natural products by CE has been discussed previously. A brief overview of some CZE applications is given below. The... 

Kartal, M. (2007) Intellectual property protection in the natural product dmg discovery, traditional herbal medicine and herbal medicinal products. PhytotherRes 21 113-119. 

Several members of the Amaryllidaceae family of alkaloids display pronounced biological activities, and some Amaryllidaceae plants have played an important role in traditional herbal medicine for the treatment of various ailments. The most prominent examples of Amaryllidaceae alkaloids of biological relevance are narciclasine (55) and its congeners (pancratistatin and 7-deoxypancratistatin) and galantamine (62) (also commonly spelled galanthamine). These natural products also find application in modem medicine, and in this respect, pancratistatin is used in clinical... 

The hetisine natural products are a family of complex Cao-diterpenoid alkaloids isolated from the Aconitum, Con-solida. Delphinium, Rumex, and Spiraea genera, plants that have been widely used in traditional herbal medicine (Figure 16.10). Several of the more than 100 members... 

Zimbabwe has mles regarding the practice of traditional medicine, but not for registration of traditional medicinal products. In future, however, the Medicines control agency can be expected to exert some control over this category of product. In Cypms, there are no legislative provisions for herbal, dietary or homeopathic medicines, but some herbal medicines are registered as allopathic medicines. 

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