According to the European Directive 2001/83/EC, medicinal products, contrary to foodstuffs, require a pre-marketing authorisation by competent authorities. Quality has to be proven in accordance with the European directives and guidelines, while safety and efficacy through pharmacological- toxicological and clinical studies and/or bibliographic application (Art. 10.1 (a) (ii)). Apart from these options, some European countries have established a simplified proof of efficacy, e.g. for traditional herbal medicinal products. The study of AESGP (European Medicines Manufacturers’ Association), “Herbal Medicinal Products in the European Union”, which was performed in 1998 on behalf of the European Commission, elucidates the regulatory situation in member states of the European Union, in particular the implementation of the option of bibliographic application. ESCOP, the European Scientific Cooperative on Phytotherapy, has published 80 monographs on the medicinal use of herbal drugs in order to provide harmonised criteria of assessment on a European level. A similar project has been initiated by the World Health Organisation (WHO). The Herbal Medicinal Products Working Party (HMPWP) at the European Agency for the Evaluation of Medicines (EMEA) has published various guidelines on the quality, safety and efficacy of herbal medicinal products, e.g. the so-called core-data on herbal drugs based on monographs.Apart from the area of the ‘well-established medicinal use’ products suitable for bibliographic applications, a further category of traditionally used herbal medicinal products is being established on a European level. The European directive on traditional herbal medicinal products amending Directive 2001/83/EC provides the option of a simplified registration procedure under certainconditions, e.g. established safety, plausible efficacy on the basis of long-term use and experience as well as proven quality. A new Committee for Herbal Medicinal Products is being founded which is to be responsible for the preparation of Community herbal monographs on products with well- established medicinal use and on traditional herbal medicinal products. The parties involved hope that further discussion in ESCOP/ WHO monographs and the preparation of new core-data takes place as a basis for well-established medicinal use in order to facilitate mutual recognition and to achieve a European-wide rational assessment for all kinds of herbal medicinal products.
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