sábado, 29 de agosto de 2009

Human Medicines - Herbal Medicinal Products - Adopted Monographs

Human Medicines - Herbal Medicinal Products
Publication and consultation of Community monographs

In accordance with Directive 2001/83/EC as amended, the Committee on Herbal Medicinal Products (HMPC) is responsible for establishing Community herbal monographs. These will have relevance for the registration as well as the authorisation of herbal medicinal products.

A Community herbal monograph comprises the Committee’s scientific opinion on a given herbal medicinal product, based on its evaluation of available scientific data (well-established use) or on the historic use of that product in the European Community (traditional use). For some herbal medicinal products, the Community monograph covers both well-established use and traditional use.

The Community herbal monographs provide a harmonised approach to the scientific assessment of herbal medicinal products in the EU, and the Member States shall take them into account when they examine an application relating to a product for which a Community monograph has been established.

When the HMPC has produced a draft Community monograph it is released for public consultation on this website, usually for a period of 3 months. The comments received are subsequently reviewed and the final version of the Community herbal monograph is published.

The HMPC is also responsible for establishing a ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products’. For a further description of this work, and for published draft entries to the list, please refer to: Community list

In contrast to the Community list, Community herbal monographs are not legally binding. A Community herbal monograph covering the traditional use of a substance, preparation or combination shall be taken into account by competent authorities when examining a traditional use registration application, which is based on the information contained in this monograph. A national competent authority may have a different position on a certain recommendation or statement set out in the monograph. The applicant may therefore be requested by a competent authority to provide supplementary information during the national evaluation procedure, in particular on the safety and the traditional use of the product.

An overview of ongoing HMPC assessment work in relation to establishing Community herbal monographs and/or enteries to the Community list can be found here.

Template for submitting comments on Draft Community Herbal Monograph / Draft Entry to the Community List

abrir aquí para acceder al documento EMEA completo, con todas sus monografías herbales (fitoterápicas):
Human Medicines - Herbal Medicinal Products - Adopted Monographs

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