Human Medicines - Herbal Medicinal Products - Calls for submission of scientific data

Human Medicines - Herbal Medicinal Products
Calls for submission of scientific data
In accordance with Directive 2001/83/EC as amended, the Committee on Herbal Medicinal Products (HMPC) shall prepare a draft ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products’. Furthermore, the HMPC shall establish Community herbal monographs for herbal medicinal products.

The legislation does not specify how scientific data relating to the assessment work for the monographs and draft entries to the list should be identified and compiled. The HMPC has developed and adopted a ‘Procedure for calls for scientific data for use in HMPC assessment work’. This represents an important route for Rapporteurs to obtain a complete set of bibliographic references and scientific data for a given assessment. Scientific contributions in response to a call for the submission of scientific data can be provided to the EMEA in electronic format (e-mail or CD-rom) or paper format (2 copies by post or fax) during the 2-month period following the publication date.

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Human Medicines - Herbal Medicinal Products - Calls for submission of scientific data