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1 December 2008
Breaking News:

Commission announces legislation on herbal medicines 

Published: Tuesday 22 January 2002   

The European Commission announced that it intends to propose a specific registration procedure for herbal medicinal products with a long-standing traditional use.

Background:


While demand for herbal medicines is growing across the EU, there is currently no legislation at EU level.

The Commission proposes:

  • asimplified registration systemfor traditional herbal medicinal products:
    • quality requirements will be identical to those for all medicinal products
    • safety and efficacy will be assessed on the basis of information gathered on its traditional use (even partially outside the EU) over a period of min. 30 years (instead of new tests)
  • anew scientific committee of herbal medicine expertswill be established within the European Agency for the Evaluation of Medicinal Products (London)
    • its major task will be to establish monographs that further harmonise and facilitate registration applications

 

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