Draft public statement on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum

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Download document Draft public statement on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum
Reference number EMA/HMPC/712649/2014
Status draft: consultation open
First published 11/12/2015
Last updated 11/12/2015
Consultation start date 11/12/2015
Consultation end date 15/03/2016
Email address for submissions hmpc.secretariat@ema.europa.eu

Summary

The HMPC/MLWP decided to prepare a European Union herbal monograph on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum, as announced in the July 2013 HMPC meeting report. A comprehensive literature search was conducted and available data, including information on products on the market in the European Union, were assessed in relation to the requirements laid down in Directive 2001/83/EC and its Annex I, in particular Article 1, Article 10a and Chapter 2a.