Commission Implementing Decision (EU) 2016/1658
of 13 September 2016
amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
(notified under document C(2016) 5747)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to the opinion of the European Medicines Agency, formulated on 25 March 2014 by the Committee for Herbal Medicinal Products,
Whereas:
As part of its review of monographs and list entries to keep them relevant, the Committee for Herbal Medicinal Products has reviewed the list entry Eleutherococcus senticosus (Rupr. et Maxim) Maxim and adopted an opinion to change the list entry with regard to the name of the herbal substance in certain EU official languages, the phrasing of the herbal preparations, update of the reference to the European Pharmacopoeia and update of some information necessary for the safe use, e.g. revision of the contraindications. Some of those changes are the result of an update of the template for list entries.
Decision 2008/911/EC should therefore be amended accordingly.
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,
HAS ADOPTED THIS DECISION: