Article 1
Annex II to Decision 2008/911/EC is amended in accordance with...
Article 2
This Decision is addressed to the Member States.
ANNEX
In Annex II to Decision 2008/911/EC, the entry Eleutherococcus Senticosus...
The section ‘Common name in all EU official languages of...
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 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use , and in particular Article 16f thereof,
Having regard to the opinion of the European Medicines Agency, formulated on 25 March 2014 by the Committee for Herbal Medicinal Products,
Whereas:
(1)
In 2008 an opinion of the European Medicines Agency established that Eleutherococcus senticosus (Rupr. et Maxim) Maxim complied with the requirements set out in Directive 2001/83/EC as a herbal substance, a herbal preparation or a combination thereof within the meaning of that Directive and it was therefore included in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC .
(2)
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.
(3)
Decision 2008/911/EC should therefore be amended accordingly.
(4)
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:
OJ L 311, 28.11.2001, p. 67.
Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (OJ L 328, 6.12.2008, p. 42).