Article 1Annexes I and II to Decision 2008/911/EC are amended in...
Article 2This Decision is addressed to the Member States.
ANNEX
Decision 2008/911/EC is amended as follows:
In Annex I, the following substance is inserted after Pimpinella...

Commission Implementing Decision (EU) 2018/134

of 24 January 2018

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(2018) 218)

(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 use1, and in particular Article 16f thereof,

Having regard to the opinion of the European Medicines Agency, formulated on 2 February 2016 by the Committee for Herbal Medicinal Products

Whereas:

(1)

Sideritis scardica Griseb., herba can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and it complies with the requirements set out in that Directive.

(2)
It is therefore appropriate to include Sideritis scardica Griseb., herba in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC2.
(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: