Document ID: 32010D0028

COMMISSION DECISION
of 28 July 2009
amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
(notified under document C(2009) 5804)
(Text with EEA relevance)
(2010/28/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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 (1), and in particular Article 16(f) thereof,
Having regard to the opinions of the European Medicines Agency, formulated on 10 January 2008 and 6 March 2008 by the Committee for Herbal Medicinal Products,
Whereas:
(1)
Calendula officinalis L and Pimpinella anisum L comply with the requirements set out in Directive 2001/83/EC. Calendula officinalis L and Pimpinella anisum L can be considered as herbal substances, herbal preparations or combinations thereof.
(2)
It is therefore appropriate to include Calendula officinalis L and Pimpinella anisum L in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established in Annex I to Commission Decision 2008/911/EC (2).
(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:
Article 1
Decision 2008/911/EC is amended as follows:
1.
Annex I is amended in accordance with Annex I to this Decision.
2.
Annex II is amended in accordance with Annex II to this Decision.
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 28 July 2009.

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