L 328/42 Official Journal of the European Union 6.12.2008 COMMISSION DECISION of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document number C(2008) 6933) (Text with EEA relevance) (2008/911/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, (3)  The measures provided for in this Decision are in 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 7 September 2007 by the Committee for Herbal Medicinal Products, Whereas: (1) Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung comply with the requirements set out in Directive 2001/83/EC. Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung can be considered as herbal substances, herbal preparations andfor combi- nations thereof. (2) It is therefore appropriate to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products including the entry of Foeniculum vulgare Miller subsp. vulgare var. vulgare and the entry of Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung. () O] L 311, 28.11.2001, p. 67. accordance with the opinion of the Standing Committee on Medicinal Products for Human Use, HAS ADOPTED THIS DECISION: Article 1 A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is estab- lished in Annex I including the entry of Foeniculum vulgare Miller subsp. vulgare var. vulgare and the entry of Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung. Atrticle 2 The indications, the specified strengths and the posology, the route of administration and any other information necessary for the safe use as a traditional medicinal product relevant for Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung are set out in Annex II to this decision. Atrticle 3 This Decision is addressed to the Member States. Done at Brussels, 21 November 2008. For the Commission Gilinter VERHEUGEN Vice-President