Prováděcí rozhodnutí Komise (EU) 2026/334 ze dne 13. února 2026, kterým se mění rozhodnutí 2008/911/ES, kterým se stanoví seznam rostlinných látek, rostlinných přípravků a jejich kombinací pro použití v tradičních rostlinných léčivých přípravcích, pokud jde o Foeniculum vulgare (oznámeno pod číslem C(2026) 808)

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 useOJ L 311, 28.11.2001, p. 67 , ELI: http://data.europa.eu/eli/dir/2001/83/oj. , and in particular Article 16f thereof,

Annex II to Decision 2008/911/EC is amended in accordance with the Annex to this Decision.

OJ L 311, 28.11.2001, p. 67 , ELI: http://data.europa.eu/eli/dir/2001/83/oj.

(1) In 2007, the European Medicines Agency established in its opinions that Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus complied with the requirements set out in Directive 2001/83/EC as herbal substances, herbal preparations or combinations thereof within the meaning of that Directive and were 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/ECCommission 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 , ELI: http://data.europa.eu/eli/dec/2008/911/oj). .

(2) The Committee on Herbal Medicinal Products of the European Medicines Agency has reviewed the list entries Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus and adopted two respective opinions to change those entries. Based on those opinions, it is necessary to amend the scientific and common name of those herbal substances in EU official languages, the description of herbal preparations, the reference to the European Pharmacopoeia monograph, the numbering of the indications, the type of tradition, the specified posology, the duration of use, pharmaceutical particulars and the information on the safe use, including contraindications, special warnings and precautions for use with respect to fertility, pregnancy and lactation.

(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,

This Decision is addressed to the Member States.

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 , ELI: http://data.europa.eu/eli/dec/2008/911/oj).

Article 1 Article 1

Article 2 Article 2

HAS ADOPTED THIS DECISION: