Official Journal |
EN L series |
REGULATION (EU) 2025/13 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 19 December 2024
on the collection and transfer of advance passenger information for the prevention, detection, investigation and prosecution of terrorist offences and serious crime, and amending Regulation (EU) 2019/818
Having regard to the Treaty on European Union and 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 (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) ‘Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’ comply with the requirements set out in Directive 2001/83/EC. ‘Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’ can be considered as herbal substances, herbal preparations or combinations thereof.
(2) It is therefore appropriate to include ‘Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’ 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:
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.
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 328, 6.12.2008, p. 42.
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 328, 6.12.2008, p. 42.
ELI: http://data.europa.eu/eli/dec/2010/30(1)/oj