
Article 1 
Annex II to Decision 2008/911/EC is amended in accordance with the Annex to this Decision.
Article 2 
This Decision is addressed to the Member States.
Done at Brussels, 13 September 2016.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX

In Annex II to Decision 2008/911/EC, the entry Eleutherococcus Senticosus (Rupr. et Maxim) Maxim., Radix is amended as follows:

((1)) The section ‘Common name in all EU official languages of herbal substance’ is amended as follows:

((a)) After ‘FR (français): racine d'éleuthérocoque (racine de ginseng sibérien)’ the following is inserted:
'HR (hrvatska): Korijen sibirskog ginsenga'
((b)) ‘Všehojovcový koreň’ related to SK (slovenčina) is replaced by ‘Koreň eleuterokoka’;
((2)) The section ‘Herbal preparation(s)’ is amended as follows:

((a)) ‘Comminuted herbal substance for preparation of herbal tea’ is replaced by ‘Comminuted herbal substance’;
((b)) ‘Liquid extract (1:1, ethanol 30-40 % v/v)’ is replaced by ‘Liquid extract (DER 1:1, extraction solvent ethanol 30-40 % v/v)’;
((c)) ‘Dry extract (13-25: 1, ethanol 28-40 % v/v)’ is replaced by ‘Dry extract (DER 13-25:1, extraction solvent ethanol 28-40 % v/v)’;
((d)) ‘Dry aqueous extract (15-17:1)’ is replaced by ‘Dry aqueous extract (DER 15-17:1)’;
((e)) ‘Tincture (1:5, ethanol 40 % v/v)’ is replaced by ‘Tincture (ratio of herbal substance to extraction solvent 1:5, extraction solvent ethanol 40 % v/v)’;
((3)) In the section ‘European Pharmacopoeia monograph reference’‘6.0’ is replaced by ‘7.0’;
((4)) In the section ‘Type of tradition’‘Chinese, European.’ is replaced by ‘European, Chinese.’;
((5)) In the section ‘Specified strength’‘Not applicable.’ is replaced by ‘Please see “Specified posology”.’;
((6)) The section ‘Specified posology’ is amended as follows:

((a)) ‘over 12 years of age’ is deleted;
((b)) ‘Daily dose.’ is replaced by ‘Average daily dose.’;
((c)) ‘The use is not recommended in children under 12 years of age’ is replaced by ‘The use in children under 12 years of age is not recommended’;
((7)) The section ‘Any other information necessary for the safe use’ is amended as follows:

((a)) ‘Contra-indications’ is replaced by ‘Contraindication’;
((b)) The words ‘Arterial hypertension.’ are deleted;
((c)) The sentence ‘The use in children under 12 years of age is not recommended because sufficient experience is not available’ are replaced by ‘The use in children under 12 years of age is not recommended due to lack of adequate data’;
((d)) After ‘If the symptoms worsen during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.’ the sentence ‘For tinctures and extracts containing ethanol the appropriate labelling for ethanol, taken from the Guideline on excipients in the label and package leaflet of medicinal products for human use, must be included.’ is inserted;
((e)) The title of subsection ‘Pregnancy and lactation’ is replaced by ‘Fertility, pregnancy and lactation’;
After the sentence ‘In the absence of sufficient data, the use during pregnancy and lactation is not recommended.’‘No fertility data available.’ is inserted;
((f)) In subsection ‘Undesirable effects’ after ‘The frequency is not known.’ The sentence ‘If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.’ is inserted;
((g)) After subsection ‘Overdose’ the following subsections are inserted:
'
Not applicable.

Not applicable.
'
