
Article 1 
Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.
Article 2 
This Decision is addressed to the Member States.
Done at Brussels, 24 January 2018.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX

Decision 2008/911/EC is amended as follows:

((1)) In Annex I, the following substance is inserted after Pimpinella anisum L:
'Sideritis scardica Griseb., herba.';
((2)) In Annex II, the following is inserted after the COMMUNITY LIST ENTRY on Pimpinella anisum L:
'

Scientific name of the plant
Sideritis scardica Griseb.
Botanical family
Lamiaceae (Labiatae)
Herbal substance
Ironwort (Sideritis herba)
Common name in all EU official languages of herbal preparation
BG (bălgarski): Мурсалски чай, стръкCS (čeština): nať hojníkuDA (dansk): KortkroneurtDE (Deutsch): Balkan-GliedkrautEL (elliniká): Πόα σιδηρίτουEN (English): IronwortES (español): Siderita, partes aéreas deET (eesti keel): haavarohuürtFI (suomi): raudakki, versoFR (français): Crapaudine (parties aériennes de)HR (hrvatska): očistova zelenHU (magyar): sármányvirág virágos hajtásaIT (italiano): Stregonia parti aeree fiorite LT (lietuvių kalba): Timsrų žolėLV (latviešu valoda): Siderītu lakstsMT (Malti): ħaxixa tas-SideritisNL (Nederlands): (Griekse) bergthee, kruidPL (polski): Ziele gojnikaPT (português): Siderite, partes aéreasRO (română): iarba de ceaiul muntelui cretanSK (slovenčina): Vňať ránhojaSL (slovenščina): zel sklepnjakaSV (svenska): Sårmynta, örtIS (íslenska):NO (norsk): Gresk fjellte
Herbal preparations
Comminuted herbal substance
European Pharmacopoeia monograph reference
Not applicable
Indications

Traditional herbal medicinal product used for the relief of cough associated with cold.

Traditional herbal medicinal product used for the relief of mild gastrointestinal discomfort.

The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Type of tradition
European
Specified strength
Please see “Specified posology”.
Specified posology

Single dose: Herbal tea: 2-4 g of the comminuted herbal substance in 150-200 ml of water as a herbal infusion 2-3 times daily

Daily dose: up to 12 g

The use in children and adolescents under 18 years of age is not recommended (see section “Special warnings and precautions for use”)

Route of administration
Oral use
Duration of use or any restrictions on the duration of use

If symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

If symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Hypersensitivity to the active substance and to other plants of the Lamiaceae (Labiatae) family.

The use in children and adolescents under 18 years of age has not been established due to lack of adequate data.

If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

None reported

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.

No fertility data available.

No studies on the effect on the ability to drive and use machines have been performed.

None known

If adverse reactions occur, a doctor or qualified health care practitioner should be consulted.

No case of overdose has been reported.

Not applicable

Not applicable.

'
