Commission Implementing Decision (EU) 2018/134 of 24 January 2018 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2018) 218) (Text with EEA relevance. )
Date: 2018-01-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: alternative medicine, crop production, market approval, medical plant, medicinal product








L_2018022EN.01004101.xml










26.1.2018   


EN


Official Journal of the European Union


L 22/41








            COMMISSION IMPLEMENTING DECISION (EU) 2018/134
of 24 January 2018
         
amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products


(notified under document C(2018) 218)


(Text with EEA relevance)


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 use (1), and in particular Article 16f thereof,


Having regard to the opinion of the European Medicines Agency, formulated on 2 February 2016 by the Committee for Herbal Medicinal Products

Whereas:







(1)



Sideritis scardica Griseb., herba can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and it complies with the requirements set out in that Directive.












(2)


It is therefore appropriate to include Sideritis scardica Griseb., herba in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by 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:



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






(1)  
            OJ L 311, 28.11.2001, p. 67.

(2)  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).




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:

                                 ‘UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBA







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, стрък
CS (čeština): nať hojníku
DA (dansk): Kortkroneurt
DE (Deutsch): Balkan-Gliedkraut
EL (elliniká): Πόα σιδηρίτου
EN (English): Ironwort
ES (español): Siderita, partes aéreas de
ET (eesti keel): haavarohuürt
FI (suomi): raudakki, verso
FR (français): Crapaudine (parties aériennes de)
HR (hrvatska): očistova zelen
HU (magyar): sármányvirág virágos hajtása
IT (italiano): Stregonia parti aeree fiorite


LT (lietuvių kalba): Timsrų žolė
LV (latviešu valoda): Siderītu laksts
MT (Malti): ħaxixa tas-Sideritis
NL (Nederlands): (Griekse) bergthee, kruid
PL (polski): Ziele gojnika
PT (português): Siderite, partes aéreas
RO (română): iarba de ceaiul muntelui cretan
SK (slovenčina): Vňať ránhoja
SL (slovenščina): zel sklepnjaka
SV (svenska): Sårmynta, ört
IS (íslenska):
NO (norsk): Gresk fjellte





Herbal preparations





Comminuted herbal substance





European Pharmacopoeia monograph reference





Not applicable





Indications





Indication (1)
Traditional herbal medicinal product used for the relief of cough associated with cold.
Indication (2)
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






Adults and elderly

Indication (1) and (2)
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





Indication (1)
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.
Indication (2)
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






Contraindications

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

Special warnings and precautions for use

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.

Interactions with other medicinal products and other forms of interaction

None reported

Fertility, pregnancy and lactation

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.

Effects on ability to drive and use machines

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

Undesirable effects

None known
If adverse reactions occur, a doctor or qualified health care practitioner should be consulted.

Overdose

No case of overdose has been reported.

Pharmaceutical particulars (if necessary)

Not applicable

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)

Not applicable.’