# L_2018022EN.01004101.xml

| 26.1.2018 | EN | Official Journal of the European Union | L 22/41 |
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26.1.2018

EN

Official Journal of the European Union

L 22/41

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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. |
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(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). |
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(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. |
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(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, |
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(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

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

1

(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).

2

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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.’; |
| --- | --- |

(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.’ |

(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.’

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