Commission Implementing Decision (EU) 2018/134

Contents

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^note, 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 ProductsWhereas:

(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^note.

(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.

(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., HERBAScientific name of the plantSideritis scardica Griseb.Botanical familyLamiaceae (Labiatae)Herbal substanceIronwort (Sideritis herba)Common name in all EU official languages of herbal preparationBG (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 fjellteHerbal preparationsComminuted herbal substanceEuropean Pharmacopoeia monograph referenceNot applicableIndicationsIndication (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 traditionEuropeanSpecified strengthPlease see Specified posology.Specified posologyAdults and elderlyIndication (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 dailyDaily dose: up to 12 gThe use in children and adolescents under 18 years of age is not recommended (see section Special warnings and precautions for use)Route of administrationOral useDuration of use or any restrictions on the duration of useIndication (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 useContraindicationsHypersensitivity to the active substance and to other plants of the Lamiaceae (Labiatae) family.Special warnings and precautions for useThe 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 interactionNone reportedFertility, pregnancy and lactationSafety 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 machinesNo studies on the effect on the ability to drive and use machines have been performed.Undesirable effectsNone knownIf adverse reactions occur, a doctor or qualified health care practitioner should be consulted.OverdoseNo case of overdose has been reported.Pharmaceutical particulars (if necessary)Not applicablePharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)Not applicable.

Decision 2008/911/EC is amended as follows:

Commission Implementing Decision (EU) 2018/134

Article 1 #

Article 2 #

Key facts

Connections

History · 2 versions

Article 1 #

Article 2 #

Article 1#

Article 2#

Key facts

Connections

History · 2 versions

Article 1#

Article 2#

Article 1 #

Article 2 #

Article 1 #

Article 2 #