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Commission Decision of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document number C(2008) 6933) (Text with EEA relevance) (2008/911/EC)

EU Decision 2008/911 · Adopted 21 November 2008 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Commission Decision

of 21 November 2008

establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products

(notified under document number C(2008) 6933)

(Text with EEA relevance)

(2008/911/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 usef1, and in particular Article 16(f) thereof,

Having regard to the opinions of the European Medicines Agency, formulated on 7 September 2007 by the Committee for Herbal Medicinal Products,

Whereas:

(1)

Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung comply with the requirements set out in Directive 2001/83/EC. Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung can be considered as herbal substances, herbal preparations and/or combinations thereof.

(2)

It is therefore appropriate to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products including the entry of Foeniculum vulgare Miller subsp. vulgare var. vulgare and the entry of Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung.

(3)

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:

Annotations to the whole text

Footnotes

f1

OJ L 311, 28.11.2001, p. 67.

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. Annex IList of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established in accordance with Article 16f of Directive 2001/83/EC as amended by Directive 2004/24/EC
  5. Annex II
  6. COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L
  7. Scientific name of the plant
  8. Botanical family
  9. Herbal substance
  10. Common name in all EU official languages of herbal substance
  11. Herbal preparation(s)
  12. ADivision A
  13. BDivision B
  14. CDivision C
  15. European Pharmacopoeia monograph reference
  16. Indication(s)
  17. (a)Division (a)
  18. (b)Division (b)
  19. Type of tradition
  20. Specified strength
  21. Specified posology
  22. Route of administration
  23. Duration of use or any restrictions on the duration of use
  24. Any other information necessary for the safe use
  25. Contraindications
  26. Special warnings and precautions for use
  27. Interactions with other medicinal products and other forms of interaction
  28. Pregnancy and lactation
  29. Effects on ability to drive and use machines
  30. Undesirable effects
  31. Overdose
  32. COMMUNITY LIST ENTRY ON ECHINACEA PURPUREA (L.) MOENCH, HERBA RECENS
  33. Scientific name of the plant
  34. Botanical family
  35. Herbal substance
  36. Common name in all EU official languages of herbal substance
  37. Herbal preparation(s)
  38. European Pharmacopoeia monograph reference
  39. Indication(s)
  40. Type of tradition
  41. Specified strength
  42. Specified posology
  43. Route of administration
  44. Duration of use or any restrictions on the duration of use
  45. Any other information necessary for the safe use
  46. Contra-indications
  47. Special warnings and precautions for use
  48. Interactions with other medicinal products and other forms of interaction
  49. Pregnancy and lactation
  50. Effects on ability to drive and use machines
  51. Undesirable effects
  52. Overdose
  53. COMMUNITY LIST ENTRY ON ELEUTHEROCOCCUS SENTICOSUS (RUPR. ET MAXIM.) MAXIM., RADIX
  54. Scientific name of the plant
  55. Botanical family
  56. Herbal substance
  57. Common name in all EU official languages of herbal substance
  58. Herbal preparation(s)
  59. European Pharmacopoeia monograph reference
  60. Indication(s)
  61. Type of tradition
  62. Specified strength
  63. Specified posology
  64. Route of administration
  65. Duration of use or any restrictions on the duration of use
  66. Any other information necessary for the safe use
  67. Contraindication
  68. Special warnings and precautions for use
  69. Interactions with other medicinal products and other forms of interaction
  70. Fertility, pregnancy and lactation
  71. Effects on ability to drive and use machines
  72. Undesirable effects
  73. Overdose
  74. Pharmaceutical particulars (if necessary)
  75. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
  76. COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. VULGARE, FRUCTUS
  77. Scientific name of the plant
  78. Botanical family
  79. Herbal substance
  80. Common name in all EU official languages of herbal substance
  81. Herbal preparation(s)
  82. European Pharmacopoeia monograph reference
  83. Indication(s)
  84. Type of tradition
  85. Specified strength
  86. Specified posology
  87. Adults
  88. Adolescents over 12 years of age, indication (a)
  89. Children between four and 12 years of age, indication (a)
  90. Route of administration
  91. Duration of use or any restrictions on the duration of use
  92. Adults
  93. Adolescents over 12 years of age, indication (a)
  94. Children between four and 12 years of age, indication (a)
  95. Any other information necessary for the safe use
  96. Contraindications
  97. Special warnings and precautions for use
  98. Interactions with other medicinal products and other forms of interaction
  99. Pregnancy and lactation
  100. Effects on ability to drive and use machines
  101. Undesirable effects
  102. Overdose
  103. Pharmaceutical particulars (if necessary)
  104. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
  105. COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. DULCE (MILLER) THELLUNG, FRUCTUS
  106. Scientific name of the plant
  107. Botanical family
  108. Herbal substance
  109. Common name in all EU official languages of herbal substance
  110. Herbal preparation(s)
  111. European Pharmacopoeia monograph reference
  112. Indication(s)
  113. Type of tradition
  114. Specified strength
  115. Specified posology
  116. Adults
  117. Adolescents over 12 years of age, indication (a)
  118. Children between four and 12 years of age, indication (a)
  119. Route of administration
  120. Duration of use or any restrictions on the duration of use
  121. Adults
  122. Adolescents over 12 years of age, indication (a)
  123. Children between four and 12 years of age, indication (a)
  124. Any other information necessary for the safe use
  125. Contraindications
  126. Special warnings and precautions for use
  127. Interactions with other medicinal products and other forms of interaction
  128. Pregnancy and lactation
  129. Effects on ability to drive and use machines
  130. Undesirable effects
  131. Overdose
  132. Pharmaceutical particulars (if necessary)
  133. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
  134. COMMUNITY LIST ENTRY ON HAMAMELIS VIRGINIANA L., FOLIUM ET CORTEX AUT RAMUNCULUS DESTILLATUM
  135. Scientific name of the plant
  136. Botanical family
  137. Herbal preparation(s)
  138. European pharmacopoeia monograph reference
  139. Indication(s)
  140. Indication (a)
  141. Indication (b)
  142. Type of tradition
  143. Specified strength
  144. Specified posology
  145. Children over six years of age, adolescents, adults and elderly
  146. Indication (a)
  147. Adolescents, adults and elderly
  148. Indication (b)
  149. Route of administration
  150. Duration of use or any restrictions on the duration of use
  151. Children over six years of age, adolescents, adults and elderly
  152. Indication (a)
  153. Adolescents, adults and elderly
  154. Indication (b)
  155. Any other information necessary for the safe use
  156. Contraindications
  157. Special warnings and precautions for use
  158. Indication (a)
  159. Indication (b)
  160. Interactions with other medicinal products and other forms of interaction
  161. Pregnancy and lactation
  162. Effects on ability to drive and use machines
  163. Undesirable effects
  164. Indication (a)
  165. Indication (b)
  166. Overdose
  167. Pharmaceutical particulars [if necessary]
  168. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [if necessary for the safe use of the product]
  169. UNION LIST ENTRY ON MELALEUCA ALTERNIFOLIA (MAIDEN AND BETCH) CHEEL, M. LINARIIFOLIA SMITH, M. DISSITIFLORA F. MUELLER AND/OR OTHER SPECIES OF MELALEUCA , AETHEROLEUM
  170. Scientific name of the plant
  171. Botanical family
  172. Common name in all EU official languages of herbal preparation
  173. Herbal preparation
  174. European Pharmacopoeia monograph reference
  175. Indications
  176. Indication (a)
  177. Indication (b)
  178. Indication (c)
  179. Indication (d)
  180. Type of tradition
  181. Specified strength
  182. Specified posology
  183. Indication (a)
  184. Adolescents, adults and elderly
  185. Single dose
  186. Indication (b)
  187. Adolescents, adults and elderly
  188. Single dose
  189. Indication (c)
  190. Adolescents, adults and elderly
  191. Single dose
  192. Indication (d)
  193. Adolescents, adults and elderly
  194. Route of administration
  195. Indications (a), (b) and (c)
  196. Indication (d)
  197. Duration of use or any restrictions on the duration of use
  198. Indication (a)
  199. Indications (b) and (c)
  200. Indication (d)
  201. Any other information necessary for the safe use
  202. Contraindications
  203. Special warnings and precautions for use
  204. Indication (a)
  205. Indication (b)
  206. Indication (c)
  207. Indication (d)
  208. Interactions with other medicinal products and other forms of interaction
  209. Fertility, pregnancy and lactation
  210. Effects on ability to drive and use machines
  211. Undesirable effects
  212. Overdose
  213. Pharmaceutical particulars (if necessary)
  214. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
  215. COMMUNITY LIST ENTRY ON MENTHA x PIPERITA L., AETHEROLEUM
  216. Scientific name of the plant
  217. Botanical family
  218. Herbal preparation(s)
  219. European Pharmacopoeia monograph reference
  220. Indication(s)
  221. Type of tradition
  222. Specified strength
  223. Indications 1, 2 and 3
  224. Children between 4 to 10 years of age
  225. Children between 10 to 12 years of age, adolescents between 12 to 16 years of age
  226. Adolescents over 16 years of age, adults
  227. Specified posology
  228. Route of administration
  229. Duration of use or any restrictions on the duration of use
  230. Indication 1
  231. Indications 2 and 3
  232. Any other information necessary for the safe use
  233. Contraindications
  234. Special warnings and precautions for use
  235. Interactions with other medicinal products and other forms of interaction
  236. Pregnancy and lactation
  237. Effects on ability to drive and use machines
  238. Undesirable effects
  239. Overdose
  240. COMMUNITY LIST ENTRY ON PIMPINELLA ANISUM L
  241. Scientific name of the plant
  242. Botanical family
  243. Herbal substance
  244. Common name in all EU official languages of herbal substance
  245. Herbal preparation(s)
  246. European Pharmacopoeia monograph reference
  247. Indication(s)
  248. (a)Division (a)
  249. (b)Division (b)
  250. Type of tradition
  251. Specified strength
  252. Specified posology
  253. Route of administration
  254. Duration of use or any restrictions on the duration of use
  255. Any other information necessary for the safe use
  256. Contraindications
  257. Special warnings and precautions for use
  258. Interactions with other medicinal products and other forms of interaction
  259. Pregnancy and lactation
  260. Effects on ability to drive and use machines
  261. Undesirable effects
  262. Overdose
  263. UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBA
  264. COMMUNITY LIST ENTRY ON THYMUS VULGARIS L., THYMUS ZYGIS LOEFL. EX L., AETHEROLEUM
  265. Scientific name of the plant
  266. Botanical family
  267. Herbal preparation(s)
  268. European Pharmacopoeia monograph reference
  269. Indication(s)
  270. Type of tradition
  271. Specified strength
  272. Specified posology
  273. Adults and elderly
  274. Adolescents
  275. Children 6-12 years
  276. Children 3-6 years
  277. Route of administration
  278. Duration of use or any restrictions on the duration of use
  279. Any other information necessary for the safe use
  280. Contraindications
  281. Use as bath additive:
  282. Special warnings and precautions for use
  283. Cutaneous use:
  284. Use as bath additive:
  285. Interactions with other medicinal products and other forms of interaction
  286. Pregnancy and lactation
  287. Effects on ability to drive and use machines
  288. Undesirable effects
  289. Overdose
  290. Pharmaceutical particulars [If necessary]
  291. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [If necessary for the safe use of the product]
  292. UNION LIST ENTRY ON VALERIANA OFFICINALIS L.
  293. COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM
  294. Scientific name of the plant
  295. Botanical family
  296. Herbal substance
  297. Common name of herbal substance in all EU official languages
  298. Herbal preparation(s)
  299. European Pharmacopoeia monograph reference
  300. Indication(s)
  301. Type of tradition
  302. Specified strength
  303. Specified posology
  304. Adults and elderly
  305. Route of administration
  306. Duration of use or any restrictions on the duration of use
  307. Adults and elderly
  308. Any other information necessary for the safe use
  309. Contraindications
  310. Special warnings and precautions for use
  311. Interactions with other medicinal products and other forms of interaction
  312. Pregnancy and lactation
  313. Effects on ability to drive and use machines
  314. Undesirable effects
  315. Overdose
  316. Pharmaceutical particulars (if necessary)
  317. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)