Académique Documents
Professionnel Documents
Culture Documents
EMA/HMPC/494079/2007
Column A: Herbal substances (working term) proposed for Community herbal monograph/Community list entry establishment
Column B: HMPC Total priority after survey among interested parties (IPs) 2005 (AEFMUTA, AESGP, EFCAM, ESCOP, GA, IVAA, PSE)
mentions with high, medium or not specified priority, mentions with low priority
Column C: Priority request by IPs or National Competent Authorities (NCAs) after 2005
Abbreviation IP or Member State NCA (month/year), H=High, M=Medium, L=Low priority
Column D: Addition to the HMPC priority list for assessment (EMA/HMPC/278067/2006)
Specified date (dd/mm/yyyy)
Column E: Related monographs on quality in the European Pharmacopoeia:
Specified monograph term and Ph. Eur. monograph number, (in prep.) = planned or in preparation
Related monographs and list entries of other selected scientific or regulatory publications:
Column F: ESCOP monographs
published monographs (2nd ed. including suppl. 2009; indiv. monographs published online by Jul 2014)
Column G: German Commission E monographs (BfArM)
monographs published successively until 1994 (corrections until 2002)
Column H: French Avis aux fabricants (AFSSAPS)
list entries in Les Cahiers de lAgence No 3, Les mdicaments base de plantes 1998
Column I: WHO monographs
1 published in Volume 1 (1999), 2 published in Volume 2 (2002), 3 published in Volume 3 (2007), 4 published in Volume 4 (2009)
Column K: Indian monographs
* monograph in the Ayurvedic Pharmacopoeia of India, first edit. 2001, Part 1 Vol. 1 (**Vol. 2, *** Vol. 3, **** Vol. 4, ***** Vol. 5)
monograph in the Database on medicinal plants used in Ayurveda, Central council for research in Ayurveda & Siddha. Vol. 1 2000, (Vol. 2 2001)
monograph in the Quality Standards of Indian medicinal plants, Indian Council of Medical Research 2003. Vol. 1 ( Vol. 2, Vol. 3, Vol. 8)
Column L: Chinese monographs
monograph in Chinese Pharmacopoeia (PPRC, Vol. 1 Traditional Chinese Materia Medica, 2010), related species not considered e.g. Agrimonia pilosa
instead of Agrimonia eupatoria or Aesculus chinense instead of Aesculus hippocastanum
Page 2/21
Total
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Ph. Eur.
ESCOP
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French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
23/11/2005
Absinthii herba
Mon.
**
AYUSH
folium
08/2008
12/07/2011
*/****
07/09/2007
Agropyri repentis
M (AESGP
10/01/2008
09/10)
rhizoma
Allii cepae bulbus
M (AESGP
10/01/2008
09/10)
M (AESGP
11/03/2010
09/10)
Allii sativi bulbus
H (AESGP
23/11/2005
***
23/11/2005
09/10)
Aloe
Althaeae radix
07/09/2006
*****
Andrographidis
M (AESGP
paniculatae folium
09/10)
27/01/2011
2
2
Page 3/21
Total
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Ph. Eur.
ESCOP
German
French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
22/11/2011
Mon.
2
Arctii folium
23/11/2005
23/11/2005
(Bardanae folium)
Arctii radix
06/11/2008
M (AESGP
07/09/2007
09/10)
tota
Aspidium filix-mas
folium
Astragali radix
Avenae fructus
13/07/2006
prep.)
Avenae herba
13/07/2006
AYUSH
**
08/2008
Balsamum peruvianum
(AESGP
28/01/2014
07/13)
Betulae folium
Page 4/21
Boldi folium
Total
Later
Added to
Ph. Eur.
ESCOP
German
French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
23/11/2005
Mon.
Bryophyllum folium =
Kalanchoe pinnata
folium
Bupleuri radix
Calendulae herba
Calendulae flos
EDQM
fermentata folia
(03/11)
Capsici fructus
M (AESGP
28/01/2014
23/11/2005
31/03/2011
09/10)
Carvi aetheroleum
M (AESGP
06/11/2008
23/11/2005
15/07/2010
09/10)
Carvi fructus
H (AESGP
09/10)
Caryophylli floris
aetheroleum
Caryophylli flos
L (AESGP
09/10)
12/03/2009
Page 5/21
Total
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Ph. Eur.
ESCOP
German
French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
23/11/2005
08/05/2008
16/07/2009
06/11/2008
Centaurii herba
Centellae folium
Centellae asiaticae
Mon.
***
()
herba
Chamomillae romanae
***
flos
H (AESGP
09/10)
Chelidonii herba
Chelidonium majus
rhizoma
Cichorii intybi planta
tota
()
15/01/2009
07/09/2006
x
Cimicifugae rhizoma 2069
rhizoma
Cinnamomi camphorae
(07/13)
28/01/2014
folium/cortex
Cinnamomi corticis
aetheroleum
11/11/2009
1
2
Page 6/21
Cinnamomi cortex
Total
Later
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Ph. Eur.
ESCOP
German
French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
06/11/2008
Mon.
1
(07/13)
d-Camphora 1400
camphora, aetherolei
fractio solida
Cistus creticus,
(07/13)
28/01/2014
Citri bergami
M (AESGP
11/11/2009
aetheroleum
09/10)
folium/resinum
Aurantii amari epicarpii et mesocarpii
tinctura 1604
Aurantii amari epicarpium et
mesocarpium 1603
Aurantii amari flos 1810
Aurantii dulcis aetheroleum 1811
Colae semen
Coptidis rhizoma
****
M (AESGP
16/07/2009
09/10)
flore
13/07/2007
05/07
L (AESGP
quantificatum 1864
09/10)
()
1865
Page 7/21
Crataegi fructus 3
Total
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Ph. Eur.
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German
French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
AESGP
13/07/2007
Mon.
05/07
H (AESGP
09/10)
Cucurbitae semen
10/01/2008
Curcurmae longae
23/11/2005
rhizoma
Curcumae xanthorrhizae
prep.)
rhizoma
H (AESGP
06/11/2008
09/10)
Cyani flos
Cynarae folium
(FR 07/13)
(in prep.)
28/01/2014
13/07/2006
IVAA
05/07
Echinacea angustifolia
planta tota
Echinaceae angustifoliae
13/07/2006
13/07/2006
23/11/2005
radix
Echinaceae pallidae
radix
Echinaceae purpureae
herba
Page 8/21
Echinacea purpurea
Total
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Ph. Eur.
ESCOP
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French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
Mon.
fabr.
(July 2013)
Mon.
planta tota
Echinaceae purpureae
13/07/2006
23/11/2005
radix
Eleutherococci radix
Emblicae officinalis
AYUSH
fructus
08/2008
Ephedrae herba
Epilobii herba
Equiseti herba
(CZ 07/13)
28/01/2014
AESGP
13/07/2006
05/06
Eschscholziae herba
22/11/2011
cum flore
Eucalypti aetheroleum
H (AESGP
07/09/2007
07/09/2007
09/10)
Eucalypti folium
H (AESGP
Euphrasiae herba
06/11/2008
Filipendulae ulmariae
06/03/2008
06/03/2008
23/11/2005
23/11/2005
09/10)
flos
Filipendulae ulmariae
herba
Foeniculi amari fructus
Foeniculi amari fructus
aetheroleum
Foeniculi dulcis fructus
Page 9/21
Total
Later
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Ph. Eur.
ESCOP
German
French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
Mon.
fabr.
H (AESGP
10/01/2008
Fragariae folium
(July 2013)
Mon.
09/10)
Frangulae cortex
23/11/2005
Frangulae cortex 25
L (AESGP
16/07/2009
09/10)
Fucus vesiculosus
Fumariae herba
M (AESGP
()
11/03/2010
07/09/2007
09/10)
Gentianae radix
L (AESGP
07/09/2007
09/10)
Ginseng radix
L (AESGP
07/09/2007
09/10)
Glycine max and/or
(DE 07/13)
28/01/2014
L (AESGP
11/03/2010
09/10)
Page 10/21
Total
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Ph. Eur.
ESCOP
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WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
Hamamelidis cortex
23/11/2005
Hamamelidis folium
23/11/2005
Hamamelidis folium et
23/11/2005
23/11/2005
Mon.
2
2
2
Helichrysi flos
07/09/2007
(PL 07/13)
28/01/2014
Hippocastani cortex
06/05/2010
Hippocastani semen
07/09/2006
()
*****
26/10/2006
Imperatoria ostruthium
rhizoma
4
Page 11/21
Total
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Ph. Eur.
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WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
Mon.
fabr.
Iridis rhizoma
Juglandis folium
(July 2013)
Mon.
() *
M (AESGP
10/01/2008
**
***
***
09/10)
Juniperi aetheroleum
Juniperi pseudo-fructus
Juniperus communis
17/09/2009
06/03/2008
(FR 07/13)
28/01/2014
AESGP
15/01/2009
15/01/2009
17/09/2009
summitates
Lavandulae aetheroleum
10/08
Lavandulae flos
Leonuri cardiacae herba
Company
08/09
Levistici radix
H (AESGP
23/11/2005
27/01/2005
Lini semen 95
09/10)
Lichen islandicus
Lini semen
L (AESGP
09/10)
03/07/2008
Page 12/21
Total
Later
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Ph. Eur.
ESCOP
German
French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
Mon.
fabr.
(July 2013)
Mon.
Lysimachia nummularia
23/11/2005
herba
Marrubii herba
L (AESGP
07/09/2007
07/09/2007
07/09/2007
09/10)
Mate folium
Matricariae aetheroleum
07/09/2007
aetheroleum
H (AESGP
06/11/2008
09/10)
Meliloti herba
23/11/2005
Melissae folium
23/11/2005
23/11/2005
aetheroleum
23/11/2005
Page 13/21
Mercurialis perennis
Total
Later
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Ph. Eur.
ESCOP
German
French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
Mon.
planta tota
Millefolii flos
10/01/2008
Millefolii herba
10/01/2008
Myrrha (Commiphora
06/10/2008
Myrrha 1349
molmol)
Myrtilli folium
M (AESGP
16/07/2009
09/10)
Myrtilli fructus siccus
H (AESGP
10/01/2008
09/10)
AYUSH
08/2008
Oenotherae biennis
**/***
*
06/11/2008
oleum
(deleted)
Oleae folium
31/10/2008
Oleae folium
Onopordon acanthium
24/01/2012
12/07/2011
flos
Origani dictamni herba
Origanum majoranae
fructus
Page 14/21
Origanum majoranae
Total
Later
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Ph. Eur.
ESCOP
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French
WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
(AESGP
28/01/2014
10/01/2008
28/01/2014
herba
07/13)
Orthosiphonis folium
Paeoniae radix
(AESGP
07/13)
Paulliniae semen
EDQM
(=Guaranae semen)
(03/11)
Passiflorae herba
Mon.
23/11/2005
L (AESGP
16/07/2009
09/10)
Phaseoli fructus (sine
13/09/2011
***
**
**,***
semine)
Picrorhizae kurroae
AYUSH
rhizoma
Pilosellae herba cum
12/07/2011
08/2008
(in prep.)
22/11/2011
flore
Piperis methystici
rhizoma
Piperis nigri fructus
Pistacia lentiscus,
(07/13)
28/01/2014
*****
resinum (Mastix)
Plantaginis lanceolatae
07/09/2007
()
folium
Page 15/21
Plantaginis ovatae
Total
Later
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Ph. Eur.
ESCOP
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WHO
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Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
23/03/2005
23/03/2005
Mon.
semen
Plantaginis ovatae
seminis tegumentum
Platycodi radix
Polygalae radix
1334
(= Senegae radix)
Polygoni avicularis herba
(PL 07/13)
28/01/2014
Polypodii rhizoma
08/03/2007
Primulae flos
13/07/2006
Primulae radix
23/11/2005
12/07/2011
M (AESGP
09/10)
Pruni spinosae
summitates
M (AESGP
09/10)
Psyllii semen
23/03/2005
Quercus cortex
10/01/2008
Rauwolfiae radix
****
1
*****
Resina laricis
(see Terebinthinae
laricina)
5
Page 16/21
Rhamni purshianae
Total
Later
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Ph. Eur.
ESCOP
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WHO
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Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
23/11/2005
cortex
Mon.
Rhei radix
23/11/2005
H (AESGP
rhizoma et radix
Ribis nigri folium
16/07/2009
09/10)
Ricini oleum
(PL 07/13)
23/11/2005
28/01/2014
Rosae flos
12/07/2011
Rosmarini aetheroleum
Rosmarini folium
*/***
15/01/2009
07/09/2007
13/09/2011
Sabalis serrulatae
fructus (Serenoae
L (AESGP
13/07/2006
07/09/2007
09/10)
repentis fructus)
Saccharomyces
(DE 07/13)
28/01/2014
cerevisiae/
S. boulardii
Salix sp. cortex
23/11/2005
Page 17/21
Total
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ESCOP
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WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
17/09/2009
Mon.
Salviae officinalis
aetheroleum
prep.)
Salviae lavandulifoliae aetheroleum 1849
Salviae sclareae aetheroleum 1850
08/03/2007
(07/13)
28/01/2014
Sambuci flos
IVAA
08/03/2007
05/07
Sambuci fructus
Scolopendrium officinale
13/09/2011
folium
Sennae folium
31/05/2005
31/05/2005
Sideritis herba
Silybi mariani fructus
(07/13)
28/01/2014
M (AESGP
11/03/2010
09/10)
Sisymbrii officinalis
H (AESGP
09/10)
27/01/2011
herba)
Page 18/21
Solani dulcamarae
Total
Later
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Ph. Eur.
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priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
Mon.
fabr.
Mon.
L (AESGP
06/03/2008
stipites
Solidaginis virgaureae
09/10)
23/11/2005
herba
Storax/ Benzoe tincture
(July 2013)
08/05/2008
08/05/2008
Taraxaci folium
06/03/2008
07/09/2007
herba
1851
(= Taraxacum officinale
()
()
()
planta tota)
Terebinthinae laricina 8
(Resina laricis)
Thymi aetheroleum
Thymi herba
pinastro 1627
07/09/2007
23/11/2005
07/09/2007
fixed combination
Page 19/21
Total
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WHO
Indian
Chin.
priority
request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
H (AESGP
11/03/2010
11/03/2010
Tiliae flos
Mon.
09/10)
Tiliae tomentosae flos
L (AESGP
09/10)
Tormentillae rhizoma
03/07/2008
Trigonellae foenugraeci
10/01/2008
16/07/2010
**
semen
(Foenugraeci semen )
Uncariae tomentosae
cortex
prep.)
Urticae folium
23/11/2005
Urticae herba
23/11/2005
Urticae radix
23/11/2005
23/11/2005
Valerianae radix
27/01/2005
2400Valerianae extractum
hydroalcoholicum siccum 1898
Valerianae radix 453
Valerianae radix minutata 2526
(Valerianae tinctura 1899
Valerianae radix/
Lupuli flos
31/10/2007
fixed combination
Page 20/21
Total
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Ph. Eur.
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Indian
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request IP
HMPC
related monographs
Mon.
Comm. E
Avis a.
Mon.
Mon.
Ph.
2005
or NCA
Priority list
(July 2013)
Mon.
fabr.
Verbasci flos
08/03/2007
10/01/2008
15/01/2009
31/10/2008
12/07/2011
Withaniae somniferae
AYUSH
radix
08/2008
Zingiberis rhizoma
Mon.
***
4
*/
prep.)
23/11/2005
Page 21/21