Transcript Final yellow list

Federal agency for medicines and health
products
JUSTIFICATON OF HOMEOPATHIC USE – SUB WORKING
GROUP
August 28th 2012
Marie-Anne Mouyart – Belgium, Unit Homeo-Phyto
HMPWG Gdańsk – October 23th 2012
Available and already compiled data
ECH pilot list
20 stocks
HMPWG
List of most commons stocks
HMA Job1
(Materia Medica)
HMA Job3
(Old Provings)
Preparation of the subgroup:
compilation of 2 drafted lists of stocks
(differences in the raw materials description in bold characters)
Draft
Green list
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
Draft Yellow
list
October 23th 2012
2
Discussion within the sub working group
case by case 28.08.2012 - Decision
Draft Green list
Draft Yellow list
Positive advice
Pending advice
Light* yellow list
Stocks put on hold
Light *green list
Pink and orange colored
stocks
Final Yellow list
Final Green list
* Same raw material, small differences in
the degree of precision of the description
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
Positive advice after discussion case by case
need to send a signal to the Pharmacopoeias authorities
October 23th 2012
3
LIGHT* GREEN LIST (1/2)
*Non significative difference concerning the description of the
raw materials
Starting material
Pharmacopoeia
Definition of the raw material
Atropa belladonna
GHP
Belladonna
Strychnos Nux
vomica
FP
GHP
Whole fresh plants of Atropa bella-donna L., without
woody lower stem sections, collected at the end of
flowering
Whole fresh blooming plant
Dried ripe seeds of Strychnos nux-vomica L.
Nux vomica
Thuja occidentalis
FP
GHP
Thuya occidentalis FP
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
Dried seed of strychnos nux vomica L.
Fresh, leafy, one-year-old twigs of Thuja occidentalis
L.
Fresh leafy branch of Thuya occidentalis harvested
during spring
October 23th 2012
4
LIGHT* GREEN LIST (2/2)
*Non significative difference concerning the description of the
raw materials
Lachesis (mutus) GHP
Gently dried venom of Lachesis melano-cephala
Solorzano and
Cerdas, Lachesis stenophrys Cope or Lachesis muta
(L.)
Bryonia cretica
GHP
Fresh root of Bryonia cretica L. ssp. dioica (Jacq.) Tutin
or
Bryonia alba L., harvested before the plant comes
into flower
Bryonia
FP
Fresh underground parts of Bryonia cretica L. subsp.
dioica (Jacq.) Tutin or Bryonia alba L.
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
October 23th 2012
5
Light* yellow List (1/2)
*Non significative difference concerning the description of the
raw materials
Starting material
Pharmacopoeia Definition of the raw material
Berberis vulgaris
GHP
Berberis vulgaris
FP
Cinchona pubescens GHP
(China)
China rubra
FP +Ph. Eur.
Selenicereus
GHP
grandiflorus (Cactus)
Cactus grandiflorus FP
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
Dried bark of aerial and underground parts of Berberis
vulgaris L.
Dried bark of underground parts of Berberis vulgaris L.
Dried bark of the trunk and twigs of Cinchona
pubescens Vahl (Cinchona succirubra Pav.), of
Cinchona calisaya Wedd., of Cinchona ledgeriana
Moens ex Trimen, or of their varieties or hybrids
Whole or cut dried bark of Cinchona pubescens Vahl
of Cinchona calisaya Wedd.,of Cinchona ledgeriana
Moens ex trimen or of their varieties or hybrids.
Fresh young stem and flowers of Selenicereus
grandiflorus (L.) Britt. et Rose
Fresh young stem with or without flowers of
Selenicereus grandiflorus (L.) Britt. Et Rose
October 23th 2012
6
Light* yellow List (2/2)
*Non significative difference concerning the description of the
raw materials
Strychnos ignatii
GHP
Dried ripe seeds of Strychnos ignatii Bergius
Ignatia amara
FP
Dried seeds of Strychnos ignatii Bergius
Solanum dulcamara
(Dulc.)
GHP
Fresh shoots of Solanum dulcamara L., collected prior
to flowering
Dulcamara
FP
Viscum album
GHP
Fresh young blooming leafy-stem of solanum
dulcamara L.
Fresh leafy shoots and fruits of Viscum album L see
monograph coniferous and deciduous trees
Viscum album
FP
Fresh aerial fructiferous part of Viscum album
collected on the apple tree
Carbo vegetabilis
FP
Carbonisation of plants
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
October 23th 2012
7
Final green list (1/1):
same description of the raw material
Starting material
Pharmacopoeia
Definition of the raw material
Acidum arsenicosum
(Ars.alb.)
GHP/FP
Ph eur arsenii
trioxidum
Arsenious trioxide according to Ph. Eur. monograph
Sulfur
GHP/FP
Sublimed sulfur
Lycopodium clavatum
GHP/FP
Dried ripe spores of Lycopodium clavatum L.
Pulsatilla pratensis
GHP
Rhus toxicodendron
GHP
Rhus toxicodendron
FP
Lachesis mutus
FP
Whole fresh flowering plants of Pulsatilla pratensis (L.)
Mill.
Fresh, young, not yet lignified shoots of Rhus
toxicodendron L., with leaves
Fresh leafy branch of Rhus toxicodendron harvested at
the end of summer.
Dried venom of Lachesis muta L.
Phosphorus
GHP
White phosphorus
Calcium carbonicum
Hahnemanni
GHP
Inner parts of broken shells of the oyster Ostrea edulis L.,
Calcarea carbonica
ostrearum
HMPWG
Gdańsk
Sepia
officinalis
FP
Inner parts of broken shells of the oyster Ostrea edulis L.,
GHP/FP
Dried secretion from the ink gland ofOctober
Sepia23th
officinalis
L
2012
famhp/Unit Homeo-Phyto
8
Final yellow list (1/4):
same description of the raw material
Starting material
Pharmacopoeia
Definition of the raw material
Arnica montana e planta tota
GHP
whole fresh blooming plant
ARNICA MONTANA
FP
whole fresh blooming plant
Aconitum napellus
GHP
Fresh whole plants of Aconitum napellus L., collected at
the start of flowering
Aconitum napellus
FP
Whole fresh flowering plant of Aconitum napellus
Apis mellifica
GHP
Live worker honey bee (Apis mellifera L.). according to
Ph. Eur. monograph
Apis mellifica
Ph. Eur. Apis mellifera(2024) Live worker honey bee (Apis mellifera L.)
Matricaria recutita (Chamomilla) GHP
Whole fresh flowering plants of Matricaria recutita (L.)
Chamomilla vulgaris
FP
Whole fresh blooming plants of Chamomilla recutita
(L.)Rauschert ( Matricaria recutitaL.,M;chamomilla L;
Citrullus colocynthis
GHP
Dried, peeled, deseeded fruits of Citrullus colocynthis
(L.) Schrad. or pieces thereof
Colocynthis
FP
Dried pulp of deseeded fruit of Citrullus colocynthis (L.)
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
October 23th 2012
9
Final yellow list (2/4):
same description of the raw material
Psychotria ipecacuanha (Cephaelis
ipecacuanha)
GHP
Dried underground organs of Psychotria
ipecacuanha (Brot.) Stokes
IPECA
Carduus marianus (Silybum marianum)
FP +Ph eur Ipecacuanha
root (094)
GHP
Carduus marianus
FP +Milk Thistle(1860)
Conium maculatum
GHP
Fragmented and dried underground organs of
Cephaelis ipecacuanha(Brot)
Mature fruit, devoid of the pappus, of Silybum
marianum L. Gaertner
Mature fruit,devoid of the pappus of Silybum
marianumLGaertner
Fresh, aerial parts of flowering, but not yet fruiting
specimens of Conium maculatum L.
Conium maculatum
FP
Fresh flowering aerial parts of Conium maculatum
L., harvested at the end of the blooming season.
Calcium fluoratum
GHP
Calcium fluoride according to DAB monograph
Clacarea fluorica
Ca F2
Hydrastis canadensis
no FP Monograph, to be
checked in Ph. Eur
GHP
Hydrastis
FP +Hydrastis Ph E (1831)
Hepar sulfuris
GHP
Hepar sulfur
no monograph in FP
Whole or cut dried rhizome and root of Hydrastis
canadensis L.
Substance obtained by calcining a mixture of
Calcium carbonicum Hahnemanni and Sulfur
Substance obtained by calcining a mixture of
Calcium carbonicum Hahnemanni and Sulfur
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
Dried underground parts of Hydrastis canadensis L.
October 23th 2012
10
Final yellow list(3/4):
same description of the raw material
Secale cornutum
GHP
Secale cornutum
no monograph in FP
Anamirta cocculus (Cocc.) check ph eur new GHP
monograph
Cocculus indicus check ph eur new
FP
monograph
Kalium jodatum
GHP +FP + Ph. Eur.
Argentum nitricum
GHP +FP+ Ph. Eur.
Hypericum
Ph,Eur
Hypericum perforatum (hypericum)
GHP
Lytta vesicatoria (Canth.)
GHP
Cantharis
no monograph in FP
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
Sclerotium of Claviceps purpurea (Fries) Tulasne,
grown on rye plants (Secale cereale L.) and dried
at a temperature not exceeding 40°C.
Sclerotium of Claviceps purpurea (Fries)Tulasne
Ripe, dried fruits of Anamirta cocculus Wight et
Arn.
Ripe, dried fruits of Anamirta cocculus Wight et
Arn.
Potassium iodide according to Ph. Eur.
monograph
Silver nitrate according to Ph. Eur. monograph
Whole fresh plants according to Ph. Eur.
monograph on Hypericum for homoeopathic
preparations
Whole fresh plants according to Ph. Eur.
monograph on Hypericum for homoeopathic
preparations
Spanish flies (Lytta vesicatoria L.), as far as
possible intact specimens, sacrificed and dried at
a temperature not exceeding 40°C
Dried Lytta vesicatoria
October 23th 2012
11
Final yellow list(4/4):
same description of the raw material
Stibium sulfuratum nigrum (Ant.
crud.)
Antimonium crudum
GHP
Antimony(III) sulfide
FP
Sb2S3
Magnesium phosphoricum
GHP
Magnesia phosphorica
FP
Magnesium hydrogen phosphate
trihydrate according to DAB
monograph
MgHPO4 3H2O
Graphites
GHP
Naturally occurring mineral graphite
Graphites
FP
Pulverized mineral graphite
Carbo vegetabilis
GHP
Well carbonized charcoal obtained
from beech or birch wood
Acidum nitricum
GHP + FP + Ph.Eur.
Nitric acid according to Ph. Eur.
monograph
Kalium bichromicum
GHP+FP
Potassium dichromate
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
October 23th 2012
12
Conclusion of the subgroup
A
Proposal of a first final list of justified stocks
Final Green
Final Yellow
Light yellow
Light green
Submission to the HMPWG members
For approval and publication on the HMA website
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
October 23th 2012
13
Conclusion of the subgroup
B
Signal to the authorities in charge of Homeopathic Pharmacopoeias
Light green list
Light yellow list
Ph. Eur.
French Ph.
G.H.P.
In order to check the
adapt
level of precision of
the description of the
Raw Material
(See bold characters)
e.g. : End of flowering / blooming
Dried Ripe seeds / Dried Seeds
One year old twigs / harvested during spring
Lightfied shoots / harvested at the end of summer
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
October 23th 2012
14
Conclusion of the subgroup
C
List of « negative »/pending advice / stocks put on hold,
• Same Name / different compositions
e.g. : Calcarea phos, Kalium phosphoricum,
• Same description of the Raw Material / Poor
available Homeopathic litterature
e.g.: Avena sativa
Check the MRP procedure
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
October 23th 2012
15
Pending advice: stocks put on hold
Starting material
Pharmacopoeia
Calcium phosphoricum
GHP + Ph. Eur. 0116 Calcium hydrogen phosphate dihydrate
according to Ph. Eur. monograph
Calcarea phosphorica
FP+ Ph eur phosphate Mixture of Calcium phosphates
tricalcique(1052)
Kalium phosphoricum
GHP + Ph.Eur. 920
Kalium phosphoricum
FP+Ph.Eur. 1003
Pulsatilla pratensis
GHP
Whole fresh flowering plants of Pulsatilla
pratensis (L.) Mill.
Pulsatilla
FP
Whole fresh flowering plants of Pulsatilla
vulgaris (L.) Mill.
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
Definition of the raw material
Potassium dihydrogen phosphate
according to Ph. Eur. monograph
Dipotassium phosphate according to
Ph.Eur. Monograph
October 23th 2012
16
AVENA SATIVA:
check MRP
Starting material
Pharmacopoeia
Definition of the raw material
Avena sativa
GHP
Fresh aerial parts of Avena sativa L., collected
at flowering time.
Avena sativa
FP
Fresh blooming aerial parts of Avena sativa L.
ECH HMA job 1 MM
ECH HMA Job 3 old provings
nbr symptoms
2
pages 125-126
Boericke
yes (-)
Charette
no
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
Nbr
provers
1
Clarke
yes
Kent
no
Leeser
no
Mezger
yes
nbr
ref
1
Stauffer
yes
page
18
Voisin
yes (-)
October 23th 2012
17
Next meeting of the subgroup
Proposal of the next meeting on 26/03/2013 ?
Same methodology
Second list
of Justified stocks
For approval in Dublin (30/05/2013)
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
October 23th 2012
18
Interactions in order to increase
harmonization
In order to increase harmonisation and to facilitate MRP/DCP, a lot of
interactions are/ should be induced by this project between
-
Prescribers (via ECH),
HMA (via HMPWG and the HU sub working group),
Pharmacopoeias authorities
Companies (via the public consultation)
Prescribers
Homeopathic
Litterature
ECH
Pharmacopoeias Authorities
ECH Pilot List
HMA Jobs
HMPWG
HMPWG
List
Public
(consultation)
HMPWG Gdańsk
famhp/Unit Homeo-Phyto
Sub working group
FR, UK,DE,GR, ES, IRL, PT, BE (Rapporteur)
Final
lists
October 23th 2012
19