Federal agency for medicines and health products

JUSTIFICATON OF HOMEOPATHIC USE – SUB WORKING GROUP

August 28th 2012

Marie-Anne Mouyart – Belgium, Unit Homeo-PhytoHMPWG Gdańsk – October 23th 2012

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 20122

Available and already compiled data

ECH pilot list 20 stocks

HMPWG List of most commons stocks

HMA Job1(Materia Medica)

HMA Job3(Old Provings)

Draft Green list

Draft Yellow list

Preparation of the subgroup:

compilation of 2 drafted lists of stocks (differences in the raw materials description in bold characters)

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 20123

Discussion within the sub working group case by case 28.08.2012 - Decision

Light *green list

Positive advice

Pending advice

Stocks put on holdPink and orange colored

stocks

* Same raw material, small differences in the degree of precision of the description

Final Yellow list

Positive advice after discussion case by case need to send a signal to the Pharmacopoeias authorities

Draft Green list Draft Yellow list

Light* yellow list

Final Green list

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 20124

LIGHT* GREEN LIST (1/2)*Non significative difference concerning the description of the

raw materials

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 20125

LIGHT* GREEN LIST (2/2)*Non significative difference concerning the description of the

raw materials

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 20126

Light* yellow List (1/2)*Non significative difference concerning the description of the

raw materials

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 20127

Light* yellow List (2/2)*Non significative difference concerning the description of the

raw materials

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 20128

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 Whole fresh flowering plants of Pulsatilla pratensis (L.) Mill.

Rhus toxicodendron GHP Fresh, young, not yet lignified shoots of Rhus toxicodendron L., with leaves

Rhus toxicodendron FP Fresh leafy branch of Rhus toxicodendron harvested at the end of summer.

Lachesis mutus FP 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

FP Inner parts of broken shells of the oyster Ostrea edulis L.,

Sepia officinalis GHP/FP Dried secretion from the ink gland of Sepia officinalis L

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 20129

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 Gdańskfamhp/Unit Homeo-Phyto

October 23th 201210

Final yellow list (2/4): same description of the raw material

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 201211

Final yellow list(3/4): same description of the raw material

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 201212

Final yellow list(4/4): same description of the raw material

Stibium sulfuratum nigrum (Ant. crud.)

GHP Antimony(III) sulfide

Antimonium crudum FP Sb2S3

Magnesium phosphoricum GHP Magnesium hydrogen phosphate trihydrate according to DAB monograph

Magnesia phosphorica FP 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 Gdańskfamhp/Unit Homeo-Phyto

October 23th 201213

Conclusion of the subgroup

A Proposal of a first final list of justified stocks

Final GreenFinal YellowLight yellowLight green

For approval and publication on the HMA website

Submission to the HMPWG members

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 201214

Conclusion of the subgroup

B

Light green list Light yellow list

Ph. Eur.French Ph.G.H.P.

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

In order to check the adapt level of precision ofthe description of the Raw Material (See bold characters)

Signal to the authorities in charge of Homeopathic Pharmacopoeias

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 201215

Conclusion of the subgroup

C List of « negative »/pending advice / stocks put on hold,

• Same Name / different compositions

• Same description of the Raw Material / Poor available Homeopathic litterature e.g.: Avena sativa

e.g. : Calcarea phos, Kalium phosphoricum,

Check the MRP procedure

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 201216

Pending advice: stocks put on hold Starting material Pharmacopoeia Definition of the raw material

Calcium phosphoricum GHP + Ph. Eur. 0116 Calcium hydrogen phosphate dihydrate according to Ph. Eur. monograph

Calcarea phosphorica FP+ Ph eur phosphate tricalcique(1052)

Mixture of Calcium phosphates

Kalium phosphoricum GHP + Ph.Eur. 920 Potassium dihydrogen phosphate according to Ph. Eur. monograph

Kalium phosphoricum FP+Ph.Eur. 1003 Dipotassium phosphate according to Ph.Eur. Monograph

Pulsatilla pratensis GHP Whole fresh flowering plants of Pulsatilla pratensis (L.) Mill.

Pulsatilla FP Whole fresh flowering plants of Pulsatilla vulgaris (L.) Mill.

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 201217

AVENA SATIVA: check MRP

ECH HMA job 1 MM ECH HMA Job 3 old provings

nbr symptomsNbr

proversnbr ref page

pages 125-126 2 1 1 18

yes (-) no yes no no yes yes yes (-)Boericke Charette Clarke Kent Leeser Mezger Stauffer Voisin

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.

HMPWG Gdańskfamhp/Unit Homeo-Phyto

October 23th 201218

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 Gdańskfamhp/Unit Homeo-Phyto

October 23th 201219

Interactions in order to increase harmonization

Pharmacopoeias Authorities

PrescribersECH

ECH Pilot ListHMA Jobs

HMPWG

HMPWGList

Sub working groupFR, UK,DE,GR, ES, IRL, PT, BE (Rapporteur)

Homeopathic Litterature

Public (consultation)

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)

Final lists