HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP

(HMPWG)

LIST ENTRY OF FIRST SAFE DILUTION

1. RHEUM OFFICINALE BALLON or RHEUM PALMATUM
European Pharmacopoeia (Ph. Eur.) in force monograph 2371: Method
of preparation Ph. Eur. 1.1.10 and Ph. Eur. 1.1.8. of Homoeopathic
Stocks and Potentisation
2. MATRICARIA RECUTITA L.
European Pharmacopoeia (Ph. Eur.) in force monograph 2371: Method
of preparation Ph. Eur. 1.1.10 and Ph. Eur. 1.1.5. of Homoeopathic
Stocks and Potentisation

DISCUSSION IN THE SUBGROUP

DISCUSSION IN THE HMPWG
ADOPTION BY THE HMPWG
TRANSMISSION TO HMA for release for consultation
DEADLINE FOR COMMENTS

Identity of the
stock*/raw/starting
material/, **

Name Ph.Eur.
Name national Ph.
Ref. to monograph
Synonyms
Plant part
Fresh/dried

Rheum officinale
Baillon
Rheum palmatum L.
Ph. Fr.
underground parts
dried
Rheum officinale
Baillon
Rheum palmatum L.
GHP
underground parts
dried

Preparation

Constituents of toxicological
concern

Homeopathic
Manufact. Method/
Method of
preparation

(international nomenclature,
CAS #)

European
Pharmacopoeia (Ph.
Eur.) in force
monograph 2371:
Method of preparation
Ph. Eur. 1.1.10 of
Homoeopathic Stocks
and Potentisation
European
Pharmacopoeia (Ph.
Eur.) in force
monograph 2371:
Method of preparation
Ph. Eur. 1.1.8 of
Homoeopathic Stocks
and Potentisation

Acceptable amount
mg/kg/day based on PDE
/TTC/(LHRD/100)

First Safe
dilution
(as defined
point 3.4 in the
points to
consider)

Toxicological Comments
e.g. target organs, major
toxic concern,
patients groups with special
concern for which the use is
not recommended

Known toxic or possibly toxic

Substances
with max % in raw/starting
material/ stock (to be specified,
if possible
Not known

Based on stock/raw/starting
material/ (to be specified)
Based on known or possible
toxic constituent

3 to 12 % hydroxanthracene
derivatives

TTC = 0.15*10-3 mg/day

FSDMT = 7 D
(expressed
relative to the
dried plant)

Use of the TTC concept to have

any contraindication.

3 to 12 % hydroxanthracene
derivatives

TTC = 0.15*10-3 mg/day

FSDMT = 8 D
(expressed
relative to the
dried plant)

Use of the TTC concept to have

any contraindication

 Matricaria recutita L.
matricaria chamomilla
L.
Ph. Fr.
whole flowering plant
Fresh

European
Pharmacopoeia (Ph.
Eur.) in force
monograph 2371:
Method of preparation
Ph. Eur. 1.1.10 of
Homoeopathic Stocks
and Potentisation

No sever toxic components :

Cumarins; essential oil;
flavonods

Matricaria recutita L.
matricaria chamomilla
L.
Ph. Fr.
whole flowering plant
Fresh

European
Pharmacopoeia (Ph.
Eur.) in force
monograph 2371:
Method of preparation
Ph. Eur. 1.1.5 of
Homoeopathic Stocks
and Potentisation

No sever toxic components :

Cumarins; essential oil;
flavonods

Food legislation: intake

limited by limited maximal
amount of ingested bisabolol (1.9mg) and
apigenine-7-glucoside
(5.6mg). in the calculation
of the FSD, the content in
apigenine-7-glucoside is
the critical factor and
determine the FSD
Food legislation: intake
limited by limited maximal
amount of ingested bisabolol (1.9mg) and
apigenine-7-glucoside
(5.6mg). in the calculation
of the FSD, the content in
apigenine-7-glucoside is
the critical factor and
determine the FSD

FSD = 2D

Taking into account the fact that

allergies are dependent of the
sensibility of each individual, BE
proposes, by analogy to the
proposal for excipients, to put a
special warning on the
packaging.

FSD = 3D

Taking into account the fact that

allergies are dependent of the
sensibility of each individual, BE
proposes, by analogy to the
proposal for excipients, to put a
special warning on the
packaging.

* As defined in the Ph. Eur.

** For information related to the identity, refer to Guidance on module 3 of the homeopathic medicinal product dossier
http://www.hma.eu/uploads/media/HMPWG_dossier_guidance_mod3.pdf