Organotherapy

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

Notes

  • By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.
  • Text in parentheses is additional optional information which can be included on the label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant on the label.
  • The use of the web-based PLA is not possible where reference is made to this monograph. Please use the PDF format available at: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodnatur/applications/licen-prod/form/form_pl-dlmm-eng.pdf
  • This monograph cannot be combined with any other monograph at Class II.

Date

January 10, 2025

Proper name(s), Common name(s)

Table 1. Proper name(s), Common name(s)
Proper name(s) Common name(s)
Anas barbariae Duck
Cavia porcellus Guinea pig
Danio rerio Zebra danio/Zebrafish
Gallus gallus domesticus Chicken
Sus scrofa Pig
Oryctolagus cuniculus Rabbit

Source information

Please refer to Appendix I.

Route(s) of administration

  • Oral
  • Sublingual
  • Nasal
  • Opthalmic
  • Topical
  • Rectal

Dosage form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

The acceptable dosage forms are those indicated in Table 2 below.

Use(s) or Purpose(s)

Organotherapy (preparation/remedy/medicine).

Dose(s)

Subpopulation(s)

Adolescent 13-17 years, Adults 18 and older

Quantity(ies)

The dilution for each medicinal ingredient must be equal to or greater than 3X (or equivalent).

Table 2. Dosing information
Dosage form(s) Maximum General Dosing Maximum Acute Dosing
Amount Frequency (Optional)
Globules (small pellets, pilules) 1 whole unit dose (tube of container) 1 time per day 1 unit dose, 3 times per day
Granules (regular and large pellets) 5 granules 3 times per day Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosing.
Tablets 4 tablets 4 times per day Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosing.
Oral Drops 30 drops 3 times per day Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosing.
Oral Spray 10-15 sprays 3 times per day Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosing.
Liquids (oral drinkable vials) 1 ampoule 3 times per day Up to 3 times per day
Oral Solutions (unit dose) 1 unit dose 3 times per day Give one unit dose upon onset of symptoms. Repeat two more times at 15-minute intervals. Repeat process up to 9 times per day if symptoms reappear.
Oral Syrups 1-2 teaspoons Every 4-6 hours Not applicable
Creams/Ointments Cover affected area As needed Not applicable
Nasal Sprays 2 sprays/nostril 5 times per day Not applicable
Suppositories 1 suppository 1-4 times per day Up to 4 times per day

Method(s) of preparation

The method of preparation must be one of the following:

  • HPUS1 Class L, Method I or II;
  • HAB2 method 42 a or b;
  • PhF3 mother tinctures for drugs of animal origins; or
  • Ph. Eur.4 monograph 1038

Notes:

1Homeopathic Pharmacopoeia of the United States

2Homöopathisches ArzneiBuch.

3French Pharmacopoeia

4European Pharmacopoeia

Direction(s) of use

Use/Take as directed by a health care practitioner/health care provider/health care professional/doctor/physician.

Duration(s) of use

No statement required.

Risk information

Caution(s) and warning(s)

Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

Contraindication(s)

Do not use if you are pregnant or breastfeeding.

Known adverse reaction(s)

No statement required.

Non-Medicinal Ingredient(s)

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.
  • All medicinal ingredients of animal origin must be sterilized as per HPUS and HAB requirements or equivalent.
  • If the method of preparation includes the use of natural lactose for trituration, an Animal Tissue form for lactose must be submitted.

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

Product Facts Table

References cited

  • HAB 2023: Homöopathisches ArzneiBuch. Deutscher Apotheker Verlag, 2024. The most current version applies.
  • HPUS 2024: Homeopathic Pharmacopeia of the United States, Online: Homeopathic Pharmacopoeia Convention of the United States, 2024. The most current version applies.
  • Ph.Eur. 2024: European Pharmacopoeia, 11th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM), 2024. The most current version applies.
  • PhF 2024: French Pharmacopoeia, 11th edition. Saint-Denis Cedex (FR) : French Agency for the Safety of Health Products, 2024. The most current version applies.

References reviewed

  • Reckeweg HH. Organ Therapy. Homotoxin-Journal. Journal for Holistic Research and Synthesis in Medicine 1963;6(1):317-320.
  • Rozencwajg J. Organotherapy, Drainage and Detoxification. Kandern (Germany): Natura Medical Ltd, 2010.
  • Tétau M, Bergeret C. L'organothérapie diluée et dynamisée. Paris (FR) : éditions Maloine, 1973.
  • Tétau M. Nouvelles cliniques d'organothérapie diluée et dynamisée. Paris (FR): éditions Similia, 1986.

Appendix I

Acceptable Source Materials for Organotherapy Medicinal Ingredients. A B C D E F G H I J K L M N O P Q R S T U V W Y

A

  • Adipose tissue
  • Adrenal cortex/Suprarenal cortex
  • Adrenal gland/Suprarenal gland
  • Adrenal medulla
  • Adrenal gland/Suprarenal gland
  • Ankle articulation
  • Anterior cruciate ligament
  • Anterior pituitary gland/Andenohypophysis
  • Aorta
  • Appendix/Caecum
  • Aqueous humor
  • Artery
  • Articular capsule
  • Ascending colon
  • Atlas
  • Auditory nerve
  • Auricle
  • Auriculo-ventricular wall

B

  • Bile
  • Bladder
  • Blood
  • Blood plasma
  • Bone marrow
  • Bones
  • Brachial plexus
  • Brain/Encephalon/Whole brain
  • Bronchial mucosa
  • Bronchus

C

  • Calcaneal tendon/Achilles tendon
  • Canal of cervix
  • Capillary tissue
  • Cardia/Esophagogastric junction
  • Carotid artery
  • Carotid plexus
  • Cartilage
  • Cephalorachidien liquid
  • Cerebellum
  • Cerebral artery
  • Cerebral cortex
  • Cerebral cortex and hypothalamus
  • Cervical disc
  • Cervical marrow
  • Cervical vertebrae
  • Choroid
  • Ciliary body
  • Coccyx
  • Collagen
  • Colon
  • Common bile duct
  • Conjunctiva
  • Conjunctive tissue
  • Cornea
  • Coronary artery
  • Coronary vein
  • Corpus callosum
  • Corpus cavernosum
  • Corpus luteum/Yellow body
  • Corpus spongiosum
  • Cortex and hypothalamus
  • Coxo-femoral cartilage
  • Cranial nerve
  • Crystallin
  • Cubital nerve/Ulnar nerve
  • Cystic duct

D

  • Deferent duct/Vas deferens
  • Dental pulp
  • Descending colon
  • Diaphragm
  • Diencephalon/Interbrain
  • Dorsal marrow
  • Dorsal vertebrae
  • Duodenum

E

  • Elbow articulation
  • Elbow ligament
  • Embryo
  • Endocardium
  • Endothelium tissue (Bone marrow + spleen + thymus)
  • Epididymis
  • Epiphysis/Pineal body/Pineal gland
  • Epiphyseal cartilage
  • Eye
  • Eustachian tube

F

  • Facial nerve
  • Fallopian tube
  • Femoral artery
  • Fibrin
  • First cervical vertebrae
  • Flat bone
  • Frontal lobe

G

  • Gall bladder
  • Gizzard
  • Glossopharyngeal nerve
  • Gray matter
  • Greater curvature of the stomach
  • Gums

H

  • Hair
  • Heart
  • Heart ventricles
  • Hemorrhoidal vein/Rectal vein/Anal vein
  • Hepatic duct
  • Hepatopancreatic sphincter
  • Hip articulation
  • Hip ligament
  • Hippocampus
  • Hyaline cartilage
  • Hypogastric plexus
  • Hypothalamus

I

  • Ileocecal valve
  • Ileum
  • Inferior vena cava
  • Internal ear
  • Intervertebral discs
  • Intestinal mucosa

J

  • Jejunum

K

  • Kidney
  • Knee articulation
  • Knee ligament

L

  • Labyrinth
  • Lacrimal glands
  • Larynx
  • Left ventricule
  • Lens of the eye
  • Ligaments
  • Limbic system
  • Liver
  • Long bone
  • Lower portion of the brain stem
  • Lumbar discs
  • Lumbar marrow
  • Lumbar plexus
  • Lumbar vertebrae
  • Lung
  • Lung with histamine
  • Lymph gland/Lymphatic gland
  • Lymph vessel/Lymphatic vessels
  • Lymphatic ganglia Lymphatic node

M

  • Mammary glands
  • Medial collateral ligament
  • Median nerve
  • Medulla oblongata
  • Meninges
  • Meniscus
  • Mesencephalon
  • Middle ear
  • Minor curvature of the stomach
  • Mitral valve
  • Mucosa of the bile duct
  • Mucosa of the bladder
  • Mucosa of the colon
  • Mucosa of the duodenum
  • Mucosa of the duodenum and pylorus
  • Mucosa of the gall bladder
  • Mucosa of the gums
  • Mucosa of the ileum
  • Mucosa of the intestine
  • Mucosa of the jejunum
  • Mucosa of the lung
  • Mucosa of the oesophagus
  • Mucosa of the pyloric region
  • Mucosa of the rectum
  • Mucosa of the rectum and sigmoid
  • Mucosa of the rhinopharynx
  • Mucosa of the sinus
  • Mucosa of the small intestine
  • Mucosa of the stomach
  • Myocardia
  • Muscles

N

  • Nail
  • Nasal mucosa
  • Natural/Genuine lard
  • Neck of urinary bladder
  • Nerve
  • Nervous tissue

O

  • Occipital lobe
  • Occipital nerve
  • Ocular muscle
  • Oculomotor nerve
  • Oesophagus
  • Olfactive nerve
  • Olfactory bulb
  • Ophthalmic artery
  • Optic chiasma
  • Optic nerve
  • Optic thalamus
  • Oral mucosa
  • Orbicular muscle of eye
  • Ossicles
  • Ovary

P

  • Pancreas
  • Pancreatic duct
  • Parathyroid
  • Parietal lobe
  • Parotid gland
  • Pelvis of the kidney
  • Penis
  • Pericardium
  • Periodontium
  • Peritoneum
  • Periosteum
  • Peyer's patches
  • Pharyngeal tonsil/Adenoids
  • Pharynx
  • Pilosebaceous glands (cranial region)
  • Pituitary gland/Hypophysis
  • Placenta
  • Pleura
  • Pons
  • Posterior cruciate ligament
  • Posterior pituitary gland/Neurohypophysis
  • Poultry gizzard
  • Prostate
  • Pulmonary artery

Q

  • Quadrigeminal bodies

R

  • Radial nerve
  • Rectum
  • Red blood cells
  • Red bone marrow
  • Renal cortex
  • Renal medulla
  • Reticuloendothelial system
  • Retina
  • Right ventricle
  • Rhinencephalon

S

  • Sacral marrow
  • Sacral plexus
  • Sacral vertebrae
  • Salivary glands
  • Saphenous vein
  • Sciatic nerve
  • Second cervical vertebrae
  • Seminal vesicle
  • Short bone
  • Shoulder articulation
  • Shoulder ligament
  • Sigmoid colon
  • Small bronchi mucosa
  • Small intestine
  • Smooth muscle
  • Solar plexus
  • Spinal cord
  • Spleen
  • Spongy bone
  • Stomach
  • Striated muscle
  • Submandibular gland
  • Sympathetic ganglia
  • Sympathetic nerve
  • Synovial fluid

T

  • Tegument/Skin
  • Temporal lobe
  • Temporomandibular articulation
  • Tendon
  • Testis
  • Thalamus
  • Thoracic discs
  • Thoracic vertebrae
  • Thymus gland
  • Thyroid gland
  • Tongue
  • Tonsil
  • Tooth
  • Trachea
  • Transverse colon
  • Trigeminal nerve
  • Tympanic membrane

U

  • Umbilical cord
  • Ureter
  • Urethral sphincter
  • Ureterovesical junction
  • Urethra
  • Uterus

V

  • Vaginal mucosa
  • Vagus nerve
  • Vegetative ganglia
  • Vein
  • Vertabrae
  • Vertebral column ligament
  • Vertebral ligament
  • Vesical trigone
  • Vitreous humour
  • Vulva

W

  • White matter

Y

  • Yellow bone marrow

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