Homeopathy

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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 PLA and product 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.

Date

July 16, 2015

Proper name(s), Common name(s), and Source material(s)

Notes

• The proper name(s), common name(s) and source material(s) must be as per the homeopathic monograph referenced as the Standard or Grade (please refer to the specifications).
• The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one of the Natural and Non-Prescrition Health Products Directorate (NNHPD) accepted homeopathic pharmacopoeias ^{1, 2, 3, 4, 5}.
• Medicinal ingredients considered imponderables are not included within the scope of this monograph.

Route(s) of administration

The acceptable route(s) of administration must be acceptable as per the Evidence for Homeopathic Medicines guidance document.

Dosage form(s)

• The acceptable pharmaceutical dosage forms include, but are not limited to those indicated in Table 1 below,
• This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of

Homeopathic preparation/remedy/medicine

OR

Homeopathic preparation/remedy/medicine for the relief of ^{1, 2}....

¹The use or purpose must only be for the relief of a symptom or set of symptoms. The use or purpose must not imply the prevention/risk reduction or the treatment/cure of a disease, disorder, or abnormal state. The use or purpose must be supported by a reference in Appendix I.

²Indications either direct or implied for the relief of cough, cold and flu (influenza) symptoms are not allowed in products indicated for children 12 years and under.

Dose

Subpopulation(s) and Quantity(ies)

Table 1: Dosage forms and their recommended dose for each subpopulation

Dosage Form	Sub-Population	Maximum General Dosing	Maximum Frequency	Maximum Acute Dosing (Optional)
Table 1 Footnotes Table 1 Footnote 1 Dissolve dose in a small amount of water before administration to infants and children 0-2 years old. Return to Table 1 footnote 1* referrer
Granules (regular and large pellets)	Adults and children ≥ 12 years	1 whole unit dose (tube or container)	Once per day	10-20 granules 2-3 times per day
	Children 1-11 years*
	Infants 0-11 months*
Globules (small pellets, pilules) (Oral)	Adults and children ≥ 12 years	3-5 granules	2-3 times per day	Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosing.
	Children 1-11 years*
	Infants 0-11 months*
Tablets	Adults and children ≥ 12 years	1-4 tablets	1-4 times per day	Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosing.
	Children 6-11 years	1-3 tablets	1-4 times per day
	Children 1-5 years*	½-3 tablets	1-3 times per day
	Infants 0-11 months*	½-3 tablets	1-2 times per day
Oral Drops	Adults and children ≥ 12 years	10-30 drops	1-3 times per day	Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosing.
	Children 6-11 years	5-15 drops
	Children 1-5 years	5-10 drops
	Infants 0-11 months	1-5 drops
Liquid (Oral drinkable vials)	Adults and children ≥ 12 years	1 ampoule	1-3 times per day	Up to three times per day
	Children 6-11 years	2/3 ampoule
	Children 1-5 years	½ ampoule
	Infants 0-11 months	1/3 ampoule
Oral solution (Unit dose)	Adults and children ≥ 12 years	Unit oral dose	1-3 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.
	Children 1-11 years
	Infants 0-11 months
Oral Syrup	Adults and children ≥ 12 years	1-2 tsp	Every 4 to 6 hours	Not applicable
	Children 1-11 years	½-1 tsp	1-3 times per day
	Infants 0-11 months	½ tsp	1-3 times per day
Cream/Ointment	Adults and children	Cover affected area	Use as needed	Not applicable
Nasal spray	Adults and children ≥ 12 years	1-2 sprays/ nostril	3-5 times per day	Not applicable
	Children 1-11 years	1 spray/ nostril	4 times per day
	Infants 0-11 months	1 spray/ nostril	4 times per day
Eye Drops	Adults and children ≥ 12 years	2-3 drops	3 times per day	1 drop in the affected eye every 15 minutes for a maximum of 3 hours.
	Children 1-11 years	1-2 drops	3 times per day
	Children 0-11 months	1 drop	2 times per day
Ear Drops	Adults and children ≥ 12 years	1 complete vial	3 times per day	Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosage.
	Children 1-11 years	3-4 drops
	Infants 0-11 months	2-3 drops
Suppositories	Adults and children ≥ 12 years	1 suppository	1-4 times per day	Maximum 5 per day
	Children 6-11 years		1-3 times per day	Maximum 4 per day
	Children 1-5 years		1-2 times per day	Maximum 3 per day
	Infants 0-11 months		1-2 times per day	Maximum 2 per day

Potency

The homeopathic potency of each medicinal ingredient must be at or above the minimum potency as specified in the Natural Health Products Ingredients Database (NHPID)

Note:
The minimum potencies indicated in the NHPID are generally based on the following unless specific safety concerns have been identified:

• The OTC limit for HPUS
• 4D for HAB
• 12 CH for pharmacopoeia other than HPUS or HAB/GHP

Method(s) of preparation

The method(s) of preparation must be as per the homeopathic monograph referenced as the Standard or Grade (please refer to the specifications). It is also acceptable to use another method from an NNHPD accepted homeopathic pharmacopoeia not referenced as the Standard or Grade. In this case, the selected method of preparation must be appropriate for the medicinal ingredient.

Directions for use

Take as directed by a health care practitioner.

Duration of use

No statement required.

Risk information

Cautions and warnings

• If symptoms persist or worsen, consult a health care practitioner.
• If you are pregnant or breastfeeding, consult a health care practitioner prior to use.
• Ingredient specific risk statements where required by the NHPID.

Contraindications

No statement required.

Known adverse reactions

No statement required.

Non-medicinal Ingredients

Must be chosen from the current NHPID and must meet the limitations outlined in the database.

Storage conditions

No statement required.

Specifications

• The finished product must comply with the requirements outlined in the current NNHPD Evidence for Homeopathic Medicines guidance documents.
• The finished product specifications must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide.
• The medicinal ingredient(s) must be chosen from the current NHPID and must comply with the requirements outlined in the database
• 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.

Standard or Grade

Must reference a homeopathic monograph in one of the most recent versions of NNHPD accepted homeopathic pharmacopoeias: HPUS¹, HAB/GHP², PhF³, Ph.Eur.⁴, EHP⁵.

¹Homeopathic Pharmacopeia of the United States (HPUS)
²Homöopathisches ArzneiBuch (HAB) or German Homeopathic Pharmacopoeia (GHP)
³Pharmacopée française or French Pharmacopoeia (PhF)
⁴European Pharmacopoeia (Ph.Eur.)
⁵Encyclopedia of Homeopathic Pharmacopoeia (EHP)

Reference reviewed

• EHP 2002: Encyclopaedia of Homeopathic Pharmacopoeia, Volume 3. New Delhi (IN): Kuldeep Jain and B.Jain, 2002.
• GHP 2008: German Homeopathic Pharmacopoeia, Volume 1.Stuttgart (DE): MedPharm, 2008.
• HAB 2003: Homöopathisches ArzneiBuch, Band 1. Stuttgart (DE): MedPharm, 2003.
• HPUS 2004: Homeopathic Pharmacopeia of the United States, Revision Service. Pennsylvania (PA): Homeopathic Pharmacopoeia Convention of the United States, 2004.
• Ph.Eur. 2011: European Pharmacopoeia, 7th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM), 2011.
• PhF 2003: Pharmacopée Française, 10^ème édition. Saint-Denis Cedex(FR) : Agence Française de Sécurité Sanitaire de Produits de Santé, 2003.

Appendix I

References for Homeopathic medicines with a specific recommended use or purpose

• Boericke W. Materia Medica with Repertory. New Delhi (IN): Pratap Medical Publishers PVT Ltd; 1996.
• Allen TF. The Encyclopedia of Pure Materia Medica. A record of the positive effects of drugs upon the healthy human organism. New Delhi (IN): Jain Publishers; 1877.
• Allen TF. Encyclopedia of Pure Materia Medica (10 vol). Edit. New York, (NY): Boericke et Tafel; 1879-1974.
• Boericke W. Pocket Manual of Homeopathic Materia Medica with Repertory (9th Ed.): New Delhi (IN): Jain Publishers Pvt. Ltd. 1984, 1985 (Indian Reprint).
• Bradford LTh. Index to Homeopathic Provings. India: Boericke et Tafel; 1901.
• Charrette G. La Matière Médicale Homéopathique expliquée. Paris (FR): Le François; 1952 – 2ième édition, Le François; 1976.
• Charrette G. La Matière Médicale Pratique.; François (FR): 2ième édition, 1932, 3ième édition, Le 1949.
• Chiron. Eléments de Matière Médicale Homéopathique. Peyronnet (FR): 1935; 3ième édition; 1955.
• Clarke JH. A Dictionary of Practical Materia Medica (3 vol.). London (GB): The Homeopathic Publishing Co.; 1902.
• Clarke JH. Dictionary of Practical Materia Medica. New Delhi (IN): The Homeopathic Publishing Company; 1925.
• Coulamy A, Jousset C. Basses dilutions et drainage en homéopathie. Paris (FR): Similia; 2000.
• Demarque D, Jouanny J, Poitevin B, Saint-Jean Y. Pharmacologie et matière médicale homéopathique. France: CEDH, 1993.
• Duprat H. Traité de matière médicale homéopathique. France: Tome I : Imprimerie de Trévoux; 1948; Tome II : Baillière et fils; 1948; Tome III : Georg & Cie; 1948.
• Ecalle H, Delpech L, Peuvrier A. Pharmacopée Homéopathique française. Paris (FR): Librairie J.B. Baillière et Fils; 1898.
• Espanet A. Traité méthodique et pratique de matière médicale & de thérapeutique. Paris (FR): Baillière; 1861.
• Fare Ch. éléments de matière médicale homéopathique vétérinaire. France: CEDH; 1993.
• Farrington EA. A Clinical Materia Medica. Philadelphia (PA): Sherman & Co.; 1887.
• German Commission D. Keller K, Greiner S, Stockebrand P. Homöopathische Arzneimittel - Materialien zur Bewertung (Commission D). Francfort (GE): Govi Verlag, Band I, II, III;1995.
• Ghose SC. Drugs of Hindoosthan. Calcutta (IN): Hahnemann Publishing Co. Private Ltd.; 1970.
• Guermonprez M et al. Matière médicale homéopathique (1 vol.). Paris (FR): Doin Editeurs; 1985.
• Guermonprez M, Pinkas M, Torck M. Matière médicale homéopathique. France: Boiron; 1995.
• Hahnemann CFS, Jourdan AJL. [Trad. de]. Traité de matière médicale ou de l'action pure des médicaments homéopathiques. Paris (FR): Baillière; 1834.
• Hahnemann S, Jourdan AJL. [Trad. de]. Doctrine et traitement des maladies chroniques. Paris (FR): Baillière; 1846.
• Hahnemann S, Simon V et L [Trad. de]. Traité de matière médicale homéopathique comprenant les pathogénèses du traité de matière médicale pure et du traité des maladies chroniques. Paris (FR): Baillière; 1891.
• Hering C. The Guiding Symptoms of our Materia Medica (10 vol.), Philadelphia (PA): Boericke et Tafel; 1890.
• Hering C. The Guiding Symptoms of our Materia Medica. New Delhi (IN): Jain Publishers; 1974.
• Homoepathic Pharmacopoeia of India. India: Government of India, Ministry of Health; 1971.
• Horvilleur A. Matière médicale homéopathique. Lyon (FR): Camugli; 1979.
• Jahr GHG, Catellan Frères. Nouvelle Pharmacopée Homoeopathique. Paris (FR): J.B. Baillière et Fils; 1862.
• Jouanny J. The Essentials of Homeopathic Materia Medica. France: Boiron; 1984.
• Jouanny J. Notions essentielles de matière médicale homéopathique. Lyon (FR): Boiron; 1975.
• Julian OA. Matière médicale d'homéopathie. Paris (FR): Peyronnet; 1971.
• Julian OA. Dictionnaire de Matière médicale homéopathique - Les 130 nouveaux homéothérapiques. Paris (FR): Masson; 1981.
• Kent JT. Matière médicale homéopathique. France: Annales Homéopathiques Françaises; 1976.
• Kent JT. Repertory of Homeopathic Materia Medica. Delhi (IN): B. Jain Publishers (P) Ltd.; 1996.
• Kollitsch P. Homéopathie. Matière Médicale. Thérapeutique. Paris (FR): Maloine; 1965.
• Lathoud JA. études de Matière Médicale Homéopathique. France: Martin & Ternet; 1982.
• Murphy R. Homeopathic Remedy Guide (2^nd edition). Blacksburg (VA): H.A.N.A. Press; 2000.
• Nash EB. Principe de Thérapeuthique Homéopathique. France: Doin; 1950.
• Sarembaud A, Poitevin B. Médicaments à usage homéopathique : dictionnaire pratique. Paris (FR): Masson; 1996.
• Schroyens F. Synthesis - Repertorium Homeopathicum Syntheticum (edition 8.1). London (GB): Homeopathic Book Publishers; 2001.
• Schwabe W. Pharmacopoea homeopathica Polyglotta. Leipzig (GE): Edition française Willmar Schwabe; 1933.
• Sieffert G. Formulaire de thérapeutique positive (Homéopathie). Leipzig (GE): Dr. Willmar Schwabe; 1899.
• Tetau M. Matière médicale homéopathique clinique et associations biothérapiques. Paris (FR): Maloine; 1978.
• The Pakistan Homoeopathic Pharmacopoeia. Pakistan: published by National Council for Homoeopathy Pakistan (2^nd ed.); 1997.
• Vannier L, Poirier J. Précis de Matière Médicale Homéopathique. Paris (FR): Doin; 1972.
• Varma PN, Indu Vaid. Encyclopaedia of Homoeopathic Pharmacopoeia. New Delhi (IN): Jain Publishers (P) Ltd.; 1995.
• Vermeulen F. Concordance Materia medica. Haarlem (NL): Ary Bakker; 1994.
• Villechauvaix J. Pour comprendre et utiliser l'homéopathie. France: G. Doin & Cie; 1934.
• Voisin H. Homéopathie Clinique. Matière Médicale. Annecy (FR): Imprimerie Moderne; 1949.
• Voisin H. Matière Médicale du Praticien Homéopathe. Paris (FR): Maloine SA éditeur - LHF; 1978 (2ème édition, 2ème tirage).
• Weber GPF. Codex des médicaments homéopathiques. Paris (FR): J.B. Baillière et Fils; 1854.
• Wyrth Post Baker. Compendium of Homeotherapeutics. Leesburg Pike, Falls Church (VA): American Academy of Homeotherapeutics; 1974.
• Zandvoort RV. The complete repertory mind including Boger's Boenninghausen repertory additions (3^rd revised edition). IRHIS; 1998.
• Zissu R, Guillaume M. Fiches de Matière Médicale Homéopathique - 3 volumes. France: Doin; 1973-1977.