Homeopathy

Date

August 5, 2019

Proper name(s), Common name(s), 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-Prescription 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 NNHPD 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 excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Homeopathic preparation/remedy/medicine.

Dose(s)

Subpopulation(s)

As specified below.

Quantity(ies)

*Dissolve dose in a small amount of water before administration to infants and children 0-5 years old.

Potency

The homeopathic potency of each medicinal ingredient must be at or above the minimum potency 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.

Direction(s) for use

Use 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)

• Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
• Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.
• Ingredient specific risk statements when required by NHPID.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (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 document.
• 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(s) 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.

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.

¹ Homeopathic Pharmacopeia of the United States (HPUS)

² Homöopathisches ArzneiBuch (HAB) or German Homeopathic Pharmacopoeia (GHP)

³ Pharmacopée française or French Pharmacopoeia (PhF)

⁴ European Pharmacopoeia (Ph.Eur.)

⁵ Encyclopedia of Homeopathic Pharmacopoeia (EHP)

References Cited

• 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: French Pharmacopoeia, 10th edition. Saint-Denis Cedex(FR) : French Agency for the Safety of Health Products , 2003.