Homeopathic Medicines (HM) Labelling Standard

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Date: November 26, 2007

Brand name: The brand name does not imply a specific claim, recommended use or purpose.

Standard or Grade: Must reference a homeopathic monograph in one of the NHPD accepted homeopathic pharmacopoeias: HPUS¹, HAB/GHP², PhF ³, Ph.Eur. ⁴, EHP⁵.

Medicinal Ingredient(s): Must be a permitted substance with a homeopathic monograph in one of the NHPD accepted homeopathic pharmacopoeias ¹,²,³,⁴,⁵.

Homeopathic Potency:The homeopathic potency of each medicinal ingredient must be at or above one of the following:

• the OTC limit if attesting to an HPUS monograph;
• 4D if attesting to a HAB monograph;
• If attesting to a homeopathic monograph other than HPUS or HAB/GHP and for medicinal ingredients Aristolochia spp. And Asarum spp., 12CH must be listed as the homeopathic potency.

Proper name(s): Must be as per the homeopathic monograph referenced as the Standard or Grade.

Common name(s): Must be as per the homeopathic monograph referenced as the Standard or Grade.

Source material(s): Must be as per the homeopathic monograph referenced as the Standard or Grade.

Method of preparation: Must be as per the homeopathic monograph referenced as the Standard or Grade. It is also acceptable to use another method from an NHPD 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.

Note: All medicinal ingredients of animal origin (nosodes, sarcodes, etc.) must be sterilised as per HPUS and HAB requirements or equivalent.

Note: If the method of preparation includes the use of natural lactose for triturations, the PLA form must indicate "yes" to the question "Was animal tissue used in the processing of this product" and an Animal Tissue form for lactose must be submitted.

Recommended Use(s) or Purpose(s):
"Homeopathic Medicine"
"Homeopathic Remedy"
"Homeopathic Preparation"
"Homeopathic Drug"

Route of administration: Must be acceptable as per the Evidence for Homeopathic Medicines guidance document. 

Dosage form: Must be acceptable as per the Evidence for Homeopathic Medicines guidance document. 

Dosage Information: Must be acceptable as per Table 3 (Dosage forms and their suggested recommended dose) of the Evidence for Homeopathic Medicines guidance document. 

Duration of use: Consult a health care practitioner for prolonged use.

Risk information:

Cautions and warnings:
"Consult a health care practitioner if symptoms persist or worsen."
"Consult a health care practitioner before use if you are pregnant or breastfeeding."

Contraindications:
Any known contraindications for the product must be declared.

Known adverse reactions:
Any known adverse reactions from use of the product must be declared.

Non-medicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Finished Product Specifications: Must comply with the Evidence for Quality of Finished Natural Health Products and the Evidence for Homeopathic Medicines guidance documents.  

Product Label Text: Must meet the labelling requirements for Homeopathic Medicines as per the Evidence for Homeopathic Medicines guidance document and Chapter 3 of the Labelling Guidance Document.

Animal Tissue Form(s), if applicable: This is required for each medicinal and non-medicinal ingredient from animal source as well for any ingredient used in the processing of the product (e.g. natural lactose used in trituration).

Note: certain animal tissues and parts are considered specified risk materials (SRMs), and as such, are prohibited in natural health products. If any non-medicinal ingredients are SRMs they must be removed or replaced by a non-SRM animal source material. Section B.01.047.1 of the Food and Drug Regulations defines which animal substances are considered SRMs

References must be the most recent versions of:

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)