Clara di Tella, BSc, Pharm QA
Regulatory Affairs Specialist
Health Canada has released a notice to inform drug manufacturers/sponsors of its expectations for non-medicinal ingredient labeling for nonprescription drug products. The amendment to the Food and Drug Regulations published in the Canada Gazette II on May 26, 2010, will come into effect on May 13, 2012. The amendment requires that non-medicinal ingredients be listed on the outer label of nonprescription drug products for human use.
This amendment affects drugs that have already received market authorization and new applications. This revision does not affect prescription drugs, non-prescription drugs that are only administered by a health care practitioner, low-level disinfectants or veterinary-use drugs.
For drug products that have already received market authorization, Health Canada is requesting that manufacturers/sponsors submit an attestation letter indicating the date on which their products have been or will be in compliance with the non-medicinal labeling requirements. A template of the attestation can be found on the Health Canada website and it should be submitted as part of the response to the Annual Drug Notification request. New applications submitted should be in compliance with the regulations as they will be assessed based upon the new requirements.
The regulations outline that the outer label of the drug product must have a list of the non-medicinal ingredients contained in the product. If the outer label is too small and cannot present the non-medicinal ingredient list, the list must be on a card or tag and attached to the package. The list must be preceded by a heading which clearly distinguishes the non-medicinal ingredients from the medicinal ingredients, for example “non-medicinal ingredients” or “inactive ingredients”. The ingredients must be listed in alphabetical order or in descending order of its proportion in the drug.
For assistance in this matter or other regulatory issues, please contact our experts at Dicentra.
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