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Contact: Policy Bureau Enquiries
This Frequently Asked Questions document provides information about the future changes to the Food and Drug Regulations pertaining to non-medicinal ingredient labelling of non-prescription drugs (coming into force May 13, 2012).
The NMI labelling regulations are an emerging regulatory requirement that will come into force on May 13, 2012 and will introduce changes to Part C, Division 1, subsection C.01.001(1) and section C.01.004 of the Food and Drug Regulations. These amendments will require a listing of NMIs on the outer label of non-prescription drug products specifically for human use that are marketed in Canada. These regulations do not apply to prescription drugs, non-prescription drugs only administered under the supervision of a practitioner, low-level disinfectants, or veterinary-use drugs.
May 13, 2012.
Any non-prescription drug product that is/will be marketed in Canada, for human use. The expectation is that all applicable products will be in compliance by 2012. We recognize, however, that there may be products that have higher stability (expiry dates greater than 2 years) and are still on the store shelves after May 2012. We expect this situation to be rare but as long as the new products coming onto shelves are in compliance, this will be acceptable. See 2.4 for details on exemptions.
The following drug products will be exempt from the regulatory requirements for NMI labelling:
Please note that this requirement is not applicable to Natural Health Products (NHPs).
* Drugs that are represented as being solely for use as disinfectants on hard, non-porous surfaces.
In addition to the requirements outlined in 2.1, when a drug is intended for human use, its outer label must contain a list of all non-medicinal ingredients, or, if the outer label is too small, the list must appear on a tag, tape or card that is attached to the package.
The non-medicinal ingredients must be listed in alphabetical order or in descending order of predominance by their proportion in the drug, preceded by words that clearly distinguish them from the medicinal ingredients.
In the case of flavour, fragrance or pharmaceutical ink, the expressions "flavour/saveur", "fragrance/parfum" and "pharmaceutical ink/encre pharmaceutique", respectively, may be included in the list to indicate that such ingredients have been added to the drug, instead of listing those ingredients or combinations of them individually.
When the composition of the drug varies from one lot to another, the outer label must include a reference to all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol "+/-" or "▒" or the expression "or/ou" or "may contain/peut contenir".
Manufacturers/sponsors will be asked to submit a letter of attestation to Health Canada to certify that their marketed non-prescription drug products meet the requirements stipulated in the NMI labelling regulations, and to indicate the effective/expected date of compliance. See 2.4 for details on exemptions.
Manufacturers/sponsors of non-prescription drug products that are already marketed in Canada and do not fall under the list of exempted products. See 2.4.
Although the NMI labelling requirement comes into force on May 13th, 2012, manufacturers/sponsors of non-prescription drug products that are currently marketed in Canada and do not fall in the exemption categories (see 2.4), are strongly encouraged to send the attestation letter as a part of their response to the annual drug notification request sent by Health Canada.
Health Canada requires one attestation letter from each manufacturer/sponsor listing all eligible drug products and their associated DIN. (See format for Non-Medicinal Ingredients Labelling Attestation Letter Template).
Yes, each letter should be signed by the responsible office of the Company certifying the accuracy of the document. That is - certifying and confirming that the drug product sponsored by the company does/will adhere to the NMI labelling requirement for non-prescription drug products.
Please reproduce the appended Non-Medicinal Ingredients Labelling Attestation Letter Template in the official language of your choice, and print the attestation letter on your company's letterhead then sign it.
All attestation letters will be recorded, scanned and tracked. Health Canada may also conduct random spot checks.
A drug manufacturer/sponsor should send the attestation letter as a part of the response to the Submission and Information Policy Division's (SIPD) annual notification request to the following address:
Submission and Information Policy Division
Therapeutic Products Directorate
101 Tunney's Pasture Driveway
Address Locator: 0201A1
Questions or comments regarding this document should quote "NMI Labelling" in the subject line and should be directed to:
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1