Non-Medicinal Ingredient (NMI) Labelling Regulations: Frequently Asked Questions

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Contact: Policy Bureau Enquiries

Table of Contents

• 1. Purpose
• 2. Overview of Non-Medicinal Ingredient Labelling Regulatory Requirements
  • 2.1 What are the Non-Medicinal Ingredient Labelling Regulations?
  • 2.2 When do the Non-Medicinal Ingredient labelling requirements come into force?
  • 2.3 What kind of drug products will be required to include Non-Medicinal Ingredient labelling?
  • 2.4 What are the exemptions?
  • 2.5 What type of Non-Medicinal Ingredient information needs to be included on the label?
• 3.0 Documentation Requested from Sponsors
  • 3.1 What kind of documents will Health Canada require from manufacturers/sponsors in order to fulfill the emerging NMI labelling regulatory requirements?
  • 3.2 Who should submit an attestation letter?
  • 3.3 When should my company send the attestation letter to Health Canada?
  • 3.4 How does it work? Do I submit an attestation letter for each Drug Identification Number (DIN)? Or each product?
  • 3.5 Does the attestation letter need to be signed?
  • 3.6 What information should the attestation letter include? Is there a required format?
  • 3.7 What is Health Canada going to do with the attestation letters?
  • 3.8 How can I submit the attestation letter?
  • 3.9 Who can I contact for more information on this notice and on the Non-Medicinal Ingredient labelling amendment?

1.0 Purpose

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).

2.0 Overview of Non-Medicinal Ingredient Labelling Regulatory Requirements

2.1 What are the Non-Medicinal Ingredient Labelling Regulations?

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.

2.2 When do the Non-Medicinal Ingredient labelling requirements come into force?

May 13, 2012.

2.3 What kind of drug products will be required to include Non-Medicinal Ingredient labelling?

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.

2.4 What are the exemptions?

The following drug products will be exempt from the regulatory requirements for NMI labelling:

1. Prescription drugs;
2. Non-prescription drugs only administered under the supervision of a health care practitioner;
3. Low-level disinfectants*; and
4. Veterinary-use drugs.

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.

2.5 What type of Non-Medicinal Ingredient information needs to be included on the label?

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".

3.0 Documentation Requested from Sponsors

3.1 What kind of documents will Health Canada require from manufacturers/sponsors in order to fulfill the emerging NMI labelling regulatory requirements?

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.

3.2 Who should submit an attestation letter?

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.

3.3 When should my company send the attestation letter to Health Canada?

Although the NMI labelling requirement comes into force on May 13^th, 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.

3.4 How does it work? Do I submit an attestation letter for each Drug Identification Number (DIN)? Or each product?

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).

3.5 Does the attestation letter need to be signed?

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.

3.6 What information should the attestation letter include? Is there a required format?

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.

3.7 What is Health Canada going to do with the attestation letters?

All attestation letters will be recorded, scanned and tracked. Health Canada may also conduct random spot checks.

3.8 How can I submit the attestation letter?

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
Health Canada
101 Tunney's Pasture Driveway
Address Locator: 0201A1
Ottawa, Ontario
K1A 0K9

3.9 Who can I contact for more information on this notice and on the Non-Medicinal Ingredient labelling amendment?

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
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Fax: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca