Notice to stakeholders: Additional guidance for label mock-up requirements for non-prescription drugs

December 2022

In advance of a regulatory proposal amending the Food and Drug Regulations to simplify market access for non-prescription drug products, Health Canada has developed a Non-prescription Drug (NPD) Action Plan. This Action Plan advances the concepts of the Self-Care Framework to reduce burden where possible and to align the level of oversight of NPDs based on their level of risk. This Action Plan introduces policy and operational-based solutions to remove barriers for getting NPDs (excluding ethical drugs, controlled substances, and biocides) to market.

Through this notice, and effective immediately, Health Canada is providing additional guidance on the label mock-up submission requirements for NPDs for certain post-authorization amendments. Additionally, Health Canada is introducing options to submit alternative documentation to mock-up requirements for certain post-authorization changes outlined in the Food and Drug Regulations.

The guidance provided in this Notice should be used in conjunction with the Guidance Document Post-Drug Identification Number (DIN) Changes, Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document, the Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document, and/or the Guidance Document: Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs.

Additional guidance on label mock-up requirements

The label mock-up of a NPD is not required for submissions or applications filed for post-authorization amendments that do not impact labelling (e.g., certain quality changes). For additional clarity, this signifies that sponsors may submit or apply to make changes to their product license, as prescribed by the Food and Drug Regulations, without submitting label mock-ups for review, if the changes do not impact labelling.

Post-authorization changes filed under the administrative pathway

These apply to manufacturer name change, change in product ownership and merger/buyout, and labelling update to match licensor.

When submitting these changes, instead of submitting mock-ups for all Stock-Keeping Units (SKUs), sponsors may instead submit one representative label for SKUs with identical label format, accompanied by an attestation filed by the company that no other elements of the labels have been revised, and no new package size variants are being introduced. For added clarity, this means that where there are no differences other than pill count or volume on the label, and/or manufacturer name and address, submitting the smallest format and attesting that the other labels will have identical text, format, size, layout, colour, with all minor differences clearly cited, is acceptable. The submission should contain inner and outer labels of the representative package format, and the corresponding product monograph, leaflet, and electronic Canadian Drug Facts Table (eCDFT), as applicable.

The Labels and Packages Certification Form for NPDs will be updated to include the attestation.

To be eligible for administrative processing, these submissions/applications should not contain scientific data, or require regulatory review, as outlined in the Guidance Document: Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs. All aspects of the product, except for the manufacturer name and address, must be identical to those previously authorized for that product, including the product’s name. Any deviations from the previously authorized product are not accepted under the administrative pathway.

Post-authorization changes other than administrative changes

Private labels:

• Sponsors will be permitted to file a masterboard for each representative label format for changes to the text of the Canadian Drug Facts Table (CDFT) and other panels (other than the principal display panel (PDP)) of the inner and outer labels.

This masterboard would apply to all the private brands as well, eliminating the need to review each private brand’s label. In this case, the private brands’ labels would not need to be submitted.

• For changes affecting only the PDP, PDPs of inner and outer labels for one (1) representative SKU per private brand should be submitted.

Quality changes impacting labels:

When a submission or application is filed for qualitative changes to non-medicinal ingredients or change to storage conditions,

• For private brands, the requirements for mock-up labels for private labels stated above would apply for these quality changes.
• For all other products, sponsors would be permitted to submit representative labels for non-identical label formats.

Regarding Division 1 products where a Post-authorization Division 1 Change (PDC) is filed, the Labels and Packages Certification Form for Non-prescription Drugs will be updated to include attestation that representative labels are submitted.

In order to facilitate review, a Note to Reviewer should be included:

• Indicating which labels are mock-up label(s) of smallest package size(s) representing identical labels.
• Stating the control number(s) under which the complete private brand labels were approved, to allow Health Canada to link mock-ups.

Please note that these changes do not impact other aspects of PLL review and requirements, as outlined in the Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs .

Information resources

• Guidance Document: Post-Drug Identification Number (DIN) Changes
• Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document
• Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document
• Guidance Document: Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs

Contact information

Questions can be sent to:
E-Mail: nnhpd-dpsnso@hc-sc.gc.ca