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Electronic media in prescription drug labelling guidance: Submission and assessment

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Pre-submission meeting

You are encouraged to indicate the inclusion of electronic labelling materials if you request a pre-submission meeting prior to filing a submission. You can ask specific submission-related questions about with electronic labels in writing to the designated Health Canada regulatory project manager or senior regulatory affairs officer.

Initial request to incorporate a link to an electronic platform

You can make the initial request to incorporate a link to an electronic platform on a prescription drug label through existing submission pathways including a prescription drug's:

You cannot make a request using:

Like other submissions requiring an assessment of prescription drug labels, you are required to submit mock-ups of physical and electronic labels at the time of initial filing. You must provide final label mock-ups during the review process, before the issuance of the NOC/DIN. You do not need to submit non-labelling materials on an electronic platform (for example, general disease information).

Mock-ups of physical labels, such as inner or outer labels with a newly incorporated link to an electronic platform, should be:

For acceptable file formats, please refer to the electronic Common Technical Document (eCTD) and non-eCTD guidance documents.

Mock-ups of electronic labels consist only of those parts of the platform that speak directly to topics covered by the drug label (that is, the PM). Mock-ups of electronic labels should reflect the format of the electronic material in its final state. For example, if the platform contains an electronic image depicting the administration of the drug, the corresponding mock-up should be submitted as an image file. All forms of non-text media which constitute an electronic label should also be accompanied by a written transcript, or alternative text in the case of an image, to facilitate the review. Non-text media includes:

For certain media formats, such as videos or interactive media, we recognize that it may not always be feasible for you to provide electronic label mock-ups that reflect the final format of the electronic material. This may not be feasible either at the time of filing or before the issuance of a NOC/DIN. In such circumstances, we will accept the following materials, which when taken together, would be considered to represent the important components of a mock-up:

For audio-based information without a visual or interactive component, we will accept a written transcript as a mock-up in lieu of an audio file.
At the time of initial filing, in addition to mock-ups, you are also asked to submit a:

The Note to Reviewer should provide a written overview of the platform, including:

You are also asked to include a wireframe (a visual schematic) that:

While we will not review the design and format of the platform for authorization purposes, the latter information provides important contextual information in order to enhance the review of electronic labels.

In addition to these requirements, we strongly encourage you to submit all electronic materials to an independent advertising agency for preclearance prior to launching an electronic platform.

The Note to Reviewer should also briefly describe:

Request to make changes to an already approved electronic label

Like printed labels, post-market changes to electronic labels require the filing of the appropriate submission type using the same principles outlined in Health Canada guidance documents, including:

However, you only need to submit content-related changes for authorization. You do not need to submit design and format related changes that do not have any impact on the content of electronic labels. You should note that content-related changes are not limited to text-based content. For example, a change in the way that non-text based elements convey drug information would be considered a content-based change.

You must provide mock-ups of affected electronic labels at the time of filing, and submit updated copies prior to approval of the submission. Any change to electronic label content must be consistent with the most current approved version of the PM.
We strongly encouraged you to submit all electronic materials to an independent advertising agency for preclearance before implementing any subsequent changes to the platform.

Submitting files in eCTD and non-eCTD formats

For more information on how to prepare submissions in eCTD format, refer to the:

For more information on how to prepare submissions in non-eCTD format, refer to the:

You should submit mock-ups of electronic labels that are represented in different formats as separate files in section 1.3.2 of an eCTD format or non-eCTD electronic only format submission.
Health Canada performance standards and fees for the review of submissions will apply.

Assessment

We will assess physical label mock-ups by reviewing any words or symbols associated with the newly incorporated link, as well as its impact on the overall design and format of the label.
We will assess electronic label mock-ups by reviewing content elements, including information manifested as text as well as non-text formats. Specifically, we will ensure that:

As part of the pre-market review process, we will not assess:

If we become aware of contraventions to labelling or advertising regulatory requirements following approval, we will make an assessment to determine the most appropriate type of intervention.

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