Background
On April 22, 2022, Health Canada issued a notice to the industry on the interim implementation of electronic labelling for human prescription drugs. Consultation on the draft guidance “Electronic media in prescription drug labelling” was open between March 12, 2021, and May 7, 2021. The guidance document released by Health Canada outlines the expectations for distributing information about a prescription drug product using an electronic platform that is linked to that drug product’s label.
An electronic platform refers to any type of electronic technology used to distribute information, for example, a website. A link refers to any type of reference on a label that points to or provides access to an electronic platform such as a barcode or web address.
A drug label is any legend, word, or mark attached to, included in, belonging to, or accompanying a drug. Traditionally, this would include a drugs:
- package inserts
- inner and outer labels
- product monograph (PM)
- any other physical materials that are included in the drug package or supplied at the time of dispensing
Health care providers and medical patients have become more reliant on digital technologies as a source of health information. To facilitate access to this information, some sponsors have submitted applications to Health Canada seeking authorization to add useful information to prescription drug labels, such as 2D bar codes and web addresses/URLs. These links guide users to a product-specific electronic platform with the help of an electronic device such as a phone or tablet.
Interim Implementation Approach
Health Canada has confirmed that in general, replacement of physical labels (package inserts and other physical materials noted above) with ‘electronic labels’ is not being considered at this time for human prescription drugs. If Sponsors would like to include ‘links’ on their physical product labels directing end-users to electronic platforms, the information contained on such electronic platforms should be limited only to the most up-to-date approved Product Monographs and/or Risk Management Plans or other Health Canada approved documents such as risk communications (i.e., verbatim copies). Health Canada has stated that this interim implementation approach may be revisited in the future, after further consultation with stakeholders.
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Conclusion
The interim implementation approach proposed by Health Canada will streamline the regulatory process for both Sponsors and Health Canada, while also facilitating access to up-to-date approved labelling information to end-users.
Sponsors must continue to ensure that their broader electronic platforms remain in compliance with regulatory advertising requirements. At this time, there are no restrictions on what kind of ‘links’ may be used but consideration should be given to ensure adequate accessibility and legibility of the physical labels.
There will be no impact on any previously approved physical labels containing ‘links’ to information included on electronic platforms. The interim implementation approach will be applied on a go-forward basis. Sponsors are encouraged to reach out to relevant operational areas and through regular engagement channels (e.g., pre-submission meetings) to discuss their labelling submission requirements and/or proposals.
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References
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-interim-implementation-electronic-labelling-human-prescription-drugs.html
