Notice – Interim implementation of electronic labelling for human prescription drugs
April 22, 2022
Our file number: 21-120620 – 181
Consultation on the draft guidance "Electronic media in prescription drug labelling" was open between March 12, 2021 and May 7, 2021. Based on some stakeholder feedback received and additional considerations related to business delivery, this notice serves to communicate Health Canada's intent to adopt the interim implementation measures detailed below.
As a reminder, Health Canada considers information on an electronic platform to meet the definition of a label when:
- reference to the electronic platform is made on a drug's label, defined as a 'link' in the aforementioned draft guidance; and
- the electronic platform that has been referenced contains information that speaks directly to topics covered by the label of the drug in question (i.e., claims, properties, conditions of use and safety and efficacy information), that is drug information.
Electronic materials that meet both of these conditions, henceforth referred to as 'electronic labels', must comply with federal drug labelling laws.
A drug label refers to any legend, word or mark attached to, included in, belonging to or accompanying a drug. Traditionally, this definition has been applied to a drug's:
- package inserts
- inner and outer labels
- product monograph (PM)
- any other physical materials generated by a sponsor that are included in the drug package or supplied at the time of dispensing
Interim implementation approach
- As a general policy approach, replacement of physical labels (package inserts and other physical materials noted above, which satisfy regulatory requirements) with 'electronic labels' is not being considered at this time for human prescription drugs.
- If Sponsors choose to include 'links' on their physical 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).
- This interim implementation approach may be revisited in the future, after further consultation with stakeholders.
Such an interim implementation approach will greatly streamline the regulatory process for both Sponsors and Health Canada, while still facilitating additional access to up-to-date approved labelling information to end-users.
Notwithstanding the above interim implementation approach, the role of advertising pre-clearance agencies remains valuable to Sponsors 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 to 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 continue to be 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.
For any comments or inquiries related to this notice, please contact:
Bureau of Policy, Science and International Programs, Therapeutic Products Directorate
Please include "Interim Implementation of Electronic Labelling for Human Prescription Drugs" in the subject line.
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