On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft Guidance sets out Health Canada’s expectations for drug manufacturers distributing information about a prescription drug through an electronic platform linked to the drug’s label. Comments may be submitted until May 7, 2021.
I. Scope of Application and Legal Framework
The draft Guidance operates based on Health Canada’s existing legal framework on prescription drug labelling and advertising, meaning the incorporation of electronic labelling is voluntary and supplementary to the existing legal requirements.
As currently written, the draft Guidance would apply when:
- The product is a prescription drug for human use;
- The drug’s label (including package inserts, inner and outer labels, and product monograph) is linked (for example, via URL or 2-D barcode) to an electronic platform (such as a website or mobile application); and
- The electronic platform contains product-specific information.
The draft Guidance does not apply to the use of electronic labelling for clinical trial purposes, or when the electronic platform only contains electronic versions of product monographs or package inserts without any other product-specific information.
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, for example through a link, and
- the electronic platform which has been referenced contains information that speaks directly to topics covered by the label of the drug in question (i.e. drug information).
Electronic materials that meet both these conditions (i.e. electronic labels) must comply with federal drug labelling laws. Information is not considered to be part of a drug's label if:
- it is on an electronic platform that is not linked to the label; or
- the content is unrelated to topics covered by the label of the drug in question (for example, general health information).
An electronic platform can contain both labelling and non-labelling information.
Although an electronic platform can sometimes be an extension of a drug's label, it does not mean all information required to appear on a label can be transferred to an electronic platform. As the terms "inner label" and "outer label" are narrowly defined, the relocation of information required to appear on inner and outer labels to an electronic platform is generally not permitted. The draft Guidance also does not address the appropriateness of disseminating labelling materials that have been traditionally distributed through print (for example, package inserts) using an electronic platform.
II. Electronic labelling guidelines
The draft Guidance specifies seven guidelines when using electronic labels for prescription drugs:
- Incorporation of links should take into account the label’s overall legibility and maximize user accessibility. The location and format of the link should not impede the understanding of information on the label. Recommended strategies to facilitate user access include offering more than one way to connect to the platform (for example, using both a URL and a 2-D barcode), selecting a short, user-friendly URL, and providing a short statement explaining the link’s purpose and instructions for use.
- The design and content of the platform must comply with federal advertising law. To avoid potential violations of prescription drug advertising laws, the Guidance strongly recommends that drug manufacturers submit their electronic platforms for review by an independent advertising preclearance agency prior to launching the platform, even if the content is intended to be non-promotional or the platform is gated to prevent public access.
- Drug information must be consistent with the product monograph while non-drug information must be reliably sourced. While Health Canada will not review non-drug information on the platform, the draft Guidance requires the information to be derived from a trusted, high-quality, and up-to-date source.
- Health Canada approved electronic labels must be clearly separated from other non-labelling information. Electronic platforms containing both drug labelling information and other types of information must not blend the two kinds of information together. Statements such as “Health Canada approved” cannot be used to separate the content on the platform.
- Information must be clear, understandable, and expressed in plain language. Similar to print labels, consideration should be given to print-specific features (such as type style and size, use of white space, colour, and contrast) and accessibility to different types of digital media (such as audio and video content).
- Protecting personal information. Any personal information collected by interacting with an electronic platform is subject to the Personal Information Protection and Electronic Documents Act (PIPEDA), the federal privacy law for private-sector organizations.
- Sponsors must maintain full control over the platform, including third-party links. Drug manufacturers are responsible for any information on, or linked to, the electronic platform and therefore should avoid incorporating links to third-party platforms that are beyond their control or which may become non-compliant.
III. Submission for assessment and approval
Electronic prescription drug labels must be submitted to Health Canada for assessment and approval under the existing regulatory review processes. Drug manufacturers are required to submit mock-ups of the physical and electronic labels at the time of initial filing and the final mock-ups before the issuance of the Notice of Compliance. Subsequent content-related changes to the electronic label will require further submission and approval. The draft Guidance also sets out various formatting and technical requirements. Health Canada encourages drug manufacturers to indicate the inclusion of electronic labelling materials when requesting a pre-submission meeting and to submit questions in writing about the materials.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
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