Health Canada drafts guidance on electronic media in labeling

Regulatory NewsRegulatory News
| 17 March 2021 | By Michael Mezher 

Health Canada last week launched a public consultation on its draft guidance for drugmakers on incorporating electronic media, such as websites or mobile applications, in prescription drug labeling.
The public consultation runs until 7 May 2021 and seeks feedback from industry, health professionals and the public on the agency’s proposed guidance. The draft guidance is built around Health Canada’s existing legal framework for labeling and explains the agency’s expectations for drugmakers interested in linking to electronic platforms in product labeling, such as package inserts, inner and outer labels, product monographs or any other physical materials generated by a sponsor that are included in the drug package or supplied at the time of dispensing.
The draft guidance also explains the submission and assessment process for incorporating links, either in the form of barcodes or URLs, to electronic platforms in labeling or making changes to already approved electronic labels.
Health Canada notes that the guidance is limited to human prescription drugs and does not apply to the use of electronic labeling for the purpose of a clinical trial or linked electronic platforms that only provide electronic versions of approved product monographs and do not contain other product-specific information. Neither does the guidance apply to electronic platforms that are not linked to electronic platforms that are not linked to a products label.
Under the proposed guidance, Health Canada explains that drugmakers are permitted to distribute information through an electronic platform linked to labeling in compliance with applicable laws and regulations.
In addition to containing the complete and factual account of a product’s claims, properties, conditions of use and safety and efficacy, product monographs may also include additional information so long as that information complies with Section 9 of the Food and Drugs Act.
“You may wish to distribute more information in order to help prescription drug users better understand your product and the condition for which it was prescribed,” Health Canada writes. For instance, a company could link to a video demonstrating how to administer a medicine or non-drug specific information about disease management.
The agency notes that labeling laws apply to electronic platforms when they are referenced on a drug’s label and the referenced platform contains information on topics covered by the drug’s label. Additionally, advertising laws apply to electronic platforms linked to prescription drug labels.
The guidance provides specific recommendations on the location and format of links and barcodes in labeling, how to comply with advertising law, ensuring that electronic information is consistent with the approved product monograph and how to separate approved electronic labels and other types of information on electronic platforms. The guidance also discusses plain language labeling approaches, the protection of personal information and electronic platform maintenance requirements.
Health Canada, Draft Guidance


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