Health Canada writes guidelines for electronic media in labeling


Posted on March 17, 2021 | Through Michel mezher

Health Canada launched a public consultation last week on its draft guidelines for drug manufacturers on integrating electronic media, such as websites or mobile apps, into prescription drug labeling. .

The public consultation runs until May 7, 2021 and seeks comments from industry, health professionals and the public on the directions proposed by the agency. The draft guidance is built around Health Canada’s existing legal framework for labeling and explains the agency’s expectations of drug manufacturers interested in establishing a link with electronic product labeling platforms. , such as package inserts, inner and outer labels, product monographs, or other sponsor-generated physical material that is included in the drug package or provided at the time of dispensing.

The draft guidance also explains the submission and evaluation process to incorporate links, in the form of bar codes or URLs, to electronic platforms in the labeling or to make changes to already approved electronic labels.

Health Canada notes that the guidelines are limited to prescription drugs for human use and do not apply to the use of electronic labeling for the purposes of a clinical trial or related electronic platforms that only provide versions. electronic product monographs and do not contain additional information. The guide also does not apply to electronic platforms that are not linked to electronic platforms that are not linked to a product label.

According to the proposed guidelines, Health Canada explains that drug manufacturers are authorized to disseminate information via an electronic platform related to labeling in accordance with applicable laws and regulations.

In addition to containing the full and factual account of a product’s claims, properties, conditions of use, safety and efficacy, Product Monographs may also include additional information as long as such information comply with section 9 of the Food and Drugs Act.

“You may wish to disseminate more information to help prescription drug users better understand your product and the condition for which it was prescribed,” writes Health Canada. For example, a company could link to a video showing how to administer a drug or non-drug specific information on 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 label. of the drug. In addition, advertising laws apply to electronic platforms related to prescription drug labels.

The guide provides specific recommendations on the location and format of links and barcodes in labeling, how to comply with advertising law, ensure electronic information is consistent with the approved product monograph, and how separate approved electronic labels and other types of information on electronic platforms. The guide also discusses plain language labeling approaches, privacy protection, and electronic platform maintenance requirements.

Health Canada, Draft Guidelines

© 2021 Society of Regulatory Affairs Professionals.



Daniel C. Williams

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