Consultation: Electronic media in prescription drug labelling draft guidance document

From Health Canada

Current status: Open

Opened on March 12, 2021 and will close to new input on May 7, 2021.

This draft guidance describes Health Canada's expectations for drug sponsors interested in distributing information about a prescription drug product using an electronic platform (for example, website, mobile application) that is linked to that product's label. It also provides information on how sponsors can apply to incorporate an electronic platform into their prescription drug label.

This draft guidance is based on Health Canada's existing legal framework. As such, information distributed through an electronic platform generally cannot replace information that is required by law to appear on a drug's physical label. The use of electronic media in prescription drug labelling is considered voluntary and supplementary to existing legal requirements. Furthermore, this document does not address the appropriateness of disseminating labelling materials that have been traditionally distributed through print (for example, package inserts) using an electronic platform.

How to participate

Send us an email

Send an email to hc.policy.bureau.enquiries.sc@canada.ca with your ideas or comments to make yourself heard.

Who is the focus of this consultation

Health Canada wants to hear from:

Goals of the consultation

We are seeking comments on the draft guidance. We will use input gathered through this consultation to finalize the guidance document.

Contact us

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9
E-mail: hc.policy.bureau.enquiries.sc@canada.ca

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