Draft Guidance Document - Electronic media in prescription drug labelling

(PDF Version)

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• Purpose
• Scope and application
• Policy objectives
• Background

Purpose

This guidance document describes Health Canada’s expectations for distributing information about a prescription drug product using an electronic platform linked to that product’s label.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

Scope and application

The scope of this document is currently limited to prescription drugs for human use. The use of electronic labelling for the purpose of a clinical trial is not within the scope of this document.

This document applies to product-specific electronic platforms, containing drug and other information, that are linked to prescription drug labels.

In this context, an electronic platform refers to any type of electronic technology used to distribute information. Websites are a common example of an electronic platform.

A link refers to any type of reference on a label which points to or provides access to an electronic platform such as a:

• barcode
• web address

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

Electronic platforms that only contain electronic versions of approved PMs (or package inserts), but that do not provide any other product-specific information, are not subject to the same obligations described in this document. Examples of such platforms include corporate websites that contain electronic versions of approved PMs, in addition to corporate and other general information. You are permitted to include a link to such platforms on their product’s label and are not required to resubmit electronic versions of approved PMs to Health Canada for assessment.

Electronic platforms that are not linked to a product’s label are not bound by the same obligations as those platforms that are linked, particularly with respect to federal labelling laws. Because of this important difference, this document only focuses on platforms that are linked to a product’s label.

It is also important to note that the guidance provided in this document 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 (that is, inner and outer labels). The use of electronic media in prescription drug labelling is voluntary and supplementary to existing legal requirements.

This document complements other Health Canada guidance documents related to prescription drug labelling and advertising, such as:

• Guidance Document: Labelling of Pharmaceutical Drugs for Human Use
• Good Label and Package Practices Guide for Prescription Drugs
• Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs
• The Distinction Between Advertising and Other Activities
• Guidance Document - Health Canada and Advertising Preclearance Agencies' Roles Related to Health Product Advertising

Policy objectives

Health Canada’s objective is to ensure that you comply with federal laws when distributing drug and other information electronically. This includes federal labelling and advertising laws under the:

• Food and Drugs Act (FDA)
• Food and Drug Regulations (FDR)

This document also conveys certain expectations that may not be explicitly expressed in legislation or in regulation, but are nonetheless important in support of universally recognized principles such as patient safety and accessibility.

We reserve the right to request information or material, or define conditions not specifically described in this document, in order to allow adequate assessment of the safety, efficacy, or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

Background

Health care providers and their patients have become increasingly reliant on digital technologies as a source of health information. To facilitate access to this information, some sponsors have submitted applications to Health Canada seeking authorization to add useful information to prescription drug labels. This information includes:

• 2D bar code
• links, such as a web address/URL

These links guide users to a product-specific electronic platform with the help of an electronic device.