Guidance document: Electronic Canadian Drug Facts Table (eCDFT) Technical Standards

From Health Canada

Overview

This guidance document provides direction to sponsors, manufacturers and license holders on the technical web publication standards for the Electronic Canadian Drug Facts Table (eCDFT) of non-prescription drugs.

The outlined approaches are intended to provide consumers access to on-line information presented in a standardized format, which supports the implementation of the Plain Language Labelling (PLL) Regulations.

Who this guide is for

The guide is intended for regulated parties (industry) who are affected by the regulations.

In this guide

• 1. Introduction
  • 1.1 Objectives
  • 1.2 Policy Statements
  • 1.3 Scope and Application
  • 1.4 Background
• 2. Technical Requirements for Electronic Canadian Drug Fact Table
  • 2.1 Languages
  • 2.2 URL (Uniform Resource Locator) naming conventions
  • 2.3 Use of two-dimensional (2D) barcodes
  • 2.4 Technical approaches for accessing individual eCDFT
  • 2.5 Web Experience Toolkit publication template
  • 2.6 Using a third party
• 3. Important accessibility considerations implemented in the wet templates
  • 3.1 Accessibility considerations
  • 3.2 Language of the Page
  • 3.3 Non-text Content
  • 3.4 Sensory Characteristics
  • 3.5 Language of Parts
• 4. Submission Process

View complete guide

Details and history

Published: August 01, 2017

Updated: September 28, 2018

Consulted: June 26, 2018