Management of Applications and Performance for Drug Establishment Licences (GUI-0127) - Summary

From: Health Canada

Overview

The purpose of this document is to outlines; the responsibilities of applicants in the Drug Establishment Licence (DEL) application process and how Health Canada manages DEL applications. This document also covers; DEL application policies, application best practices, and processes and timelines used by Health Canada to manage DEL applications.

Important notice

Revised fees for drugs and medical device will be implemented on April 1, 2020 and have been published in Canada Gazette, Part II on May 29, 2019. To implement the new fees, new policies have been established including the pause-the-clock policy and process improvements have been made for the review of DEL applications. These new policies and process improvements are included in GUI-0127 and will be implemented on April 1, 2020.

GUI-0127 describes a DEL application processes very similar to those currently used by Health Canada and therefore can be used as a reference immediately. Guide-0127 also includes policies that are currently applicable and were previously communicated in DEL bulletins, including:

  • implementation of the new evidence required by date (NERBY), DEL bulletin #1, and
  • issuance practices, bulletin #51

Who this guide is for

This guide is for DEL applicants.

In this guide

View complete guide
Download PDF (1.6 MB, 34 pages)

Details and history

Published: March 18, 2020

For assistance

By email: DEL Question hc.del.questions-leppp.sc@canada.ca

Service standards: We answer to email within 10 business days. If we cannot answer your question within the service standard, we will inform you and we will aim to get you a response as soon as possible.

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