Consultation on the Pause-the-Clock Proposal for Drug and Medical Device Establishment Licence Applications

From Health: Canada

Current Status: Open

We want your feedback on the development and implementation of the Pause-the-Clock mechanism for Drug and Medical Device Establishment Licence applications. The purpose of the pause-the-clock is to allow applicants the opportunity to rectify application deficiencies during the review of the application, but that this time is not counted as Health Canada time.

Who this document is for

We are seeking the views of:

  • people who work with drugs as:
    • fabricators
    • packagers
    • labelers
    • testers
    • distributors
    • importers
    • wholesalers
  • people who work with medical devices as:
    • Class I manufacturers
    • Importers
    • Distributors
  • Others who are interested

What

We are interested in stakeholder feedback on the following questions:

  • What are your thoughts on the proposed triggers listed? Please provide specific feedback on the proposed triggers.
  • Can you think of a situation in the application process beyond those mentioned within our proposal where a trigger could be used?
  • When would it be valuable from industry's point of view to be able to pause the clock? Please describe under what circumstances this would occur.
  • Is the proposed maximum 20 business day (1 month) of paused clock before rejecting an application reasonable? Would you suggest a shorter or longer timeframe? Please describe situations where more or less time would be more appropriate.

When

Feedback on the public consultation on the proposal will be collected between October 31, 2018 and November 30, 2018.

How to participate

  1. Read our Proposal: Pause-the-Clock Proposal for Drug and Medical Device Establishment Licence Applications
  2. Consider the four questions highlighted above.
  3. Provide your comments related to Drug Establishment Licences by email to hc.del.questions-leppp.sc@canada.ca and your comments related to Medical Devices Establishment Licences by email to hc.mdel.questions.leim.sc@canada.ca. Please use the subject line "Pause-the-clock feedback".

Related information

Contact us

Regulatory Operations and Regions Branch
Jeanne Mance Building
200 Eglantine Driveway, 13th Floor
Address Locator 1913B
Tunney's Pasture
Ottawa, Ontario K1A 0K9
Email: hc.del.questions-leppp.sc@canada.ca
hc.mdel.questions.leim.sc@canada.ca

Details and history

Published:

[Month DD, YYYY]

Updated:

May 18, 2015 (see all updates)

Consulted:

[Month DD, YYYY] (see all consultations)

Part of topic(s):

Guidance on legislation, [other relevant topic or content]

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