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

From Health Canada

Current status: Closed

Opened on October 31, 2018 and will close to new input on November 30, 2018.

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.

Join in: how to participate

Send us an email

If you have comments related to Drug Establishment Licences, send an email to hc.del.questions-leppp.sc@canada.ca with your ideas or comments to make yourself heard. Please use the subject line "Pause-the-clock feedback".

If you have comments related to Medical Device Licences, send an email to hc.mdel.questions.leim.sc@canada.ca with your ideas or comments to make yourself heard. Please use the subject line "Pause-the-clock feedback".

Webinar

Health Canada intends to schedule targeted webinar sessions with impacted stakeholder associations. Health Canada will be contacting associations shortly. Associations that wish to participate can identify themselves via email to: hc.del.questions-leppp.sc@canada.ca.

Who is the focus of this consultation

We will engage with:

• 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

Consultation Questions

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

Your ideas and input are sought around 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 days (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.

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 Drugs by email to hc.del.questions-leppp.sc@canada.ca with the subject line "Pause-the-clock feedback" or provide your comments related to Medical Devices by email to hc.mdel.questions.leim.sc@canada.ca with the subject line "Pause-the-clock feedback".

Attend a meeting

Health Canada intends to schedule targeted webinar sessions with impacted stakeholder associations. Health Canada will be contacting associations shortly. Associations that wish to participate can identify themselves via email to: hc.del.questions-leppp.sc@canada.ca.

Related information

• Revised Fee Proposal for Drugs and Medical Devices

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