COVID-19 SL Transition process and New Web-Based SLA Form

Posted Date: 3-August-2021

DEL Bulletin LEPP No. 117 Health Canada transitions interim order to the FDR for importing, selling, & advertising drugs in relation to COVID-19

Posted By:  Linitha Ganesh

 

Important Notice to COVID-19 Site Licence Holders – 60 Day Notice and New Application Form

The Natural and Non-prescription Health Products Directorate has released their 60-day Notice for COVID-19 Site Licence Holders.  Cosmetics Alliance and stakeholders have engaged with Health Canada on the transition process and what it should look like over the last number of months via surveys and stakeholder engagement sessions.  As a reminder, COVID-19 Site Licence holders were afforded authorizations under an interim pathway to allow the import, manufacture, package, and label alcohol-based hand sanitizers using an expedited process with reduced evidential requirements.

If you are the holder of a COVID-19 Site Licence you are required to act before September 30th if you:

  • wish to continue activities beyond September 30th
  • do not wish to continue activities beyond September 30th
  • have already stopped or never carried out activities

Should you not act before September 30th you are required to cease your activities affective at the end of September 30th.  For details on these three categories see here

Health Canada has implemented a web-based application form for the Interim COVID-19 Site Licence transition pathway to enable stakeholders and Health Canada to process applications more efficiently for stakeholders wishing to continue activities beyond September 30th.

Health Canada has provided details on:

 

Health Canada releases version 2.0 of the Harmonized Site Licence and Foreign Site Reference Number Web-Based Application Form

The revised application form was released on July 24th to address several overall improvements to the form and to add a pathway for COVID-19 Site Licence to transition to full Site Licenses allowing for a more efficient application process for stakeholders and processing by Health Canada.

Cosmetics Alliance is pleased with the progress in enabling on-line systems for use by stakeholders.  These on-line systems are an integral portion of the Self-Care Framework in enabling the concept of pre-cleared information (PCI) in making application processes more efficient for stakeholders and the regulator.

For details on how to transition from a COVID-19 Site Licence to a full Site Licence please click here.

For details on the overall improvements to the web-based form in general, please click here.