Health Canada - DEL Bulletin LEPP No. 62

Health Canada - DEL Bulletin LEPP No. 62

Health Canada is pleased to share a new guide with you, the Management of Applications and Performance for Drug Establishment Licences (GUI-0127). (View or Download) GUI-0127 will be implemented on April 1st, 2020 and is being shared with you now so that you have time to prepare for its implementation. GUI-0127 contains best practices that can and should be used as a reference immediately.
GUI-0127 outlines:
  • the responsibilities of applicants in the Drug Establishment Licence (DEL) application process
  • how Health Canada manages DEL applications,
  • DEL pause-the-clock policy
  • new process improvements for the review of DEL applications, and
  • 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
Health Canada is taking steps to makes this new guidance document available on the Canada.ca website, a DEL Bulletin will be issued to notify you when the document is available online.
Sincerely,
Health Product Inspection and Licensing Division

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