Health Canada changes filing requirements for product monographs

Health Canada changes filing requirements for product monographs

Published on April 10, 2023

Did you know, effective immediately, Health Canada is changing the submission requirements for second language product monographs for human drugs? This is for only post-life cycle management (PLCM) activities.

 The second language product monograph is no longer required at the time of submission filing or during review if it is available in both official languages on the:

  • Drug Product Database (DPD) online and
  • Drug and Health Product Portal (DHPP)

This change applies to product monographs for the following product types:

  • biologic drugs (Schedule D)
  • radiopharmaceuticals (Schedule C)
  • pharmaceutical drugs (prescription and non-prescription)
  • Labels and package inserts are not part of this change.

 The final second language product monograph must still be submitted following the issuance of the notice of compliance (NOC), drug identification number (DIN) or no objection letter (NOL).

The second language product monograph is still required, as set out in the plain language labelling guidance for prescription and non-prescription drugs, if it is:

 available in only 1 language on the DPD and DHPP or

  • for a product that has not yet been authorized

 See below table for more information:

Product monograph (PM) available on DPD Online At time of filing During review Post-authorization
None   

Both official languages preferred

Minimum is first language PM   

Second language PM (if not already provided)    Final second language PM
One official language PM only

Both official language PMs preferred

Minimum is first language PM
Second language PM (if not already provided) Final second language PM
Both official language PMs First language PM only N/A Final second language PM

Blog Contributor: Bhavesh Patel

Reference: Health Canada web accessed on April 4, 2023, 3.50pm.

 

 

 

 

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