Health Canada changes filing requirements for product monographs
Published on April 10, 2023Did 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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