New filing requirements for second language product monographs and package insert mock-ups: Notice
June 20, 2025
Our file number: 25-101629-22
On March 10, 2023, Health Canada changed the submission requirements for second language product monographs (PM) for human drugs.
Effective immediately, the filing requirements for second language package insert (PI) mock-ups for human drugs has been provided below for clarification purposes.
This change applies to the following product types:
- biologic drugs (Schedule D)
- radiopharmaceuticals (Schedule C)
- pharmaceutical drugs (prescription and non-prescription)
Note: Package labels are not in scope of this change.
Second language product monograph
The second language PM is no longer required at the time of submission filing or during review if it is available in both official languages on the:
The final second language PM 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 PM 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
| 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 languages 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 |
Second language package inserts mock-ups
The second language PI mock-up is no longer required at the time of submission filing or during review if all of the following requirements are met:
- A second language PM is not required to be submitted at the time of filing or during review as outlined in the table.
- The PI mock-up was reviewed and approved after the plain language labelling requirements were implemented on June 13, 2015.
- The design (font size, font type, layout and amount of white space) of the PI mock-up is to be consistent with the last approved version once the proposed revisions are implemented.
The final second language PI mock-ups must still be submitted following the issuance of the notice of compliance (NOC), drug identification number (DIN) or no objection letter (NOL).
| All requirements have been met | At time of filing | During review | Post-authorization |
|---|---|---|---|
| No | Both official languages preferred Minimum is first language PI mock-ups |
Second language PI mock-ups (if not already provided) | Final second language PI mock-ups |
| Yes | First language PI mock-ups only | N/A | Final second language PI mock-ups |
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