March 10, 2023
Our file number: 23-101262-834
Health Canada is currently making changes to the second language product monograph submission requirements for human drugs.
The second language product monograph is no longer required at the time of submission or during review if the document is available in both official languages in the following portals:
This amendment applies to the following product monographs:
- Biological drugs (Appendix D)
- Radiopharmaceuticals (Annex C)
- Pharmaceutical drugs (prescription and non-prescription)
Product labels and package inserts are not affected by this change.
The final second language product monograph must be submitted following the issuance of the Notice of Compliance (NOC), Drug Identification Number (DIN) or Letter of No Objection (LNO).
The second language product monograph is still required as outlined in the plain language labeling guide for prescription and non-prescription drugs if:
- It is available in one language only on the BDPP and PMPS or
- The product of the monograph in question has not yet been authorized
| Product Monograph (PM) available on the DPD online | Deposit | During the exam | Post-authorization |
|---|---|---|---|
| None | Preferably available in both official languages The PM must be provided at least in the first language |
PM in second language (if not already provided) | Final PM in second language |
| One official language | Document preferably available in both official languages The PM must be provided at least in the first language |
PM in second language (if not already provided) | Final PM in second language |
| Both official languages | First language only | S.O. | Final PM in second language |