What Health Canada requires
- Guidance Document: Product Monograph (adopted August 30, 2024, effective December 23, 2024): for products that have received a Notice of Compliance (NOC) and are marketed, the product monograph must be available in both official languages.
- For prescription products and those administered or obtained through a healthcare professional, the product monograph is supplied to Health Canada in Canadian English and French.
- The monograph has three parts: Part 1, Healthcare Professional Information; Part 2, Scientific Information; and the Patient Medication Information, in plain language, aiming for a Grade 6 to 8 reading level.
- Since March 10, 2023, the second-language version is no longer required at filing or during review if both versions are already on the Drug Product Database (DPD) and the Drug and Health Product Portal (DHPP). The final second-language version is still required after the NOC, DIN or no objection letter is issued.
- The guidance refers to the final second-language monograph being filed within 20 days of authorization: the translation is prepared before approval.
What we translate
- Complete monographs: Part 1, Part 2 and Patient Medication Information.
- Updates: only the changed sections are retranslated and reviewed, from the previous version.
- Package inserts drawn from the Healthcare Professional Information.
- Submission documents: response letters and regulatory correspondence.
How we work
- Translation by a medical translator, then review by a second linguist.
- Headings and standard statements taken from Health Canada’s master template in the target language.
- Patient Medication Information: plain language preserved, consistent with Parts 1 and 2.
- One translation memory per product: the same terminology from one revision to the next. Word file preserved, with tracked changes if you wish.
Scientific and regulatory content remains the sponsor’s responsibility: we translate the version the sponsor has prepared. Approval rests with Health Canada.
Frequently asked questions
When must the second-language monograph be filed?
Since March 10, 2023, it is no longer required at filing or during review if both versions are already on the DPD and the DHPP. The final second-language version must be submitted after the NOC, DIN or no objection letter is issued; the guidance refers to filing within 20 days.
Is a certified translation required for a product monograph?
Health Canada’s guidance does not mention certified translation. It states that the sponsor is responsible for ensuring that any translation of the Patient Medication Information accurately reflects the meaning of the authorized version. We deliver a medical translation reviewed by a second linguist.
Which French do you use?
Canadian French: the guidance asks for the monograph in Canadian English and French. Our translators apply the terminology and typography used in Quebec, not those of France.
Do you translate updates to an approved monograph?
Yes. Send us the revised version with tracked changes: we retranslate the changed sections using the translation memory of the previous version, then a second linguist reviews the whole document.
How much does a monograph translation cost, and how long does it take?
Price and turnaround depend on length, document type (new monograph or revision) and how much was already translated. Tell us the expected authorization date so we can plan the translation, and send the document for a quote.
- Health Canada: Guidance Document – Product Monograph (2024)
- Health Canada: filing requirements for second-language product monographs (notice)
- Health Canada: product monograph master template
Rules checked on October 18, 2026. Check the requirements that apply to your product.