What is a product monograph? Health Canada PM, where to find it
A product monograph is Health Canada's factual, scientific document on a drug's properties, claims and use. See what it contains and how to find one.
What is a product monograph?
A product monograph (PM) is a factual, scientific document on a drug product. It describes the properties, claims, indications and conditions of use, without promotional material. Health Canada's PM guidance says it holds the information needed for safe and effective use. Authorized monographs are free to download from Health Canada's Drug Product Database (DPD).
Guidance Document: Product Monograph, in force since December 23, 2024, treats the PM as the standard that promotion and advertising of the drug are compared against.
Where the Health Canada product monograph comes from
You won't find "product monograph" defined in the Food and Drug Regulations. The legal hook is indirect. Section C.08.002 requires a new drug submission to include a statement of all the representations to be made for promoting the drug: route of administration, proposed dosage, claims, contra-indications and side effects. C.08.003 does the same for supplements. The guidance says the PM contains all the representations required by paragraphs C.08.002(2)(k) and C.08.003(2)(h).
The guidance says sponsors should include a draft PM with new drug submissions and their supplements. This covers New Drug Submissions (NDS), Abbreviated New Drug Submissions (ANDS) and supplements to either, for prescription or non-prescription drugs. Safety revisions are required when new information becomes available, such as new warnings, precautions or adverse reactions.
Not every drug has one. Health Canada's PM FAQ says "most prescription drugs and some non-prescription drugs" have a PM. Drugs with a long market history and an established safety profile generally don't.
What a drug product monograph contains
The 2024 guidance, section 2, divides a PM into three parts. Part 1, Healthcare Professional Information, contains sections 1 to 12. It covers indications, contraindications, the serious warnings and precautions box, dosing, warnings, adverse reactions and interactions. Other sections address overdosage, dosage forms and packaging, clinical pharmacology, storage and disposal, and special handling. If a package insert is included, Part 1 supplies its content.
Part 2, Scientific Information, holds sections 13 to 17: pharmaceutical information, clinical trials (including comparative bioavailability studies), microbiology, non-clinical toxicology and supporting product monographs. The third part is the Patient Medication Information, a plain-language version drawn from Parts 1 and 2. Older PMs still say "Part III" or "Consumer Information," and the labelling guidance still says "Part III."
The product monograph template
Sponsors now write to a single Product Monograph Master Template dated 2024-12-23. It replaced six earlier templates, including the separate Schedule D and Schedule D biosimilar templates. Health Canada's product monograph index page also lists an XML PM format (guidance and samples are available by email request) and the current notices.
PMs have had to be bilingual since June 13, 2015 for prescription drugs and June 13, 2017 for non-prescription drugs (PM FAQ). If only one language is posted, the final version hasn't been filed or the PM hasn't been updated since then. Under a June 20, 2025 notice, the second-language PM can wait until after the NOC or DIN when both versions are already on the DPD and the Drug and Health Product Portal.
Product monograph vs label
People often treat these as separate things. But legally they overlap. The Food and Drugs Act defines "label" broadly, as "any legend, word or mark attached to, included in, belonging to or accompanying" a drug or its package. Health Canada's labelling guidance reads that to include container labels, package inserts, product monographs, prescribing information and patient medication information. Advertising is generally not drug labelling.
| Product monograph | Inner and outer labels | |
|---|---|---|
| What it is | Full scientific reference for the drug | Text on the container and the package |
| Content | Indications, dosing, warnings, trials, toxicology, patient information | Name, manufacturer, lot, directions, medicinal ingredients, expiry and other required items (C.01.004) |
| Where you see it | DPD PDF | On the product |
For prescribed drugs, a package insert isn't required under the labelling guidance, section 5.4.2. Without an insert, the label should state that the PM, package insert or prescribing information is available on request.
How to find a product monograph in the DPD
The DPD is updated nightly and holds the PM for human drugs (DPD overview). To find one:
- Open the DPD online query.
- Search by brand name, active ingredient, company, ATC code or the 8-digit DIN. The search isn't case sensitive, and it doesn't take punctuation or wildcards (search tips).
- Check the "Product Monograph" column in the results (YES or NO).
- Open the product record and download the PDF. Note the date printed on it.
Use the same search for an Ozempic, Wegovy, Rinvoq or Keytruda product monograph. One brand can have several DIN records. Pick the record that matches the strength and dosage form you need.
Some PMs simply aren't online. The PM FAQ says prescribing information for products authorized before January 2004 may not be posted if no changes have since been filed. In that case, ask the sponsor.
Other Health Canada pages help with a PM's history. The Drug and Health Product Portal carries Consumer Information extracted from PMs, plus Summary Basis of Decision documents. The Notice of Compliance database, listed on the same page, holds authorization dates.
To see what changed in a brand PM, check the monthly product monograph brand safety updates tables, which name the brand PMs revised and the sections changed. A generic's PM should follow its brand, since the DPD overview says generic manufacturers must align their PMs with the Canadian Reference Product.
If you'd rather ask than search, RegAffairs AI has a cited answer on product monographs that links back to the Health Canada sources.
Other things called a monograph
"Monograph" means several different things, which makes searching annoying. In the US, the closest match to a Canadian PM is the FDA prescribing information, often called the package insert. US OTC monographs are different: they set conditions for whole OTC drug categories, and since the CARES Act of March 27, 2020 they're issued as administrative orders. In Canada, nonprescription labelling standards and natural health product monographs also cover categories, not a single drug.