Know whether your application is ready to file.
Ask what a Health Canada monograph requires, and check your Product Licence Application against the monographs it attests to.
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CheckingA lysine product at 4,000 mg per day
Comparing with the monographs
Recorded from this system.
How it works
Ask in your own words
Every answer names the monograph section it came from.
Upload the exported form
Read in memory, checked, and never stored.
Fix what the report finds
Each finding quotes the monograph text behind it.
What a check covers
Every answer and every finding quotes the Health Canada monograph passage behind it, and each report lists what it checked and what it did not.
Checked here
Daily doses
Every daily dose against the bounds its monograph sets.
Risk statements
The risk and duration statements the monographs require.
Attested versions
The monograph versions the application attests to.
Internal consistency
Quantities the form contradicts within itself.
Route and dosage form
Route of administration and dosage form against each monograph.
NHPID ingredients
Whether each non-medicinal ingredient was chosen from the NHPID.
Screened by the NNHPD, not here
Brand name
Reviewed by the NNHPD under section 9(1) of the Food and Drugs Act.
NHPID limitations
Whether each non-medicinal ingredient meets the limitations the NHPID sets for it.
Label layout
Label text and the product facts table.
Class III evidence
The evidence that supports a Class III application.
A report is consistency with the monographs held here. It is not a Health Canada decision and does not predict one.