Notice - Release of draft Part I: Health Professional Information and Part II: Scientific Information - Guidance Document: Product Monograph

Notice to the reader:

The online consultation is now closed.

December 19, 2014
Our file number: 14-114988-418

As part of the Health Products and Food Branch's Plain Language Labelling Initiative, Health Canada is working to improve drug product labels. In June 2014, Health Canada began implementation of the revised Patient Medication Information section of the Product Monograph. Health Canada is now proposing revisions to Part I: Health Professional Information, and Part II: Scientific Information - Guidance Document: Product Monograph.

The Product Monograph is intended to provide the necessary information for the safe and effective use of a new drug and also to serve as a standard against which all promotion and advertising of the drug can be compared. The information described in Part I (Health Professional Information) of the Product Monograph contains information required for the safe and appropriate prescribing, dispensing and administering of the medication. The information in Part II (Scientific Information) contains more in-depth and complete scientific/research information such as toxicology and data from animal studies and human clinical trials. It complements and extends the information contained in Part I. Parts I and II of the Product Monograph were adopted in 2004 and haven't been revised since that time.

The proposed revisions to Parts I and II of the Product Monograph will make health professional information in the Product Monograph easier to read and critical safety information easier to find. This is a key aspect of plain language labelling.

Recognizing the importance of broad input in our decisions, Health Canada now welcomes your comments on these proposed changes; particularly any comments you have on the following topics:

  • Restriction on the reference section
  • More clarity on comparator data expectations
  • More clarity on adverse reactions
  • More specificity with respect to pediatric data
  • Streamlining toxicology
  • Streamlining pharmacology
  • Rearranging the placement of certain information
  • General plain language improvements
  • General editorial improvements

In order to see the proposed revisions to Parts I and II of the Product Monograph, please request a copy of the: Draft Guidance Document: Product Monograph. Once you submit your email request, we will send you the draft guidance, a Product Monograph template, and a comment template. Revised sections of the draft guidance will be highlighted.

Comments should be submitted before March 4, 2015 to the address below:

  • Bureau of Policy, Science and International Programs
    Therapeutic Products Directorate
    Health Products and Food Branch
    Health Canada
    1600 Scott Street
    Holland Cross, Tower B
    2nd Floor, Address Locator 3102C1
    Ottawa, Ontario
    K1A 0K9
  • Telephone: 613-948-4623
    Fax: 613-941-1812

We appreciate your time and effort as we work together to improve the health and safety of all Canadians.

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