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

December 9, 2016
Reference number: 16-113259-317

This notice was updated on May 12, 2020.

Under the continuing efforts of the Health Product and Foods Branch's Plain Language Labelling Initiative, Health Canada has revised Part I: Health Professional Information, and Part II: Scientific Information - Guidance Document: Product Monograph and the five associated templates for prescription products.

Comments received during consultations on Parts I and II were taken into consideration during the development of the finalized guidance document and templates. These updated sections, along with the Patient Medication Information section (that is, Part III, formerly titled: Consumer Information) which was implemented on June 1, 2014, complete the updates to the Guidance Document: Product Monograph.

The revisions to Parts I and II of the guidance document and templates will make health professional information easier to read and critical safety information easier to find in the Canadian Product Monograph. Some of these revisions include:

• Removal of the References section
• More specificity with respect to inclusion of pediatric data
• Streamlining toxicology information
• Streamlining pharmacology information
• Moving dosing information closer to the top
• General plain language and formatting improvements
• Improved navigation

In order to provide industry with sufficient time to transition to the new format, there will be a 6 month delay before implementation.

As of June 9, 2017, the following submission types are required to file under the 2016 format, for biologics and radiopharmaceuticals and for prescription pharmaceutical products:

• New Drug Submissions (NDSs)
• Abbreviated New Drug Submissions (ANDSs) and Supplements to Abbreviated New Drug Submissions (SANDSs), where the corresponding innovator PM is in the 2016 format

Furthermore, beginning June 9, 2017, sponsors are also required to file under the 2016 format for Part III of the Product Monograph, for biologics and radiopharmaceuticals and prescription pharmaceuticals, for the same submission types outlined above. This expands the scope of the 2014 Patient Medication Information section which is currently required for New Active Substance (NASs)/NDS.

The implementation plan will be in effect for a minimum of 2 years, after which time the Department will assess the scope and next steps for a broader implementation.

Under certain circumstances, the 2016 format could be applied to drugs which may otherwise be outside of this scope described. In these cases, Health Canada will notify the sponsor.

Any questions should be directed to:

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 3102C5
Ottawa, Ontario
K1Y 4N7

Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca