Update: Implementation of Plain Language Revisions to Part III: Patient Medication Information and Associated Templates of the Guidance Document: Product Monograph
November 20, 2015
Our reference number: 15-111865-364
In April 2014, Health Canada announced the final release of the revised Part III: Patient Medication Information (formerly titled: Consumer Information) of the Guidance Document: Product Monograph, along with the five revised associated templates. This work aligned with the Department's Plain Language Labelling Initiative, which aims to provide more relevant and easier to understand drug information on labels, so that Canadians can make better informed decisions about their medications.
Phase I of the implementation plan for the Patient Medication Information began on June 1, 2014, and was proposed to run for 18 months, until November 30, 2015. This period was intended to provide industry with sufficient time to transition to the 2014 Patient Medical Information format.
Phase I of the implementation plan means:
- all biologics, radiopharmaceuticals and prescription pharmaceutical products are required to file under the 2014 Patient Medical Information format when filing New Active Substance (NASs) New Drug Submissions (NDS);
- all subsequent submissions of a product already filed in the 2014 format, are also required file in the 2014 format;
- where a corresponding innovator Product Monograph is in the 2014 Part III format, all Abbreviated New Drug Submissions (ANDSs) and Supplements to Abbreviated New Drug Submissions (SANDSs) must file in the 2014 format.
Health Canada is extending Phase I of the implementation plan for the 2014 Patient Medication Information until further notice. The intent is to minimize the burden on stakeholders, as the Department aligns the next implementation phase for the Patient Medication Information with the upcoming revisions to Part I: Health Professional Information and Part II: Scientific Information, of the Guidance Document: Product Monograph in 2016.
For those products falling under the scope of Phase I as outlined above, Health Canada asks that sponsors continue to use the documents implemented June 1, 2014, in place of the Guidance Document: Product Monograph, adopted September 22, 2003; Standard Template (Appendix E), dated February 2010; Notice of Compliance with Conditions Template (Appendix F); Subsequent Entry Products Template (Appendix G); Schedule C Template (Appendix H); and the Schedule D Template (Appendix I).
Please note that under certain circumstances, the 2014 Part III format could be applied to drugs which may otherwise be outside of the scope described for the phased implementation. 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
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
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