Notice: Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes – Safety and Efficacy

August 12, 2019

Our file number: 19-110903-997

Health Canada is pleased to announce the release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes - Safety and Efficacy.

The Guidance Document: Post-Notice of Compliance (NOC) Changes - Safety and Efficacy released in September 2009 provides a comprehensive guidance regarding the reporting categories for any post authorization change relating to safety and efficacy and recommendations for supporting documentation.

In June 2015, changes were made to reflect amendments to the Food and Drug Regulations: Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) which came into force on June 13, 2015 for prescription products and those administered or obtained through a health professional.

In February 2016, changes were made to reflect that, under the Plain Language Labelling requirements, Level II and Level III changes no longer require the submission of mock-ups.

In February 2018, administrative changes were made such as:

• the rewording of sections to add clarity to existing text,
• the addition/deletion of examples,
• the addition of new terms to the Glossary, and
• clarification of when Level III changes should be filed and the documentation that should be submitted.

In addition, consequential changes have been made over the past several years to include new initiatives that have been implemented such as:

• The interim measure on how Health Canada initiated safety changes for human drugs under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) (2014) are managed.
• The Plain Language Labelling (PLL) Requirements for all non-prescription drugs that came into force on June 13, 2017. Specifically, the additional requirement of the Canadian Drug Facts Table (CDFT) on the outer label.
• As part of the Plain Language Labelling initiative, revisions to certain sections of the Guidance Document: Product Monograph resulted in changes to this guidance (e.g., Part III Consumer Information changed to Part III: Patient Medication Information and removal of the References section).

This version of the guidance reflects the following changes:

• The name of the Guidance Document for the Management of Drug Submissions is now the Guidance Document: The Management of Drug Submissions and Applications.
• For non-prescription drug products, the addition of two Level I - Supplement examples and the clarification of two Level III Changes.
• Examples of Level I - Supplements and Level III Changes, for prescription drugs have been deleted from this guidance and incorporated into the revised Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs. For non-prescription drugs, the examples for Level I - Supplements and Level III Changes - Annual Notifications remain in the guidance.

This guidance document becomes effective from the date of posting on the Health Canada website. Questions or concerns related to this guidance document should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

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