Notice: Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes - Safety and Efficacy
June 26, 2018
Our file number: 18-103273-150
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 provided 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.
This version of the guidance reflects the following changes:
Administrative changes 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.
Consequential changes to include the new initiatives that have been implemented over the past several years:
- 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 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
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
- Facsimile: 613-941-1812
- E-mail: email@example.com
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