Notice to stakeholders: Clarifying post-authorization requirements for quality-related changes to non-prescription drugs
April 2024
In advance of a regulatory proposal amending the Food and Drug Regulations to simplify market access for non-prescription drug products, Health Canada has developed a Non-prescription Drug (NPD) Action Plan. This Action Plan advances the concepts of the Self-Care Framework to reduce burden where possible and to align the level of oversight of NPDs based on their level of risk. This Action Plan introduces policy and operational- based solutions to remove barriers for getting NPDs (excluding ethical drugs, controlled substances, and biocides) to market.
Through this notice, Health Canada is clarifying submission requirements for NPDs, as they are currently outlined in the Guidance Document Post-Drug Identification Number (DIN) Changes (Post-DIN Changes Guidance) and the Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document (Post-NOC Quality Changes Guidance).
Division 1 Non-prescription Drugs:
If a change is proposed to a drug product authorized under Part C, Division 1 of the Food and Drug Regulations (the Regulations), for applicable changes, sponsors must notify Health Canada of the change through the reporting categories outlined in the Post-DIN Changes Guidance.
For Division 1 drugs for which quality data was reviewed as part of the original or subsequent submissions (including but not limited to sterile products, modified release products, transdermal patches, some nasal sprays), the Post-NOC Quality Changes Guidance should be consulted for the required supporting data.
- If the reporting category of the change is defined as Level I – Supplement in the Post-NOC Quality Changes Guidance, the supporting data should be filed as an Application for Drug Identification Number (DINA) Chemistry and Manufacturing (C&M) for applicable Division 1 drugs.
- If the reporting category of the change is not defined as Level I – Supplement in the Post-NOC Quality Changes Guidance, no submission filing is required at the time of the change. The supporting data should be kept on file and be readily available to Health Canada upon request. If the changes impact the labels, updated labels should be submitted during the next submission filing for the product.
Division 8 Non-prescription Drugs:
If a change is proposed to a drug product authorized under Part C, Division 8 of the Regulations, sponsors must notify Health Canada of the change through the reporting categories outlined in the Post-NOC Quality Changes Guidance.
If the reporting category of the change is defined as Level I – Supplement in the Post-NOC Quality Changes Guidance, the supporting data should be filed as a Supplement to a New Drug Submission (SNDS) C&M or Supplement to an Abbreviated New Drug Submission (SANDS) C&M, as applicable.
If the reporting category of the change is defined as Level III – Annual Notification, the change should be submitted using the Post-Notice of Compliance Changes: Notices of Change (Level III) Form. Supporting data for the Level III changes recommended in this guidance document should not be submitted; however, the data should be available to Health Canada within thirty (30) calendar days, if requested at any time. If the changes impact the labelling of the product, updated Product Monograph/Package Insert and/or labels should only be submitted with the filing of the next Level I – Supplement that requires a label change or quality change.
Information Resources
- Guidance Document Post-Drug Identification Number (DIN) Changes
- Guidance document: Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
- Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document
- Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs
Contact Information
Questions can be sent to:
E-Mail: nnhpd-dpsnso@hc-sc.gc.ca