Post-Notice of Compliance changes: Framework document for veterinary drugs
On this page
Foreword
This page sets out the framework for post-Notice of Compliance (NOC) changes for veterinary drugs. There are 2 companion guidance documents that give detailed instructions about the changes:
- Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs
- Post-Notice of Compliance changes: Quality guidance
- A revised guidance for veterinary drugs is currently under consultation: Post-Notice of Compliance changes: Draft guidance for quality of veterinary drugs
Both guidance documents include:
- detailed instructions about the classification of:
- changes
- criteria
- specific change examples
- recommended supporting data, including any labelling documentation affected by the proposed change
These documents will help industry and health care professionals comply with Health Canada's Veterinary Drugs Directorate's policies, governing statutes and regulations. They also provide review and compliance guidance to staff. This ensures that we implement our mandates and objectives in a fair, consistent and effective manner.
Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable if there is adequate justification to support them. Discuss alternate approaches with the directorate in advance to make sure you meet applicable statutory or regulatory requirements.
The directorate reserves the right to:
- request information or material
- define conditions not specifically described in this document
This allows the department to assess the safety, efficacy, or quality of a therapeutic product. The directorate is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
Read this framework in conjunction with the accompanying notice and relevant sections of other applicable guidance documents. This includes the 2 companion guidance documents mentioned above.
About post- NOC changes
After a new drug (as defined in section C.08.001 of the Food and Drug Regulations) receives a NOC, sponsors may make changes to the drug. A post‐NOC change is any change made to a new drug that has received an NOC pursuant to section C.08.004 of the Food and Drug Regulations (referred to as Regulations hereinafter).
Post-NOC changes can be made for a number of reasons, such as to:
- improve the quality of the product
- increase the efficiency of the manufacturing process
- add new indications, warnings, or other updates to the drug's label
The directorate reviews these changes because:
- any change to a drug may impact its safety, efficacy and quality
- any change to the information associated with the drug (such as labelling) may impact its safe and effective use
If manufacturers make certain significant changes to a drug with an NOC, then they cannot sell the drug unless they seek directorate approval (see Section C.08.003(1) of the Regulations).
The directorate's approach for post-NOC changes considers:
- concepts of risk management
- the practices of other regulatory agencies
- guidelines produced by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and adopted by the directorate
Learn more about:
Classification of changes
We classify post-NOC changes to quality and to safety and efficacy based on the significance of the proposed changes. If the submission is inappropriately classified, the directorate will notify the sponsor, typically at the screening stage.
Level 1: Supplements
Level 1 changes, or supplements, are changes to a new drug that are "significantly different" as it relates to the matters specified in C.08.003 (2) of the Regulations. These changes have the potential to impact the safety, efficacy, quality and/or effective use of the drug.
File all changes included in this reporting category, along with the recommended supporting data, to the directorate as a:
- Supplement to a New Drug Submission or
- Supplement to an Abbreviated New Drug Submission
The sponsor may not implement the proposed change until the directorate issues an NOC.
Level 2: Notifiable changes
Level 2 changes, or notifiable changes, are changes to a new drug that have the potential to impact the safety, efficacy, quality and/or effective use of the drug but do not require the issuance of an NOC.
The sponsor may not implement Level 2 changes until the directorate issues a No Objection Letter.
Multiple Level 2 changes may be filed in a single submission provided those changes are related or supported by the same information. If there are too many changes or the same information doesn't support the changes, the directorate may work with the sponsor to divide the changes into separate submissions to facilitate the review.
In addition, although individual changes may be classified at a particular reporting category (e.g., Notifiable Change), collectively the changes may warrant a higher risk reporting category (e.g., Supplement). Contact the directorate for guidance before you file.
Level 3: Annual notifications
Level 3 changes, or annual notifications, are changes to a new drug that have minimal potential to impact the safety, efficacy, quality and/or effective use of the drug. The sponsor may implement the changes included in this reporting category without the directorate reviewing the data supporting such a change beforehand.
Sponsors should file Level III changes at the time they implement the proposed change. They should submit these changes during the Annual Drug Notification period (Section C.01.014.5).
Level 4: Record of changes (quality only)
Level 4 changes, or Record of changes (quality only), are changes to a new drug that are not expected to impact the safety, efficacy, quality and/or effective use of the drug. The sponsor may implement the changes included in this reporting category without the directorate reviewing the data supporting such a change beforehand. The sponsor or manufacturer should retain these changes as part of the drug product's record.
Drug submission filing information
Refer to the companion guidance documents for complete information regarding filing or notifying post-NOC changes with recommended supporting data where applicable.
The listings of changes in the two guidance documents for quality and safety/efficacy post-NOC changes do not cover all possible situations. Contact the directorate for clarification if in doubt about the classification or supporting documentation.
Supporting data: Level 1 and 2 changes
Learn more about preparing and filing submissions and data to support changes:
- Guidance for Industry: Preparation of Veterinary New Drug Submissions
- Guidance document: preparation of regulatory activities in non‐eCTD format
Consult the companion guidance documents for more details regarding supporting data common to Level 1 and 2 changes.
Supporting data: Level 3 changes
Generate supporting data for Level 3 changes before making the change. You do not need to submit the data to Health Canada, but the directorate may request and review this data at any time. Provide the data within 30 calendar days of a request to review.
Submit your changes:
- at the time you implement the change, or
- during the annual drug notification period, in accordance with C.01.014.5 of the Regulations
File your changes using the Post-Notice of Compliance changes: Level 3 form.
Record of changes: Level 4
The sponsor or manufacturer should retain changes included in this category as part of the product's record. Annotate these changes in the affected documents when you file the next submission to the directorate.
Administrative information
Learn more about submission filings, procedures, review target dates and fees:
Contact the directorate if you need further guidance.
Page details
- Date modified: