Canada Post Noc Guidance
Karon Howey
Changes were made to the document 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.
Changes are mainly administrative (e.g., rewording sections to add clarity to existing text, 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 were made to reflect the requirements of new initiatives that have been implemented over the past several years such as: the interim measure on how Health Canada initiated safety changes for human drugs under 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, with the additional requirement of the Canadian Drug Facts Table on the outer label, and as part of the PLL initiative, certain sections of the Guidance Document: Product Monograph(2016-12-09) were revised that resulted in changes to this guidance, (e.g., Part III: Consumer Information changed to Part III: Patient Medication Information and the removal of the References section).
Examples of Level I - Supplements and Level III Changes exclusive to labelling design elements for prescription drugs were 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 is applicable to pharmaceutical, biologic and radiopharmaceutical drugs for human use only. It has been revised to reflect the changes to the reporting categories for the safety and efficacy updates with the implementation of the cost recovery framework on April 1st, 2020. Information pertaining to drugs for veterinary use is not included in this guidance as the Veterinary Drugs Directorate will continue to follow the reporting categories and use the current guidance posted on the Health Canada website.
Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.
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 provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use, including those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.
Information regarding general submission requirements, current processes and target performance standards may be found in the Health Canada Guidance Documents: Management of Drug Submissions and Applications.
The following criteria and examples are meant to provide guidance with respect to the classification of a safety or efficacy related change. For assistance in classifying a change, sponsors are advised to contact Health Canada. Contact information is provided in the Guidance Document: Management of Drug Submissions and Applications.
A Level I change is defined as a change to the label of a drug that has the potential to increase the exposure levels of the drug, either by expanding the population that is exposed (i.e. related to market expansion), or by increasing individual exposure. Label changes that can result in increased exposure levels of the drug include:
j. Health Canada initiated label changes of pharmaceuticals, biologics, and radiopharmaceuticals products for human use that are "necessary to prevent injury to human health" under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law). Refer to the Notice: How Health Canada is managing safety updates when a serious health risk is identified under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) (April 22 2016).
For prescription drug products, refer to the Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs, Section 5.11 for changes that are considered to be necessary to file as a S(A)NDS Labelling Only.
This list is not exhaustive; it is meant to provide guidance on the types of changes that require the filing of a submission for review. Health Canada encourages sponsors to contact the appropriate Directorate should they require further direction on the most appropriate submission type and/or class to file.
Changes included in this reporting category, along with the recommended supporting data (refer to section 4), shall be filed, with Health Canada as a Supplement to a New Drug Submission (SNDS), a Supplement to an Extraordinary Use New Drug Submission (EU SNDS), a Supplement to an Abbreviated New Drug Submission (SANDS), or a Supplement to an Extraordinary Use Abbreviated New Drug Submission (EU SANDS).
Multiple Level I - Supplements for the same drug product may be filed in a single submission (e.g., mock-up label changes and changes exclusive to labelling design elements). However, if too many changes are filed within the same submission or major issues are identified with a change that requires extensive time to review, Health Canada may request the changes be filed under separate submissions.
A Level II - Supplement (Safety) change (i.e. risk/harm management change) is defined as a change to the label that has the potential to improve the management of risk/harm to the population currently indicated for use of the drug, or in any other way exposed to the drug by:
There are some Level II - Supplement (Safety) changes that do not meet the criteria of a Level I - Supplement or a risk/harm management change of a Level II - Supplement (Safety), but for which prior approval by Health Canada is required.
This list is not exhaustive; it is meant to provide guidance on the types of changes that would be considered acceptable as the different Level II - Supplement (Safety) changes. Health Canada encourages sponsors to contact the appropriate Directorate should they require further direction.
A Level III change is defined as any change to the label that is not expected to impact the safety, efficacy, and/or effective use of the drug. The changes included in this reporting category may be implemented by the sponsor without prior review by Health Canada of the data supporting such a change.
For prescription drug products, refer to the Guidance Document Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs, Section 5.11 for changes that are considered Level III Changes - Annual Notifications.
For non-prescription drug products, any change to the layout of the label that does not represent a change to the requirements of Sections C.01.004 and A.01.017 of the Food and Drug Regulations (e.g. contrast, artwork, font, and/or position) or the terms of market authorization.
For non-significant label changes, that requires the filing of a Level III form, refer to the Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs.
This list is not exhaustive; it is meant to provide guidance on the types of changes that would be considered acceptable as Level III changes. Health Canada encourages sponsors to contact the appropriate Directorate should they require further direction.
Notification of a Level III label change should be filed at the time the change is implemented using the Post-Notice of Compliance (NOC) Changes: Notice of Change - Level III Form. The implementation date is the date when the change is made to the labels.
A copy of the revised annotated labels, Product Monograph/Package Insert should only be submitted with the filing of the next Level I - Supplement or Level II NC that necessitates a label change as well. The dates of implementation for these Level III changes should be clearly identified.
Supporting data for 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 of a request.
Depending on the issue or concern, a pre-submission meeting may be arranged to allow more in-depth discussion between the sponsor and Health Canada. Contact information and procedures are provided in Health Canada's Guidance Document: Management of Drug Submissions and Applications.
Health Canada has the mandated responsibility to perform a thorough and rigorous assessment on a drug submission received for a change to a new drug and render an evidence and context-based decision within a specified time frame.
The presence of an information category in these lists does not necessarily mean the data is required. However, it is anticipated that when a specific topic is relevant to a submission, the sponsor will acknowledge and address it by either providing the information, or a rationale as to the absence of the information. This will help to minimize delays that can result when a submission is silent on a relevant topic. As stated in the Foreword of this document, alternate approaches to the principles and practices described in this document may be acceptable to Health Canada provided they are supported by adequate justification.
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