The Natural and Non-Prescription Health Products Directorate (NNHPD) has published a handy tool ahead of schedule (dated Winter 2017) to remind applicants about the attestation process for natural health product license applications. The monograph attestation form should be completed for all applications where one or more ingredients is supported by an NHP monograph, otherwise known as pre-cleared evidence.
The attestation process involves confirming that either all or part of the conditions contained within a monograph are met by the product for which a product licence application has been submitted.
The best strategy and quickest route to approval of natural health products (dietary supplements) is to maximize the use of pre-cleared evidence when ever possible in order to avoid submitting safety and efficacy evidence to support your product. This should be kept in mind for both new applications and post-license amendments, as the attestation form is required for both type of applications.
The attestation forms have been revised since their introduction, and now allow for partial attestations. There are two potential scenarios for the attestation process:
Either your application is completely supported by information in a monograph and you would therefore select the first box on Page 1 of the form; or alternatively your application contains a combination of information based on pre-cleared information (monographs) and additional evidence for review. Note when this option is chosen then the Table on Page 2 of the form must be completed.
The electronic product license application forms contain an embedded monograph attestation form, and there is also a stand-alone version that can be provided with the application at the following link: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/forms-templates/monograph-attestation.html.