Today, the Natural and Non-prescription Health Products Directorate launched version 1.0.1 of the Amendment and Notification form.
This version will improve the ability to triage amendments and notifications for review.
Fixes within the Product changes section of the form include:
- Addition of a new field to identify whether or not the application is in response to a monograph revision
- Revision of the term “Submitter” to “Application contact”
- Revision to the list of salutations
- Increase in character allowances for city, recommended use or purposes, directions for use, and risk statements
- Improvements to the loading and display of product information for dosage forms, ingredient potencies, dosage ranges, and risk statements
- Addition of the strain field for probiotics
- Inclusion of the dosage unit field in the recommended dosage section
- Correction to how the summary page represents changes to risk information, medicinal ingredient proper name and common name, directions for use, and non-medicinal ingredients
- Revision to the list of application requirements to include the monograph attestation form (MAF) when attesting to a monograph
- Removal of the ePLA (and its generated label) as an alternative to providing a revised label, i.e. only a revised label is required
Additionally, the company code is now a mandatory field in the Company updates section of the form and the Licence transfers section has been removed.
Any questions related to the amendment and notification form can be submitted to our Client Services team via email (hc.nnhpd-dpsnso.sc@canada.ca). To facilitate triaging and timely responses at Health Canada’s end, please include a subject line that clearly indicates the inquiry is related to the amendment and notification form.
To report technical issues, please email Natural Health Products Online Support at hc.nhp.initiative-psn.sc@canada.ca.
