Management of NHP Applications
Health Canada’s Natural and Non-Prescription Health Products Directorate provided an update today to their management policy for product license applications during a live webinar for industry. The updated performance targets were confirmed during the webinar and are as follows.
Class I applications, where all conditions of a monograph are met will be reviewed within 60 calendar days. Class II applications, where all conditions of more than one monograph are met will be reviewed in 90 calendar days. Class III applications are reviewed in 210 calendar days which includes a 30-day screening period followed by a 180-day review.
Heath Canada confirmed that these revised timelines are currently in place and have been for several months. There are many reasons behind the protracted review of even the most straight forward applications, such as a high volume of applications, limited resources and the findings during post-license audits that many applicants were not fully compliant with the monographs for which they had provided attestations.
Additional details on the Natural and Non-Prescription Health Products Directorate (NNHPD) expectations for submissions can be found in the updated Natural Health Products Management of Applications Policy which was published in April 2019 and is now available on line.
New changes are on the horizon for applications. The eSubmission builder that was in use for on-line packaging of applications will be phased out. The ePLA form that is used in association with the eSubmission builder program will also be phased out and will not be accepted after the fall of 2019. Instead applicants should use the new web-based application form.
The new web-based application form should also be used when filing any post-license amendments, even if original applications were filed using the ePLA form. Revised product labels are required for post-license amendments, and applicants who submit amendments without a corresponding updated label will face a refusal of their amendment submission.
The NNHPD is optimistic that once the new web-based application form is in use by all applicants, the review times may get faster once again, as the new forms allow the NNHPD to easily and quickly validate whether or not products are compliant with all requirements of the monographs.
The ePost connect system is still the communication method of choice for applicants to provide information to NNHPD for review.
The NNHPD expects all applicants to understand with confidence whether their application is a Class I, Class II or Class III application. A statement regarding the classification should be included in the cover letter that accompanies the application. Those applicants that provide the wrong information regarding product classification will see their submissions being refused by the NNHPD and will therefore need to withdraw and refile their product license applications.
Link to new Guidance Document: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-health-products/legislation-guidelines/guidance-documents/management-product-licence-applications-attestations.html#4.7
