Proposed Changes to the Natural Health Products Management of Applications Policy (NHP MAP)
In February 2018, the Natural and Non-prescription Health Products Directorate (NNHPD) invited stakeholders to partake in a discussion about proposed changes to the existing management of applications policy (MAP)to enhance the quality of applications and streamline the licensing process for Natural Health Products (NHPs). A proposed MAP was made available for a 60-day written feedback period with stakeholders ending on November 5, 2018.
With the final policy slated for publication in spring 2019, the following key areas of the MAP should be considered as industry members prepare for change and look for ways to seamlessly incorporate these amendments into their practices.
Product Application Timelines
The NNHPD reported a high refusal rate in 2018, especially for Class I and II applications, which resulted in a longer review time for these applications. Consequently, under the revised policy, NNHPD plans to increase the length of the service standard for these applications: Class I Product License Applications (PLAs) will be subject to a 60-calendar day review and Class II PLAs subject to a 90-calendar day review.
Following in the steps of a more comprehensive approach, the policy outlines a proposed limit of two Information Request Notices (IRNs) to be issued during product assessments on the premise that these will be more in-depth in review. We will also see the 2-day IRN response time be changed to a 5-day turnaround allowing for a more feasible response period for industry players.
In response to the high refusal rates with applications and the sometimes high number of IRNs received for an application, the NNHPD will shift their focus to screening. The NNHPD has recognized the refusal criteria is not clearly defined and currently, a “Rejection Notice” is issued for files with administrative deficiencies. Moving forward with the finalized MAP, the NNHPD will more readily exercise their refusal powers for administration and application deficiencies and rename the “Rejection Notice” to a “Notice of Refusal” to align with terminology used under the Natural Health Product Regulations (NHPR).
Information Technology Modernization
In March 2018, the NNHPD unveiled a web-based Amendment and Notification form (ANF). Using this online form ensures amendments and notifications fall within the confines of the regulations, as the online form will not support fundamental changes or non-notifiable changes.
Additionally, in November 2018, NNHPD rolled out a web-based Product Licence Application (PLA) form. This initiative includes auto-population of data entry fields, as new monographs have and will continue to be prepared to support this web-based function. An in-form monograph attestation form will also support this new modernization effort, providing more functionality over the current PDF based forms. Although the web-based PLA form has recently become available for use, applicants are still permitted to use the current PDF based form until November 23, 2019. It is expected all monographs will be updated by spring 2019, allowing a smoother implementation of this web-based model for PLAs going forward.
Statements to the Effect of (STTEO) and Monograph Revisions
Monograph updates currently being undertaken by the NNHPD aim to remove “statements to the effect of” (STTEO) for claims and risk statements. This will better enable electronic validation of the web-based model for PLA submissions and will also help to reduce subjectivity of information.
In further efforts to support the web-based PLA form, other types of revisions are also being undertaken, including:
- Revision to risk statements to start with action (i.e. “Consult a health care practitioner” comes first)
- Removal of appendices
- Representation of proper, common name and source material (to match NHPID)
- Consistent definition of adult, adolescent and children subpopulations
- Merging of claims (same paradigms and similar claims) added in monographs as combined additional claims
- Risk statements involving medical conditions merged and risk statements involving medications merged (i.e. Consult a health care practitioner prior to use if you are taking blood thinners or blood pressure medications).
- Monographs with multiple routes of administration separated
- “Discontinue” term replaced with “stop”
Given the major push to finalize the policy in spring 2019, it is pertinent that industry members are aware of how these revisions will affect their practices and clients. The 60-day written feedback period for the proposed Management of Applications Policy (MAP) ended on November 5, 2018, with the final policy slated for publication in spring 2019. However, we are already receiving application acknowledgement letters from Health Canada when we submit PLAs that indicate the new timelines, suggesting the updated timelines are already in effect.For support in preparation of these revisions, NHP Consulting can assist you with your application to ensure compliance is at the forefront of your projects. Feel free to contact us for more information.