The Natural and Nonprescription Health Products Directorate (NNHPD) held two “What we Heard” sessions on NHP MAP Wave 1 and the Two New Tools. A summary of what they heard is captured in the documents linked below.
MAP
You will notice for the MAP – Wave 1 consultation, the items considered are addressed in the revision column. For the MAP – Wave 2 – they have only summarized the stakeholder asks, without a revision column at this time as they consider the feedback received.
During the call, it was communicated that the NNHPD does not plan to reinstate the archived Product Licence Guidance document, your main ask from our PCMA Committee stakeholder feedback letter. Instead, their direction is to consolidate product licensing-related content within the MAP. Accordingly, our request during the discussion was to revisit and clarify the purpose/objectives section of the MAP document, ensuring it encompasses product licensing information and is not limited solely to MAP-related activities. This would allow for a centralized repository of product licensing content, rather than the current fragmented approach across multiple documents. The NNHPD confirmed on the call that this consolidation within the MAP is their intended path forward, in place of reviving the Product Licence Guidance document.
Interchangeable Terms (estimated publication date: end of Oct 2025)
We are pleased with where they have landed on this document, meeting and exceeding the requirements for statements to the effect of (STTEO) under CUSMA, aligning US alternative terminology with Canadian terminology. The list they are proposing goes well beyond those listed in the US.
Monograph Combination Guide (estimated publication date: end of Oct 2025)
This guide provides predictability when Class II combination applications can be successful, when they will not, and when further assessment is required as a Class III application. The document also provides updated examples of additive combination calculations.
