Health Canada's Natural and Non-Prescription Health Products Directorate ("NNHPD") recently outlined proposed changes to its natural health product ("NHP") Management of Applications Policy ("MAP"), which sets out how various NHP submissions are received and processed by NNHPD. The MAP proposed changes, if implemented, would significantly impact industry and NHP product applications.
Changes of note in the proposed MAP include the following:
1. Application Timelines – service standards would be considerably prolonged:
a. A Class I application
would increase from a 10-day service time to 60 days.
b. A Class II application would increase from a 30-day service time to 90 days.
c. A Class III application would remain the same (210 days).
2. Information Request Notices ("IRN") – whereas an applicant can currently receive an unlimited number of IRNs as NNHPD reviews the materials and raises various questions or requested changes, the proposed MAP curtails this practice by limiting an application to a maximum of 2 IRNs with only limited exceptions.
3. Post-Licensing Amendments – under the proposed MAP, all post-licensing amendments require NNHPD submissions, including amendments to Class I applications that are entirely supported by a monograph and
4. Method of Submission – while communications and application submissions can currently be done either electronically using Canada Post's secure mail service epost Connect ("ePost") or by mail/courier, the proposed MAP would force all applicants to file submissions electronically via the ePost system, requiring acceptance of all terms and conditions associated with use of this system.
Given the impact these proposed changes would have on industry, we encourage companies to review the proposed MAP and provide comments to your industry association, or directly to the NNHPD.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.