Health Canada’s Natural Non-Prescription Health Products Directorate (NNHPD) recently announced that beginning at the end of October, they will begin consulting on monograph revisions. This initiative is geared toward enhancing the accuracy, consistency, and conciseness of natural health product (NHP) monographs, in alignment with new NHP Labelling requirements. Below, we outline the purpose, scope, process, how you can prepare, and the implications of this endeavor.
The primary purpose of the monograph revision initiative is to update NHP monographs, ensuring they conform to the new NHP Labelling requirements, that there is consistency across monographs, and that the most up-to-date information is incorporated. This aims to improve the quality and reliability of product information, ultimately reducing the need for repetitive licensing and labelling updates.
Monograph Revisions: The NNHPD plans to revise 97 NHP monographs in 4 batches (20-25 monographs per batch) between October 2023 and December 2024. These revisions will be conducted with the goal of enhancing the accuracy, consistency, and conciseness of the information they contain.
Consultation Period: Each batch of revised monographs will undergo a 30-day consultation period. During this time, licence holders and stakeholder associations can provide feedback and suggestions.
Limited Changes: The remaining 169 monographs will undergo minor adjustments to align with new labelling requirements. While these revisions should have a “limited impact” on existing content or product licences, it is important to note that they will be done without any prior consultation. These adjustments will be made in parallel with the consultation cycles.
Stay Informed: To be well-prepared for the new labelling requirements, we recommend that licence holders refer to the Labelling of NHPs guidance document, which provides essential information on compliance and added context for the upcoming monograph changes.
Participate in Consultations: We recommend that licence holders actively participate during the consultation periods to share feedback, voice concerns, and contribute to the refinement of revised monographs.
Get Expert Advice: Our consultants are here to assist you in reviewing your products and ingredients and provide you with a tailored compliance strategy to help you be prepared for the upcoming monograph revisions. Don’t hesitate to get in touch today, and together, we can ensure your readiness for these important changes.