Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) is undertaking a critical initiative to revise existing Natural Health Product (NHP) monographs.
These revisions are essential for aligning monographs with new labelling standards, ensuring consistency, and incorporating the latest scientific information. Health Canada’s goal is to improve the quality and accuracy of product information, reducing the need for repetitive licensing and labelling changes.
The NNHPD began this revision process in October 2023, with the primary objective of meeting new NHP labelling requirements.
Other focus areas include:
Bringing NHP monographs up to date with current labelling standards and incorporating the latest scientific evidence.
Ensuring uniformity across all monographs to improve the clarity and reliability of product information.
Addressing potential risks identified by the NNHPD to maintain the safety and efficacy of NHPs.
Incorporating new medicinal ingredients and claims supported by robust evidence and adding product facts tables for enhanced transparency.
Revision Timeline and Process
A total of 97 NHP monographs are scheduled for revision, grouped into four batches (being released from October 2023 to December 2024). Each batch of monographs will undergo a 30- to 60-day consultation period, during which time product license holders and stakeholders are invited to provide feedback. Health Canada has also advised industry that are 169 additional monographs (not included in these batches) which will receive minor updates without stakeholder consultation.
The consultation period for Batch 4 began on September 1, 2024.
We encourage our clients who hold current product licenses to stay informed and actively participate during the consultation periods for updates that may impact their product lines.
Your feedback is crucial and can influence proposed Health Canada revisions. Your input can play a key role in refining these NHP monographs!
We’re Here to Help!
Our team is ready to assist with any questions regarding these Health Canada monograph revisions and associated impact on product formulations, and labelling. Contact us today to ensure your products comply with the new standards.
