The Natural Non-Prescription Health Products Directorate (NNHPD) has an important update – they will begin revising all NHP monographs.
The primary objective of the monograph revision initiative is to modernize the NHP monographs, ensuring they meet the new NHP labeling standards, exhibit consistency and incorporate the most updated information. This effort seeks to enhance the quality and reliability of product information, reducing the need for duplicate licence and labeling updates.
NNHPD plans to revise 97 NHP monographs, grouped into four batches (with 20-25 monographs per batch) between October 2023 and December 2024.
The remaining 169 monographs will receive minor adjustments to align with the new labeling requirements. These revisions will have a limited impact on existing content or product licences, but it’s important to note that they will be implemented without prior consultation. These adjustments will run concurrently with the consultation cycles.
Consultation Period: Each batch of revised monographs will undergo a 30-day consultation period. During this time, licence holders and stakeholders can provide valuable feedback and suggestions.
We encourage licence holders to engage actively during consultation periods for updates to those that may impact your product line. Your feedback, concerns, and contributions are invaluable in refining the revised monographs. We also recommend licence holders refer to the Labeling of NHPs guidance documents and be prepared to comply with the new labeling requirements.
Our team is ready to assist you with any monograph queries, review your products, formulations, and labels. Feel free to contact us today.
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