Natural Health Products
The Natural Health Products (NHP) Regulations require any Canadian site where NHPs are manufacured, imported, labelled, packaged, distributed, and/or stored to have a site licence.
Pharmaffair can assist you with:
• Pre-market analysis and review
• Preparation and submission of NHP Applications (Class I, II and III)
• Post-approval changes
NHP Application Review Times
Classification | Risk | Review |
---|---|---|
Class I | • High Level of certainty (pre-defined authorization standards such as monographs) | 10 day processing |
Class II | • Medium Level of certainty (partial use of monographs combined with some review) | 30 day review |
Class III | • Low Level of certainty (highest level of pre-market review) | 180 day review |