NHP Master File Submissions
If your product has proprietary information surrounding its manufacturing process and/or ingredients that you do not wish to make public, an NHP Master File may be of value to you.
This reference document enables you, the manufacturer, to avoid potential information disclosure by bypassing product licence applications or clinical trial applications and allowing direct submission to the Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada.
Master Files are held in strict confidence by the NNHPD, allowing information to remain confidential. Our regulatory affairs specialists will review all quality, manufacturing, generic and product-specific data for suitability, and then compile a Quality and/or Safety and Efficacy Master File which will be submitted to Health Canada on your behalf.
Customers can be made privy to the applicable content of the Master Files by providing them with the Master File submission number along with a letter of access on company letterhead. These letters can also be given out as studies are compiled - supporting new health claims which are submitted to the Master File to notify customers that new clinical information has been made available.
Master Files may be updated at any time to act as a record for the most recent data available about the safety and efficacy of an ingredient.
Looking for more information on NHP Master Files? Contact a member of our team today or email us directly at firstname.lastname@example.org. You may also request a customized quote and we will contact you with details within two business days.