A Natural Health Product Master File allows the manufacturer of the raw material to provide proprietary information to the Natural Health Products Directorate without disclosing the information to the applicant. The NHP-MF would include manufacturing details and/or technical information such as clinical studies, safety, and efficacy information.
- Quality Smart Solutions prepares the Master File application on your behalf.
- Quality Smart Solutions submits the Master File Application to Health Canada.
- A Master File Number (NHP-MF) is provided by Health Canada. All information is kept strictly confidential by Health Canada. No one can access the contents of the file except you or any party to whom you grant written permission. The format of the Master File Number would be a series of letters and digits.
- You provide an authorization letter on your company letterhead to your client stating the master file number and granting them permission to use it for their specific product license application.
- Your customer will reference the Master File number on their Canada NPN license application for safety, efficacy, and/or quality.