Natural Health Product Master File Submission (NHP-MF)

NHP-MFs are not filed using a specific form although a PLA form should not be submitted with an NHP-MF application. You can submit a single copy of the MF electronically because NNHPD does not accept the file in hard copy. When submitting the Natural Health Product Master File, the following information is required.

• Name and address of the company
• Name of ingredient or product
• Contact person information
• Senior Official information

• You can provide the master file number to your client on your company letterhead and grant them permission to use it for their product license application.
• Your client can reference your Master File number on their Canada NPN license application for safety, efficacy, and quality.

The authority strictly keeps all information confidential. None other than you or any party to who you grant written permission can access the contents of the file.

If you are an active-ingredient supplier, your customers will possibly be attempting to register their products with the NNHPD. An NHP-MF enables manufacturers or suppliers of raw materials or a medical ingredient to provide proprietary information directly to the Natural and Non-prescription Health Products Directorate (NNHPD) without having to disclose the information to the Product License Applicant

NHP-MFs are important for active ingredient suppliers. If you are a supplier of active ingredients, partner with us to prepare and submit your Natural Health Product Master File (NHP-MF) application to Health Canada. We’re adept in reviewing quality and product-specific data and we can successfully compile a Master File submission that substantiates safety, efficacy, and quality.

An NHP-MF enables manufacturers or suppliers of raw materials or a medical ingredient to provide proprietary information directly to the Natural and Non-prescription Health Products Directorate (NNHPD) without having to disclose the information to the Product License Applicant. 

The file contains manufacturing details and technical information, such as relevant safety, clinical studies, efficacy, and quality data for a particular active ingredient. Once the NNHPD receives the file, it assigns a master file submission number. The file is referenced by a PLA to support the registration of a finished dose product.

A letter of access is a written letter that is signed by the Master File (MF) Holder, Authorized MF Agent or Authorized Third Party filing on behalf of the MF Holder indicating to Health Canada that the Applicant and the MF Holder have agreed that the MF can be referred to during the assessment of the Applicant’s submission.

Yes. The NHP-MF number would be referenced on the ingredient buyer’s NHP license application. However, only Health Canada, the NHP-MF holder and, if applicable, a third party who prepared the NHP-MF would have access to the information on file. It would not be shared with the ingredient buyer at all. 

According to Health Canada’s website their performance standard for a NHP-MF is 30 days.