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If your customers are applying for NPN licences in Canada, they need your ingredient data. An NHP Master File (NHP-MF) lets you provide that information directly to Health Canada without disclosing proprietary details to the product licence applicant. QSS prepares and submits NHP-MF applications for ingredient suppliers and raw material manufacturers. Since 2007.
An NHP-MF is the mechanism through which ingredient suppliers provide safety, efficacy, and quality data for a specific active ingredient directly to the Natural and Non-prescription Health Products Directorate (NNHPD), without that data being shared with the finished product company referencing it. The file contains manufacturing details and technical information, including relevant safety data, clinical studies, and quality documentation. Once the NNHPD receives and processes the file, it issues a Master File Number.
That number is what your customers need. They reference it on their NPN product licence application to substantiate the safety, efficacy, and quality of your ingredient. You provide the number on company letterhead along with written permission to reference the file. Health Canada treats everything in the file as strictly confidential, accessible only to the NNHPD, the NHP-MF holder, and any authorized third party involved in preparing the submission.
Health Canada's performance standard for issuing an NHP-MF number is 30 days from receipt of a complete submission. A well-prepared file moves through that window without requests for additional administrative information. Keeping your NHP-MF current is also what protects your customers' ability to rely on it when they need to update or renew their licences.
We compile your NHP Master File submission, which includes company and contact details, ingredient identification, manufacturing information, and the required safety, efficacy, and quality documentation. The file is prepared for electronic submission to the NNHPD, which does not accept hard-copy applications.
We review your ingredient-specific data, including manufacturing details, clinical studies, and quality data, to confirm the file contains what the NNHPD needs to process the submission without issuing a request for additional information.
We submit your NHP-MF directly to Health Canada’s Natural and Non-prescription Health Products Directorate on your behalf, and follow up through the review process to the point of Master File Number issuance.
Once your NHP-MF number is issued, we can assist with preparing the Letter of Access, the written authorization your customers need to reference your Master File on their NPN product licence applications.
Health Canada will review the contents of the Master File only once a Product Licence Application (PLA) is submitted by your customer that references your assigned NHP-MF number. Following its review, Health Canada may issue an Information Request Notice (IRN) to both the product license applicant and the Master File holder to request clarification or revisions to the ingredient Master File. We support manufacturers by assisting with Master File IRN updates and IRN responses to the NNHPD, should one be issued.
When manufacturing details, formulation data, or company information change, the NHP-MF may need to be updated to remain accurate. We manage amendments so your file stays current and continues to support your customers’ licence applications.
If you are also registering a finished NHP product in Canada, QSS supports the full NPN application process alongside your NHP-MF submission.
Ingredient suppliers selling into the U.S. dietary supplement market have their own notification requirements under the FDA. QSS supports NDI notifications as well.
An NHP-MF is a confidential file submitted by an ingredient supplier or raw material manufacturer directly to Health Canada’s NNHPD. It contains safety, efficacy, quality, and manufacturing data for a specific active ingredient. Once processed, Health Canada issues a Master File Number that finished product companies can reference on their NPN licence applications to substantiate the ingredient’s use, without the supplier having to disclose proprietary information to the product applicant.
NHP-MFs are used by active ingredient suppliers and raw material manufacturers whose ingredients are being incorporated into finished NHP products by other companies. If your customers are applying for NPN licences in Canada and your ingredient data is needed to support their applications, an NHP-MF is the mechanism that allows you to provide that data to Health Canada while keeping it confidential from the product applicant.
The submission must include the company name and address, the name of the ingredient or product, contact person information, and Senior Official information. It also includes the supporting technical documentation: manufacturing details, safety data, efficacy data, stability data, and quality information relevant to the active ingredient. The NHP-MF is not filed on a specific form, and a Product Licence Application form should not be submitted alongside it. Submission is electronic only; the NNHPD does not accept hard-copy filings.
No. Health Canada treats the contents of an NHP-MF as strictly confidential. Only the NNHPD, the NHP-MF holder, and any authorized third party involved in preparing the submission have access to the file. Your customers receive only the Master File Number, which they reference on their NPN application. None of the underlying technical or manufacturing data is disclosed to them.
A Letter of Access is a written authorization signed by the NHP-MF holder, or an authorized agent, that grants a specific company permission to reference the Master File in their NPN licence application. Your customers will need this letter to include the Master File Number in their product licence submissions. QSS can assist with preparing a Letter of Access template that can be updated for each applicant’s company once your NHP-MF number has been issued.
Health Canada’s performance standard for NHP-MF review is 30 days from receipt of a complete submission. Submissions that are complete and well-documented at the time of filing move through this window more reliably. Incomplete submissions or those requiring additional information will take longer.
Yes. If manufacturing details, formulation data, contact information, or other information in the file changes, the NHP-MF should be updated to keep it accurate. An outdated file can create issues for your customers when they are renewing or amending their NPN licences and need to rely on the file to substantiate their ingredient. QSS manages NHP-MF amendments alongside new submissions.
Yes. International ingredient suppliers whose ingredients are being used in NHP products sold in Canada can submit an NHP-MF to Health Canada. The same submission requirements apply regardless of where the company is based. QSS works with international suppliers to prepare and submit NHP-MF applications on their behalf.