Working with Natural Health Product Master Files

Unlike in the United States, natural health products sold in Canada must be licensed as part of the Natural Health Products Directorate (NHPD). To obtain a product license, manufacturers must describe ingredients in great detail. To this end, a natural health product (NHP) master file can help.

What is an NHP master file?
A natural health product master file is a submission package that is sent to the NHPD containing the relevant safety, efficacy, and quality data for a particular active ingredient.

While a master file may be constructed to contain all of the aforementioned information (safety, efficacy, and quality data), there is no requirement as to its content. The master file could contain any of this information.

What will the NHPD do with the file?
Once NHPD receives a master file, the file is assigned a submission number and is kept on file. Unlike a product license application, the master file is not immediately reviewed, and the initial review will occur the first time the master file is referenced by a plant master file to support the registration of a finished dose product.

Why should I register a master file with the NHPD?
If you are an active-ingredient supplier, many of your customers will likely be seeking to register their products with the NHPD and will be requesting from you the required active ingredient information. By having the re-quired information on file with the NHPD, you have granted permission to reference the file and provide them with the master file submission number and a letter of access.

How secure is the information contained in the master file?
Third parties can only reference your master file if they receive written permission from the master file holder. The permission must be signed by the company senior official or by the contact person for the master file. This letter must accompany third-party submissions that cite your master file. Even in the event of an access to information request, only those sections of the master file deemed nonproprietary will be released to a third party as part of this request. Nonproprietary includes any information that has already been made available in the public domain-for example, through published papers and information in advertisements.

As part of the NHPD requirements for licensing a product in Canada, clinical studies supporting the safety and efficacy of a product or its ingredients are absolutely required. When clinical data are not available, it is recommended that companies conduct clinical trials rather than face the removal of these products from the Canadian marketplace. As these ingredients are not patentable, companies should then file the resulting clinical safety and efficacy data with the NHPD as part of a master file. This safeguards the investment in a clinical trial and ensures the proprietary nature of the data. It is strongly recommended that companies work with an experienced firm to help them get through the rigorous path laid down by the NHPD.

A Note about the NHPD
The information presented in this article is accurate and current as this publication went to press. However, the master file submission process is still under development by the NHPD and certain aspects may change.

Jon-Paul Powers, PhD, is scientific adviser for Dicentra Inc. (Toronto, ON, Canada), an international scientific and regulatory consulting firm. Powers may be contacted by calling 416/361-3400 or by visiting www.dicentra.ca.