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 requi
