Dear stakeholders,
As of August 9, 2010, NHPD will no longer accept Product Licence Applications (PLA) containing medicinal or non-medicinal ingredients which are not listed as acceptable ingredients in the Natural Health Products Ingredient Database (NHPID). NHPD has adopted and developed a standardized nomenclature for product licence applications in order to facilitate information management and exchange of product information. Applicants must use the standard terminology when preparing their product licence application.
Applicants must ensure that the medicinal ingredients contained in the product are natural health product substances in accordance with Schedules 1 and 2 of the Natural Health Products Regulations before any Product Licence Application (PLA) is submitted. All medicinal and non-medicinal ingredients found in the product must be listed as such within the NHPID. Please note that some ingredients within the NHPID have associated limits or restrictions and these must also be considered when filing. In addition, the NHPID also lists some ingredients which are not natural health product ingredients and those are clearly indicated as not acceptable. An entry in the database does not imply that the ingredient has been reviewed for safety or efficacy.
If these ingredients are not listed in the NHPID, applicants are responsible for submitting a request to NHPD to add these ingredients to the database before the application is filed. The application can only be filed once the ingredients are deemed acceptable and added to the database. This message describes the process and requirements for requesting the addition of ingredients to the database.
Medicinal ingredients
Medicinal ingredients and the associated source information must be present and acceptable in the NHPID in order to submit a PLA. If a medicinal ingredient or source is not listed as acceptable in the NHPID, the requestor must send a classification request to NHPD’s attention using a NHPID Issue Form. The NHPID Issue Form must be accompanied by evidence that demonstrates that the medicinal ingredient meets the substance definition of a Natural Health Product (NHP). As such, all product licence applications which list MIs or MI sources that are not indicated as acceptable in the NHPID will result in a rejection of the product licence application. Please refer to the appendix: Classification of Medicinal Ingredients for more information regarding the Issue Form requirements. The information provided in the Issue Form will assist NHPD in classifying the proposed substances and allow for a shorter turnaround time for requests.
Non-medicinal ingredients
Non-medicinal ingredients and the associated excipient purpose and source information (if the NMI is obtained from an organism) must be present and acceptable in the NHPID in order to submit a PLA. If a non-medicinal ingredient name, purpose or source is not listed as acceptable in the NHPID, the requestor must send a classification request to NHPD’s attention using a NHPID Issue Form. The NHPID Issue Form must be accompanied by evidence that demonstrates that the non-medicinal ingredient meets the definition of a non-medicinal ingredient with an acceptable excipient purpose. As such, all product licence applications which list NMIs, NMI purposes or NMI source information (if the NMI is obtained from an organism) that are not indicated as acceptable in the NHPID will result in a rejection of the product licence application. Please refer to the appendix: Classification of Non-medicinal Ingredients for more information regarding the Issue Form requirements. The information provided in the Issue Form will assist NHPD in classifying the proposed substances and allow for a shorter turnaround time for requests.
Respectfully,
The Natural Health Products Directorate
Health Canada