As of August 9, 2010, the NHPD will no longer accept a product licence application (PLA) referring to ingredients that are not listed in the Natural Health Products Ingredient Database (NHPID) or are listed but the use and/or source of the ingredient is different from that listed in the NHPID.
Applicants must ensure that both the medicinal and non-medicinal ingredients (NMI) in the product are, in the case of a medicinal ingredient, a NHP substance which meets the definition of an NHP in accordance with Schedules 1 and 2 of the Natural Health Products Regulations (NHP Regulations) and in the case of an NMI, are recognized by the NHPD as an NMI and the use and/or source is acceptable for the NMI before the PLA is submitted. A failure to do so will result in the PLA being rejected.
The NHPID lists some ingredients with quantity limits or associated restrictions which must be complied with. In addition the NHPID may also designate certain ingredients as unacceptable for use in NHPs. The listing of an ingredient in the NHPID is not a reflection of safety or efficacy, but rather that the ingredient is one that is acceptable for use in an NHP, in the case of a medicinal ingredient, by meeting the definition contained in the NHP Regulations, and for an NMI, that the ingredient meets the NHPD's definition of an NMI including the purpose and source. If the ingredient to be used is not listed as acceptable in the NHPID, or the applicant's use or source is not one listed on the NHPID, the applicant must send a classification request to the NHPD using a NHPID Issue Form.
In the case of a medicinal ingredient, the NHPID Issue Form must be accompanied by evidence that demonstrates that the medicinal ingredient meets the substance definition of an NHP contained in the NHP Regulations. In the case of an NMI, the NHPID Issue form must be accompanied by evidence that demonstrates that the ingredient meets the definition of an NMI with an acceptable non-medicinal purpose and/or source.
For information on the NHPID Issue Form or the requirements for listing an ingredient on the NHPID, refer to the Appendix: "Classification of Medicinal Ingredients", Classification of Non-medicinal Ingredients" August 9, 2010, by way of a request to [email protected] until such time as it is listed on the NHPD website.