NHPD – Regulatory Updates: Quarterly Report – March 7, 2011

March 7, 2011 By


Quarterly Report (October 1, 2010 to December 31, 2010)

During this quarter, a total of 3017 PLAs were completed, 49% (1477) of these completions resulted in product licences, 46% (13787) were refusals and the remaining 5% (162) of completions were as a result of the applicant withdrawing the application.


Of the 1378 applications refused this quarter, the reasons were as follows:


o 45% failed to meet basic application requirements.

o 21% were refused when applicants did not respond to a request for further information.

o 18% were refused when the applicant’s response to a request for further information did not meet the requirements.

o 10% were refused for containing an ingredient not listed in the Natural Health Products Ingredient Database NHPID).

o 5% were refused when quality, safety and/or efficacy issues were identified.

o 1% were refused as a result of significant changes having been made to the product itself in response to a request for further information (i.e. an “unsolicited change”).

o <1% did not meet the definition of a NHP.

Chart 3 – Total Number of PLAs Completed during Quarter 3 (by Year of Application)

Chart 3- Total Number of Product Licence Applications (PLAs) Completed during Quarter 3 (by year of application)