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Description - Appendix F ľ Product licensing process map

The product licensing process varies depending on whether a product can be indexed against a single monograph (class I) or multiple monographs (class II). A class III application is more complex, requiring addition research and evidence; a class III application may have no monograph reference or some of the products may be indexed to multiple monographs. The following process is effective as of October 30, 2014.

The target timeframe for processing a class I application is 10 business days. The process is as follows:

  • The applicant fills out a product licence application (PLA), which can be submitted online, on a CD or DVD or in paper format.
  • Within ten business days of receipt of the application, it is examined for completeness and a decision is made.
  • If the application is accepted, a product licence is issued.
  • If the application is found to have administrative deficiencies, a rejection notice is sent to the applicant.
  • If the application is deemed not to be a class I type application, an application refusal letter is sent to the applicant.

The target timeframe for processing a class II application is 30 calendar days. The process is as follows:

  • The applicant fills out a product licence application (PLA), which can be submitted online, on a CD or DVD or in paper format.
  • Within ten business days of receipt of the application, it is examined for completeness.
  • If the application is found to have administrative deficiencies, a rejection notice is sent to the applicant.
  • If the application meets the administrative completeness requirements, an application acknowledgement letter is sent to the applicant.
  • The product is then screened for safety and efficiency evidence. This step in the process can take up to 20 calendar days.
  • If the application is accepted, a product licence is issued.
  • If the application is found to have small deficiencies, an information request notice is sent to the applicant.
  • If the application is found to have major deficiencies, an application refusal letter is sent to the applicant.

The target timeframe for the initial processing a class III application is 30 calendar days. A further 180 calendar days is required in order to conduct a full assessment of the product and render a decision. The process is as follows:

  • The applicant fills out a product licence application (PLA), which can be submitted online, on a CD or DVD or in paper format.
  • Within ten business days of receipt of the application, it is examined for completeness.
  • If the application is found to have administrative deficiencies, a rejection notice is sent to the applicant.
  • If the application meets the administrative completeness requirements, an application acknowledgement letter is sent to the applicant.
  • The product is then screened for safety and efficiency evidence. This step in the process can take up to 20 calendar days.
  • If the application is found to have small deficiencies, an information rejection notice is sent to the applicant.
  • If the application is found to have major deficiencies, an application refusal letter is sent to the applicant.
  • If the application is accepted, it is submitted for the full assessment process, which can take up to 180 calendar days.
  • At the end of the full assessment process, if the application is accepted, a product licence is issued.
  • If the application is found to have small deficiencies, an information request notice is sent to the applicant.
  • If the application is found to have major deficiencies, an application refusal letter is sent to the applicant.