The NNHPD announced today, their solution to the Class III product licence backlog, which currently stands at 3365 files. Of the 3365, 431 are past the 210-day service standard.
As you are aware from our Fall Regulatory Workshop, hypothetical product licence applications (those applications where manufacturers, packagers, and labellers (Section 22 of the NHPR) have not been identified) allow for the issuance of International Trade Certificates upon the issuance of a product licence. These hypothetical product licence applications do not benefit people and companies in Canada as there may be no intent to manufacture or sell the product in Canada.
The details of this announcement may be found in NHP Product Licensing Bulletin No.1 located here.
Over the past years, the NNHPD has experienced a significant increase in the number of product licence applications, specifically Class III, which are the most complex and resource intensive to review. This high volume of Class III applications has continued to exceed the Directorate’s review capacity. As a result, the NNHPD has accumulated a significant backlog and has not been meeting the 210-calendar day service standard. We understand this is a challenge for applicants with respect to the uncertainty on when they will receive decisions on their Class III applications.
Historically, NNHPD has processed applications on a first-come first-served basis. NNHPD has been made aware that some applications are for products that will not be sold or manufactured in Canada. Under a new workload management approach, NNHPD will prioritize applications for products destined for the Canadian market, or products being manufactured in Canada, to benefit the people and companies in Canada.
NNHPD will focus its review of Class III applications that meet one of the following criteria:
• A new application for a product that is to be sold in Canada within six months of being licensed
• Amendments to authorized and market notified NHPs, or authorized products to be sold in Canada within six months of being revised, regardless of the nature of the change(s)
• An application or an amendment for a product that is or will be manufactured in Canada within six months of being licensed.
Applicants who wish to have their application prioritized will be required to fill out one of the two Workload Management Forms. A bulletin is posted online to provide additional context and steps for submitting the form(s) for applications already in queue.
Submissions for which a form has not been submitted will be deprioritized for review. The NNHPD will review deprioritized submissions, when it is able to do so based on workload volumes and available resources.
Please keep us informed of any challenges you encounter or concerns you may have with this approach by reaching out to regulatory@cosmeticsalliance.ca.
