Those familiar with the Site Licensing renewal process know that SL renewals must be filed 30 days before the expiry date of the licence. Failure to meet the deadline will mean cancellation of the SL without further recourse other than to submit a new application.

Submitting a new application means having to wait for the new approval before a company can resume manufacturing, packaging, labelling, and or importing activities. It also means returning to an annual renewal cycle, as opposed to the every-two-year or every-three-year cycle enjoyed by more longstanding SL holders.

Therefore, it is very important that you meet your renewal deadline. We strongly recommend that you set up a calendar reminder, and that you have more than one individual in your organization do so.

But there is another important reason to be mindful of SL renewal periods. Health Canada is currently backlogged with processing renewals. Based on their own internal performance targets, SL renewals should be fully processed in 30-90 days. As of the writing of this article, they are facing a 10-month backlog.

Fortunately, so as not to shut down the industry entirely, Health Canada is permitting applicants to continue conducting their licenced activities while the renewal submission is in queue, even if the licenced expiry date has pass. Nevertheless, this concession is only a half-measure, and does not fully mitigate the impact of the backlog.

Of particular concern is the ongoing impact on licence amendments. In general, Health Canada is processing amendments in a timely manner; that is, unless you happen to be caught in the renewal quagmire.

Consider the following scenario: You are an importer who wants to launch a new product in 4^th Quarter. The foreign manufacturer needs to be annexed to your Site Licence, so you duly file the annexation amendment in 1st Quarter.  Fortunately, the manufacturer holds a valid GMP Certificate of Compliance from a Regulatory Body, so you qualify for a Stream 1 application, which means the SL amendment to add the foreign site should be processed by Health Canada in 30 days. No doubt you are feeling good about your 4^th Quarter launch, but guess again…

If it so happens that your SL renewal comes due while the amendment is in queue (say 2^nd Quarter) and expires before the amendment is approved, Health Canada will put approval of the amendment on pause until the renewal is processed. Since, as mentioned, renewals are currently taking as long as 10 months to process, your happy “30-day” turnaround could turn into a twelve+ month nightmare. Contracts may need to be cancelled and commitments renegotiated.

For our part, dicentra has reached out directly to Health Canada to try and resolve this dilemma. Our recommendation to Health Canada is that they review all amendments according to their performance standard. If compliant, they should issue the applicant with conditional approval. This would not involve issuing a formal amended SL (since the SL would be expired), but would allow the amended activity to proceed in the same way that Health Canada is permitting the current site licence activity to proceed. This would result in a consistent policy approach, would not mean much more work on the part of Health Canada, and would alleviate the pressure on industry.

Our proposal is still under consideration. Hopefully wiser heads will prevail, and industry will see some sort of policy change that will minimize business disruption without compromising product safety, efficacy, or quality.

Are you looking to obtain, amend, or renew a site licence, or perhaps just looking for regulatory guidance in general when it comes to natural health products? dicentra welcomes the opportunity to discuss your needs and how we may be of assistance.