The Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada announced interim COVID-19 Site Licences (COVID-19 SL) for manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers will expire on September 30, 2021.
The interim measures were introduced in March 2020 to expedite site licensing to address hand sanitizer shortages at the start of COVID-19. During August 2020, the NNHPD notified COVID-19 SL holders their commitment to provide 60 days’ advance notice prior to ending of the temporary measures.
If you are a COVID-19 SL holder, there are three options that will need to consider prior to your license expiring.
- First, companies that wish to continue with manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers, a pathway to obtaining a site license is available by filing an application no later than 11:59 PM on September 30, 2021. If a Site License Application (SLA) is not filed by the deadline, all activities are required to stop by that date. If your application for a site license was submitted on time and complete, and a decision remains pending, activities can continue under the temporary license. According to the NNHPD, an acknowledgement of receipt of the application will be issued within 30 days, and the transition to site license from the interim COVID-19 SL license will be dependent on volume, time to review, and completeness of applications. As an applicant you will be required to submit certain GMP records such testing, release, and batch records along with Quality Assurance Report (QAR) or other applicable GMP evidence. It is important that the application is submitted as soon as possible to take the advantage of the presented timelines.
- Secondly, if you wish to discontinue activities under the COVID-19 SL license, no action will be required on your part other than to stop manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers on September 30. You may however liquidate the remaining stock that was imported or manufactured while the interim COVID-19 SL was valid. You will be asked to confirm that you have ceased licensable activities. As well, you must retain samples of your product(s) and records to enable a recall should the need arise.
- Lastly, if you have already stopped or never carried out activities under your interim COVID-19 site licence, you can notify the NNHPD that you wish to discontinue your license ahead of the September 30 deadline. If you take no action, the activities listed on your interim COVID-19 SL will no longer be allowed after September 30, 2021.
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MCS Associates can support your site licencing, product licencing, submissions and amendment requests, label and claim reviews, and importation. If you require testing, Canadian Analytical Laboratories provides testing to help your products meet quality standards.