Deadline approaching for Canadian interim COVID-19 site licence holders

To help address shortages in the Canadian market at the beginning of the pandemic, Health Canada issued interim COVID-19 site licences (COVID-19 SL) for manufacturing, packaging, labelling, and/or importing alcohol-based hand sanitizers. The interim licences will end at 11:59 PM PST on September 30, 2021, so persons holding a COVID-19 SL that wish to continue activities for alcohol-based hand sanitizers after this date must apply for a site licence in accordance with Section 18 of the Natural Health Products Regulations (NHPR).

Persons holding a COVID-19 SL who wish to continue activities beyond the public health emergency must submit a complete site licence application (SLA) by 11:59 PM PST on September 30, 2021 and should receive an Acknowledgement of Receipt within 30 days. The normal service standards for new applications will not apply to the COVID-19 SL transition. Provided the application is complete and on time, activities may continue under the temporary COVID-19 SL until a decision is made on the SLA. If the application is refused, all manufacturing, packaging, labelling, and/or importing of alcohol-based hand sanitizers must stop as of the date of the notice of refusal, and Health Canada may also issue compliance or enforcement actions to address any concerns. If a complete site licence application is not submitted by 11:59 PM PST, September 30, 2021, all manufacturing, packaging, labelling, and/or importing of alcohol-based hand sanitizers must stop.

Persons who do not wish to continue activities beyond September 30, 2021 can discontinue their interim COVID-19 SL by contacting the Natural and Non-Prescription Health Products Directorate (NNHPD). After September 30, 2021, existing alcohol-based hand sanitizer stock may continue to be liquidated but all new manufacture/import must stop. Confirmation that all activities under the interim COVID-19 SL have ceased must be provided, and product samples and records must be retained to enable a recall, if needed.

For either transition pathway scenario, persons holding COVID-19 SLs should have received a bulletin from Health Canada outlining the full instructions, information requirements, and contact details.