In March 2020, Health Canada introduced interim measures to expedite the issuance of site licences for alcohol-based hand sanitizers, to address the shortage of these products due to the COVID-19 pandemic. Alcohol-based hand sanitizers are considered natural health products (NHP) and all Canadian companies engaged in manufacturing, packaging, labelling, or importing a natural health product for sale, require a natural health product site licence.
However, as the demand for alcohol-based hand sanitizers stabilizes, the interim order is approaching an end. The Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada has set forth that temporary COVID-19 site licences (COVID-19 SL) for manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers will expire on September 30, 2021. Health Canada issued a bulletin to all temporary COVID-19 SL holders that gave a 60-day notice period in advance for the end of interim measures.
Therefore, COVID-19 SL holders are presented with two options prior to licence expiry:
- Stop manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers.
- Apply for a valid SL to continue producing hand sanitizer until you receive a decision on your application.
If the SL holder would like to continue activities beyond September 30, 2021, then a complete site licence application (SLA) must be submitted, as per Section 28 of the NHPR, by September 30, 2021, at 11:59 pm PST. The applicant will be required to complete the web SLA form and must select the “COVID-19 SL Transition” option. The applicant will also be required to demonstrate compliance with the Good Manufacturing Practices (GMPs) (i.e. Quality Assurance Report (QAR), and applicable testing, release, and batch records).
Once the SLA form is completed and GMP evidence documents are collected, the applicant then must retrieve the ePost Connect conversation thread. If the applicant does not have a COVID Applications conversation, Health Canada has recommended to contact the following e-mail address: email@example.com with the subject line “COVID transition – No applications conversation”. It is worth noting that any applications submitted through other means will not be accepted.
If Health Canada deems that the application requires more information to be sent, then an Information Request Notice (IRN) may be sent. The IRN will state a timeline and define the additional information required. Failure to respond adequately or on time will result in an application refusal.
The service standards normally in place for new applications will not apply to COVID-19 SL transition applications. Therefore, temporary COVID-19 SL holders will be allowed to continue activities under the temporary licence, until a decision is issued. The NNHPD is striving to issue an acknowledgement within 30 days of receiving the application. Please be advised, if you receive a site licence, you will be required to renew it within one year.
Alternatively, if you wish to discontinue activities under the COVID-19 SL licence, Health Canada has requested that you send an email to the following e-mail address; firstname.lastname@example.org ahead of the September 30, 2021, end date. The email will need to include a cover letter, reference your COVID-19 SL number and the discontinuation date.
It is important to understand that if you choose to discontinue activities, you may 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. Also, you must retain samples of your products and records to enable a recall should the need arise.
In the event 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, following the same directions as above.
If you take no action, the activities listed on your interim COVID-19 SL will no longer be allowed after September 30, 2021.