COVID-19 Bulletin #17 – May 14, 2020
Late yesterday, Health Canada made the following changes to their COVID-19 pandemic interim measures for hand sanitizers:
- The allowance of unilingual labelling has been eliminated, and
- Reference to a 24-48 hour turn-around time for product and site licence
applications under their expedited licensing approach has been deleted.
Background:
Given the shortage of hand-sanitizers in the Canadian marketplace and industry’s eagerness to help in the COVID-19 pandemic, Health Canada (HC) established an expedited licensing approach for alcohol-based hand sanitizers to assist the fight against the COVID-19 pandemic. Through this expedited process, HC has issued market authorizations for the manufacture and sale of over 1,900 hand sanitizer products! Another flexibility provided by HC allowed for domestic hand sanitizer manufacturers to use unilingual labelling.
In light of the short-term success in meeting an unprecedented demand and urgent need for disinfectants and hand sanitizers during the COVID-19 pandemic, the following interim measures are being changed.
BILINGUAL LABELLING
Please read carefully to determine which scenario applies to your business.
1. In order to benefit from the interim measures, importers of disinfectants and hand sanitizers will be required to post bilingual label text on their website and provide sellers with a means to inform consumers, at the time of sale, of the website where bilingual label text is posted. This could be made available through a sticker applied directly to the products, or posters or signage with take-away pamphlets at the point of sale. Effective immediately, all NEW importers of these products through the interim measure must meet this requirement. All importers PREVIOUSLY AUTHORIZED must meet this requirement no later than June 8, 2020.
2. Effective immediately, all NEW Canadian manufacturers of disinfectants and hand sanitizers must use bilingual labelling. Canadian manufacturers of hand sanitizers who are CURRENTLY LICENSED and are using unilingual labelling under the interim measure will be required to adopt bilingual labeling no later than June 8, 2020.
3. HC will take a risk-based approach to addressing any non-compliance identified.
This updated approach is posted on HC’s website HERE.
NOTE: Products that are already in the distribution channel or at retail will be allowed to sell-through. The June 8, 2020 date is not a point-of-sale deadline. All product entering distribution channels after June 8, 2020 should feature bilingual labels.
CA continues to be engaged with Health Canada to keep these flexibilities for products imported or manufactured for internal use within domestic operations and “behind-the-counter” workplace settings (e.g. beauty counters).
UPDATED PROCESSES & GUIDANCE
The 24-48 hour turnaround time for product licence and site licence applicants has been removed. The expectation is now 5 – 7 days. We encourage you to follow-up with officials as we have previously directed in our communications if this timeline has been exceeded.
Links to HC’s updated document are as follows:
Hard-surface disinfectants and hand sanitizers (COVID-19): Information for manufacturers
Interim guide on the production of ethanol for use in alcohol-based hand sanitizers
NEXT STEP – ADDRESSING NON-COVID APPLICATION BACKLOG
We will be working through our Product Compliance & Market Access (PCMA) committee for assistance on how to approach the mounting backlog of non-COVID submissions in a fair and transparent manner.
The NNHPD has acknowledged that nearly their entire focus over the past few weeks has been on CoVID-related activities such as reviews and approvals and they have openly confirmed (as many of you already realize) that there is now a significant backlog of outstanding reviewers related to non-CoVID related submissions
If you are a member of our PCMA committee, please stand by for an invite to this meeting. In advance of the meeting, please come prepared with ideas on:
– How HC can begin to address the backlog
– How best to prioritize the queue given different relative “urgencies”
– Any input/suggestions we may wish to present to the NNHPD for consideration
If you are not a member of our PCMA committee and wish to become a member, please reach out to us at regulatory@cosmeticsalliance.ca.
If you have any questions, please don’t hesitate to contact your CA Regulatory Team.
