Alberta EDTT April 8 Webinar Synopsis - COVID19 Hand Sanitizer Production
A number of natural health product producers, spirits licensees, licenced users and brewer licensees (excise licensees) have stepped forward in response to the COVID-19 pandemic with an interest in temporarily expanding their operations to produce hand sanitizer. In some cases, licensees are requesting specially denatured alcohol registrations to allow them to possess and use specially denatured alcohol for this purpose. In other cases, spirits or brewer licensees are requesting user licences and/or approved formulations.
In response to the current circumstances, the Canada Revenue Agency has implemented a streamlined process to expedite the approval of these applications: applications for these licences or registrations should be submitted to your regional excise duty office using Form L63 Licence and Registration Application Excise Act, 2001. Applications for formulation approval should be submitted using Form Y15D - Request for Formula Approval. Note that a sample is not currently required for excise licensees applying for an approved formulation for the production of hand sanitizer.
Health Canada is establishing an interim approach to support those companies in acquiring the needed licences during this public health emergency. Following this, Health Canada will discontinue this approach and return to regular licensing approach for hand sanitizers.
Companies interested in manufacturing, packaging, or labelling alcohol-based hand sanitizers need to apply for and receive a product authorization (resulting in the issuance of a Natural Product Number (NPN)) and a site licence. This process is only in play during the COVID-19 response and applies to three separate scenarios:
1. An applicant would require a Product Licence only if they already have a site licenced for manufacturing, packaging, labelling and/or importation of Natural Health Products and they are adding a hand sanitizer to their product line, which they intend to sell to the public.
2. An applicant would require a Site Licence only if they are currently manufacturing, packaging, labelling or importing alcohol-based hand sanitizers, and not distributing them to another party or selling them to the public but intends to do so.
3. Companies that do not manufacture or import Natural Health Products (e.g. a distillery) and would like to manufacture and sell alcohol-based hand sanitizers to the public would need to get a Product and Site Licence.
To proceed as described below, companies are asked to provide a cover letter indicating whether they are applying for a Product Licence, a Site Licence, or both.
This directive only applies to alcohol-based hand sanitizers containing the following medicinal ingredients:
- Ethanol (60-80% v/v), also known as anhydrous alcohol, ethyl alcohol, grain alcohol
- Isopropanol (60-75% v/v), also known as isopropanol, 2-propanol
Companies must hold a natural product number (NPN) and a site licence (SL) before manufacturing and selling a hand sanitizer as described above to the public. Please note that a licence is required for the production of finished natural health products, and is not required if you are only producing raw materials.
Companies interested in producing hand sanitizer can contact Health Canada directly at firstname.lastname@example.org for more information. In addition you may reach out to the Alberta Liquor & Gaming Commission for assistance in getting a product registered at email@example.com.