Health Canada COVID-19 Interim Measures

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HealthCanada
COVID-19Interim
Measures
o Exceptional release products – For Hand
Sanitizers registered in the USA, MRA or
PIC/S countries
o Hand sanitizers and disinfectants for
Domestic production & supply, including
temporary certificates for TDG shipping of
these products
o Consumer products including cleaning
chemicals, body and hand soap
o Workplace products
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Helping global clients buy, sell,
manufacture and distribute
chemicals safely since 1980

Interim Measures:
Exceptional Release for Imported Products
In response to unprecedented demand and critical need for hand sanitizers
and disinfectants during the COVID-19 pandemic, Health Canada is
permitting the IMPORTATION of some disinfectant and hand sanitizer
products that may not meet all of the Health Canada regulatory
requirements.
DEL Bulletin LEPP No. 74 COVID‐19 Disinfectants and Hand Sanitizers –
March 17, 2020
Permits the import of Hand Sanitizer and Disinfectants that are not
authorized for sale in Canada but are authorized or registered in:
-The United States
-An MRA Member Country
(Mutual Recognition Agreement between Canada & the European Community)
-A PIC/S Member Country
Pharmaceutical Inspection Convention &Pharmaceutical Inspection Co-operation Scheme

Interim Measures:
Hand Sanitizer
NHP
Alcohol Based
Eg: Ethanol, IPA
NHP Site Licence
GMP
Non-Prescription Drug
Eg: BKC, BZK, Triclosan
Drug Establishment
Licence
GMP
Hard Surface
Disinfectant
Exempt from Drug
Establishment
Licence
Exempt from GMP
requirements

Interim Measures:
Important Interim Measures for GMP of Imported Products
DEL Bulletin LEPP No. 76 Interim drug product testing
measures for licensed importers
1. Expanded use of unique identifiers.
2. Allowance for Shipping of Product from the Fabricator to Canada in
Quarantine
3. Defer Confirmatory Testing When Required

Interim Measures:
DEL Bulletin LEPP No. 77 Health Canada alleviates confirmatory
and identity testing requirements for certain low risk non-
prescription drugs
1. Identity testing will no longer be required after receipt in Canada as part of
the release process.
2. Confirmatory testing will also no longer be required.
Product Types: Mouthwashes, Personal Care Use Antiseptic Skin Cleansers,
Sunscreens, Anti-Dandruff Products, Diaper Rash Products, Medicated Skin Care
Products, Acne Therapy Products, Throat Lozenges, Athletes Foot Products
Requirement for stability studies have been waved for NHP Hand Sanitizers.

Interim Measures:
What do you need to do to import Hand Sanitizers and
Disinfectants that are not authorized for sale in Canada
but are authorized or registered within the USA, MRA
or PIC/S?
Complete the Health Canada Application and
Notification Form for Exceptional Release of Disinfectant
and Sanitizing Products”
Submit to: hc.covid19healthproducts-
produitsdesante.sc@canada.ca

Interim Measures:
Domestic Supply of Hand Sanitizers + Disinfectants
• Natural Health Product Licence & Site Licence for Domestic
Supply
• GMP considerations
• Temporary certificates for TDG

Interim Measures:
Domestic Supply of Hand Sanitizers
HEALTH CANADA COVID-19 INTERIM MEASURES FOR HAND SANITIZER
REGISTRATIONS.
Two Licences are required for Hand Sanitizers
1. Product Licence
Natural Health Product: Alcohol or Isopropyl Alcohol, Natural Product Number
(NPN)
Drug: Quaternary ammonium chlorides, Chlorohexidine, Chloroxylenol or
Triclosan Drug Identification Number (DIN)
2. Site Licence or Drug Establishment Licence (DEL)
Natural Health Products (NPN) require a Site Licence (SL)
Drugs (DIN) require a Drug Establishment Licence (DEL).

Interim Measures:
Process for applying for a NHP Hand Sanitizer Product
Licence and/or Site Licence
• Request Company Code
• Receive epost Connect Conversation from Canada
Post/NNHPD
• Submit application with heading “HAND SANITIZER –
COVID-19 application”

Interim Measures:
NHP GMP Considerations
• attest that you meet the Good Manufacturer Practices (GMP)
• Unless, you are importing. The Foreign Manufacturer must be listed on
the NHP Site Licence and proof of GMP compliance for the Foreign
Manufacturer should be submitted to avoid delays.
• A Site Licence issued will remain valid only while the interim approach is
in effect.
• This interim approach is in effect immediately, and will be in effect until
March 31, 2021 or until a notice is issued by Health Canada to Licence
holders

Interim Measures:
NHP GMP Considerations
• GMP is a very extensive Quality system required for the
manufacture of Natural Health products.
• Processes and procedures are required
• Records keeping required
• Medicinal Ingredients (Alcohol and IPA) are required to
be of a Pharmacopeial (USP) Grade https://www.canada.ca/en/health-
canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-
documents/good-manufacturing-practices.html

Interim Measures:
Hand Sanitizers - Transportation of Dangerous Goods
Regulations
• Ethanol & Isopropanol Hand Sanitizers are Flammable: TDG Class 3
Flammable Liquid
• In response to the COVID-19 crisis the Transport Canada has issued a
Temporary Certificate that is directly relevant to Hand Sanitizers
TU 0752.1: Hand sanitizer authorizes shipping and handling that does not fully
comply with the Regulations
Not a complete exemption from TGDR or the entire sections noted above
TU 0752 expires September 30, 2020 or when it is cancelled by the Minister,
whichever comes first.

Interim Measures:
HEALTH CANADA COVID-19 INTERIM MEASURES FOR HAND SANITIZER
REGISTRATIONS.
Read the fine print!
Health Canada’s Guide on Health Canada’s Interim Expedited Licensing
Approach for the Production and Distribution of Alcohol-Based Hand Sanitizers
is strictly for products that comply with Health Canada’s Antiseptic Skin
Cleansers (Personal Domestic Use) monograph.
• So what if you want to supply healthcare institutions, such as hospitals or
clinics, or other commercial settings? (Personal Commercial Use)
• Companies must notify Health Canada by email

Interim Measures:
Domestic Supply of Disinfectants
Disinfectants based on the Hard Surface Disinfectants Monograph cannot make
indirect claims against COVID-19, as such will not be eligible for expedited
review under the Interim measures and will not be added to Health Canada list of
approved Disinfectants for Use Against SARS-CoV-2 (COVID-19).
To be eligible for expedited licensing and inclusion on the list of approved
disinfectants, the Disinfectant needs to be authorized:
• labelled as a broad-spectrum virucide
• carry a specific claim against non-enveloped viruses of the
• carry a specific claim against a specific coronavirus, such as
Expedited review for COVID Disinfectant submission, ~ 30 days compared to 12
months.
Submission fees still apply, $5712 for Disinfectant full review (As of April 1, 2020)

• Cleaning Chemicals
• Hand + Body Soap
Will permit the importation & sale product that do not fully comply
with the labelling Requirements of:
Canada Consumer Product Safety Act (CCSPA)/Consumer Chemicals
& Containers Regulations (CCCR) Food & Drug Act (FDA)/Cosmetics
Regulation
Interim Measures:
Consumer cleaning products, body and hand soaps

Interim Measures:
Interim Policy for Household cleaning products, hand soaps
and body soaps.
• Will permit the importation & sale product that does not fully comply
with the labelling Requirements of Canada Consumer Product Safety Act
(CCSPA) or Food & Drug Act (FDA)
• The interim policy does change compliance requirements for other
elements such as
• packaging requirements (for example, child-resistant and leak-proof)
• other labelling information, such as the need for instructions for safe
use and avoidable hazards
• prohibiting products that contain an ingredient that may cause injury

Interim Measures:
The Interim Policy applies to:
• Cleaning and furnishing care products used mainly to clean, bleach or
scour surfaces
• But not for products used to polish, protect or improve the
appearance of surfaces.
• Laundry and dishwashing products used mainly to clean
• But not for fabric softeners or other products
• Hand and body soaps, regulated as cosmetics used mainly to clean the
skin.
• But not products with a Drug Identification Number (DIN)
or Natural Product Number (NPN)
• But not products where skin cleaning is not the main function

Will permit sale and importation of
certain cleaning products regulated under
the Hazardous Products Act
(HPA)/Hazardous Products Regualtions
(HPR) and, as applicable, Hazardous
Materials Information Review Active
(HMIRA , aka Trade Secrets) coming from
the U.S. that do not fully comply with
WHMIS 2015 requirements for SDS and
Label.
Interim Measures:
Cleaning products for use, handling or storage in workplaces

Interim Measures:
Interim Policy for Cleaning products for use, handling
or storage in workplaces
(Published April 27)
Will permit sale and importation of certain cleaning
products regulated under the HPA/HPR and, as
applicable, HMIRA coming from the U.S. into Canada
which do not fully meet all of our labelling and
information requirements including, but not limited to,
SDS in one language and wording of precautionary
information

Interim Measures:
The interim policy covers the following cleaning products
regulated under the HPA/HPR and, as applicable, HMIRA:
• Cleaning products used mainly to clean, bleach or scour
surfaces
But not for products used to polish, protect or improve the
appearance of surfaces
• Laundry and dishwashing products used mainly to clean
But Not fabric softeners or other products.

Interim Measures:
COVID-19
How can Dell Tech Help You?
 Preparation, Submission and Management of NHP and/or DIN Applications
 Product Testing for hazard classification; (i.e. Flashpoints)
 Classification and Labelling for Consumer Products
 Classification, Safety Data Sheets and Labelling for workplace Products.
 HMIRA Claim For Exemptions (SDS Trade Secret registrations)

Interim Measures:
COVID-19
QUESTIONS
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Dell Tech Laboratories
Joe McCarthy/ Lab Services Manager
519-858-5021
jmccarthy@delltech.com
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Questions & Answers
Q1. I'm looking to import liquid sanitizer in bulk from the US, and selling it to a Canadian company who will bottle, label and sell it under
their brand and NPN. Who requires the site license? The manufacturer in the US, me as the importer/reseller, or the bottling
company selling the final product?
A1. The Canadian company who will bottle, label and sell it under their brand and NPN will need a Site Licence to Fabricate, Package,
label and Import. The Manufacturer in the US will need to be listed on the Canadian Site Licence as a Foreign Manufacturer.
Q2. Once you have a Site Licence can you receive product with an NPN and repackage it for the NPN holder?
A2. Yes, if the Site Licence incudes the Activities of Packaging & Labelling, and if the product is importer the Site Licence includes
Importing.
Q3. Do you have to have a facility in Canada in order to obtain DIN? Does that facility have to be approved by HC as a GMP facility?
A3. You do not need a facility in Canada to get a Product Licence. Only facilities physically located in Canada may receive a NHP Site
Licence or Drug Establishment Licence.
Q4. When filing for a Site Licence for import, is the Site Licence applicant required to include GMP evidence (QAR, Drug GMP Audit, etc.)
for each of the foreign sites involved in the Manufacturing, Packaging and/or Labeling of Hand Sanitizers (as per monograph)? Is an
attestation for the Foreign Sites sufficient as well?
A4. Yes when applying for a Site Licence to Import you must included each Foreign Site on the application and provide evidence of GMP
compliance. You do not submit a signed attestation (Interim Measures Cover Letter) for the Foreign Sites.

Questions & Answers
Q5. Do you know if a hand sanitizer (NHP) with evidence against COVID-19 and/or a viral surrogate will require the full Class III Submission
Review timeline? Or if this review is expedited?
A5. Yes, a NHP Hand Sanitizer application with evidence against COVID-19 and/or a viral surrogate will require the full Class III Submission
Review. However during the Interim Measures, the Natural & Non-Prescription Health Products Directorate (NNHPD) will expedite the
review, it should not take 210 days for a Class III submission review.
Q6. Does a copy of the proposed label for domestically manufactured hand sanitizer formulations need to be submitted with Product and
Site applications?
A6. Yes a label is required for all Product Licence applications. A label is not required for Site Licence Applications.
Q7. If we have a temporary site licence to manufacture an alcohol based hand sanitizer, we need to apply for a separate one for a quat
based hand sanitizer, correct? This would be a DEL, correct?
A7. Yes a Quat based hand sanitizer requires both a Drug

Questions & Answers
Q8. If we already have NPN/DIN for hand sanitizer, are we allowed to change the supplier of alcohol (sda 200 proof and not technical
grade) and rheology modifier using the same NPN/DIN #?
A8. Yes you may change the supplier of the raw material as long as the new sources meet that raw material specification of the product
registration.
Q9. Is proof of GMP required to obtain a DIND # for Surface Disinfectant (following monograph) at this time?
A9. No, Hard Surface Disinfectants are exempt from Drug Establishment Licences and Good Manufacturing Practices (GMP) requirements.
Q10. If we buy from Canada and want to sell sanitizer in Canada, do we need licence or NPN?
A10. If you buy a product that already has a NPN Product Licence, you do not need a licence to sell the product.
Q11. Can we just start selling?
A11. No. The Product must be licenced and the Site of Manufacture must be licenced.

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needs of their business.
AboutUs
Helping global clients buy, sell,
manufacture and distribute
chemicals safely since 1980

Health Canada COVID-19 Interim Measures

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Health Canada COVID-19 Interim Measures