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Health Canada COVID-19 Interim Measures

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This presentation offers information on Health Canada's COVID-19 Interim Measures for expedited access to disinfectants, hand sanitizers, household cleaning products/hand soaps, body soap/workplace cleaning products.

o Exceptional release products – for Hand Sanitizers registered in US, MRA and PIC/S countries
o Hand sanitizers and disinfectants for domestic product & supply,
including temporary certificates for TDG shipping of these products
o Consumer products including cleaning chemicals, body and hand soap
o Workplace products (interim measures expected, not released as of today)

This webinar will provide useful information on how to import, manufacture and distribute COVID-19 supplies safely, quickly and within compliance.

Dell Tech is a London Ontario company providing expert regulatory compliance, product safety and laboratory services for 40 years.

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Health Canada COVID-19 Interim Measures

  1. 1. Dell Tech 1visit us at www.delltech.com or email Dell Tech 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 AboutUs Helping global clients buy, sell, manufacture and distribute chemicals safely since 1980
  2. 2. Dell Tech 2visit us at www.delltech.com or email Dell Tech 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
  3. 3. Dell Tech 3visit us at www.delltech.com or email Dell Tech Interim Measures: Exceptional Release for Imported Products 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
  4. 4. Dell Tech 4visit us at www.delltech.com or email Dell Tech Interim Measures: Exceptional Release for Imported Products 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
  5. 5. Dell Tech 5visit us at www.delltech.com or email Dell Tech Interim Measures: Exceptional Release for Imported Products 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.
  6. 6. Dell Tech 6visit us at www.delltech.com or email Dell Tech Interim Measures: Exceptional Release for Imported Products 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
  7. 7. Dell Tech 7visit us at www.delltech.com or email Dell Tech Interim Measures: Domestic Supply of Hand Sanitizers + Disinfectants • Natural Health Product Licence & Site Licence for Domestic Supply • GMP considerations • Temporary certificates for TDG
  8. 8. Dell Tech 8visit us at www.delltech.com or email Dell Tech 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).
  9. 9. Dell Tech 9visit us at www.delltech.com or email Dell Tech Interim Measures: Domestic Supply of Hand Sanitizers 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”
  10. 10. Dell Tech 10visit us at www.delltech.com or email Dell Tech Interim Measures: Domestic Supply of Hand Sanitizers 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
  11. 11. Dell Tech 11visit us at www.delltech.com or email Dell Tech Interim Measures: Domestic Supply of Hand Sanitizers 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
  12. 12. Dell Tech 12visit us at www.delltech.com or email Dell Tech Interim Measures: Domestic Supply of Hand Sanitizers 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.
  13. 13. Dell Tech 13visit us at www.delltech.com or email Dell Tech Interim Measures: Domestic Supply of Hand Sanitizers 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
  14. 14. Dell Tech 14visit us at www.delltech.com or email Dell Tech 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)
  15. 15. Dell Tech 15visit us at www.delltech.com or email Dell Tech • 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
  16. 16. Dell Tech 16visit us at www.delltech.com or email Dell Tech Interim Measures: Consumer cleaning products, body and hand soaps 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
  17. 17. Dell Tech 17visit us at www.delltech.com or email Dell Tech Interim Measures: Consumer cleaning products, body and hand soaps 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
  18. 18. Dell Tech 18visit us at www.delltech.com or email Dell Tech 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
  19. 19. Dell Tech 19visit us at www.delltech.com or email Dell Tech Interim Measures: Cleaning products for use, handling or storage in workplaces 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
  20. 20. Dell Tech 20visit us at www.delltech.com or email Dell Tech Interim Measures: Cleaning products for use, handling or storage in workplaces 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.
  21. 21. Dell Tech 21visit us at www.delltech.com or email Dell Tech 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)
  22. 22. Dell Tech 22visit us at www.delltech.com or email Dell Tech Interim Measures: COVID-19 QUESTIONS ? Dell Tech Laboratories Joe McCarthy/ Lab Services Manager 519-858-5021 jmccarthy@delltech.com Dell Tech: Lab Services News/Events/Newsletter subscribe Dell Tech YouTube channel for webinars Dell Tech Slideshare channel for webinar slides and presentations
  23. 23. Dell Tech 23visit us at www.delltech.com or email Dell Tech 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.
  24. 24. Dell Tech 24visit us at www.delltech.com or email Dell Tech 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
  25. 25. Dell Tech 25visit us at www.delltech.com or email Dell Tech 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.
  26. 26. Dell Tech 26visit us at www.delltech.com or email Dell Tech CompanyOverview Providing expert compliance and testing services since 1980, Dell Tech is an industry leader in assisting companies with North American regulatory compliance. Our team has over 100 years of combined experience and specializes in custom testing and consulting. We are proud to offer our global clients personalized service that is flexible to meet the needs of their business. AboutUs Helping global clients buy, sell, manufacture and distribute chemicals safely since 1980

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