In light of the recent Coronavirus pandemic, the demand for antimicrobial products such as disinfectants and hand sanitizers are skyrocketing. The aim of this article is to help you to understand the regulatory requirements needed to bring your disinfectant products into the Canadian or the US market, as well as the current regulatory exemptions and interim measures in place to help respond to COVID-19.
Canada
Most chemical products represented for use in Canada as disinfectants/sanitizers are regulated as drugs under the Food and Drugs Act. The Natural and Non-prescription Health Products Directorate (NNHPD) is the regulatory body within Health Canada that assesses applications for these products. There are two main categories of these products – Disinfectant drugs and Human-Use Antiseptic Drugs.
Disinfectant Drugs
Disinfectant Drugs are disinfectants for use
on non-critical medical devices and hard non-porous environmental surfaces and
inanimate objects in domestic, industrial / institutional, hospital, food
processing and/or barn premises. All disinfectant drugs are subject to
pre-market assessment by NNHPD and will be assigned a Drug Identification Number
(DIN) upon market authorization. All disinfectant drug applications must
support the general safety, efficacy, and quality requirements, as well as the
labelling requirements set out by the Food and Drugs
Act and Regulations.
Health Canada has developed Monographs for
Disinfectant Drugs that outlines the permitted active ingredients and
concentrations, target microorganism classes, contact times, and associated use
areas for these products to be licensed without the submission of additional
evidence to Health Canada. The Monograph permits general claims such as “Kills
viruses / fungi / bacteria / germs” and “Kills 99.99% of viruses / bacteria / fungi”.
The Monograph application stream allows for an abbreviated review process and
the approximate review timeline for a monograph Disinfectant application is 45
days.
When a proposed product or its labelling is
outside the scope of a published Monograph, applicants are required to submit
evidence to Health Canada to support the safety, efficacy and quality of the
product when used in accordance with the label directions; these applications
require a scientific assessment as part of their market authorization.
Fabricators,
packagers/labellers, distributors, importers and testers of Disinfectant Drugs
are not required to obtain an establishment licence or meet GMP compliance
requirements. However, they are still expected to meet the provisions of
section 8 of the Food and Drugs Act, which denotes the prohibition on
selling drugs manufactured under unsanitary conditions or that are adulterated.
Human-Use Antiseptic Drugs
The
Human-Use Antiseptic Drugs are antiseptic skin products for human use that are
intended for personal, professional, or commercial use. All Human-Use
Antiseptic Drugs are subject to pre-market assessment by NNHPD and will be
assigned a Natural Product Number (NPN) or Drug Identification Number (DIN)
upon market authorization. Human-Use Antiseptic Drugs containing ingredients
that meet the definition of natural health product substances as per the Natural
Health Product Regulations are required to apply for a Natural Product
Number (NPN). All other Human-Use Antiseptic Drugs are required to file an
application for a Drug Identification Number (DIN). All
applications must demonstrate that the product meet safety, efficacy, quality, and
labelling requirements set out by the Food and Drugs Act and Regulations and
Plain Language Labelling requirements (for DINs only).
Health
Canada has also developed a Monograph for Antiseptic Skin Cleansers for certain
personal domestic use Human-Use Antiseptic Drugs. Personal
domestic use products are those that can be self-selected by a consumer from a
retail outlet for their own personal household use as part of a daily skin
cleansing routine to reduce transient organisms on the skin. The Monograph
specifies the allowed medicinal (active) ingredients and their concentrations,
indications, and adequate directions for use. The Monograph permits general
claims such as “Kills harmful bacteria / germs” and “Antiseptic skin cleanser”.
Products which meet the Monograph specifications can be submitted for review
under the Monograph application stream which allows for an abbreviated review
process. The approximate review timelines are 45 days and 60 days for monograph
DIN applications and NPN applications respectively.
Products
that are outside the scope of this Monograph must submit a DIN application or an
NPN application with appropriate supporting safety, efficacy and quality data
for assessment. For example, products making Antiviral claims, % reduction
claims, or organism specific claims must submit supporting evidence such as in-vitro
test data to demonstrate efficacy.
In addition, a Drug Establishment Licence (for
DIN products) or a Site Licence (for NPN products) is required for any person (business
or individual) in
Canada to fabricate, package, label, test, import, distribute, or wholesale a drug.
These activities must be conducted in compliance with GMP requirements.
Canada Summary
Regulatory requirements for hard surface disinfectant drugs
- Drug Identification Number Application for market authorization
- Products eligible for the Monograph application stream may receive
approval in 45 days
- Food and Drug Regulations
compliant product label
Regulatory requirements for antiseptic skin cleansers (i.e. hand
sanitizers)
- Drug Identification Number (DIN) Application or Natural Health Product
(NHP) Application for market authorization
- Products eligible for the Monograph application stream may receive
approval in 45 days (DIN application) or 60 days (NHP applications)
- Food and Drug Regulations
compliant product label
- Manufacturers in Canada would need a Drug Establishment License (for
DIN) or Site License (for NHP)
- Manufacturers outside of Canada would need a Canadian importer with a
Drug Establishment License (for DINs) or Site License (for NHPs).
US – Products regulated by Environmental Protection Agency
In the
United States, chemical germicides formulated as sanitizers, disinfectants, or
sterilants used on environmental surfaces and non-critical surfaces are
regulated by the United States Environmental Protection Agency (EPA), under the
authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Under FIFRA, any substance or mixture of substances intended to prevent,
destroy, repel, or mitigate any pest (including microorganisms but excluding
those in or on living humans or animals) must be registered before sale or
distribution. To obtain a registration, a manufacturer must submit specific
data about the safety and effectiveness of each product. For example, EPA
requires manufacturers of sanitizers, disinfectants, or chemical sterilants to
test formulations by using accepted methods for microbiocidal activity,
stability, and toxicity to animals and humans. The manufacturers submit these data
to EPA along with proposed labeling. If EPA concludes the product can be used
without causing “unreasonable adverse effects,” then the product and its
labeling are registered, and the manufacturer can sell and distribute the
product in the United States.
Pesticides produced by foreign manufacturers
and imported for sale or distribution in the United States must comply with all
requirements applicable to domestic producers. This includes registering the
pesticide product and obtaining an EPA Pesticide-Producing Establishment number
before starting production. In addition, regulations require an importer to
submit to EPA a Notice of Arrival of Pesticides and Devices (EPA Form 3540-1)
for review and determination as to whether the shipment should be sampled and/or
permitted entry into the United States.
US – Products regulated by Food and Drug Administration
Antiseptics are antimicrobial drugs used on
living tissue and thus are regulated by Food and Drug Administration (FDA) under
the Food, Drug and Cosmetic Act. The FDA has established OTC (Over-the-Counter)
monographs for drugs that are generally recognized as safe and effective (or
GRAS/GRAE), which are published in the government’s Code
of Federal Regulations (CFR). A Monograph is a regulatory standard for ingredients, covering
acceptable ingredients, doses, formulations, indications, and labeling. Any OTC
product that conforms to a finalized monograph may be manufactured and marketed
without the need for FDA pre-approval. Any drug product that does not comply
fully to an OTC monograph will require FDA approval under a new drug
application (NDA) or abbreviated new drug application (ANDA) prior to
marketing. In addition, all drug products must comply with the standardized labelling
requirements as outlined in the CFR.
Domestic and foreign establishments that
manufacture, repack, or re-label drug products in the United States are
required to register their facilities with the FDA. They are also required to provide
the FDA with a current list of all commercially marketed drug products. Drug
products are identified and listed using a unique, three-segment number, called
the National Drug Code (NDC), which serves as a universal product identifier
for drugs. This information helps the FDA maintain a catalog of all drugs in commercial
distribution in the United States. Foreign drug establishments whose drugs are
imported into the United States are also required to register with FDA,
identify a U.S. Agent, and submit drug listing information for their drugs
intended for commercial distribution in the United States.
US Summary
Regulatory requirements for
hard surface disinfectant products
- Obtain product registration
with the United States Environmental Protection Agency (EPA)
- EPA approved product label
- Obtain an EPA
Pesticide-Producing Establishment number
- Importers need to submit a
Notice of Arrival of Pesticides and Devices to EPA for approval
Regulatory requirements for antiseptic skin cleansers (i.e. hand
sanitizers)
- May be manufactured and
marketed without FDA pre-approval If the product is fully compliant to a FDA
OTC monograph
- Any product that does not
comply fully to an OTC monograph will require FDA approval under a new drug
application (NDA) or abbreviated new drug application (ANDA).
- Code
of Federal Regulations compliant product label
- Establishment Registration
with the FDA
- Drug Product Listing with
NDCs
- A U.S. Agent is required
for Foreign drug establishments whose drugs are imported into the US
COVID-19 regulatory exemptions and Health Canada interim measures
In light
of the unprecedented demand and urgent need for disinfectants and hand
sanitizers during the COVID-19 pandemic, as an interim measure, Health Canada
will facilitate the importation of the following:
- Products that are already authorized for sale in Canada but are not
fully compliant with Health Canada requirements
- Products that are not authorized for sale in Canada but are authorized
or registered in the United States or an MRA country.
Importers
of products that fall under these categories are required to notify Health
Canada prior to importation.
In
addition, manufacturers and distributors of authorized hard surface disinfectants
with the following anti-virus claims are allowed to make indirect efficacy
claims for SARS-CoV-2 (the virus that causes COVID-19).
- broad-spectrum virucide or
- specific claim against a specific coronavirus, such
as MERS-CoV, SARS-CoV, or human coronavirus strain 229E
Health Canada is also prioritizing the review of applications for market authorization related to disinfectants or hand sanitizers. If you or your company is looking to market your disinfectant or antiseptic products in Canada, now is the time act.
Quality
Smart Solutions has a team of specialists who can provide
product licensing, label compliance, and import solutions for you. We have licensed over 5000 NPNs and DINs
including hand sanitizers and disinfectants.
We are also a licensed importer of record for disinfectant natural
health products through our sister company, Quality
IMPORT Solutions. Get prepared now and contact us today to
discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions
expert which has been assisting clients for 11 years in the areas of Dietary
Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in
Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.
References
Guidance document – Disinfectant drugs https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/disinfectant-drugs.html
Guidance document – Management of
Disinfectant Drug Applications
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/management-disinfectant-drug-applications.html
Guidance Document – Human-Use Antiseptic
Drugs
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/human-use-antiseptic-drugs.html
Guidance Document: The Management of Drug
Submissions and Applications
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html
Pesticide Registration Manual: Chapter 4 –
Additional Considerations for Antimicrobial Products https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-4-additional-considerations
Pesticide Registration Manual: Chapter 1 –
Overview of Requirements for Pesticide Registration and Registrant Obligations https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-1-overview-requirements-pesticide
Safety and Effectiveness of Consumer
Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human
Use https://www.federalregister.gov/documents/2019/04/12/2019-06791/safety-and-effectiveness-of-consumer-antiseptic-rubs-topical-antimicrobial-drug-products-for
Development & Approval Process | Drugs https://www.fda.gov/drugs/development-approval-process-drugs#:~:text=FDA%20approval%20of%20a%20drug,risks%20for%20the%20intended%20population.
Expedited access to disinfectants, hand
sanitizers and personal protective equipment to help limit the spread of
COVID-19, as well as swabs for testing https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php