Notice of Proposal to expand lists of certain products for distribution as samples and a list of certain non-prescription drugs for which testing requirements do not apply

Background

On March 13, 2020, Bill C-4 entitled the Canada-United States-Mexico Agreement Implementation Act received Royal Assent. In order to implement the Canada-United States-Mexico Agreement (CUSMA), regulatory amendments to the Food and Drug Regulations (FDR) and the Natural Health Products Regulations (NHPR) were necessary for Canada to meet its commitments.

On July 1, 2020, amendments to the Food and Drugs Act, the FDR and the NHPR came into force and allow:

As part of the implementation, Health Canada established a guidance document on the distribution of drugs as samples, as well as lists of the specific non-prescription drugs and natural health products that can be distributed as samples directly to consumers:

Health Canada also established a list of certain non-prescription drugs for which additional (i.e., identity and confirmatory) testing is not required upon importation and that may be directly shipped to retailers or wholesalers:

Guidance

The guidance document entitled Distributing samples of prescription drugs, non-prescription drugs and natural health products will be updated following the public comment period.

The current guidance document is available by requesting a copy from the Natural and Non-prescription Health Products Directorate via email at: hc.nnhpd.consultation-dpsnso.sc@canada.ca.

Other existing guidance documents will also be updated in response to the regulatory amendments associated with the release of certain non-prescription drugs to the Canadian market without quarantine and additional testing upon importation and direct shipment of such products to retailers and wholesalers:

Note: GUI-0066 will apply to all products under the proposed List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019 (1) and (2) of the Food and Drug Regulations Do Not Apply and the title of the guidance document has been changed to reflect its expanded scope.

Proposal

Health Canada intends to amend the lists for non-prescription drugs and natural health products to include all currently authorized products in the product categories set out in the CUSMA and meeting the identified criteria, i.e., for topical use, localized and non-systemic effect, and meets the definition of a cosmetic.

The product categories covered across these lists include: toothpastes, mouthwashes, anti-septic skin cleansers, sunscreens, anti-dandruff products, diaper-rash products, medicated skin care products, acne therapy products and antiperspirants, as well as athlete's foot products and throat lozenges.

This means that, within those products categories, all three lists will be expanded to include all approved ingredients, all approved quantities and all approved uses or purposes with the exception of medicated skin care products. The CUSMA does include some exclusions related to medicated skin care products (i.e., antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics), and these exclusions will be maintained for the current proposal.

The proposed lists are as follows:

Proposed list A: List of Certain Natural Health Products for Distribution as Samples

Only natural health products listed below can be distributed as samples to adult consumers (18 years or older).
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6
Class of Natural Health Products Medicinal Ingredient (s) Quantity of Medicinal Ingredient(s) Qualifier (s) Route(s) of Administration Permissible Use(s) or Purpose(s)
Toothpastes All approved ingredients All approved quantities For human use Oral cavity All approved uses or purposes
Mouthwashes All approved ingredients All approved quantities For human use Oral cavity All approved uses or purposes
Antiseptic Skin Cleansers All approved ingredients All approved quantities For human use Topical All approved uses or purposes
Sunscreens All approved ingredients All approved quantities For human use Topical All approved uses or purposes
Anti-Dandruff Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes
Diaper Rash Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes
Medicated Skin Care Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes except antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics
Acne Therapy Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes
Throat Lozenges All approved ingredients All approved quantities For human use Oral cavity All approved uses or purposes
Athlete's Foot Treatments All approved ingredients All approved quantities For human use Topical All approved uses or purposes
Antiperspirants All approved ingredients All approved quantities For human use Topical All approved uses or purposes

Proposed list D: List of Certain Non-prescription Drugs for Distribution as Samples

Only non-prescription drugs listed below can be distributed as samples to adult consumers (18 years or older).
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7
Class of Non-prescription Drugs Medicinal Ingredient (s) Quantity of Active Ingredient (s) Qualifier (s) Route(s) of Administration Permissible Use(s) or Purpose(s) Last Revised (YYYY-MM-DD)
Toothpastes All approved ingredients All approved quantities For human use Oral cavity All approved uses or purposes  
Mouthwashes All approved ingredients All approved quantities For human use Oral cavity All approved uses or purposes 2020-03-13
Antiseptic Skin Cleansers All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Sunscreens All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Anti-Dandruff Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Diaper Rash Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Medicated Skin Care Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes except antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics 2020-03-13
Acne Therapy Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Throat Lozenges All approved ingredients All approved quantities For human use Oral cavity All approved uses or purposes 2020-03-13
Athlete's Foot Treatments All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Antiperspirants All approved ingredients All approved quantities For human use Topical All approved uses or purposes  
Proposed List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019 (1) and (2) of the Food and Drug Regulations Do Not Apply
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7
Class of Non-prescription Drugs Active Ingredient (s) Quantity of Active Ingredient (s) Qualifier (s) Route(s) of Administration Permissible Use(s) or Purpose(s) Last Revised (YYYY-MM-DD)
Toothpastes All approved ingredients All approved quantities For human use Oral cavity All approved uses or purposes  
Mouthwashes All approved ingredients All approved quantities For human use Oral cavity All approved uses or purposes 2020-03-13
Antiseptic Skin Cleansers All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Sunscreens All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Anti-Dandruff Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Diaper Rash Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Medicated Skin Care Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes except antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and analgesics 2020-03-13
Acne Therapy Products All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Throat Lozenges All approved ingredients All approved quantities For human use Oral cavity All approved uses or purposes 2020-03-13
Athlete's Foot Treatments All approved ingredients All approved quantities For human use Topical All approved uses or purposes 2020-03-13
Antiperspirants All approved ingredients All approved quantities For human use Topical All approved uses or purposes  

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