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:
- the distribution of certain products to the general public under certain conditions;
- the distribution of products to a larger subset of health care practitioners; and
- importation of certain non-prescription drugs into Canada without quarantine and additional testing requirements and direct shipment of such products to retailers and wholesalers.
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:
- List A: List of Certain Natural Health Products for Distribution as Samples, and
- List D: List of Certain Non-prescription Drugs for Distribution as Samples.
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:
- Good manufacturing practices guide for drug products (GUI-0001)
- Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines - Selected Category IV Monograph Drugs (GUI-0066).
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
| 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
| 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 |
| 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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