Traditional Medicines and OTC Products
An intro to the legal situation for traditional products and OTC medicines in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
In Canada, traditional, herbal, complementary or alternative medicines are included under the previously defined term “NHPs.” NHPs are governed by the Food and Drugs Act and the Natural Health Products Regulations, which provide requirements concerning their manufacturing, packaging, labelling, storage, importation, distribution and sale. An NHP is defined as a “drug” within the meaning of the Act but is governed under a separate regulation than conventional drugs. NHPs are manufactured, sold, or represented to diagnose, treat, mitigate, or prevent diseases, disorders, abnormal physical states, or to restore, correct, or modify organic functions. They are comprised of substances listed under the Natural Health Product Regulations Schedule 1, and can never include a substance listed under Schedule 2.
To market an NHP in Canada, applicants must submit an authorization request to acquire a product licence issued from the Minister. The NHP must meet safety and efficacy requirements. Once authorized, NHPs are issued an eight digit numerical code called a “Natural Product Number” (“NPN”) and a product licence containing the terms of market authorization. The product licence specifies Health Canada’s authorizations for the NHP’s dosage form, recommended dose, recommended route of administration, recommended use or purpose, recommended duration of use, as well as the quantity, potency, and source material of any medicinal ingredients. The Product Licence also specifies its date of issue in addition to the licensee’s name and address. Requests to test NHPs in clinical trials must also be authorized and conducted according to accepted principles of good practice.
NHP applicants must apply for a Site Licence under the Natural Health Products Regulations to manufacture, import, label, or package NHPs for sale in Canada. Site Licence applications must contain the applicant’s name, address, and contact information, the address of the buildings in which activities are to be conducted, and a report demonstrating compliance with GMPs.
As of July 2018, Health Canada plans to update its approach to regulating “self-care” products, including NHPs, non-prescription drugs, and cosmetics. Currently, three different sets of rules apply to the regulation of self-care products, each with different requirements and oversight. Under the proposed new system Health Canada would bring all self-care products under a single set of rules and regulate them based on the foreseeable risk to consumers. Products of similar risk profiles would be treated in a similar manner to help ensure that the rules for bringing products to market are more consistent and easier to understand.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, NHPs can be advertised directly to the public, subject to certain exceptions. First, an NHP cannot be advertised as a treatment or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A of the Food and Drugs Act (i.e. conditions for which self-care is not appropriate, including, for example, cancer, diabetes, hypertension, etc.). Second, NHPs must not be labelled, packaged, treated, processed, sold or advertised in a false, misleading, or deceptive manner, or in a manner likely to create an erroneous impression regarding the product’s character, value, quantity, composition, merit, or safety. A person cannot therefore advertise an NHP outside of the terms of its market authorization. To this end, an NHP should not be advertised if the terms of its market authorization have been withdrawn by Health Canada, or if the NHP has been voluntarily withdrawn or discontinued by the manufacturer.
As with all drug advertisements, NHP advertisements must present accurate, objective, and balanced information about the product’s health benefits and risks.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Health, advertising, and marketing claims concerning an NHP must remain consistent with and cannot exceed the scope of the terms of market authorization. The advertisement must clearly identify the advertised product or product line visually and/or in audio. It must present at least one indication for recommended use and one symptom addressed per medicinal ingredient. The product category (e.g. homoeopathic, traditional) must be accurately represented. Additionally, the advertisement must remain consistent with the NHP’s terms of market authorization in any descriptions of:
- Directions for product use, dosing, administration, and storage;
- The product’s therapeutic mechanism of action, performance, efficacy, and the ability to prevent or reduce risks;
- The product’s onset of effects, duration, and absence of side effects; and,
- Depictions of the NHP’s potency, by describing only the quantity of medicinal ingredient and the number of standardized components per dosage units.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
In Canada, over-the-counter (“OTC”) non-prescription medications are regulated in the same manner as all drugs. For additional details on the regulatory requirements, see Question 3 of Regulatory, Pricing and Reimbursement Overview.
OTC drugs are identified as medicinal products with ingredients that do not appear on Health Canada’s “Prescription Drug List,” which sets out medicinal ingredients with prescription status.
5. Are there any limitations on locations or channels through which OTC products may be sold?
NAPRA Schedule III drugs are sold from the self-selection area of pharmacy which is operated under the direct supervision of a pharmacist, who must be available, accessible, and approachable to assist the patient in making an appropriate self-medication selection.
Unscheduled drugs are sold without professional supervision, and may be sold from any retail outlet, including internet platforms not belonging or referring to an accredited pharmacy. In the case of unscheduled drugs, adequate information must be available on the label for the patient to make a safe and effective choice.
6. What health, advertising, and marketing claims may be made for OTC products?
As with all drugs identified under the Food and Drugs Act, health, advertising, and marketing claims concerning OTC products must be consistent with the product’s terms of market authorization. The list of requirements and limitations on claims that can be made for OTC products is substantively identical to the list concerning NHPs in Question 3 above.
7. Can OTC products be marketed or advertised directly to the public?
Yes, OTC products can be advertised directly to the public, subject to the same exceptions applicable to advertising of NHP products. See Question 2 above for details.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
A prescription-only product’s medicinal ingredient can be fully or partially converted to an OTC product by submitting a request to convert a medicinal ingredient from prescription to non-prescription to Health Canada. A full conversion changes the prescription status without any change to the conditions of use of the medicinal ingredient, and removes the medicinal ingredient completely from the Prescription Drug List. A partial conversion changes the product’s conditions of use (i.e. dosage, administration, indication, or target population) and results in both a prescription and non-prescription version of the drug product on the Canadian market. The request must contain evidence demonstrating that the medicinal ingredient no longer meets any of the Prescription Drug List requirements, and that the medicinal ingredient can be used safely and effectively in a self-care environment.
Consumer studies may be required for indications, directions of use, and/or warnings or contra-indications that have never been marketed for sale in a self-care environment in Canada or internationally, or are considered complex for the self-care environment and therefore present a possible risk of misuse.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Commercial importers of NHPs or OTC products destined for retail, distribution, or other commercial activities must hold a Site or Establishment Licence, upon which the foreign manufacturing site must be listed. The products which are imported must be authorized for sale in Canada (i.e. they must possess either an NPN or DIN).
Personal use importations of NHPs or OTC products are permitted to individuals seeking to import a single course of treatment or a 90-day supply based on the directions for use of the product (whichever is less). The product must be for personal use, or for the use of a person for whom the importer is responsible and with whom they are travelling. The product must be shipped/carried in hospital or pharmacy dispensed packaging, original retail packaging, or have the original label affixed to it which clearly indicates the health product and what it contains.
For use in a clinical trial, NHP importers require a Notice of Authorization issued by Health Canada. OTC drug importers, as with all drug importers, must include a “No Objection Letter” issued by Health Canada authorizing the use of the drug in a clinical trial (other than clinical trials in Phase IV, which are performed after the drug is approved and on the market). For NHP and OTC products, copies of the authorization or letter must be provided at the port of entry.