Guidance on distinction between advertising and other activities for health products: Definitions

For the purpose of this guidance document, the following terms are defined as follows:

Advertisement:

Including any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device.

Advertising preclearance agencies (APA):

Independent entities, which review and preclear advertising material, prior to its use in the marketplace, to help interested parties ensure compliance with the advertising provisions of federal legislation, the various Health Canada guidance documents, as well as their own codes of advertising. Some agencies also offer mechanisms to resolve complaints on advertising for authorized health products.

The board of directors or advisory bodies of these agencies may include stakeholders from academia, consumer groups, the media, advertising agencies, the pharmaceutical industry and HCP associations. Health Canada acts as an ex-officio observer and advisor to some of these boards and advisory bodies, without relinquishing any part of its authority under the Food and Drugs Act (FDA) and its associated regulations.

Animal health products:

Include veterinary drugs and veterinary health products (VHPs) but exclude veterinary biologic products not regulated by Health Canada.

Biological drugs (biologics):

Products made from living sources, including vaccines. Biologics come from living organisms or from their cells. They are often made using biotechnology. Examples of biologics include insulin, growth hormones and antibodies. Biologics are generally larger and more complex in composition than chemically produced pharmaceutical drugs.

In Canada, biologic drugs are listed in Schedule D of the Food and Drugs Act.

Brand/product name:

The unique name under which the manufacturer of a health product advertises and sells it.

Claim:

Any representation made on behalf of a health product, including the indication for use and marketing claims. A marketing claim may be a statement or image that is designed to promote the sale of a health product and highlights a specific product attribute, such as "longer lasting" or "tastes great."

Comparative claim:

A statement that compares an identified attribute of 1 health product or ingredient to that of another health product(s)/ingredients(s) in terms of comparability or superiority.

Controlled substance:

Any type of substance that the federal government has categorized as having a higher-than-average potential for abuse or addiction. Such substances are divided into categories based on their potential for abuse or addiction. They include illegal street drugs and prescription medications.

Cosmetic:

Any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth. Includes deodorants and perfumes.

Device:

Please see definition of a medical device.

Directions for use:

Commonly known as the instructions for use. This refers to full information about the procedures recommended for achieving the optimum performance of the device and includes cautions, warnings, contra-indications and possible adverse effects.

Disposal:

The power or opportunity to make use of someone or something.

Drug:

Includes any substance or mixture of substances manufactured, sold or represented for use in:

1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals
2. restoring, correcting or modifying organic functions in human beings or animals or
3. disinfection in premises in which food is manufactured, prepared or kept

Drug identification number (DIN):

A computer-generated 8-digit number assigned by Health Canada to a drug product before being marketed in Canada. It uniquely identifies all drug products sold in a dosage form in Canada. It’s located on the label of prescription and non-prescription (over-the-counter) drug products that have been evaluated and authorized for sale in Canada.

Emergency drug release (EDR):

A Health Canada program that considers requests for access to drugs for veterinary use that are:

• unavailable for sale in Canada and
• submitted by veterinary practitioners, for the purpose of diagnosing or treating a medical emergency in an animal or group of animals under their care

Formulary committees:

A multidisciplinary committee responsible for making decisions about drugs whose costs are covered by a private or public (including hospitals) drug coverage program (formulary).

General public:

Ordinary people, especially all the people who are not members of a particular medical, pharmaceutical or scientific organization or who do not have any special type of medical or scientific knowledge. This excludes persons who have been prescribed a health product by a health care professional (HCP).

Health care professional:

A person who is entitled under the laws of a province to provide health services in the province.

Health product:

A prescription (including a controlled substance) or non‐prescription drug for human or animal use, a medical device for human use, a natural health product, a VHP and/or a radiopharmaceutical drug for human or animal use.

Homeopathic medicine number (DIN-HM):

A computer-generated 8-digit number assigned by Health Canada to each homeopathic medicine authorized to be marketed under the Natural Health Products Regulations.

Indication for use:

A statement that describes the limitations for use of a drug, including the disease state, condition(s) or symptom(s) and the target population, if specified, for which the health product is intended and authorized to be used by Health Canada.

Label:

Includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package.

Manufacturer:

A person who fabricates or processes a health product for the purpose of sale. Does not include a pharmacist or other HCP who, at the request of a patient, compounds a health product for the purpose of sale to that patient.

Market authorization holder (MAH): 

Also referred to as sponsor or manufacturer. The MAH is the legal entity that holds the notice of compliance, drug identification number, medical device licence number or product licence number, or has received approval to initiate clinical trials in Canada.

Marketing:

The process or technique of promoting, selling and distributing a product or service.

Medical condition:

A broad term that includes all diseases, lesions, disorders, or non-pathologic conditions that normally receive medical treatment, such as pregnancy or labour.

Medical device:

An instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for human use in:

1. diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings
2. restoring, modifying or correcting the body structure of human beings or the functioning of any part of the bodies of human beings
3. diagnosing pregnancy in human beings
4. caring for human beings during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
5. preventing conception in human beings

Does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being.

Medical device licence number:

A computer-generated number assigned by Health Canada to a medical device licence, authorizing the importation/sale of the medical device(s) listed on that licence under the Medical Devices Regulations.

Natural health product:

A substance set out in Schedule 1 of the Natural Health Product Regulations, or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine that is manufactured, sold or represented for human use in:

• diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state or its symptoms in humans
• restoring or correcting organic functions in humans or
• modifying organic functions in humans, such as modifying those functions in a manner that maintain or promote health

Does not include a substance set out in Schedule 2 of the Natural Health Product Regulations or any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2. Natural health products pertain to human beings only.

Natural product number (NPN):

A computer-generated 8-digit number assigned to each natural health product authorized to be marketed under the Natural Health Products Regulations.

New drug:

A drug, other than a VHP:

• that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug
• that is a combination of 2 or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug or
• with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration or duration of action, and that has not been sold for that use or condition of use in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug

Notification number (NN):

A number generated by the VHP notification system for a VHP, after Health Canada has ensured that the product meets all of the requirements of the VHP Notification Program. It begins with “NN” followed by a combination of 4 digits and letters.

Notice of compliance (NOC):

A document from Health Canada issued to a manufacturer, following the satisfactory review of a submission for a new drug, and that signifies compliance with the Food and Drug Regulations.

Patient:

An individual who has a medical condition and is receiving, or is registered to receive, care.

Product monograph:

A factual, scientific document on a health product that, devoid of promotional material:

• describes the properties, claims, indications and conditions of use of the drug and
• contains any other information that may be required for optimal, safe and effective use of the health product

Risk:

A measure of both the potential harm to human and animal health that may result from being exposed to a product under specific conditions of use, together with the likelihood that the harm will occur.

Sale:

Includes offer for sale, expose for sale or have in possession for sale, or distribute to 1 or more persons, whether or not the distribution is made for consideration. Also includes lease, offer for lease, expose for lease or have in possession for lease.

Special Access Program (SAP):

Health Canada’s program that considers requests from practitioners who wish to access drugs that are unavailable for sale in Canada or custom-made or unlicensed medical devices, in order to treat patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or unavailable to provide appropriate treatment for patients under their care. SAP authorizes a manufacturer to sell a drug or medical device that cannot otherwise be sold or distributed in Canada.

Drugs considered for release by the SAP include pharmaceutical, biologic, medical devices and radio-pharmaceutical products not authorized for sale in Canada.

Sponsor:

A person or an organization that pays for, plans or carries out the dissemination of a message or activity in relation to a health product, involving a medical condition and/or any health-related matter.

Terms of market authorization (TMA):

These comprise all labelling information (for example, the product monograph, prescribing information, inserts, instructions for use) that accompanies the NOC and/or in the document that assigns a DIN, NPN or DIN-HM, medical device licence number or NN and any related labelling material for health products. This information is derived from the information on the health product that is submitted for regulatory review and authorization, as required by the FDA and its associated regulations and as interpreted by guidance documents and policies.

Unauthorized product:

A health product such as a drug, vaccine, natural health product or medical device for which the market authorization has not been granted by Health Canada.

Vaccine:

Complex biologic products designed to induce a protective immune response effectively and safely. Vaccines are classified according to the type of active component (antigen) they contain.

Veterinary health product (VHP):

Low-risk drugs in dosage form that may contain ingredients such as vitamins, minerals and traditional medicines. They are used to maintain or promote the health and welfare of companion animals (pets) and food-producing animals.