Advertising or Promotion
For purposes of this Code, advertising or promotion or advertising/promotion system (APS) is defined as any paid message communicated by Canadian media, with the intent to influence the choice, opinion or behavior of those addressed by commercial messages. This definition applies even if the information: a) has been published independently of the manufacturer e.g. clinical reprints, meeting reports; b) is from an independent authoritative source; c) is unchanged and complete; d) is claimed to be educational material. Distribution of any unsolicited material about a pharmaceutical product is deemed to be advertising if the information or its distribution serves to promote the sale of that product, either directly or indirectly.
Apps are programs that typically run on Smartphones and are accessed either through download or through the App Store for the user’s platform. When the App Store includes reviews of the app products, Pharma should ensure that wording of reviews fall within the restrictions of Canadian regulations.
Refers to the practical value of the claim itself in assisting prescribers and consumers to select an appropriate therapy and to the practical value of a statistically significant effect when one treatment is compared to another.
The abbreviated computer codes created to transmit messages in brevity or secrecy (e.g., QR codes).
A statement that compares an identified attribute of one drug product/ ingredient to that of another drug product(s)/ ingredient(s) in terms of comparability or superiority.
Conditions of Use
The circumstances, under which the product is used for the authorized indication, e.g. with adjunctive therapies, in-patient vs. outpatient, daytime vs. nighttime use.
Members of the general public.
Continuing Education (CE) Event or Health Professional Meeting
A group learning activity such as a course, conference, congress, symposium, workshop, seminar or meeting, sponsored by an accredited CME provider e.g. medical school CME offices, Royal College accredited National Specialty Societies, the national and provincial chapter offices of the College of Family Physicians of Canada (CFPC), Fédération des médecins omnipraticiens du Québec (FMOQ), Fédération des médecins spécialistes du Québec (FMSQ) and the Canadian Council for Continuing Education in Pharmacy (CCCEP). Rounds are not considered to be Health Professional Meetings in the context of Meeting Reports.
- Published or unpublished clinical or laboratory studies which have not been superseded by more recent and relevant data and information.
- Market research data valid at the time of submission of the Advertising/Promotion System.
Drug Identification Number (DIN)
The 8-digit number located on the label of prescription and over-the-counter drug products that have been evaluated by Health Canada and approved for sale in Canada.
Established Healthcare Product
Any prescription, non-prescription or Natural Health Product manufactured and/or marketed in Canada for 2 years or longer.
Refers to the presentation of accurate and fair assessment of the risks as well as the benefits of the drug. Fair balance is achieved when the overall presentation of information in the APS does not convey a deceptive impression of the drug’s risk or benefits.
A substance or mixture of substances manufactured, sold or represented by a specific manufacturer for in vivo use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof; or in restoring, correcting or modifying function(s) in humans. This includes: drugs listed on all schedules of the Food & Drugs Act and Regulations that have a Drug Identification Number (DIN) assigned by Health Canada; and Natural Health Products that includes traditional herbal medicines; traditional Chinese, Ayurvedic (East Indian) and Native North American medicine; homeopathic preparations; and vitamin and mineral supplements that have a Health Canada assigned NPN or DIN-HM and “pharmaceutical products”.
This excludes medical devices and cosmetics* as defined in the Food and Drugs Act and Regulations; products used for in vitro diagnosis of conditions, both normal (pregnancy test kits) or in connection with disordered states of health (blood glucose monitoring devices for diabetes, contact lens solutions, etc.); and food and vitamins being promoted purely for the maintenance of normal health.
*Therapeutic cosmetics, e.g. medicated and hypoallergenic preparations, are classed as pharmaceutical products. Advertising/Promotion Systems (APS) for such products must be submitted for PAAB review and clearance.
Healthcare Professional (HCP)
Licensed members of the professions of medicine, dentistry, naturopathy, homeopathy, nursing, pharmacy and other related disciplines.
Indication(s) For Use
Is (are) the therapeutic/diagnostic/prophylactic use(s) defined in the authorized product information, and may include limitations to the drug product’s use, such as the applicability to a specific population e.g. pediatric, or other special conditions e.g. in combination with other therapies.
Refers to the active ingredient(s) unless otherwise qualified.
Providing the ability to display or activate another document or website from a point on the current document or website.
Marketing Benefit Claim
A statement that is designed to promote the sale of a health product. It often highlights a specific product attribute i.e. “longer lasting” or “tastes great”.
A promotional statement designed to inform about the product’s availability and benefits so as to form/alter the audience’s opinion of the medication. It can be explicit (i.e. text) or implicit (i.e. images), comparative or non-comparative. It can relate to pharmacological or non-pharmacological properties of the product.
Not all statements about a product are “marketing claims of benefit”. Common examples of product messaging which are not considered marketing benefit claims include product reconstitution instructions, monitoring instructions, dosing modifications for special populations and storage instructions when these are presented as instructions/burdens rather than features/ benefits (i.e. presented to instruct rather than alter/form the audience’s opinion of the medication in a positive way). How a statement is framed can sometimes affect whether it is a marketing benefit claim. For example, the copy “Arbace: Convenience of a single daily dose” is a marketing benefit claim, while “Patients should be instructed to take a single dose daily at the same time each day” is not.
For the purpose of this Code, media encompasses all means of distribution of Advertising/Promotion Systems (APS) to the health professions.
Natural Health Products (NHP)
Naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.
Natural Product Number (NPN)
This is a number that identifies that a natural health product has been licensed by Health Canada.
New Healthcare Product
Any prescription or non-prescription product manufactured and/or marketed in Canada by a particular company for a period of less than 2 years. Use of the word ‘new’ or statements implying “new” in advertising should be restricted to 1 year after initial marketing.
An observational study draws inferences about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus a control group is outside the control of the investigator. This is in contrast with experiments, such as randomized controlled trials, where each subject is randomly assigned to a treated group or a control group before the start of the treatment.
For the purpose of this code, an ongoing study is a study which is still in the data collection stage. It is important to note that once data gathering is complete, and/or an interim analysis is conducted, the study no longer meets the definition criteria for an “ongoing” study, even if the data has not been published, made public (e.g. at a medical/scientific meeting), or a follow/extension study is underway.
A person who has been prescribed a drug product by a health care professional.
Identifies the pharmacologic action of the healthcare product (anxiolytic, diuretic, antibiotic, analgesic, etc).
Prescribing Information (PI)
Includes important information that may be required for the optimal, safe and effective use of a drug product, such as mechanism of action; indications and contraindications for use; and dosage instructions. For example, for healthcare products having a Product Monograph, the information provided in Part I of that monograph constitutes prescribing information.
PAAB considers a link to the Terms of Market Authorization for any product (whether prescription or non-prescription) to satisfy this code’s requirement for a link to “prescribing information”.
A claim related to general merit, quality of life, economics, market position or status, or comparative advantage.
Rational Drug Therapy
Appropriate therapy, recommended or prescribed, that may be expected to remedy or ameliorate a disordered state of physical or mental health or that may be employed for diagnosis and prophylactic purposes to prevent or lower the incidence of illness.
Really Simple Syndication (RSS)
A simple XML schema that allows readers to pull data and display it any way they choose. Used for blogs and press releases to expand the ways people can access the information.
For the purpose of this code, representative research findings are those in which the evaluated sample reflects the population of interest.
Risk communications are used as part of any risk management program. For the purpose of this code, “risk communications” refers to communications issued by (or in collaboration with) Health Canada to convey new or emerging health product safety information about the promoted product. For more information, please refer to the Health Canada guidance document “Description of Current Risk Communication Documents for Marketed Health Products for Human Use”.
A strategy intended to manipulate opinion about a particular issue by arousing an exaggerated sense of fear or alarm.
Search Engine Marketing (SEM)
A form of Internet marketing that involves the promotion of websites by increasing their visibility in search engine results pages through optimization (both on-page and off-page) as well as through advertising (paid placements, contextual advertising, and paid inclusions).
Search Engine Optimization (SEO)
The process of improving the visibility of a website or a web page in a search engines’ “natural” or un-paid (“organic” or “algorithmic”) search results.
For the purposes of this code, self-care products includes over the counter, natural health, and homeopathic products. Note that it does not include ethical drugs or schedule D drugs.
A person fulfilling one or more of the following functions in an organization: Chief Executive Officer, Vice President, Head or Director of Marketing, Medical or Regulatory, Senior Counsel.
Any commissioned communication prepared or controlled by the manufacturer or its agent such as journals, newsletters and other publications.
The broad term for internet activities that engage or encourage engagement through online discussions or interactions. E.g.: blogs (personal online journal comprised of entries/posts), microblogs (Twitter), chat rooms, forums, video/photo sharing (YouTube, Flickr), social networking (Facebook), podcasts, user forums/discussion groups, wikis (website where content is added, modified or deleted by the users), news aggregation (RSS), apps etc.
Terms of Market Authorization (TMA)
Information in the Product Monograph, labeling and product license and the document that assigns a Drug Identification Number (DIN), Natural Health Product number (NPN) or homeopathic product number (DIN-HM), including related product labeling material and prescribing information, authorized by Health Canada.
A claim of effectiveness and/or safety of a healthcare product for the purpose(s) intended.
Identifies the condition(s) of therapeutic use of the healthcare product e.g. migraine, hypertension, peptic ulcer, psoriasis, etc.
User-generated Content (UGC)
Any material that is created by and posted by, a user. Examples of user-generated content are: a “like” rating on an article, a link rated and forwarded, a comment added into an open text field, a descriptor selected from a list of choices, a photo or other media uploaded.
Uniform Resource Locator (URL)
The “human-friendly” addresses of resources on the Internet. An example is: www.PAAB.ca.
For the purposes of this code, valid research findings are those in which the research instrument (e.g. the clinical trial) is designed/implemented such that it can actually measure that which it is intended to measure.
Web Link Destination
The webpage produced by clicking a provided electronic link or by entering a provided URL into the browser address bar.