A noxious and unintended response to a drug that occurs at doses normally used or tested for diagnosing, treating or preventing a disease or modifying an organic function.
Bioequivalence
The property wherein 2 drugs with identical medicinal ingredients or 2 different dosage forms of the same drug possess similar bioavailability and produce the same effect at the site of physiological activity.
Biologic drug
A drug listed in Schedule D to the Food and Drugs Act. Biologic drugs are derived through the metabolic activity of living organisms and tend to be significantly more variable and structurally complex than chemically synthesized drugs.
Biosimilar
A biologic drug that obtains market authorization following a version previously authorized in Canada and that has demonstrated similarity to a reference biologic drug. A biosimilar relies in part on prior information on safety, efficacy and effectiveness that is deemed relevant due to its similarity to the reference biologic drug.
Drug identification number
A computer-generated 8-digit number assigned by Health Canada to a drug product before being marketed in Canada. A DIN uniquely identifies the manufacturer, product name, medicinal ingredient(s), strength(s) of medicinal ingredient(s), pharmaceutical form and route of administration.
Extension of indication
An indication granted to a biosimilar based on evidence of biosimilarity and the previously established efficacy and safety of the reference biologic drug.
Generic drug
A copy of a brand name drug. The generic drug is pharmaceutically equivalent to the brand name drug: it contains the identical medicinal ingredients, in the same amounts and in a similar dosage form.
Interchangeability
The ability for a patient to be changed from 1 drug to an equivalent drug, by a pharmacist, without the intervention of the prescriber who wrote the prescription.
Medication incident (medication error)
Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a health care professional, patient or consumer.
New drug submission
An application for market authorization of a new drug in Canada.
Nocebo effect
A negative effect of a pharmacological or non-pharmacological medical treatment that's induced by patient expectations and is unrelated to the physiological action of the treatment.
Notice of compliance
A notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. These notices are issued to a manufacturer following the satisfactory review of a submission.
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other drug-related problems.
Product monograph
A factual, scientific document on a drug, issued with its authorization, describing the properties, indications and conditions of use for the drug. It may include any other information that may be required for optimal, safe and effective use of the drug. It cannot contain any promotional material.
Reference biologic drug
A biologic drug authorized on the basis of a complete quality, non-clinical and clinical data package, to which a biosimilar is compared to demonstrate similarity.
Risk management plan
A document that describes a set of pharmacovigilance activities and interventions designed to:
identify, characterize, prevent or minimize risks related to drug products
assess the effectiveness of those interventions
Substitution
The practice of dispensing 1 product for another interchangeable product at the pharmacy level, without consulting the authorized prescriber.
Switching
A change from routine use of 1 specific product to routine use of another specific product.
