Medical Health Definitions 1
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
What is Adverse Event
Is the primary mechanism by which CFIA communicates non-compliance to the regulated party.
What is Inspection Report
For the purpose of reporting cases of suspected adverse reactions, a person who is not a healthcare professional such as a patient, lawyer, friend or relative/parent/child of a patient.
What is Consumer
Is the state of conformity of regulated parties with legislative requirements.
What is Compliance
Means a detailed record of all relevant data associated with the use of a drug in a subject.
What is Case Report
For the purposes of reporting suspected adverse reactions, healthcare professionals are defined as medically qualified persons, such as physicians, dentists, pharmacists, nurses and coroners.
What is Healthcare Professional
Is a contravention of the applicable Acts and/or Regulations.
What is a Non-Compliance
An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks.
What is Risk-Benefit Balance
CFIA response when regulated parties do not comply and/or a risk needs to be controlled.
What is Regulatory Response
Is any contravention of an Agri-Food Act or its regulations that may be proceeded with in accordance with the Agriculture and Agri-Food Administrative Monetary Penalties Act and result in the issuance of a Notice of Violation with warning or penalty.
What is Violation
Means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function.
What is Adverse Drug Reaction
Are conducted by inspectors and veterinary inspectors with the predominant purpose of verifying compliance with legislation enforced by CFIA.
What are Inspections
An important identified risk, important potential risk or missing information.
What is Safety Concern
Consultation, communication, information, tools and processes to help regulated parties understand and comply with regulatory requirements.
What is Compliance Promotion
Food safety is the science of handling, preparing and storing food to reduce the risk of foodborne illnesses.
What is Food Safety
Means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the drug.
What is Serious Unexpected Adverse Drug Reaction
CFIA assessment of regulated party compliance by conducting inspections, taking samples, testing, etc., to verify that requirements are being met.
What is Compliance Verification
Means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
What is Complaint
Is an action that is taken for the purpose of controlling risk when a regulated commodity, process or thing poses or may pose a risk to human, plant or animal health, the environment, economy or trade.
What is Control Action
Refers to an individual or business entity undertaking activities that are regulated by CFIA legislation.
What is Regulated Party
Means a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.
What is Serious Adverse Drug Reaction
Is where the main purpose of an inquiry by a CFIA official is for the determination of criminal charge. Predominant purpose is to gather and secure evidence.
What is Investigation
Format and content for the reporting of one or several suspected adverse reactions to a medicinal product that occur in a single patient at a specific point of time.
What is Adverse Drug Reaction Report
Is an action taken by CFIA in response to non-compliance.
What is Enforcement Action
In respect of a food, means that the food contains any micro-organism, chemical substance, extraneous material or other substance or thing that may render the food injurious to human health or unsuitable for human consumption, including those that are not permitted under the Food and Drugs Act or those that do not comply with any limits or levels provided under that Act.
What is Contaminated