Guidance for industry on safety monitoring and reporting requirements for marketed biocides: Definitions

Adverse event
A notable incident, a serious incident, a serious unexpected incident or a serious adverse drug reaction.
Biocide
A drug that is manufactured, sold or represented for use in destroying or inactivating micro-organisms, or in reducing or controlling their number, on a non-living and non-liquid surface. However, it does not include a drug that:
  1. is manufactured, sold or represented for use exclusively on the surface of food
  2. is manufactured, sold or represented for use on the surface of a contact lens
  3. meets the following conditions:
    1. is manufactured, sold or represented for use on the surface of
      1. an invasive device or
      2. a medical device that is not an invasive device but is intended to channel or store gases, liquids, tissues or body fluids, for the purpose of being introduced into the body by infusion or other means of administration and
    2. is capable of destroying or irreversibly inactivating either
      1. all types of pathogenic micro-organisms, but not necessarily large numbers of pathogenic bacterial spores or
      2. all types of micro-organisms
Foreign regulatory action
An action taken by a foreign regulatory authority relating to the benefits or risks associated with the biocide for the purpose of mitigating or eliminating a serious risk of injury to human health. Action includes risk communications, recalls, label changes, reassessments of market authorization and suspensions or revocations of market authorization.
Foreign regulatory authority
A government agency or other entity outside Canada that controls the manufacture, sale or use of biocides within its jurisdiction and that may take enforcement action to ensure that biocides marketed within its jurisdiction comply with the applicable legal requirements.
Market authorization holder (MAH)
The person who holds the market authorization for a biocide issued under the Biocides Regulations.
Notable incident
Means a:
  1. response to a biocide that adversely affects human health or
  2. failure in the effectiveness of a biocide that, in respect to human health,
    1. could have resulted in in-patient hospitalization, prolongation of existing hospitalization, congenital malformation or chronic or significant disability or incapacity, or
    2. could have been life-threatening or resulted in death
Qualified individual
An individual qualified by a combination of education, training and experience relevant to their assigned responsibilities.
Safety monitoring
The MAH’s obligations under section 40 of the Biocides Regulations.
Serious adverse drug reaction
Applies to hospital reporting requirements and means a response to a biocide that, in respect of human health
  1. results in in-patient hospitalization, prolongation of existing hospitalization, congenital malformation or chronic or significant disability or incapacity, or
  2. is life-threatening or results in death
Serious incident
A response to or a failure in the effectiveness of a biocide that, in respect of human health:
  1. results in in-patient hospitalization, prolongation of existing hospitalization, congenital malformation or chronic or significant disability or incapacity, or
  2. is life-threatening or results in death
Serious incident reporting
The MAH’s obligations under section 39 of the Biocides Regulations.
Serious unexpected incident
A serious incident that is not identified in nature, severity or frequency in the risk information that is set out on the Canadian label of the biocide.

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