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Guidance on preparing and submitting summary reports for marketed drugs and natural health products: Definitions and resources

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Definitions

Adverse reaction:
A noxious and unintended response to a marketed health product covered by this document. Includes "adverse drug reaction" as defined in the Food and Drug Regulations (FDR) and "adverse reaction" as defined in the Natural Health Products Regulations (NHPR).
Discontinue:
In respect of the sale of a drug by the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug, to permanently cease the sale of the drug.
Drug:
According to the Food and Drugs Act (act), a drug includes any substance or mixture of substances manufactured, sold or represented for use in:
  • diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals
  • restoring, correcting or modifying organic functions in human beings or animals or
  • disinfecting premises in which food is manufactured, prepared or kept
European Union reference date (EURD):
For a medicine containing that active substance or that combination of active substances, corresponds to the:
  • date of the first marketing authorization of a medicine containing that active substance or that combination of active substances in the EU or
  • earliest of the known dates of the marketing authorizations
International birth date (IBD):
Date of the first marketing authorization for any product containing the active substance granted to any company in any country in the world.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):
A joint regulatory-industry initiative pertaining to the international harmonization of regulatory requirements for drug products. This is carried out by developing and implementing harmonized technical guidelines and standards for developing, registering and monitoring pharmaceutical products. Health Canada is committed to adopting and implementing ICH guidance.
Licence holder:
The entity that holds the natural product number (NPN) or homeopathic medicine number (DIN-HM).
Market authorization holder (MAH):
The entity that holds the notice of compliance or drug identification number (DIN).
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 the healthcare professional, patient, or consumer. Medication errors may be related to professional practice, drug products, procedures, and systems, and include prescribing, order communication, product labelling/ packaging/nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.
Natural health product (NHP):
A substance set out in Schedule 1 of the NHPR 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 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 maintains or promotes health

An NHP does not include:

  • a substance set out in Schedule 2 of the NHPR
  • 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
Pharmacovigilance:
As defined by the World Health Organization (WHO), the science and activities relating to detecting, assessing, understanding and preventing adverse effects or any other drug-related problems.
Sell:
According to the Food and Drugs Act (act), sell includes:
  • offer for sale, expose for sale or have in possession for sale, or distribute to one or more persons, whether or not the distribution is made for consideration
  • lease, offer for lease, expose for lease or have in possession for lease
Serious adverse reaction:
A noxious and unintended response to a product covered by this document 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 a medically important event or reaction
  • is life-threatening or results in death

Includes "serious adverse drug reaction" as defined in the FDR and "serious adverse reaction" as defined in the NHPR.

Significant change:
Based on new evidence about the benefits or risks of a product, a conclusion by the market authorization holder (MAH) that there is an emerging safety issue requiring urgent action to:
  • manage the potential impact of the issue on patient or public health or
  • maintain the Minister's confidence that the product's benefits outweigh its risks in accordance with the product's authorization
Vulnerable sub-population:
A group of individuals within the general population who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of experiencing adverse health effects from exposure to the drug or natural health product.

Resources

As a starting point, market authorization holders (MAHs) should refer to the most up-to-date versions of the following guidance documents.

Health Canada guidance documents and notices

International Council for Harmonization (ICH) guidance documents

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2026-09-04