Glossary: Drug, natural health product and biocide recall guide (GUI-0039)

Terms

The following definitions explain how terms are used in this document. If there’s a conflict with a definition in the Food and Drugs Act (act), Food and Drug Regulations (FDR), Natural Health Products Regulations (NHPR) or Biocides Regulations (BR), the definition in the act or regulations prevails.

Active ingredient (drugs)

A drug that, when used as a raw material in the fabrication of a drug in dosage form, provides its intended effect. (FDR)

Active ingredient (biocides)

A component of a biocide that is directly responsible for any of the biocide’s intended effects. (BR)

Adverse reaction

A noxious and unintended response to a marketed health product covered by this document and includes "adverse drug reaction" as defined in the FDR and "adverse reaction" as defined in the NHPR.

The FDR defines adverse drug reaction as a noxious and unintended response to a drug, which occurs at doses normally used or tested for diagnosing, treating or preventing a disease or modifying an organic function.

The NHPR defines adverse reaction as a noxious and unintended response to a natural health product that occurs at any dose used or tested for diagnosing, treating or preventing a disease or for modifying an organic function.

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, but it does not include:

1. such a drug that is manufactured, sold or represented for use exclusively on the surface of food
2. such a drug that is manufactured, sold or represented for use on the surface of a contact lens that is a medical device, as defined in section 1 of the Medical Devices Regulations or
3. such a drug that
   1. is manufactured, sold or represented for use on the surface of
      1. an invasive device, as defined in section 1 of the Medical Devices Regulations, or
      2. a medical device, as defined in section 1 of the Medical Devices Regulations, that is not an invasive device, as defined in that section, 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

Brand name (drug)

Defined by the FDR as the name in English or French, whether or not it includes the name of any manufacturer, corporation, partnership or individual:

• that’s assigned to the drug by its manufacturer
• under which the drug is sold or advertised and
• that’s used to distinguish the drug

Brand name (natural health product)

Defined by the NHPR as a name in English or French, whether or not it includes the name of a manufacturer, corporation, partnership or individual:

• that’s used to distinguish the natural health product and
• under which a natural health product is sold or advertised

Compliance

The state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or a product with a legislative or regulatory requirement.

Consignee

Anyone who received, purchased or used the product being recalled.

Correction

The repair, modification, adjustment, relabelling or inspection (including patient monitoring) of a product without physically removing it to another location.

Distributor

Refer to “manufacturer” (drugs).

As defined in section C.01A.003 of the FDR, divisions 1A and 2 to 4 apply to the following distributors:

• a distributor of an active ingredient or a drug in dosage form that is listed in Schedule C to the act
• a distributor of a drug for which the distributor holds the drug identification number

Distributor (natural health products)

A person who sells a natural health product to another person for the purpose of further sale by that other person. (section 1, NHPR)

Distributor (biocides)

A person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word, or mark controlled by them, sells a biocide.

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 being or animals or
• disinfection in premises in which food is manufactured, prepared or kept

Effectiveness check

Includes a survey of those affected by the recall (consignees) to verify they have received the recall information and are aware of any appropriate action to be taken and may include verification of the action taken.

Exposure assessment

A process that involves producing a qualitative and/or quantitative estimate of the magnitude, frequency, duration, route and extent of human exposure to an agent.

Fabricate

To prepare and preserve a drug for the purpose of sale. (FDR)

Food and Drugs Act

A federal statute regulating the health and safety of food, drugs, natural health products, cosmetics and medical devices. The Minister of Health is responsible for administering the act.

Hazard characterization

A process that involves the qualitative or quantitative evaluation of the nature of the adverse effects that humans may experience under expected levels of exposure to an agent.

Hazard identification

The process of recognizing that an agent has an inherent capacity to cause an adverse health effect. May be based on informal information or studies conducted under specific conditions.

Health product

Includes any product under the mandate of Health Canada and regulated under the act, such as:

• blood
• biocides
• medical devices
• veterinary drugs
• natural health products
• semen for assisted conception
• cells, tissues and organs for transplantation
• pharmaceutical, biological and radiopharmaceutical drugs for human use

Health risk classification

A numerical designation that Health Canada may assign to a particular product to indicate the relative degree of risk to human health presented by the product, as follows:

• Type I: a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death
• Type II: a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote
• Type III: a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences

Types I and II include situations where a product that does not have generally recognized or scientifically supported therapeutic value is promoted over a recognized therapy. This may lead to injury or death.

Health risk assessment

The scientific characterization of the probability of occurrence and severity of known or potential adverse health effects resulting from exposure to hazards. The process consists of the following steps:

• hazard identification
• hazard characterization
• exposure assessment
• risk characterization

Homeopathic medicine

Medicines that are:

• manufactured from or contain as medicinal ingredients only those substances or sources referenced in the following pharmacopoeias:
  • Homeopathic Pharmacopoeia of the United States (HPUS)
  • Homöopathische Arzneibuch (HAB)
  • Pharmacopée Française (PhF)
  • European Pharmacopoeia (EP) or
  • Encyclopedia of Homeopathic Pharmacopoeia as amended occasionally
• prepared in accordance with these pharmacopoeias

Homeopathic medicines are regulated as natural health products.

Importer

A person (includes an organization) in Canada who imports something into Canada, including a health product, for the purpose of sale or personal use.

Inspector

Any person designated as an inspector under section 22 of the act.

Label

Includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package. As described in package or label, the action of labelling refers to affixing the inner or outer label to the drug.

Lot

A quantity of any drug or natural health product in dosage form, a raw material or packaging material, homogeneous within specified limits, constituting all or part of a single batch. The batch is identified by a distinctive lot number that appears on the label of the finished product.

Lot number

Any combination of letters, figures or both, by which a drug or natural health product can be traced in manufacture and identified in distribution.

Manufacturer or distributor (drugs)

A person, including an association or partnership, who under their own name, or under a trade, design or wordmark, tradename or other name, word or mark controlled by them, sells a food or drug. (A.01.010, FDR)

Manufacturer (natural health products)

A person who fabricates or processes a natural health product for the purpose of sale. Does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a natural health product for the purpose of sale to that patient. (section 1, NHPR)

Medically necessary

A drug that is used to diagnose, treat or prevent a serious disease or medical condition is considered medically important. A medically important drug for which there is no other adequately available drug product judged by Health Canada to be an appropriate substitute may be considered medically necessary.

Natural health product

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
• modifying organic functions in humans

Does not include:

• a substance set out in Schedule 2
• 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

Also, in accordance with subsection 2(2) of the NHPR, a substance or combination of substances or a traditional medicine is not considered a natural health product if  a prescription is required. (C.01.043, FDR)

Pharmaceutical Inspection Cooperation Scheme (PIC/S)

A worldwide organization and cooperative arrangement between participating international pharmaceutical regulatory authorities. PIC/S leads the international development, implementation and maintenance of harmonized good manufacturing practices (GMP) standards and quality systems of inspectorates in the field of medicinal products.

Potency

For a natural health product, this is the amount per dosage unit of the standardized component that further characterizes the quantity of the ingredient. It is required only when a claim on the potency is to be on the label or for a specific product (for example, when literature supports the product with that standardized component).

In Appendix 1 of the Good Manufacturing Practices Guidance Document, potency refers to the degree of dilution of a homeopathic medicine.

Product withdrawal

The removal from further sale or use or correction of a distributed product where there is no health and safety risk and no contravention of the legislation or regulations. It is not considered to be a recall.

Quantity

The amount of medicinal ingredients per dosage unit. It is always required for a product, as it is the amount of medicinal ingredient in the product. (NHPR)

Quarantine

The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection. (ICH Q7)

Recall

A responsible party’s removal from further sale or use, or correction, of a distributed product that presents a risk to the health of consumers or violates the act or the regulations.

Recall depth

The level of distribution from which a product is recalled (for example, wholesale, retail, user or consumer).

Recall strategy

A planned course of action taken by a responsible party in conducting a specific recall, including, for example, the depth of recall, the need for public advisories and the extent of effectiveness checks for the recall.

Regulations

A form of law, often referred to as delegated or subordinate legislation. Regulations have the same binding effect as an act and usually state rules that apply generally, rather than to specific persons or things. Regulations are not made by Parliament, but are made by persons or bodies to whom Parliament has delegated authority.

Responsible party

The person responsible for initiating and conducting the recall. Responsible parties may include:

• manufacturers, distributors, importers, persons in Canada responsible for the sale of the product and wholesalers for drugs
• manufacturers, importers, distributors or product licence holders for natural health products

Risk characterization

A process involving the qualitative or quantitative estimation of the severity and probable occurrence of known or potential adverse effects in a given population, based on hazard identification, hazard characterization and exposure assessment. The estimate includes information from biophysical studies and, where appropriate, integrates information related to social, cultural, ethical and economic contributors to the risk, with consideration also being given to risk perceptions.

Sell

Offer for sale, expose for sale, have in possession for sale or distribute to 1 or more persons, whether or not the distribution is made for consideration.

Stock recovery

The removal or correction of a product that has not been distributed or that has not left the direct control of the party ordering the removal or correction. It is not considered a recall.

Voluntary disposal

An action by a responsible party to prevent a non-compliant product from being further distributed. Actions include disposal, destruction, reconditioning or returning it to the manufacturer.

In considering whether voluntary disposal is an appropriate compliance action, Health Canada considers:

• the degree of cooperation offered by a responsible party on prior occasions
• whether the product will be rendered non-saleable or usable

Wholesaler

A person who is not a distributor described in section C.01A.003 and who sells any of the following drugs other than at retail sale:

• a drug in dosage form that is listed in Schedule C or D to the act
• a drug that is a prescription drug or a controlled drug as defined in subsection G.01.001(1) of the FDR
• an active ingredient
• a narcotic as defined in the Narcotic Control Regulations or
• a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act