Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs: Glossary

As defined in the Food and Drug Regulations 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.

Any untoward medical occurrence in animals and/or humans involved in administering a veterinary drug to an animal and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (such as an abnormal laboratory finding), or disease temporally associated with the use of a drug product, whether or not considered related to the drug product.

A word, sentence, picture, symbol, graph or paragraph on product labels, package inserts or advertisements where the representation for sale is capable of being understood as:

• the capacity of producing a desired result or effect in terms of efficacy
• being safe or comparatively safer from undergoing or causing undue hurt, injury or loss as safety claims

Therefore, a claim may include any representation or statement that would communicate a "positive" interpretation of the drug product rather than a potential risk or harm.

Claims can be considered as explicit or implied by using the following:

1. Choice of language:
   • Explicit is when the representation for sale is fully revealed or expressed without vagueness or ambiguity leaving no question as to meaning or intent.
   • Implied is when the representation for sale is capable of being misunderstood or misinterpreted so as to imply or suggest something in addition to what is explicit.
2. Placement within the package insert:
   • There are 2 sections of the package insert intended for explicit claims: Indications and Target animal efficacy section.
   • The remaining sections of the package insert are not expected to include claims, and if present, would typically be considered as implied.

Any language used in the labels or package insert that provides instructions or recommendations (explicit or implied) to the prescriber or animal owner regarding the use of the product.

Examples of innovative labels include peel-back, fold-out etc. They must comply with applicable regulation and guidance documents.

Label includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package. Examples include the package insert, and inner and outer labels. (Food and Drugs Act)

A full colour, actual size copy of the labels and a colour representation of the packages intended to be used for the sale of the drug, including all:

• text
• fonts
• colours
• proposed graphics
• presentation and design elements

Mock-ups include a place holder for expiry date, drug identification number (DIN), and lot number.

As per section C.08.001 (for the purposes of the Act and Division 8 of the Food and Drug Regulations), new drug means a drug, other than a veterinary health product:

1. that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug
2. that is a combination or two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug
3. with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug

Package includes anything in which any food, drug, cosmetic or device is wholly or partly contained, placed or packed. (Food and Drugs Act).

The factual, scientific document for a veterinary drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug.

Studies involving the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.

The length of time between the last administration of a drug to an animal and the time when tissues or products collected from the treated animal for consumption as food contain a level of residue of the drug that would not likely cause injury to human health. (Section C.01.001 (1) of the Food and Drug Regulations).

Refers to the length of time, specified in 12-hour milking intervals, up to maximum of 8 intervals (96 hours) that must elapse after treating a lactating animal with a veterinary drug before milk can be collected for human consumption.