Glossary of Terms

This content was archived on June 24, 2013.

The following alphabetical list of terminology pertains to types of submissions and guidelines. Related forms can be found by clicking the "Go to Forms" button above.

Abbreviated New Drug Submission
As per section C.08.002.1 of the Food and Drug Regulations, an Abbreviated New Drug Submission refers to a submission for a generic product which is compared to a Canadian reference product on the market.

Drug Adverse Reactions (DAR)
Under Section C.08.007 - C.08.008 of the Food and Drug Regulations , a manufacturer must report any adverse reactions to a drug within 15 days. An adverse reaction to a veterinary drug is any unintended or noxious side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting a drug or/and any unusual failure of a drug to produce its expected pharmacological activity.

Cost Recovery
In accordance with the Financial Administration Act and Veterinary Drug Evaluation Fees Regulations, client fees are prescribed to recover certain costs associated with the services provided by the VDD for the evaluation of information submitted by drug manufacturers, qualified investigators and veterinary practitioners.

DIN applications ("Not New Drugs")
As per section C.08.001 of the Food and Drug Regulations, a New Drug is a substance for which information is required to be submitted by the manufacturer to establish the quality, safety and effectiveness of the drug product. A drug product which does not fall under this definition is considered a "Not New Drug".

Emergency Drug Release
An Emergency Drug Release (EDR) may be issued by the VDD to authorize the sale of a limited quantity of a drug that is not approved for sale in Canada, to a veterinarian for emergency use, as per section C.08.010 and C.08.011 of the Food and Drug Regulations. Adequate evidence and data is required to demonstrate animal and human safety of the product for the proposed use. The veterinarian assumes full responsibility for the drug's efficacy, the safety of treated animals and for any drug residue violations.

Experimental Studies Certificate
The VDD may issue an Experimental Study Certificate (ESC) to a researcher(s) pursuant to subsection C.08.015(1) of the Food and Drug Regulations, in order to carry out a specific study. A detailed experimental protocol must be submitted to demonstrate adequate animal and human safety of the product for the proposed use. See sections C.08.013 to C.08.018 of the Food and Drug Regulations.

Investigational New Drug (IND)
Following clearance of an Investigational (preclinical) New Drug submission (IND), manufacturers may be authorized to supply a new drug to a qualified investigator(s) specifically for the purpose of conducting clinical evaluations to obtain data about the safety and efficacy of that drug. Information required for a preclinical new drug submission is outlined in section C.08.005 of the Food and Drug Regulations.

New Drug Submission (NDS)
A new drug submission contains information on the quality, safety and effectiveness of the new drug, as indicated in Sections C.08.002 and C.008.003 of the Food and Drug Regulations.

Notice of Compliance
When a veterinary drug submission is found to be in compliance with the Food and Drug Regulations a Notice of Compliance (NOC) is issued from Health Canada, as per section C.08.004.

Phased Veterinary New Drug Submission
A mechanism allowing for the submission of distinct components of a New Drug Submission or Supplemental New Drug Submission as data is generated and complied. These component parts of a veterinary submission are evaluated separately by the different Divisions and Units within VDD: Human Safety Division, Manufacturing and Chemical Evaluation Division, and Pharmaceutical Assessment Division and so the components may be submitted at different times.

Supplementary New Drug Submission (SNDS)
Manufacturers must submit information in a Supplement to a New Drug Submission (SNDS) when they plan to make significant manufacturing changes or modify recommendations for use (labelling) for previously approved drugs, as per section C.08.003 and C.08.003.1 of the Food and Drug Regulations.