Definitions: Annex 4 to the good manufacturing practices guide for veterinary drugs

These definitions explain how terms are used in this document. They supplement the definitions provided in the Good manufacturing practices guide for drug products (GUI-0001). If there is a conflict with a definition in the Food and Drugs Act (FDA) or the Food and Drug Regulations (FDR), the definition in the act and/or regulations prevails.

Drug premix:

A drug for veterinary use to which a drug identification number has been assigned, where the directions on its label specify that it is to be mixed with feed as defined in section 2 of the Feeds Act. (Section C.01A.001, FDR)

Dilute drug premix:

A drug for veterinary use that results from mixing a drug premix with a feed (defined in section 2 of the Feeds Act) to such a level that at least 10 kg of the resulting mixture is required to medicate 1 tonne of complete feed (defined in section 2 of the Feeds Regulations, 1983), with the lowest approved dosage level of the drug. (Section C.01A.001, FDR)

Feed ingredient:

Any substance, or mixture of substance, that is considered to be acceptable for use in feed.

Medicated feed:

A mixed feed that contains a medicating ingredient. (Feeds Regulations, 1983)

Validation:

A documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting pre-determined acceptance criteria. (ICH Q7)

Veterinary health product (VHP):

Low-risk drugs in dosage (ready-to-use) form. They are used to maintain or promote the health and welfare of companion and food-producing animals. They are not for use to treat, prevent or cure disease. VHPs must be made using permitted substances according to conditions outlined on List C. (Section C.01A.001, FDR)

Withdrawal period:

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.01A.001, FDR)