Requirement for Labeling Materials of Veterinary Drugs and Products

Labelling materials

Refer to the label on the immediate container and package and other printed materials that are made available with the veterinary drug and product at the time of purchase and/or where the veterinary drug and product is used, such as the outer wrapper cartons, leaflet/package insert accompanying the product, which provide the accurate and necessary detailed information for the identification and proper use of the veterinary drug and product.

Veterinary drugs and products

Refer to any substance, including biological products, applied or administered to food producing, companion, aquatic, laboratory and exotic animals. Whether used for therapeutic prophylactic or diagnostic purposes or for modification of physiological functions or behavior.

Brand name

Refers to the proprietary/trade name assigned to the veterinary drug and products by the veterinary drug and product establishment.

Generic terminology

Refers to the identification of veterinary drugs and products by their scientifically and internationally recognized active ingredient as determined by the Bureau of Food and Drugs of the DOH/Bureau of Animal Industry of the DA. In case of feed products containing veterinary drugs and products, generic name refers to the internationally recognized technical name of the feeds as determined by the Bureau of Animal Industry of the Department of Agriculture.

Generic name

Refers to the internationally recognized technical name of the feeds as determined by the Bureau of Animal Industry of the Department of Agriculture.

Philippines National Drug Formulary

Refers to the classification and listings of the veterinary drug and product.

Indications

Refers to the approved clinical and non-clinical use of the veterinary drug and product in terrestrial and aquatic animals based on substantial scientific evidence of the safety and efficacy in the given dosage form.

Contraindications

Refer to statements of conditions under which veterinary drug and product should not be used.

Dosage forms

Refers to the pharmaceutical form of the preparation based on an official pharmacopoeia.

Mode of administration

Refers to the site and manner by which the product is to be introduced to animal.

Warning

Refers to statements regarding the withdrawal period of the product before the animal is slaughtered for food and/or the occurrence of potential hazard and side effects associated with the use of the product and the limitation of its use.

Antidote

Refers to a specific substance or combination of substances that would counteract the effect of any undue reaction and overdosage

“Ethical drugs” or Veterinary Prescription

Refer to any drug preparation that is to be dispensed only upon written order of a duly-licensed veterinarian for the treatment of a condition or a diagnosed disease of animals.

Batch number

Refers to any distinctive combination of letters and/or numbers, assigned to a particular batch

Lot number

Refers to any distinctive combinations of letters and/or numbers assigned to a particular lot, herein defined as a portion of batch.