Operational Notice - Veterinary Oral Tablets
November 2006
This operational notice is to clarify the position of the Australian Pesticides and Veterinary Medicines Authority (APVMA) regarding veterinary chemical products which are presented as oral tablets.
Background
Sections 14(3)(e)(iii) and 14(3)(f) of the Agvet Code require the APVMA to be satisfied of the safety and efficacy of veterinary chemical products for use in animals. Therefore, all veterinary chemical products, including individual dosage forms such as tablets, must allow the administration of a dose to the target animal which is both safe and effective, according to the directions for use on the approved product label.
APVMA Policy
The best means of ensuring product safety and efficacy for oral tablet dosage forms is by formulation of a tablet which delivers an accurate dose to the target animal without the need for the tablet to be subdivided. However, the large range of bodyweights in the target animal species may justify the formulation of a tablet which can be subdivided in order to deliver a dose for the intended purpose of the product.
The APVMA will register veterinary chemical products in an oral tablet dosage form if the formulation of the tablet is such that the dose can be delivered to the target animal in whole tablets, or if the dose is contained in one half-tablet, or one quarter-tablet, in accordance with the approved label dose rate.
To ensure accurate dosing, the tablet should be single-scored or cross-scored to deliver the dose to the target animal in accordance with the approved label dose rate, and the applicant should ensure as part of good manufacturing practice (GMP) that the tablet halves or quarters provide uniformity of content.
The APVMA will not register veterinary chemical products in an oral tablet dosage form if the formulation of the tablet does not allow dosing in accordance with the approved label dose rate.
If the pharmacokinetic/pharmacodynamic relationship of the active constituent contained in the tablet results in a narrow therapeutic window, the APVMA may require the applicant to provide specific data to satisfy the APVMA that the subdivided tablet contains a dose which would be efficacious and would not be harmful to the target animal species.