This content is current only at the time of printing. This document was printed on 12 July 2020. A current copy is located at https://apvma.gov.au/node/929
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Professional packs of oral non-prescription products
Tablets are the most common type of oral, non-prescription, individual-dose veterinary chemical products for use in companion animals. The tablets are usually registered initially for supply in a foil or blister pack.
We will generally not approve supply of larger pack sizes of these same products when they are not packaged in foil or blister packs, without requiring a risk assessment, that addresses the following issues:
- some of the individual doses could be dispensed without the full label instructions being passed on to the end user. This has implications for efficacy and the safety of the target animal, as well as end-user safety
- the product container may be introduced into the home, where young children are more likely to be exposed to significantly larger quantities of the product. This may increase the possibility of accidental poisoning
- the bulk-pack product is likely to be less stable and therefore require a different shelf life to the foil- or blister-pack product.
To minimise risk, we may require separate registration of these products where supply in larger pack sizes is proposed. We may also require a separate product name including the words ‘Professional Pack’, and a separate shelf life (if required).
The main panel of the product label should also contain the statement:
Only to be used by or under the direction of a registered veterinarian.
We may also apply a condition to the registration of these products that require the product to only be advertised and supplied to registered veterinarians.