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AgVetLink: Number 51, August 2005

Containers of multiple individually packaged units

The ACVM Group has reviewed its policy relating to the regulatory management of agricultural compounds that are marketed in containers with multiple numbers of individually packaged veterinary medicine, vertebrate toxic agent or plant compound products.  The Group is aware that inconsistent advice may have been provided regarding requirements in this area.

It is common practice for veterinary medicine products to be packaged in foils, blisters, pouches and vials and sold as multiple lots in containers.  Although it is less common for vertebrate toxic agent and plant compound products, smaller individually packaged bottles of product may be sold in bulk lots in a similar fashion. 

Policy

The current policy is that where units are individually packaged (e.g. tablets in foils or blisters, vaccine vials, bottles of product) and then included in multiple numbers in containers, the actual number of individual units included per container does not need to be stated on the label approved by the ACVM Group provided the container does not contribute to the stability profile of the product. 

In consequence, where changes are made to the number of individual units included per container, no formal ACVM approval is required provided there are no changes to the individual unit or ACVM-relevant approved label text.  Where the container contributes to the stability profile of the product the usual policy regarding approved pack sizes (which must be identified on approved label text and for which C3 applications are required prior to changes being made) is likely to apply. The labelling/advertising guides have been altered to reflect this change in policy.