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AgVetLink June 2005

Combining Two Products Under One Registration

Under the Animal Remedies Act some companies had elected to take two separately licensed products and combine them under a new single licence, complete with a different trade name and number.  This most commonly occurred in the case of animal vaccines where one product could be used as the diluent for another, or where the two products could be used concurrently in the vaccination programme.   

Past ARB procedure

In the past, the Animal Remedies Board (ARB) approved the licences even though the relevant licensing information (trade name and number) that appeared on the individual product vial labels was that relevant to the individual product’s licence, and not that of the combined licence.  An example would be taking Trade Name X ARB No. A01 and Trade Name Y ARB No. A02 and selling the individual vials (with that licensing information) in packaging with the registration information Trade Name XY ARB No A03.

This is no longer considered acceptable.  It is common practice in New Zealand veterinary clinics for product vials to be removed from the outer packaging for variable periods up to the time of use.  Following that removal, the only identifying information would be that included on the vial label, which must be relevant to the registration under which it is sold. 

New requirement

In consequence, all products identified as being affected have been required to comply with one of the following actions:

1.  modify all vial labelling to include the relevant registration information; or

2.  cancel the registration.

In the opinion of the ACVM Group, it is acceptable for two registered products to be sold in ‘convenience packs’ where the registered products are sold bound together.  The expectation is that both products will be sold in their registered packs with all approved label text and in full compliance with the conditions of registration.  Any external packaging used must also contain all relevant information that is required for outer packaging as per the relevant ACVM Labelling Guide (including, but not limited to, the registration statement and full approved trade names).