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AgVetLink December 2002

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All manufacturing sites listed in the manufacturing specification

The ACVM Group reminds registrants and applicants that all manufacturing sites must be listed in the manufacturing specifications for a registered trade name product. Manufacture, in relation to any agricultural compound, means to make up, prepare, produce, or process the agricultural compound; and includes the packing (and labelling) of an agricultural compound in a container for the purposes of sale. Therefore any site that carries out any of these activities (or any subdivision of these activities such as quality testing) must be listed in the manufacturing specification.

Any changes in manufacturers or manufacturing sites must be notified to the ACVM Group so the approved manufacturing specification can be updated. If you are concerned that a manufacturing site may not have been included in the manufacturing specifications that were provided with the application to register a product you should notify the ACVM Group. Modifying the manufacturing specification on the product file presumes that:

• its absence from the manufacturing specifications was an historical oversight; and
• the site is actually an approved manufacturing site.

If the site is in fact a new site then a registrant must lodge an application to vary a registration to get the new site properly approved.

Failure to provide comprehensive manufacturing specifications may jeopardise the continued registration of a product.

ARPPA AGM (see page 1)

A number of questions posed at the AGM were very easily answered because they related to issues that have already been addressed, e.g. the charging of actual time versus set fees for class determinations, and information on the data assessment process, which was covered in the recent workshops.

Other questions concerned ACVM Act implementation. There is general confusion on the rationale for the split of prescribing and dispensing. It appears that people think that the ACVM Group is advocating a change in this area, rather than simply clarifying the basis for setting conditions on sale and use of PAR products under the ACVM Act.

Another query in this area was mandatory wording on labels - it seems that this is another area for further clarification. This meeting provided a very useful opportunity to understand the issues facing a number of the registrant companies.

Use period statements for multi-use vaccine vials

The article that appeared in the October issue of AgVetLink regarding the proposed default in-use stability period for multi-use vaccine vials prompted only one comment. The comment did not directly impact on the proposed statement so the ACVM Group has formally adopted the policy.

In consequence, the following statement will be a mandatory label statement for all multi-use vaccines where no in-use stability data is or has been provided (with the exception noted below):

"Unused vaccine must be discarded within 10 hours of opening".

The statement will not be allowed where the vaccine will retain stability for periods shorter than 10 hours (e.g. reconstituted live vaccines). In this instance the standard will apply and supporting data must be provided.

Registrants of products that currently carry in-use statements not supported by data must ensure that the discard statement is modified to conform with the above policy when the product is updated to the ACVM Act or at the next label reprint, whichever comes first.

Note that the ACVM Labelling Guide for Veterinary Medicnes Requiring Registration has recently been revised and this policy will not be included until the next revision.