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AgVetLink, October 2004

Default in-use period statements for multi-use vaccine vials

In the December 2002 issue of AgVetLink it was advised that the following statement must be included on the labels of multi-use vaccine vials where no in-use stability data had been provided and where appropriate:

“Unused vaccine must be discarded within 10 hours of opening.”

No comments were received during the consultation period, and the statement has been ACVM Group policy since 2003.

It has now been brought to the attention of the ACVM Group that the APVMA policy relating to this issue is as follows:

“Unless a product states that it is to be used within 12 hours or less (Note: Clostridial vaccines may be used up to the following day, or 36 hours), stability data will be required to support the recommended storage time and conditions after broaching.” (Vet Labelling Code 2001, Appendix 8, A 8.6)

In the interests of label harmonisation it would be desirable for the Australian and New Zealand requirements to be the same. As yet the reason for the APVMA’s division between clostridial and non-clostridial vaccines has not been established. The possibility remains that the allowance is based on assumed most likely use pattern and not on data.

Industry is requested to consider and comment upon the advisability of adopting the APVMA default statements, bearing in mind that ultimately product efficacy and safety remain the responsibility of the registrant. In addition, it is likely that if the 36 hour period is elected for clostridial vaccines the ACVM Group will require resealing and storage advice for opened packs to be included. Industry is requested to provide comments with respect to the type of advice that will be required.

Please send your comments by 1 November 2004 to:

Jennie Moran
Assessor (Technical Standards: Veterinary Medicines)
ACVM Group, NZFSA
PO Box 2835, Wellington
Email: jennie.moran@nsfsa.govt.nz