Gazette APVMA 2, 1 February 2005

Notice

Interim Shelf Life of Veterinary Chemical Products

Up until 2000 the APVMA granted interim shelf lives for a number of veterinary chemical products. The Notices of Registration for these products included a condition that required the registrant to provide real-time stability data on three production batches as they became available, in order to confirm the interim shelf life.

The APVMA is not aware of any concern with respect to the stability of these products since the date of their registration. As a consequence, the APVMA advises registrants of products with interim shelf lives that they are no longer required to provide the APVMA with real time stability data to confirm the interim shelf lives granted for these products, as previously advised by the Notice of Registration. The condition for these products will be deleted from the Notice of Registration and the shelf life confirmed when the Notice of Registration is next re-issued subsequent to a change in registration details. Alternately, registrants may request the APVMA to re-issue the Notice of Registration.

An application must be made to the APVMA if a registrant wishes to extend the shelf life of a registered product.

Registrants are reminded of their obligation under Section 161 of the Agvet Code, with respect to notification to the APVMA of new information relevant to quality, efficacy and safety of registered products. Should any registrant become aware of data that would indicate the shelf life of their product is inconsistent with what has been approved, they must submit that data to the APVMA as soon as practicable after becoming aware of it.

For further information, contact:

Dr Adil Hussain
Veterinary Medicines Program
Australian Pesticides & Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Ph (02) 6272 5657
Fax (02) 6272 5249
Email: adil.hussain@apvma.gov.au