Regulatory Update #42

17 november - 7 December 2007

Shelf life of registered veterinary chemical products

The APVMA has updated its Guideline 48 addressing applications to extend the shelf-life of veterinary chemical products. The document should be used for guidance in making applications to the APVMA for a permit to extend the shelf life of batches of manufactured veterinary chemical product approaching the approved expiry dates. The new guideline replaces the 2002 version entitled ‘NRA Requirements for the Application/Assessment/Approval of Extension of Shelf-Life for a Particular Batch of a Registered Veterinary Chemical Product’.

Guidelines for all veterinary medicine products are listed in Volume 4 of the Manual of Requirements and Guidelines (VetMORAG)

Guidelines for all pesticide products are listed in Volume 4 of the Manual of Requirements and Guidelines (AgMORAG)

Trade Advice Notes

The APVMA is seeking written comment from stakeholders on the trade implications of:

Etoxazole in the product Paramite Selective Miticide, and Boscalid and Pyraclostrobin in the product Pristine Fungicide

Electronic product registrations

We have updated the frequently asked questions for our Electronic Application and Registration System (EARS)

Residue Updates

Updated Export Slaughter Intervals for November and Maximum Residue Limits in food and animal feedstuff for December

Record of Approved Active Constituents

The record of approved active constituents has been updated as of 7 December 2007.

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