Regulatory update #226

11 March 2016

Register now—Melbourne Industry Information and Education Session

Registrations are now open for the next APVMA Industry Information and Education Session in Melbourne on 9 May 2016.

The session will cover key areas of the APVMA’s current and priorities, and will feature a new information not covered in last year’s sessions.

For registrations and more information please visit our Events page.

Label monitoring of permethrin spot-on products for dogs

The APVMA undertakes monitoring programs of labels attached to containers as supplied in the marketplace. Label approval holders are responsible for ensuring that the marketed product labels (MPLs) meet the requirements of the Agvet Code.

Labels for products containing diuron, carbendazim, dichlorvos, carbaryl, dimethoate or haloxyfop have recently been examined with corrective action taken on some items.

The APVMA will shortly commence a label audit of products containing permethrin for spot-on application on dogs. We will write to companies marketing these products, requesting copies of current labels. Holders of these products are encouraged to check their labels to ensure that they comply with current APVMA requirements.

As with other compliance activities, we will work cooperatively to assist holders of non-compliant labels. Any enforcement action will be proportionate to the risks being managed.

Prescribed variations—changes to manufacturers of veterinary products

New legislative changes came into effect on 1 March 2016 allowing the name change of an overseas manufacturer of a registered veterinary chemical product (that requires GMP) to be submitted to the APVMA as a prescribed variation using an item 13A application.

For more information see minor changes to details of actives, products and labels.

Application tracking

A new level of functionality is now available for users of the APVMA’s online services dashboard. The changes will provide holders, authorised agents and nominated agents with greater visibility of applications that have been submitted for the company they represent.

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