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Registration model for low-risk equine electrolyte products published

8 December 2010

The APVMA has developed a registration model for certain low-risk equine electrolyte products to establish arrangements whereby low-risk equine electrolyte products may be registered with reduced cost.

Applications for the registration of products conforming to the model would not require the submission of any data or the nomination of a reference product and would be considered under Category 10, with the only applicable modules being 1 and 11.4.

The equine electrolytes model has been developed by the APVMA to serve as an example for future models addressing other low-risk product classes.  It is envisaged that future models would be developed and proposed by industry groups.  The APVMA intends to publish supporting documentation to describe the processes by which such proposals would be made and considered.

Contact

Veterinary Products, Active Constituents and Permits

  • Applications for new products and variations to existing registered products
  • Application fees, registration requirements and guidelines
  • Approval of active constituents and chemistry requirements
  • Permits for off-label minor uses, research purposes or emergency situations

Email: vetmedicines@apvma.gov.au

Phone: +61 2 6210 4789

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