Regulatory update #173

6 June 2013

New APVMA application forms published

The APVMA has made changes to the declaration section of all application forms to reflect legal requirements. The revised declaration specifies that the applicant/registrant must be an Australian resident over 18 years of age or, if the applicant/registrant is a body incorporated in Australia, the approved person acting for the applicant/registrant is an Australian resident over 18 years of age or a body incorporated in Australia.

The declaration specifies that the information provided in the application must be true and correct and warns that a false or misleading declaration may lead to prosecution under the Agricultural and Veterinary Chemicals Code Act 1994 or the Criminal Code Act 1995.

Similar changes have been made to the formulator’s declaration of all application forms that include a formulator’s declaration.

The new forms can be accessed via the APVMA website link to MORAG (Manual of Requirements and Guidelines). The updated forms should be used from Thursday 6 June 2013, although the APVMA will continue to process applications which use the superseded version until 1 July 2013.

Updated list of authorised GMP auditors

An updated list of APVMA-authorised Good Manufacturing Practice auditors is now available, incorporating updates to contact details and profiles.

Reminder—open for public consultation

The APVMA is currently seeking comment on:

Applications

Advice Summaries published since last issue are listed below. For a complete list and further information, please refer to the Advice Summaries content on our website.

  • GF-2576 Herbicide
  • Arthrocam Anti-Inflamatory Oral Suspension for Dogs
  • Pegasus Miticide/Insecticide
  • Leventa 1 mg/mL Oral Solution for Dogs

Application Summaries are updated weekly. For a complete list, please refer to the Application Summaries content on our website.

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