Regulatory update #150

28 May 2012

Seeking input into an alternate proposal for the recovery of costs for assessment of compliance with Good Manufacturing Practice

We would like to thank everyone who recently provided input to our Cost Recovery Discussion Paper (released December 2011). This paper proposed a number of changes to the current arrangements for the recovery of costs associated with the assessment of compliance with Good Manufacturing Practice (GMP), which affects manufacturers of veterinary medicines in the Australian marketplace and registrants of imported veterinary products.

Since the original consultation period closed, we've discussed an alternative proposal for the recovery of costs associated with the assessment of compliance with GMP with a number of veterinary medicines industry groups.

This alternative proposal is now outlined in a supplementary Discussion Paper for the Cost Recovery of Compliance with Good Manufacturing Practice. The supplementary discussion paper should be read in conjunction with the December 2011 Cost Recovery Discussion Paper.

Input sought

Comments are sought with regard to:

  • Do you support the alternative proposal for the recovery of the costs for assessment of compliance with GMP?
  • If not, how should these costs be recovered?

Invitation for submissions

The APVMA invites written submissions from industry and other interested parties. Submissions should be confined to relevant matters within the scope of the discussion paper. Claims made in submissions should be supported wherever possible by referencing or including relevant publically available information such as published reports, studies, research findings etc.

All information (including name and address details) contained in submissions will be made available to the public on the APVMA’s website, unless you indicate that you would like all or part of your submission to remain in confidence.

Automatically generated confidentiality statements in emails do not suffice for this purpose. Respondents who would like part of their submission to remain in confidence should provide this information marked as such in a separate attachment to the submission.

A request made under the Freedom of Information Act 1982 (Commonwealth) for a submission marked ‘confidential’ to be made available will be determined in accordance with that Act.

Submissions should be emailed to costrecovery@apvma.gov.au.

We prefer emailed submissions. However, hardcopy submissions (or files on digital media) can be sent to:

Tony de la Fosse
Program Manager
Corporate Services
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2609

Deadline for submissions: 5 pm (Canberra time) Friday, 15 June 2012

Submissions received after this date will only be considered if agreement for an extension has been given prior to this closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to the submission period.

For further information please contact:

Tony de la Fosse
Program Manager
Corporate Services
Telephone: 02 6210 4844
Email: costrecovery@apvma.gov.au

Reminder—open for public consultation

The APVMA is currently seeking comment on:

Release of our draft communication and consultation policy has been delayed, but we are more than happy to receive ongoing feedback about what's important to you and how we can communicate and keep you informed about those issues.

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.

  • Smartfresh
  • Smartfresh Smarttabs
  • Titan Glyphosate 700sg Herbicide
  • Ya Mate Insect Repellent
  • Equimax Elevation Oral Broad Spectrum Wormer And Boticide Paste For Horses
  • Strategy-T Paste Oral Broad Spectrum Worm Paste For Horses
  • Surefire Stellar Fungicide
  • Eureka Gold Op Spray-On Off-Shears Sheep Lice Treatment
  • Easicline 75 Clindamycin Antibiotic Tablets For Dogs And Cats
  • Easicline 150 Clindamycin Antibiotic Tablets For Dogs And Cats
  • Imtrade Gibber Growth Regulator
  • Mortein Naturgard Surface Spray Crawling Insect Killer Eucalyptus

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

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.