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

The Australian Pesticides & Veterinary Medicine Authority (APVMA) has thanked everyone who recently provided input to the 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, the agency has 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. APVMA are now seeking input in regards 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? 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 publicly 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. Deadline for submissions is 5 pm (Canberra time) Friday, 15 June 2012. Further information is available at: http://www.apvma.gov.au/consultation/docs/apvma_cost_recovery_discussion_paper_gmp.pdf

Australian Pesticide & Veterinary Medicine Authority, 18 May 2012 ;http://www.apvma.gov.au ;