The VMD is pleased to announce the publication of the guidance UK-Australia Regulatory Cooperation: Apply for Simultaneous Review.
The Veterinary Medicines Directorate (VMD) and Australian Pesticides and Veterinary Medicines Authority (APVMA) have developed guidance that will serve as the foundation for simultaneous reviews of veterinary medicines submissions by our two agencies.
The guidance represents an important step forward by expanding opportunities for industry to simultaneously access two major markets.
It provides opportunities to reduce burdens and to have a single project team working on the submission pathway working to common assessment timeframes. It also supports our shared aim of expanding access to treatment options for animals and helping food producers stay competitive globally.
The guidance outlines how the review process will work. It is intended to complement each country’s legislative and regulatory framework and associated technical guidelines, which remain in place.
This is an exciting opportunity, and we look forward to working with the veterinary pharmaceutical industry on this new initiative.
Please contact postmaster@vmd.gov.uk if you would like further clarification or would like to discuss any potential projects that you may have which would benefit from this opportunity.
To contact the Australian Pesticides and Veterinary Medicines Authority (APVMA) directly email InternationalCoordinator@apvma.gov.au.