AU–UK simultaneous veterinary medicine approvals commence

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veterinary medicine approvals
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Potential registrants of veterinary medicines can now have their products reviewed by the Australian and United Kingdom regulators at the same time, to facilitate speedier registration.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has published the United Kingdom–Australia Regulatory Cooperation guidance on veterinary medicines simultaneous reviews.

The APVMA and United Kingdom Veterinary Medicines Directorate (VMD) have developed this guidance, which will serve as the foundation for simultaneous reviews of veterinary medicines submissions by the two agencies.

APVMA acting chief executive officer Dr Melissa McEwen said the guidance represents an important step forward by expanding opportunities for industry to simultaneously access two major markets.

“This exciting new approach can reduce the burden and provides the opportunity for a single project team to work on the application, in line with common assessment time frames,” Dr McEwen said.

“The guidance supports the APVMA and VMD’s shared aim of expanding access to treatment options for animals and helping food producers stay competitive globally.

“The guidance outlines how the simultaneous review process will work and is intended to complement each countries’ legislative and regulatory framework and associated technical guidelines, which remain in place.

“The APVMA is excited by the opportunity to streamline the registration process, and we look forward to working with the VMD and veterinary stakeholders on this new initiative.”

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