New guidance on veterinary medicines simultaneous reviews - Veterinary Practice
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New guidance on veterinary medicines simultaneous reviews

NOAH and Agcarm welcome the publication of guidance enabling the simultaneous review of animal medicine marketing authorisation applications in the UK and New Zealand

The National Office of Animal Health (NOAH) and Agcarm, the animal health associations in the UK and New Zealand respectively, have welcomed the publication by the countries’ regulatory agencies of guidance that will enable simultaneous review of animal medicine marketing authorisation applications in the two countries. 

Arising from discussions between the UK’s Veterinary Medicines Directorate (VMD) and New Zealand’s Ministry for Primary Industries (MPI), the guidance document “United Kingdom-New Zealand Regulatory Cooperation: Guidance on Veterinary Medicines Simultaneous Reviews” will serve as the foundation to enable these simultaneous reviews to happen.  

This comes as a far-reaching trade deal has also been announced between the two countries, which includes an animal welfare chapter with a clear statement that animals are recognised as sentient beings. Provisions include a commitment to increased bilateral cooperation, as well as working together in international fora to enhance animal welfare standards. 

Dawn Howard, NOAH chief executive said: “NOAH’s priorities for all international trade negotiations have included a call for regulatory authorities to collaborate. We welcome this agreement as a way to reduce regulatory burden by having a single approach and common timeframes for the assessment of marketing authorisation submissions and complementing rather than replacing our own regulatory frameworks and technical guidelines.

“We are confident our members will find this useful in encouraging greater innovation and improve accessibility of medicines for animals in both countries, critical to the benefit of their health and welfare.” 

Mark Ross, chief executive of Agcarm, said: “New Zealand’s animal health and food safety will be major beneficiaries of this ground-breaking agreement with the United Kingdom. These joint reviews offer veterinary medicine manufacturers an opportunity to simultaneously access major markets – maximising efficiencies and building stronger global collaboration.

“Our goal is supporting faster access to new medicines and expanding disease treatment options to manage animal health and welfare. We welcome this new working relationship with the United Kingdom and congratulate all those who made it happen.” 

For further information please contact Alison Glennon, NOAH, or Dominique Bray, Agcarm.

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