All Veterinary medicines articles
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Industry newsThe VMD changes how it calculates adverse events incidents for animals
This industry news update shares the VMD’s changes to how it calculates adverse events, which has now taken full effect.
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JournalVM4: The latest EU and international developments in Good Manufacturing Practice
This is a report of the VM4 session that took place at this year’s Symposium.
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JournalVM1: Meeting the objectives of the Veterinary Regulation
This is a report of the WM1 session that took place at this year’s Symposium.
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JournalVM2: Regulatory updates
This is a report of the VM2 session that took place at this year’s Symposium.
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JournalVM3: Regulatory updates in veterinary pharmacovigilance – Navigating evolving challenges
This is a report of the VM3 session that took place at this year’s Symposium.
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JournalNew European Medicines Agency fees: The effect on veterinary medicines
In response to the EMA’s new fee system, this article dicusses the impact on marketing authorisation holders who place veterinary medicines on the market.
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JournalNew data protection for maximum residue limits
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract Maximum residue limits (MRL) have been a requirement for all substances included in veterinary medicines intended for food-producing animals since the 1990s. The new Veterinary Medicines Regulation ([EU] 2019/6) ...
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Industry newsAUS-UK joint agency vetmed approval process agreed
The UK’s VMD and Australia’s APVMA have published guidance for the simultaneous review of veterinary medicines submissions.
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JournalVM1:
Horizontal legislation and
veterinary medicine availabilityRegulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Rick Clayton, Technical Director, AnimalhealthEurope, Belgium. Speakers: Jaume Colomer, Senior Technical Manager, AnimalhealthEurope, Belgium. Nancy De Briyne, Executive Director of the Federation of Veterinarians ...
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JournalVM2: New initiatives in regulatory science
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Speakers: Raffaele Bruno, Associate Director, Regulatory Affairs, Zoetis Inc., Belgium. Michael Empl, Scientific Specialist, Toxicology & Environmental Risk Assessment, European Medicines Agency, Netherlands. Tony Humphreys, Head of ...
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JournalVM3: Regulatory exchange and new/future approaches
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Dr Mel Munro, Global Lead, Regulatory Science, knoell Animal Health, UK. Speakers: Beate Gasser, CMDv Vice Chair, Austrian Federal Office for Safety in ...
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JournalVM4: Living with post-authorisation obligations – progress, challenges and future opportunities
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: João Pedro Duarte da Silva, Senior Officer, Veterinary Medicines Unit, General Directorate for Food and Veterinary (DGAV), Portugal. Speakers: Katherine Schirmann, Scientific Officer, The ...
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JournalVM5: Digital innovation to support animal health
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Jana Schalansky, Head of Veterinary Strategic Support, Veterinary Medicines Division, EMA, the Netherlands. Speakers: Ricardo Carapeto García, Head of Area and Environmental Risks, AEMPS, ...
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JournalTransition to the new QRD template for veterinary medicines: challenges and opportunities
The product information template version 9 (QRD v.9) supports the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6[1] (VMR), which has applied since 28 January 2022. Considering the high workload and costs associated with the quality review document (QRD) updates, the huge number of veterinary medicinal products (VMPs) concerned, ...
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EditorialVeterinary medicines: the challenges of new regulation
Regulatory Rapporteur October 2023 | Volume 20 | No.9 The October 2023 edition of TOPRA’s journal – Regulatory Rapporteur – focuses on topics and developments specific for veterinary medicines: From the challenging aspects arising ...
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Industry newsEMA future ‘VetMeds’ for healthy animals and humans; seminar
In the lead up to the EMA’s Veterinary Awareness Day, Ivo Claassen sits down to discuss the agency’s progress in the field of veterinary medicines.
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Industry newsHuman COVID drug set to treat FCov-23 coronavirus in cats
A virulent strain of feline coronavirus has spread through Cyprus, and veterinarians on the island have received a first batch of anti-COVID pills.
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JournalReappraisal of regulation of agricultural and veterinary chemicals in Australia
Agricultural and Veterinary (Agvet) chemical products are registered with the Australian Pesticides and Veterinary Medicines Authority (APVMA) before they can be supplied in Australia. A mandatory scheme was introduced by the Australian government in 1993 to transfer Agvet chemical products from the State-based system to a national ...
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JournalVM1: Availability and Innovation - under a new VMP legislation
The requirements for quality data for LM products have increased under the new Regulation. It is difficult to determine which regulatory framework is most appropriate for novel ATMs.