Clinical Expertise for the
Development and Registration
of your Veterinary Medicines
To find out more about how VRM
is working with Cyton to provide
a complete clinical service, please
visit the website:
During October and November, the EMA has published updates relating to the following topics:
eSubmissions
Updated electronic application forms available from 15 December, integrating OMS from SPOR project (Link). User acceptance testing scheduled for 13 – 24 November.
Chemistry, Manufacturing and Controls
Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (Link). Updated Q & A issued in association (Link).
Reflection paper on Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances (Link).
Referrals
Moxidectin Article-35 referral - Questions and answers on the environmental impact of moxidectin-containing veterinary medicines used in cattle, sheep and horses (Link).
Antimicrobial Resistance
Seventh ESVAC report: sales of veterinary antimicrobial agents in 30 European countries in 2015 (Link).
Innovation
New EMA leaflet on support for innovative VMPs (Link).
Clinical Expertise for the
Development and Registration
of your Veterinary Medicines
To find out more about how VRM
is working with Cyton to provide
a complete clinical service, please
visit the website: