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:
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).
Moxidectin Article-35 referral - Questions and answers on the environmental impact of moxidectin-containing veterinary medicines used in cattle, sheep and horses (Link).
Seventh ESVAC report: sales of veterinary antimicrobial agents in 30 European countries in 2015 (Link).
New EMA leaflet on support for innovative VMPs (Link).