News updates from EMA in October and November

8 November, 2017

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).

Antimicrobial Resistance

  • Seventh ESVAC report: sales of veterinary antimicrobial agents in 30 European countries in 2015 (Link).


  • New EMA leaflet on support for innovative VMPs (Link).

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