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Archive for month: October, 2015


Regulatory Information Management (RIM) and VNeeS for Veterinary

The Head of Medicinal Agencies (HMA) eSubmission Roadmap (November 2014) already highlighted that from 2016 all new veterinary Marketing Authorisation Application’s (MAA’s) for the Decentralised and Centralised Procedure (DCP and CP respectively) have to be in VNeeS format. Furthermore, from 2017 all veterinary submissions via the EU procedures need to be compliant with VNeeS. The recently released guideline prepared by the Veterinary Harmonisation Group (March 2015) provides some more details with regards to formats, file folder structure and naming conventions, coming into effect October 2015 already.

This highlights a number of challenges for the pharmaceutical industry providing veterinary medicines. Read More

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