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. Firstly – and not wanting to take anything away from the huge effort all parties are putting into the adaption of the eCTD format for delivering marketing applications for human drugs – the VNeeS mandatory dates seem for once to be ahead of the game. Secondly, timelines for successful implementations seem very short considering that MAA have to stay compliant with the latest regulations.
However, isn’t VNeeS just a simple file-folder structure, i.e. a far simpler format compared to the eCTD? Well, yes, it is correct that there are no XML files, no MD5 checksum and other “technical” files you have to submit with VNeeS. Still, documents have to be compliant with regards to format, readability and naming conventions, being able to pass “technical validation”. “Technical validation” is an additional step in the process of getting MA approval and precedes “business” or “content validation”. The latest version of the ‘technical validation checklist’ EMA/668616/2014 has just been released (March 2015).
And what about the electronic exchange of documents in electronic format? The Committee for Medicinal Product for Veterinary User (CVMP) published the new guidance in March 2015 (EMA/CVMP/VICH/758781/2013) with effect of February 2016. The VICH Steering Committee adopted Step 7 of the VICH process in February 2015 for implementation by February 2016. The timeline seems tight for any solution to be implemented.
So why not make it easier via the ‘single place of truth’®, supporting compliance for documents, pre and post marketing applications as well as drug safety in one go with a limited impact on your IT infrastructure? You will be able to track licences per country, get notified about renewals and PSURs and at the same time have a full track record of all changes applied. In summary, it is much more than “just” compiling a marketing application in VNeeS. Wouldn’t that be a more sensible approach to Regulatory Information Management for a compliant veterinary product life cycle?
Get in touch via [email protected] if you have questions or would like further information why the ‘single place of truth’® might be a solution for you.