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The challenge

The Head of Medicinal Agencies (HMA) eSubmission Roadmap dated November 2014 already states that from 2016 all new veterinary MAA’s in DCP and CP have to be in VNeeS format. And from 2017 for all veterinary submissions via the EU procedures the VNeeS format will be mandatory. The guideline prepared by the Veterinary Harmonisation Group (version 2.3, March 2015) provides some further details with regards format, file folder structure and more, coming into effect October 2015 already.

This highlights a number of challenges for the pharmaceutical industry providing veterinary medicines. Firstly – and not disrespecting the enormous effort of getting all submission procedures in the EU for human drugs onto the eCTD – the VNeeS mandatory dates seem to be ahead of the game as for all submissions whether DCP, MRP or CP VNeeS will become mandatory very soon. Secondly, timelines seem very short in getting solutions in place that provide support to stay compliant with the latest regulations. Last but not least, how to make all of this happen on a limited budget?

The VNeeS format itself lacks some of the (technically) more complex structure of the eCTD as no XML backbone will be generated and no MD5 checksum is required. With that in mind, a folder structure on the file store would just do the job, wouldn’t it? Well, not quite as there are also other aspects to consider when marketing veterinary products: Firstly, compared to drugs for humans, there are different species to consider. Secondly, veterinary drugs not only have to satisfy their effectiveness supporting animal health, but they also have to be safe in case of human consumption later on. So how can this all be tracked from the active ingredients and manufacturing process via the marketing application and license approval to post marketing support and drug safety?

The solution

There are certain aspects of VNeeS that can be compared to eCTD or NeeS formats used for marketing applications for human drugs. These include naming conventions, i.e. the restriction to certain characters or the use of certain PDF versions. Other similarities include security features on the documents themselves or “best practice” such as the limit on file size. All these technical requirements have to be adhered to, enabling the technical validation to pass without errors, a step required for electronic submissions to move to “business validation”.

Samarind RMS makes the VNeeS compilation quick and easy. Following the Emerging Dossier Concept, pre-entered information about the product, its manufacturer, type of licence and more is already managed in the RMS and can be reused if and when required. The need to re-enter information is taken away, thereby minimising data entry mistakes and data inconsistencies.

Using the integrated EDMS functionality of Samarind RMS brings further advantages to our users as documents can be allocated on appropriate levels. This speeds up the document selection process during dossier compilation via minimising document availability, and improves dossier quality and consistency for later review via the use of pre-allocated documents. Furthermore, changes can be tracked via a full audit trail.

The benefits

Creating VNeeS and managing the veterinary product life cycle with Samarind RMS via the ‘single place of truth’® could not be easier and comes with many benefits.

  • Secure storage for all documents in an easy-to-manage, quick-to-learn environment.
  • Ability to allocate documents to products, submissions or licences, simplifying dossier compilation with full audit trail.
  • Automated PDF renditioning, without the need for additional software, ensuring (technical) consistency throughout the dossier to assist submission review and assessment.
  • Simple VNeeS structure creation reaping the benefit of the Emerging Dossier Concept.
  • Managing of licenses, products and manufacturers during product life cycle.
  • Alerts on PSUR deadlines and notifications on licence renewals, supporting product management throughout.
  • Planning and tracking of marketing applications worldwide.
  • Limited budget requirements.

Serving all required information from the ‘single place of truth’® makes the process of managing the entire medicinal product life cycle effective and efficient throughout.

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