Are you ready for the December 31st XEVMPD re-submission deadline?

On January 31st 2014, the EMA substantially changed the requirements for the product data that pharmaceutical companies must submit to the Eudravigilance Medicinal Product Dictionary, or XEVMPD. All Marketing Authorisation Holders (MAHs) must have updated their product records in accordance with the EMA’s “V5” guidance by December 31st 2014.  The mandatory changes are being made to address a range of issues on the road to the implementation of ISO IDMP (Identification of Medicinal Products) in 2016, including new information required to support the assignment of pharmacovigilance fees, improvements to the quality of submitted data, and modification of controlled vocabularies. 

These latest version changes are non-trivial.  Taking a specific example, in the V5 update, the controlled vocabularies have been rationalised.  This means that if an old controlled vocabulary code has been submitted for a substance, this code must be updated to the new (rationalised) code prior to re-submission.  For many pharma companies – and without the right e-submission tools in place – the sheer volume of data entries required will undoubtedly render this process tedious, error-prone and hugely time-intensive.

So, how can pharmaceutical companies tackle this latest compliance hurdle?   Whether your organisation is currently using the EV web tool, a different software solution, or even has yet to submit any data to the EMA, it’s imperative that all MAHs act now to remain compliant, plus plan ahead for future anticipated schema changes.   With the EMA deadline fast approaching, MAHs must quickly source an easy-to-implement yet fully tested solution for Article 57 compliance that can minimise the administrative burden and keep pace with evolving specifications.

Now for the good news: we can help.  Pharma eReport’s Centrality software is fully compliant with the latest XEVMPD schema changes, and offers Marketing Authorisation Holders a straightforward mechanism to import existing product data, update it to the new V5 schema and submit it to the EMA.  Pharma eReport’s quality-assured software is being used today by major global pharmaceutical companies to manage ongoing XEVMPD compliance. Built directly from the EMA schema to ensure syntactically correct EudraVigilance Product Report Message (EVPRM) messages by construction, Centrality also incorporates built-in business rules, so that the entire process – from data entry through to submission to the EMA gateway – is error-free, continuously cross-checked and seamlessly compliant.

Our solution offers extensive data import capabilities and transparently interfaces with customers’ existing data systems. With the additional option of a full range of specialist support and consulting services (including expert help to add in missing data required for the V5 schema), we can enable you to outsource the entire XEVMPD compliance process.

You can sign up now for a free online demonstration of our Centrality solution, or talk to us today about your specific needs.  With the EMA set to legally enforce the required data as of January 2015, there really is no time to lose.

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We have also made available an excel spreadsheet for data entry. If you prefer to enter your data in excel, then use this spreadsheet and we will be able to import, check and convert the data to compliant XML.

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