Home

|

EVMPD

|

Solution

 Pharma eReport Blog

Date: 11th September 2014, by: Nicky
Tags: XEVMPD, EMA

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.

Blog Posts

15th September 2014, by: Nicky
Tags: XEVMPD, EMA
Pharma eReport delivers V5-compliant solution to help MAHs meet December 31st XEVMPD resubmission deadline

11th September 2014, by: Nicky
Tags: XEVMPD, EMA
Are you ready for the December 31st XEVMPD re-submission deadline?

3rd September 2012, by: Nicky
Tags: IRISS, ISO IDMP, EMA, DIA
IRISS IDMP Topic Group Leader Andrew Marr to present work of group at DIA Conference

24th June 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA
EMA updates eSubmission Gateway Q&A

12th June 2012, by: Nicky
Tags: EVMPD, XEVMPD, Centrality
XEVMPD software provider Pharma eReport launches Excel Data Import Service

30th May 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA, EudraVigilance
Response requested by 30 May 2012: EMA Options Paper

18th May 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA, EudraVigilance
XEVMPD e-Learning Course now online

4th May 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA, EudraVigilance
April 2012 EMA controlled vocabulary update

1st May 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA, EudraVigilance
EMA to host IDMP Information Day in London on May 8th

23rd April 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA, EudraVigilance
EudraVigilance XEVMPD e-learning course coming very soon

12th April 2012, by: Nicky
Tags: EVMPD, XEVMPD, ISO IDMP
Report: first meeting of IRISS IDMP Topic Group

21st March 2012, by: Nicky
Tags: EVMPD, XEVMPD, Centrality, software
EVMPD software provider Pharma eReport announces full general availability of Centrality XEVMPD compliance solution

14th March 2012, by: Nicky
Tags: EVMPD, XEVMPD, Centrality, software
Seven reasons to invest in an EVPRM system

13th March 2012, by: Nicky
Tags: EVMPD, XEVMPD
New: EVMPD spreadsheet for data entry freely available on our website

6th March 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA
Updated EVMPD guidance from EMA

21st February 2012, by: Nicky
Tags: EVMPD, XEVMPD, Centrality, Pharma eReport
We've launched!

20th February 2012, by: Nicky
Tags: EVMPD, XEVMPD, report
Call for participation: IRISS Forum topic group on Identification of Medicinal Products (including XEVMPD)

2nd February 2012, by: Lloyd
Tags: EMA
SSI to be optional

2nd February 2012, by: Nicky
Tags: EVMPD, XEVMPD, report
End of year EVMPD report from Marr Consultancy

31st January 2012, by: Nicky
Tags: EVMPD, XEVMPD, Article 57, blog, Pharma eReport
Welcome to our blog!