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Thinking of using EVWEB to enter your xEVMPD data?

There are alternative solutions.

Many pharma companies are intending to use the free EMA tool EVWEB to send their authorised product data to the EVMPD in time for the 2 July 2012 deadline. This is understandable; there is no longer enough time to find, purchase and implement a tool for this purpose and enter all the required data, and the EMA's tool is free to use.

EVWEB does have a number of disadvantages. Users complain that it's slow to use, allowing only one MA to be entered at once, and it does not provide efficient data reuse or life cycle management. The general consensus of opinion is that it's OK for MA holders with small numbers of products, but for anyone with more than (say) 10 licences it should only be used as a last resort.

What are the alternatives?

Samarind is offering the following solutions, and the good news is that with each of these there's still time to get your data submitted by 2 July 2012.

1.   Use our unique xEVMPD data import template. Samarind has developed an easy-to-use import template in Excel specifically for this purpose. All you need to do is type or copy & paste your data into the template, send it to us, and we'll look after the rest. We will check the consistency of the data, automatically import it into Samarind RMS, create the ZIP file containing the XEVPRM message file and its attachments, and even submit it to the EMA for you if you wish. Once the data is submitted you can use either Samarind RMS for Windows or our subscription-based RMS On Demand application to keep it up to date thereafter.

2.   Completely outsource your EVMPD obligations. Samarind is working with U.S. SPL leader Reed Technology and UK pharmacovigilance consultancy Pure Drug Safety to provide a fully outsourced solution. Just give us your data, and we'll look after the rest.

3.   Use RMS On Demand instead of EVWEB. Our full-featured, subscription-based Regulatory Management System is so much more than an xEVMPD tool. Subscribe online and start entering your data now - it uses the same proven xEVMPD technology as our Windows product, it's available and working now and industry associations like BPI (the German Pharmaceutical Industry Association) agree that it's infinitely better than EVWEB.

Option 1 is proving very popular, and because it's a semi-automated process we do still have some capacity for providing this service over the next few months. Option 2 is also still available although because this is a fairly labour-intensive operation you'll need to get in touch with us soon if you're interested in this solution. Option 3 is ideal for smaller pharma companies who want to take the DIY approach and have too many MAs to manage sensibly with EVWEB.

Please get in touch if you would like to discuss any of these options in more detail.

After July 2012?

After July 2012 MA Holders have an obligation to keep their data up-to-date with the 15-day timeframe. Plus, we expect further changes in legislation over the next few years; the data requirements will be expanded and SSI will come back as the EU moves towards ISO IDMP compliance.

Samarind is committed to remaining at the forefront of EVMPD developments and enhancing Samarind RMS to meet these future challenges. And remember, Samarind RMS is more than just an xEVMPD tool - it's a fully fledged Regulatory Information Management (RIM) system too.

Please contact Phil Turner today on +44 (0) 1244 288281 or email enquiries@samarindrms.com to find out more about how Samarind can help you.

Published 02/05/2012
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