XEVMPD and ISO IDMP
Samarind worked extensively with the European Medicines Agency (EMA) on the original EVMPD in 2005, successfully submitting data for thousands of licences. As a result of this earlier work, implementing the extended EVMPD (xEVMPD) in 2012 was relatively straightforward. We were first to market with a fully working xEVMPD solution, an achievement that has been much appreciated by all our existing and new customers.
Samarind RMS – probably the best EVMPD tool
In Samarind RMS, the regulatory master data and tracking tools are fully integrated with the xEVMPD tool. This allows streamlined data entry and submission grouping for EU procedures, minimising the amount of time taken to compile each MA record. The structure of the software also eliminates much of the duplication associated with manual entry in other systems, such as the EMA’s free tool.
Samarind RMS has already been updated in line with the 2014 EMA guidance, and fully supports all operation types (insert, update, nullification and the various renewal/variation/suspension and transfer in/out processes) and the correct granularity of authorised product data as required by the EMA.
Samarind RMS has the xEVMPD business rules written into the system – no complex configuration is required. Records are automatically flagged when a change necessitates a transmission to the EMA, and our easy-to-use EVMPD summary screen makes it easy to see what data is missing and add it in. Automated alerts remind users when deadlines for submission are getting close; there’s no need to keep manual records. Printed Product Information (PPI) documents (SmPCs) can be either stored within the system’s own integrated document management system (EDMS) or pulled from an external EDMS like Documentum™.
Samarind RMS – already ahead with ISO IDMP
As soon as the ISO IDMP standards were published in 2012, Samarind’s system architects began studying them with a view to establishing how closely they fitted with the existing Samarind RMS data structures and what new data elements were likely to be required.
In comparison with EVMPD there’s a lot of new information that might be required. For this reason, and to help our customers get ahead with locating and collecting their IDMP data, we are already working on the enhancements we need to make to support the new standard, even though guidance from the EMA is not yet available.
There are five (5) new ISO standards that each define and describe different aspects relating to the Identification and Description of Medicinal Products (IDMP), as shown in the table on the right.
- ISO 11615 covers the medicinal product itself – the thing that’s actually used by the healthcare professional or the patient.
- ISO 11616 covers the pharmaceutical product. One medicinal product may contain more than one pharmaceutical product, as in the case of (for example) a thrush treatment comprising a cream and a tablet.
- ISO11238 covers data elements and structures for the unique identification and exchange of regulated information on substances.
- ISO 11239 covers data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
- ISO 11240 covers data elements and structures for the unique identification and exchange of units of measurement.