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Whose responsibility is it?

Whose responsibility is it?

Once of the most interesting questions is, within each MAH, whose responsibility is it to gather together this information and submit it to the EMA.

Clearly, according to the leglislation, it's a pharmacovigilance responsibility. The qualified person for pharmacovigilance (QPPV) is the person who is to register for EVWEB and submit the information. However, almost all of the data that is to be sent (forgetting the SSI information for now) is actually regulatory data.

In talking to our customers about compiling the required EVMPD data, it's become clear that this is actually a cross-department task. In many organisations, the pharmacovigilance team is much smaller than the regulatory affairs (RA) team, and often does not have a budget of its own -- certainly not one big enough to cope with the huge amount of work that this is, especially if there is no suitable database currently in place. And in any case, because most of the data is regulatory, it really has to be the regulatory people who put it in. The pharmacovigilance role may only be to check that the data is complete and actually submit it.

For these reasons it's important for EVMPD to be discussed at senior management/Director level within MA holder organisations and a suitable strategy put in place. There needs to be a high degree of co-operation between the RA and PVG teams and recognition of the amount of work involved. The good thing is that this may well be the reason the RA team been waiting for to find and implement a proper Regulatory Affairs database that supports XEVMPD.

It makes a lot of sense to have a single, company-wide product licence database containing both regulatory and pharmacovigilance data. A system in which regulatory people maintain regulatory information and pharmacovigilance people maintain pharmacovigilance information, and where interested parties throughout the organisation can have 'read only' access to both, can bring huge benefits in terms of visibility of the product portfolio, key timelines and resource planning generally. Systems like Samarind RMS provide regulatory affairs tracking, product lifecycle management, a built-in electronic document management systems and eCTD as well as XEVMPD.

Remember that systems based around document management are usually not able to produce and maintain the information that is needed for the EVMPD.

For more information about Samarind RMS please contact us today.