What do we have to do?

What do we have to do to comply?

Here at Samarind we've been studying the EMA's technical documents since they were variously released in July and September 2011. Our interpretation is that by 2 July 2012 at the latest, if you're a marketing authorisation holder (MAH), you needed to do the following.

  • Register with the appropriate part of EudraVigilance, if you are not registered already (the instructions are here). The person who should register is the Qualified Person for Pharmacovigilance (see Article 103 of Directive 2001/83/EC, Regulation (EEC) No 2309/93).
  • Review the information required. The 'English' version of this definition is the best place to start; this can be found here. Section 1 contains some semi-technical information, section 2 explains the timelines and section 3 describes the information required. The EMA are also providing training courses and other 'guidance' meetings where this information is explained more fully.
  • Decide whether you are going to enter and update the information manually, via the web portal, or electronically. Samarind recommends that companies with more than around 10 licences should choose the electronic route, otherwise maintaining the information will be time consuming and prone to errors and omissions.
  • Companies deciding to submit electronically need to find suitable software for doing so. The choices are typically as follows.
    • If you have an existing pharmacovigilance or registration tracking system, find out whether your software vendor has plans to add XEVMPD support to it, and at what cost. Note that eCTD and document management systems are unlikely to be able to provide this sort of functionality.
    • If you don't have a suitable system, you should consider purchasing one. For many pharmacovigilance and regulatory affairs teams this will be the reason you've been waiting for to be able to justify investing in a proper database to hold details of all your product licences.
    • As an alternative to purchasing a system you could try to develop one in house, or get one developed for you. However this is unlikely to be a cost-effective or timely solution as the information required is complex and the time scale very short.
  • If you are considering purchasing a system, make sure that your software vendor is 100% committed to providing XEVMPD support as soon as is practicable. Ask them for the date by which they expect to have an initial version ready for review, and which aspects of the EVMPD they will be supporting by when - for example some software vendors may decide not to support development products or substances initially. Do remember that no vendor can claim full support for XEVMPD until the EMA provide a test system. Click the following link for Samarind's timetable for EVMPD support.
  • It's advisable to select a system that is quick and easy to learn and use as well as comprehensive. There is a lot of information to be entered in a relatively short time and the quicker you can get it done the better. Many companies (like Samarind) will offer a trial of their product, and training, prior to sale; this is a great opportunity to ensure that the system you are choosing does everything you want it to. 
  • Find out where all the information is. This may not be simple; it's likely to involve regulatory, pharmacovigilance and manufacturing/technical staff, especially if the full technical details of every substance (active, excipient and adjuvant) is required.
  • Decide who will gather all the information together and who will input it. What's your team's workload for the first two quarters of 2012? Will you need to employ temporary or contract staff? Recruitment can be a slow task.
  • Start entering the information as soon as possible. The EMA systems are likely to get busier and busier as the deadline gets closer and the sooner you can submit the better.
    • Some software vendors will be able to provide a data migration service to your new system. If your data is already in a database or Excel, automated routines can pull the information into your new XEVMPD-compatible system quickly and easily, saving your staff a lot of time. Samarind offers both template-based and bespoke data migration services.
    • Some databases (like Samarind's) will enable you to input and submit the information in stages, so that you don't have to do everything at once. After you have entered and transmitted all the information for (say) one main product line you will have a better idea of how long the whole task is going to take.
  • Submit the information to the EMA as soon as it's complete. It's not a good idea to leave it til the last minute.

Alongside all the above will be other issues like validation and updating SOPs. It's a big task.

Who has to do it?

The legislation states that it's the responsibility of the qualified person responsible for pharmacovigilance within the MA Holder company (the QPPV). However, much of the information required is more likely to be maintained by regulatory affairs than pharmacovigilance.

It will be up to each MAH to decide which department will do the work but 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.

Perhaps now is the time to take the information that is currently in spreadsheets or people's heads and put it into a proper database.

Keeping the data up to date

After 2 July 2012, MAHs must then keep the information they have submitted up-to-date. New, varied, suspended, revoked or withdrawn authorisations must be submitted within 15 days of the authorisation, variation, suspension, revocation or withdrawal.

Another deadline in 2016

There's a further deadline beyond this; by mid 2016 all MAHs must update their information by applying the ISO IDMP standards and use the HL7 messaging format rather than XEVPRM. However these standards are not expected to be finalised until Q3 2012 and we all have quite enough to do in the meantime.

To find out how Samarind can help you meet your XEVMPD obligations contact us today.