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The latest “updates” on UK PV from MHRA after Brexit

Still plenty of work to achieve clarity

Martti Ahtola | Apr 20, 2022

Brexit is a thing of the past. Without going into too much detail, let’s say that in the context of regulatory activities for medicinal products and devices some of the related updates and transition were completed by the end of 2020 and last parts (like the requirement to have a UK QPPV or national contact person for UK) became finally effective in the beginning of 2022. But, UK legislators and MHRA still have plenty of work to do to provide clarity for license holders in the UK. As we all know, Brexit implementation had been brewing for a long time and there were (and still are) large number of changes required for the UK authorities across industries. Despite the unimaginable amounts of money and work hours spent with the transition, many practical aspects were missing on January 31, 2020, and two years later, some still are missing. We’ll look at those pertaining to our field, pharmacovigilance, and most specifically how to deal with UK ICSRs. For more details on the UK pharmacovigilance system after Brexit, see our article on Medium.

Legislation and Guidelines

From PV point of view, there is still no updated legislation for medicinal products. The existing legislation is from 2012 and does not reflect the current activities performed in the UK. In practice, this means that MHRA has questionable legal remit over the activities they are requesting the pharmaceutical companies to perform. Also, there is no updated guidance from MHRA since 2020 and the main guidance companies have at their disposal are edited versions of the EU GVP modules with modification notes and few pages on the government website. Anyone studying the legislation or the guidance to support the PV activities performed in the UK will notice that things are just missing.
MHRA ICSR reporting
One of the main changes for pharmaceutical companies is the additional adverse event reporting requirement to the MHRA ICSR database in addition to EudraVigilance, FAERS and other authority systems. The MHRA ICSR reporting system looks sleek and it is very easy to use compared to EudraVigilance. However, the user quickly notices that some functionalities offered by EudraVigilance are not available, for example downloading ICSRs related to the licence holder’s products. EudraVigilance makes these ICSRs available based on the active pharmaceutical ingredient (API) of the licence holder’s products. All ICSRs that contain the API are available for download. These can be used for signal management (if needed) and PSURs. In MHRA ICSR database, these cases are sent automatically to the inbox of the licence holder or if gateway is used, to the database of the licence holder. It also seems that these reports received from MHRA are more curated than the reports received from EudraVigilance. It seems they are not only filtered by the API but also by route of administration. This is our assumption only based on everyday experience, you know, because MHRA has not published any information about this. So, to put it differently, the MHRA ICSR database is worse than EudraVigilance in the sense that you have to acknowledge the cases sent by them (unless you are a gateway user and the acknowledgement is automatic) reports from the authority but better in the sense that you can have  less of these authority reports than in EV ICSR downloads, thanks to the better filtering (which, however, is not properly explained, because there’s basically no documentation for the system).
ICSR acknowledgement
If the licence holder is using the MHRA ICSR Submissions website, these reports are automatically sent to the report management page. These reports can be then acknowledged. This works the same way as you would receive an acknowledgement from MHRA or EMA when you submit a case to them but now the roles are reversed.

Communication with the MHRA

As there is no guidance how to process these cases except for including them in the signal management process, we sent a question to MHRA asking what the process was. After waiting for a few months, MHRA answered us saying that the cases should be acknowledged.

We asked what the legal basis was for requesting the licence holders to acknowledge these cases, as it seems a bit backwards if one actually reads the legislation that describes that the licence holders are required to send the cases to the authorities and the authorities are responsible for acknowledging those cases. But nothing is mentioned of sending the cases the other way.

8 months passed, and we finally got the response from MHRA stating that the legal basis for the requirement for licence holders to acknowledge the received ICSRs is… *drumroll*… the legislation, the guideline is the EU GVP with the modifications and the guidance is what is said on the MHRA website.

Better part of a year had passed since we asked for detail, so our initial thought was: “okay, now MHRA must have published new guidance and there is new legislation for pharmaceutical products providing more information about all this.” But no, still nothing since 2020 for the guidelines and guidance and nothing since 2012 for legislation. So just to see what they answer us next, we sent the following questions to MHRA:

  • Could you please specify which exact part of the Human Medicines Regulations mentions the licence holders responsibility to acknowledge cases from MHRA?
  • Could you please specify which exact part of the GVP modification document mentions this?
  • Could you please send a link where the MHRA guideline for MAHs sending ACKs within 48 hours is mentioned?

To be continued

If we tried to model a pattern based on the past events, we should be expecting an answer email without any useful information by early 2023 when there’s still no new pharmaceutical products legislation, pharmacovigilance guidelines for UK nor new guidance on the MHRA website.
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