The European Medicines Agency (EMA) has updated the agency's Brexit-related guidance documents. This guidance is supporting pharmaceutical companies to prepare for the United Kingdom's (UK) withdrawal from the European Union (EU). Now the "Questions and Answers" document has been updated (Rev 04, published on 1 February 2019). The new Q&As address the situation when the United Kingdom becomes a third country on 30 March 2019 without a withdrawal agreement (and hence without a transition period).
What will change regarding the reporting requirements of Individual Case Safety Reports (ICSRs) from the UK into EudraVigilance?
As of the withdrawal date, UK authorities will no longer have access to EudraVigilance. Marketing authorization holders (MAHs) are therefore reminded that they will need to submit into EudraVigilance information that they might receive from UK authorities regarding cases occurring in the UK, in line with the reporting requirements for non-EU/EEA cases.
Suspected cases of serious adverse reactions must be reported regardless of whether they occurred in the Union (EEA) or in third countries.
Suspected cases of non-serious adverse reactions that have occurred in third countries do not have to be reported in the Union (EEA). Therefore, as of the date of the UK withdrawal, the following will apply: - Non-serious adverse reactions that occurred in the UK before the date of withdrawal must be reported; - Reporting suspected non-serious adverse reactions (that have occurred in the UK) to EudraVigilance is no longer required after the withdrawal date.
For individual cases originating from UK and submitted to EudraVigilance before the withdrawal date, when a follow-up information is received by the MAH as of the withdrawal date, it should be continued to be submitted to EudraVigilance when third country reporting criteria apply.
How do I handle - as of the withdrawal date - data from UK in the Periodic Safety Update Reports?
Periodic safety update reports (PSURs) should present cumulative and interval summaries of global safety data obtained from various sources worldwide. Relevant safety data obtained from UK sources as of the withdrawal date should therefore continue to be included in PSURs as per usual requirements for third country data.
For the calculation of exposure from marketing experience by region, patients exposed in the UK until the withdrawal date should be included in the EU/EEA estimate. Thereafter, UK patient exposure should be considered as part of the non-EU/EEA regions.