Pharmacovigilance: Be prepared for "Hard Brexit"

The British Government has now published first notices in the event that the UK leaves the EU without agreement (so-called "hard Brexit"). These notices also concern the pharmacovigilance area. With the Brexit, the British regulatory authority (MHRA) will loose the connection to several central communication portals by which pharmaceutical companies and authorities can transmit data to the European Member States. This includes common systems like EudraVigilance, EUDAMED (medical devices), the PSUR (Periodic Safety Update Report) repository and the Article 57 database.

In case of a "hard Brexit", it will no longer be possible to submit data via the central EU portals to the MHRA. Therefore, information will have to be transmitted to the UK authority directly. For this purpose, individual national UK-portals will have to be programmed until the Brexit. According to this, as of 29 March 2019 information to be transmitted among the EU and to the UK will have to be submitted separately via the EU systems and the national MHRA-portals (if necessary, using different technical standards). However, the EU application forms and the standards laid down in the EU will be provisionally accepted for the transmission of data. Further information regarding the general transmission to the national UK portals should be released until the Brexit.

Establishment of a UK QPPV
If companies want to continue their distribution of products on the British market, they will have to establish a marketing authorization holder (MAH) in the UK by the end of 2020. However, companies will need a Qualified Person for Pharmacovigilance (UK-QPPV) established in the UK on the day after the Brexit, i.e. on 30 March 2019, although up to that date no current UK presence is required. In such a case, companies have to ensure that the MHRA will have access to the relevant safety data related to UK marketing authorizations at any time. During a transition period until the end of 2020, an EU-QPPV may take on responsibility for UK until a UK-QPPV can be found and established. Any variation of the QPPV has to be submitted to the MHRA. More details regarding this procedure will be announced by the British government at a later date.

Detailed Pharmacovigilance Tasks
Currently pharmacovigilance, which is the monitoring of the safety of medicines on the market, is co-ordinated almost exclusively on EU level and then implemented nationally. In case of "hard Brexit", the responsibility for those activities with regard to British marketing authorizations will be passed to the MHRA without any transition period. Therefore, the MHRA has to provide the corresponding tools and databases as of 30 March 2019. Regarding the notification of Individual Case Safety Reports (ICSRs), reference is made to a still existing own database of the MHRA. Therefore, companies do not need to transfer any retrospective information. In future, UK and non-UK ICSRs and PSURs will have to be directly submitted to the MHRA. Beside the (still existing) database mentioned above, national submission portals will have to be set up and available by the end of March 2019 - and then be further developed. Such portals are necessary for - among other things - submitting marketing authorization applications, PSURs, Pharmacovigilance System Master Files (PSMFs), establishing the QPPV and for the notification of Anonymized Single Patient Reports (ASPRs). Companies who want to be present on the markets of EU countries and UK will have to be prepared for parallel submissions in both regions. The stakeholders - among them also the MAHs in UK - are required to support the MHRA with the set up and the testing of the UK databases mentioned above. Further advice regarding the procedure is announced for later this year.

Moreover, according to Q&A No 25 of EMA's Q&A document on Brexit published on 19 June 2018: "What if Qualified Person's for Pharmacovigilance (QPPV) back-up arrangements are in the UK?, the deputy EU-QPPV has to be located in the EU and can only perform his/ her tasks in the EU. Therefore, the responsibilities of the deputy EU-QPPV cannot be fulfilled by a person living in the UK any longer.

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