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Pharmacovigilance

What Does Brexit Mean for Drug Safety in Europe and the United Kingdom?

At present, the UK’s pharmacovigilance practices are interlinked with those of the European Union. The European PV system EudraVigilance, is currently used for Adverse Event and Special Situation Reporting and much of the UK’s regulations and infrastructure are aligned with that of the EU, including QPPV. Nevertheless, it is critical to note that although there is a dependency on EU infrastructure to ensure safety of medicines in the country, UK is also a significant contributor towards the establishment of harmonised pharmacovigilance across the EU.

Brexit and EudraVigilance

At present, there is a significant contribution from the UK for EudraVigilance, through instantaneous reports generated by patients, life sciences specialists and pharma businesses. After Brexit, the UK will have to create indigenous safety vigilance systems, unless they continue to contribute through EudraVigilance. The impact on Europe are virtually homologous because the UK’s pharmacovigilance expertise and commitment to EudraVigilance and drug safety surveillance is of paramount importance. Post Brexit, the UK’s absence will be yearned for and the EU will have to work out how to remain compliant in their endeavour to safeguard the safety of its patients. From a commercial enterprise viewpoint, companies will ought to mirror efforts and file reports along with Periodic Safety Update Reports (PSURs) to both the EMA and the UK’s respective body. Thus, while Britain’s withdrawal from Eudravigilance would almost certainly have a negative impact on drug safety in both the UK and the European Union, as of now the UK’s potential withdrawal from the data processing network seems unlikely.

Pharmacovigilance - EU

  • Marketing Authorisation Holders (MAHs)
    • Should follow Article 104 of 2001/83/EC and Article 7 of Commission Implementing Regulation 520/2012
    • Should follow Article 8 of Directive 2001/83/EC and Article 74 of 2001/82/EC
    • Will need to ensure that their EU Qualified Person, responsible for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF) is located and carries out their tasks within the EU/EEA.

Changes

Any changes in the QPPV, including contact details for medicinal products for human use, may be updated through the Article 57 database without the need for a variation. Updates should be made promptly to allow continuous supervision by the Competent Authorities.

Pharmacovigilance – UK

In the absence of an MRA, Marketing Authorisation Holders (MAHs) are required to ensure that their Qualified Person responsible for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF) for the UK is located within the UK.

Freyr’s Recommendation: To circumvent any further disruption following the Brexit, the UK must ensure their new guidelines and protocols are very closely aligned to the EMA model. Furthermore, the UK must also make sure it is aligned with the FDA to ensure compliance in the Americas and avoid triggering any new impediments for pharmaceutical companies. Brexit should not be seen as an obstacle for collaboration and should remain viable, thereby ensuring patient safety worldwide. Thankfully, some of the recent statements from the regulators clearly indicate that both the UK and the EU want to ensure that European manufacturing scenario continues to flourish in a progressively competitive global market

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