I am pleased to be able to connect with you today through this September 2020 edition (the 96th in the series since April 2012) of Oviya MedSafe‘s newsletter in the backdrop of the Great British Pharmacovigilance Question that has been answered during the month thanks to the issuance of guidances on the pharmacovigilance system and procedures which are all set to be the reality in the UK in the immediate Post-Brexit era!
As we all are aware, the UK has left the EU, and the transition period after Brexit comes to an end this year. The Updated Guidance on Pharmacovigilance Procedures published on 1st September 2020 provides exhaustive details of the arrangements made for everyone to adapt to the “new normal” for pharmacovigilance procedures in the UK with effect from 1st January 2021. According to this document, the MHRA will retain responsibility for pharmacovigilance across the UK but there will be some different requirements for products placed on the market in the UK with respect to Great Britain and Northern Ireland. The term ‘Great Britain’ implies England, Wales and Scotland put together. Products placed on the market in Northern Ireland will need to be in line with EU legislation and follow EU requirements. More details are expected to follow in due course.
The Guidance on QPPV including PSMFs from 1 January 2021 published on 4th September 2020 specifically aims to explain the revised pharmacovigilance system requirements. According to this document, the following legal obligations will apply to holders of UK marketing authorisations (MA). These include those that cover the whole of the UK, or are specific to Northern Ireland or to Great Britain (England, Wales and Scotland):
1. To operate a pharmacovigilance system for UK authorised products;
2. To have an appropriately Qualified Person responsible for Pharmacovigilance (QPPV) that resides and operates in the EU or the UK and is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorised products; and
3. To maintain and make available upon request a Pharmacovigilance System Master File (PSMF) that describes the pharmacovigilance system for UK authorised products. The PSMF must be accessible electronically or physically from the UK at the same site at which reports of suspected adverse reaction may be accessed.
Apart from these two major guidance documents, a few more operational level advisories have been released for the purpose of pharmacovigilance. They are also available on the MHRA website but the primary demands of regulatory compliance appear to have been covered by and large in these two major guidance documents.
Oviya MedSafe, as an organisation, is well-equipped to meet the challenges posed by the newly announced MHRA pharmacovigilance compliance requirements. I believe this is the right time for me to share with you a brief narrative on the growth of Oviya MedSafe as a brand in the UK.
After I founded Oviya MedSafe in March 2012 with the organisation’s headquarters at Coimbatore in India, I used to often feel that we needed a European presence in order to provide location-based services like EU QPPV support, EU Local Responsible Person for PV support, EU Medical Information support, etc. This resulted in the incorporation of Oviya MedSafe UK Ltd (a 100% subsidiary of our parent Indian company Oviya MedSafe Pvt Ltd) in July 2014 at London in the UK. Obviously, UK was very much part of the EU then and we started providing onshore support through our UK subsidiary, as and when required. Over a period of time, Oviya MedSafe’s UK presence became quite pronounced and that was the time the Brexit referendum happened.
I vividly recall discussing the then unforeseen impacts Brexit may have on Pharmacovigilance in the June 2016 edition of Oviya MedSafe’s newsletter. From there, we all have come a long way and it is delightful to see that much more clarity exists now. Our UK entity has grown over time to such an extent that it is able to provide complete pharmacovigilance services support when required, to not only our UK-based clients but also our EU-based ones. Of course, with hard Brexit done, I sense that we may be justified in considering a separate EU subsidiary for Oviya MedSafe sometime in the future.
Keenly waiting to meet you all through the October 2020 newsletter,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,
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