Sj Pharma Consulting Blog A Look at How Brexit Impacts European Pharmacovigilance Compliance

As the experts in drugsafety consulting and European pharmacovigilance compliance, we have been closely monitoring how Brexit will impact the procedure for Good PV Practice (GPvP). Currently, GPvP is based on the requirements of the European Union. Unless Brexit is rescinded, procedures will indeed change. It's unlikely that they will be eradicated completely as The Medicines and Healthcare products Regulatory Agency has indicated that vigilance inspections will remain with the Brexit deal or without it.Because the European Union currently sets the requirements for inspections in Europe, the pace of inspections and how many inspectors will be available is unknown. If Brexit does indeed occur, it's not yet known how the United Kingdom will do inspections in the EU. They would henceforth be a third party, which will complicate matters considerably. In order for companies to continue selling their products in the United Kingdom, they will have to not only have their registrations completed in the EU, but they will also need them in the United Kingdom.From exit day, for medicines sold in the UK, MA Holders (MAHs) will be required to submit pharmacovigilance data including UK and non-UK Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Post-Authorisation Safety Studies (PASS) to the MHRA. The Good Vigilance Practices (GVP) modules will remain in-force but the MHRA may, in time, publish UK guidance on good pharmacovigilance practice.With so much up in the air, one thing is certain. It's imperative for companies currently running clinical trials or selling products in the United Kingdom to be prepared for inspections on any given day. As the expert consultants in European pharmacovigilance compliance, we recommend that companies review their SOPs to ensure that they are ready to handle an inspection whether Brexit occurs or not.Today, we will look to help you prepare for the inevitable inspection. We believe that the Pharmacovigilance System Master File (PSMF) will continue to be requested upon inspection. In the United States, random inspections are pretty much the norm. This isn't currently the case in the United Kingdom, but this all could change. It's vital that one is prepared for inspection on any given day.Have questions about Brexit and the state of European pharmacovigilance compliance? Give us a call or fill out our online formto learn more about our services. We look forward to hearing from you!p { margin-bottom: 0.1in; direction: ltr; line-height: 115%; text-align: left; background: transparent none repeat scroll 0% 0%; }p.western { font-family: "Times", serif; font-size: 10pt; }p.cjk { font-size: 10pt; }p.ctl { font-size: 10pt; }a:link { color: rgb(0, 0, 255); text-decoration: underline; }