How to move to post-Brexit pharmacovigilance effortlessly and efficiently

November 27, 2020

How to move to post-Brexit pharmacovigilance effortlessly and efficiently

In 2021 the United Kingdom is moving to its post-Brexit life with new processes, procedures, and laws everywhere, including clinical trials and pharmacovigilance. This piece we dedicate to a simple question – how to move to post-Brexit pharmacovigilance effortlessly and efficiently.

All information in this article is based on Updated guidance on pharmacovigilance procedures published by Medicines & Healthcare products Regulatory Agency, last updated 27 October 2020.

Let’s dive into updated submissions data:

When: From 1 January 2021

Who: Marketing Authorisation Holders (MAH) of medicines authorised in Great Britain

Where to submit: to the MHRA

What to submit: all pharmacovigilance data, including

  • UK and non-UK Individual Case Safety Reports (ICSRs)
  • Periodic Safety Update Reports (PSURs)
  • Risk Management Plans (RMPs)
  • Post-Authorisation Safety Studies (PASS) protocols and final study reports

Flex Databases Pharmacovigilance is here to help you with the new MHRA Gateway submissions of ICSRs.

Submitting Individual Case Safety Reports

As the MHRA states, “We will require submission of all UK (including NI) ICSRs (serious and non-serious) and serious ICSRs from other countries via the new MHRA Gateway or/ICSR Submissions portal which have been developed.”

The MHRA recommends registering for submissions “as early as possible”.

Move to compliant PV system within a month before regulation changes? We say let’s do it!

To start moving to post-Brexit pharmacovigilance, request a quote or learn more request a demo via the button on top of the page, or send us an e-mail to bd@flexdatabases.com!

Blog

September 2, 2025
What CROs Should Look for in CTMS and eTMF During a Tender

When preparing a tender for a Clinical Trial Management System (CTMS) and an electronic Trial Master File (eTMF), CROs must choose solutions that meet sponsor expectations and improve operational efficiency while keeping studies inspection-ready. The right choice affects study delivery, compliance, and client satisfaction. Below are the key factors CROs should consider. Regulatory Compliance and […]

August 28, 2025
Integrations in Clinical Trials: An IT/ETL Perspective

How Flex Databases connects your study ecosystem – reliably, securely, and at scale.  Why integrations matter to sponsors and CROs  Integration means that data entered once in a system of record is propagated automatically wherever it is needed. For clinical operations teams this translates into:  Core integration patterns we see most often  1) EDC → […]

August 14, 2025
Key Changes to EU Pharmacovigilance Regulation: What You Need to Know

In July 2025, the European Commission adopted Commission Implementing Regulation (EU) 2025/1466, amending Regulation (EU) No 520/2012. The changes aim to strengthen pharmacovigilance, reduce unnecessary administrative burden, and align EU requirements with global best practices. Most provisions apply from 12 February 2026, with certain Eudravigilance updates taking effect in August 2025. Why the Changes Were […]

July 31, 2025
How Much ROI Can You Expect from eTMF and CTMS? 

A Comparative Look at Europe vs. US Markets  In clinical operations, time is money – but how much money can technology really save you? We analyzed the return on investment (ROI) for implementing electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS) based on real-world benchmarks. By modeling savings from reduced manual effort, […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.