Is Your Pharmacovigilance Team Ready for Brexit?

October 13, 2020

As we approach the final months of 2020, the pharmaceutical world begins, once again, to focus its thoughts on the impact of Brexit, not least in the world of pharmacovigilance.

Of course, the UK has already formally left the EU (back on 31 January 2020), and we’ve been progressing through a transition period that is expected to end on 31st December 2020. In this 11-month period, it has been easy for Brexit to have temporarily slipped from our thoughts as pharmacovigilance activities have continued to follow the existing EU rules/legislation and a comfortable ‘status quo’ has resumed for a while longer.

However, as we approach January 2021, the end of the current transitional phase, pharmacovigilance staff must once more focus on the impact of the UK becoming a ‘’third-country’’, and what it really means for their organization and their products licensed in the UK. While some pharmacovigilance/regulatory teams have already taken proactive steps, many organizations are likely less prepared. To avoid any critical issues, now is the best time to (re)check whether your organization is ready. Here are a few key areas you can check to be sure you are on the right path.

Prepare for What is Coming with this Checklist

  • Remember that any EU QPPV or deputy currently based in the UK needs to move to the EU.
  • Consider the implementation of a UK QPPV, and identify the optimal arrangement/timing for your organization.
  • Prepare for transitioning to the new MHRA portal. This will become the new reality for the submission of ICSRs and PSURs to meet the UK requirements, so be sure you are fully registered and set-up with this tool.
  • Plan ahead for the impact on your specific internal operations and processes. The implications for pharmacovigilance may vary depending on your current organizational arrangements and company choices, but you will want to be prepared before the transition period ends.

Although some preliminary information has been published, more detailed guidance to Marketing Authorization Holders (MAHs) is expected to be released from the MHRA shortly, and the plans for your organization can be finalized and implemented.

If your organization is struggling to prepare for the new guidance or needs specific advice, ProPharma Group’s experts are available to support you on this journey into a new regulatory landscape.




Compliance

October 13, 2020

Industry Poll: What are the Leading Challenges with GMP Auditing?

In a recent poll conducted by ProPharma Group, the question “What is your biggest GMP auditing challenge?” was posed to Quality professionals in the drug manufacturing industry. The following graph...

Read More
Regulatory Sciences

October 13, 2020

Stability Testing of New Drug Substances and Products

The stability of a drug substance or product is a critical attribute for all pharmaceutical products.  As such, stability testing is required throughout the drug development phase as well as...

Read More
Regulatory Sciences

October 13, 2020

Understanding Bioequivalence and Product-Specific Guidances

The FDA regularly issues new and revised product-specific guidances to facilitate the availability of generic drugs and assist the generic pharmaceutical industry with identifying the most...

Read More