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.
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.
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