Brexit Pharmacovigilance in the UK

Brexit has caused quite the stir, and pharmacovigilance certainly didn’t miss the fun. After many years, the rules have changed and every MAH who is present in the UK market needs to adapt.

But no worries, we’re here to help.

If you’re still looking for clarity on what your post-Brexit pharmacovigilance responsibilities are, just feel free to book a 15-minute consultation with us, free of charge.

Willing to study the changes yourself?

As a quick recap, you can read our published summary of the post-Brexit pharmacovigilance changes and what it means for the UK MA Holders:

Scenarios you now may be facing

Do you need to appoint a UK QPPV or a UK national contact person?

Not a problem, just let us know when. 

Do you also need help registering your PSMF with the MHRA
and perhaps modifying it for the UK market?

Sure, we’ve done it, we’ll do it again.

Are you worried that adding a new regulatory agency
having to report ICSRs to can complicate things for you?

It’s not that bad… We can cover this very easily with our streamlined, fully transparent, and easily manageable global pharmacovigilance system solution.

Are you unclear on what this whole talk about Northern Ireland means?

We can explain and guide you through it!

Let’s have a chat

Whatever your needs are, we look forward to getting in touch with you.
Feel free to drop us a message and we will contact you right away.

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