Pharmacovigilance (QPPV) provision post-Brexit
7th February 2020Good news for severe migraine suffers everywhere as NICE agrees to look again at Novartis’ Aimovig for migraine prevention
17th February 2020
The United Kingdom has left the European Union and is now in the transition period.
But what does this mean for pharmacovigilance and regulatory? What should you be preparing for? Here's a brief overview from Pure Drug Safety, which is correct as we understand it as at 10th February 2020. We will amend the content as we find out more.
31.01.2020 - The UK left the European Union.
01.02.2020 - As of the 1st February 2020, we have entered the transition period. This period is time limited and will last until at least the 31st December 2020. It is business as usual for the UK and EU. During the transition period the UK remains part of the free trade block and subject to EU Law. The UK cannot act as a lead member state and cannot be part of the EU Institutions.
POST 31.12.2020 - What should you be doing now?
After the transition period for Pharmacovigilance and Regulatory
Transition period ends 31.12.2020 when the UK will revert to the status of a third country.
This means all pharmaceutical and medical device companies need to have completed their Brexit preparations by the end of 2020.
Companies should be prepared for a hard Brexit on the 31st December 2020.
What changes should be considered for Pharmacovigilance QPPV?
QPPVs based in the UK will not be able to act as the EU QPPV from the 31.12.2020.
However, a QPPV currently based in EU states will be able to act as the UK QPPV for a short period of time.
MA Holding
A UK pharmaceutical company will not be able to hold an EU MA after the 31.12.2020.
An EU pharmaceutical company can continue to hold a UK MA for a period of time after 31.12.2020, but they will have had to establish a contact person based in the UK within 4 weeks.
PDS can act as the applicant for your MA procedure in the UK or Europe. Our team in Europe, together with our team here in the UK will help you ensure your MAs get safely approved. Contact us now on 01476 512395 to discuss this.
Post-Brexit changes to be considered for Pharmacovigilance and Regulatory Systems
CESP no longer able to be used for UK submissions after 31.12.2020.
MHRA have a new portal for Regulatory submissions and ICSR reporting.
Revision of templates for RMPs/PSURs.
Revision of SDEAs, agreements etc..
PSMF located at a single point where all reports of suspected adverse reactions are accessible (consider the format – UK specific or EU PSMF with UK annexes).
Sold in the EU, UK QPPV requires oversight of what is happening at all times.
UK oversight of Global Database.
PSURs, DSURs require joint signatories for both UK and Europe.
Brexit planning - PDS is here to help you now and beyond the transition period
PDS has offices in both the UK and Europe that can support your Brexit planning and help you maximise your opportunities.
MAH Service (licence application) on your behalf, both here and in Europe (DCP included) although UK would be better to do separately as a national procedure
EU and UK based QPPVs.
Full Global Database.
RMA Transfer from the UK.
Change of ownership applications.
PSMF
UK Capacity.
Responsibility for case processing.
Report to MHRA.
Perform follow ups.
Local UK literature searches and reviews.
Are you ready for 31st December 2020? We are here to help you. Call us now on 01476 512395 or click here to email us.
