The Wire – read the latest news from PDS16th July 2021
By 1 January 2022 any European Marketing Authorisation Holders (MAH) who choose to establish a QPPV (Qualified Person for Pharmacovigilance) who resides and operates in the EU/EEA must also nominate a National Contact Person for Pharmacovigilance (NCPP) who resides in the UK and who reports to the QPPV.
At Pure Drug Safety we know that finding an experienced QPPV can take significant time and money, and with just five months until the end of 2021, the clock is ticking to get a qualified and knowledgeable person in place.
However, we have the perfect solution for our MAH clients – Pure Drug Safety can be your National Contact Person for Pharmacovigilance from January 2021. Many clients have already put their NCPP in place with us here at PDS and are ready for January 2022.
PDS will be offering their services to MAH clients as a NCPP from January 2021
Our NCPP will support and oversee your portfolio and will:
- have access to the reports of suspected adverse reactions referred to in regulation 187 of the HMRs and the PSMF (pharmacovigilance system master file) for UK authorised products;
- be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections;
- local literature search support;
- all other actions you require us to carry out from a NCPP perspective here in the UK.
There has been a temporary exemption in place from 1 January 2021 which gives MAHs 12 months to appoint a National Contact Person for Pharmacovigilance who resides and operates in the UK, but time is now running out fast.
PDS can be your NCPP and should you appoint us, we will notify the MHRA via the MHRA Submissions Portal.
Remain compliant in the UK after Brexit
PDS will be able to help MAHs remain compliant in the UK with a wide range of extra services, in addition to being your NCPP.
You can read all about how PDS can help you remain compliant in the UK after Brexit on our website here: https://www.puredrugsafety.com/national-contact-person-for-pharmacovigilance/
So if you need to remain compliant in the UK in readiness for January 1st 2022, email or call us today to discuss your requirements.