National contact person for pharmacovigilance
From 1 January 2021, all European Marketing Authorisation Holders (MAH) who choose to establish a QPPV who resides and operates in the EU must also nominate a National Contact Person for Pharmacovigilance (NCPP) who resides in the UK and who reports to the QPPV.
PDS will be offering their services to MAH clients as NCPP from January 2021.
The NCPP should:
- have access to the reports of suspected adverse reactions referred to in regulation 187 of the HMRs and the PSMF for UK authorised products;
- be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections.
There will be a temporary exemption in place from 1st January 2021 which gives MAHs 12 months to appoint a National Contact Person for Pharmacovigilance who resides and operates in the UK; PDS can be your NCPP.
Once the NCPP has been appointed, their details should be notified to the MHRA via the MHRA Submissions Portal.
REMAIN COMPLIANT IN THE UK AFTER BREXIT WITH PDS
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 we can also assist with other new processes from 1 January 2021, such as:
- UK ICSR downloads and submissions;
- Run, review local literature searches;
- Monthly communications reports.
And of course, PDS will still be able to help you with the following:
- Post Marketing PV Services;
- Market Authorisation Holder;
- SOP Audits;
- Patient Information User Testing;
- Rollout of OMS data in xEVMPD;
- 24/7 cover.
So if you need to remain compliant in the UK after 1 January 2021, call us today on 01476 512395 or email: email@example.com to discuss your requirements.