Have you appointed your National Contact Person for Pharmacovigilance?

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 we can help you appoint a qualified and knowledgeable person.

However, we have the perfect solution for our MAH clients – Pure Drug Safety can be your National Contact Person for Pharmacovigilance.

PDS offers their services to MAH clients as a NCPP

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.

PDS can be your NCPP and should you appoint us, we will notify the MHRA via the MHRA Submissions Portal.

PDS helps 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 on our website here: https://www.puredrugsafety.com/national-contact-person-for-pharmacovigilance/

Email or call us today to discuss your requirements.