If you choose to establish a QPPV who resides and operates in the EU/EEA, you must nominate a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV. This individual 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. The individual should be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections.
There will be a temporary exemption in place which allows you 12 months from 1 January 2021 to appoint a national contact person for pharmacovigilance that resides and operates in the UK.
Once the national contact person for pharmacovigilance has been appointed, their details should be notified to the MHRA via the MHRA Submissions Portal. You should follow the instructions for submitting these details. You should receive a confirmation by email immediately upon completion of the form.
There is no requirement to appoint a deputy for the UK national contact person for pharmacovigilance, but for periods of extended absence greater than one month (such as maternity leave, long-term sick leave, etc.), it is expected that another individual is assigned as the national contact person for pharmacovigilance and their details should be notified to the MHRA within two weeks of the change. In practice, this means editing the existing details of the national contact person for pharmacovigilance that are saved in the MHRA Submissions portal.
