Post-transition guidance from the MHRA: Pharmacovigilance, QPPV and PSMF

On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements for submission of pharmacovigilance data at the end of the Brexit Transition period, as well as guidance on the qualified person responsible for pharmacovigilance (QPPV) and pharmacovigilance system master files (PSMF).

MHRA will retain responsibility for pharmacovigilance across the UK from 01 January 2021, but notes that there will be different requirements for products sold in Great Britain (England, Scotland and Wales) and Northern Ireland (NI).

Submission requirements for Individual Case Safety Reports (ICSRs), Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) for products supplied in NI will remain aligned with EU requirements while the rest of the UK will follow national procedures.

All UK ICSRs (serious and non-serious) and serious non-UK ICSRs will need to be submitted to the MHRA via their online Gateway or ICSR Submissions portal.

The EU good vigilance practice (GVP) modules will remain applicable, although the MHRA is planning to issue guidance to explain any exceptions and modifications to the EU guidance.

The new guidance also provides updates on changes to signal detection requirements, post authorisation safety studies (PASS), safety referrals and post-authorisation measures (PAM) after the end of the transition period.

Marketing authorisation holders (MAH) of UK authorised products (including those specific to Northern Ireland or to GB) should ensure that the QPPV resides and operates in the EU or UK. They must also ensure that for marketing authorisations(MA) covering the whole of the UK or specific to Northern Ireland, qualifications and responsibilities of the QPPV remain unchanged as outlined in Article 10 of the Commission Implementing Regulation (EU) No 520/2012 (CIR). Furthermore, for MAs covering the GB only, qualifications and responsibilities of the QPPV are outlined in paragraph 10 of HMR Schedule 12A (inserted by the EU Exit Regulations 2019).

With regards to the PSMF, it must be located in the EU or in the UK where the main PV activities are performed, or where the QPPV operates. The PSMF needs to be permanently and immediately available for inspection at the stated location in the UK. The legal requirements concerning the PSMF format and content remain unchanged.

To view the full guidance on the QPPV and PSMF, click here.