UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK leaves the EU without a deal

Summary of pharmacovigilance system requirements after the UK leaves the EU

Leaving the EU with a deal remains the government’s top priority. This has not changed.

However a responsible government must plan for every eventuality, including a no deal scenario.

If the UK leaves the EU on 29 March 2019 without a deal, the following legal obligations will apply to marketing authorisation holders (MAH) in the UK:

  • To operate a pharmacovigilance system for UK authorised products.
  • To have an appropriately qualified person responsible for pharmacovigilance (QPPV) that resides and operates in the UK and is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorised products (“the UK QPPV”).
  • To maintain and make available upon request a pharmacovigilance system master file (PSMF) that describes the pharmacovigilance system for UK authorised products (“the UK PSMF”). The UK PSMF must be located in, or accessible electronically from, the UK at the same site at which adverse reaction reports may be accessed.

The purpose of this guidance note is to provide practical information and instructions to UK MAHs on the role and responsibilities of the UK QPPV, the development and registration of the UK PSMF and the notification of the summary of pharmacovigilance system to the Medicines and Healthcare products Regulatory Agency (MHRA).

Guidance on the UK QPPV

Role and responsibilities of the UK QPPV

The role and responsibilities of the UK QPPV are equivalent to that of the EU/EEA QPPV. In accordance with The Human Medicines Regulations (HMR) regulation 182(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (“the EU Exit Regulations”)), the holder must:

(a) Have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance who is ordinarily resident, and operates, in the United Kingdom and is responsible for the establishment and maintenance of the pharmacovigilance system.

Furthermore, HMR Schedule 12A (inserted by the EU Exit Regulations) paragraph 10(4) states:

« The holder must ensure that the qualified person responsible for pharmacovigilance has sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the holder. »

Further guidance on the qualifications and role of the EU/EEA QPPV is described in Good Pharmacovigilance Practice (GVP) Module I – Pharmacovigilance systems and their quality systems.

Temporary exemption as to the location of the UK QPPV

As stated in section 1.9 of the further guidance from January 2019, a temporary exemption is in place to allow you until the end of 2020 to appoint a UK QPPV that resides and operates in the UK. This temporary exemption regarding the location of the UK QPPV will allow the EU/EEA QPPV who, immediately before exit day, resided and operated in an EEA State, to assume responsibility for UK authorised products until a QPPV who resides and operates in the UK can be established…