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).

Posted on the UK MHRA website on 12 March 2019