QPPV and PSMF requirements in case of a no-deal Brexit

QPPV and PSMF requirements in case of a no-deal Brexit

September 17, 2019

On 07 August 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance, previously published on 12 March 2019, on the qualified person responsible for pharmacovigilance (QPPV) and pharmacovigilance system master file (PSMF) in the event that the United Kingdom (UK) leaves the European Union (EU) without a deal.  The guidance will apply from the exit date and covers the following topics:

  • Guidance on the UK QPPV
  • Guidance on the UK PSMF
  • Guidance on the notification of UK QPPV and UK PSMF details to the MHRA by existing holders of UK marketing authorisations (MAs)
  • Guidance for applicants for UK MAs
  • Provision of mailbox addresses in case of any queries

NB: Please note this blog was originally published on the 19th Mar 2019 and updated on the 16th Sept with the recent Brexit updates. 

Requirements for a UK QPPV for MAHs of UK authorised products:

  • The UK QPPV‘s roles and responsibilities will be equivalent to that of the EU/EEA QPPV. Further guidance on the role and qualifications of the EU/EEA QPPV is outlined in GVP Module I – Pharmacovigilance systems and their quality management systems.
  • The UK QPPV must be appropriately qualified, resident and operational in the UK.
  • The UK QPPV is responsible for the establishment and maintenance of the PV system for UK authorised products.
  • A temporary exemption as to the location of the UK QPPV is in place that allows the MAH 21 months after exit day to appoint a UK QPPV that is resides and operates in the UK. The exemption allows the EU/EEA QPPV who, immediately before exit day, resides and operates in an EU/EEA state to assume responsibility for UK authorised products until the UK QPPV is established.

Requirements for a UK PSMF for MAHs of UK authorised products:

  • The UK PSMF must be located at the same site in the UK from where suspected adverse reaction (AR) reports are accessible (electronically or physically). N.B. this differs from the EU/EEA requirement that the EU PSMF must be located either at the site where the main PV activities are performed or at the site where the EU/EEA QPPV operates.
  • The UK PSMF must be permanently and immediately available for inspection at the stated location in the UK.
  • The format and content of the UK PSMF will remain equivalent to that of the EU/EEA PSMF. Further guidance of the format and content is outlined in GVP Module II – Pharmacovigilance System Master File.
  • The UK PSMF must describe the global PV system and the global availability of safety information for UK authorised products.
  • The MAH can have more than one PV system or a PV system can be shared by several MAHs, however, they must ensure that each PV system for UK authorised products is identified by a unique PSMF number.
  • All UK PSMFs must be registered with the MHRA and the MAH should request a unique PSMF number for each PV system using a UK PSMF number request form that will be made available on the MHRA website immediately after exit day. The form should be submitted to UKPSMFadmin@mhra.gov.uk. They will receive a unique UK PSMF number via email within 10 working days.
  • The MAH should not request a PSMF number until they are planning to update the summary of pharmacovigilance (SPS) for UK MAs via submission of a variation application.

Notification of UK QPPV and PSMF details to the MHRA by existing holders of UK MAs

All UK MAHs should submit Type IAIN variations (i.e. minor variations) related to the SPS to the MHRA that cover all UK MAs. Applications to update the SPS need to be submitted as a Type IAIN C.I.8.a and the MAH needs to provide supporting documentation that demonstrates the following:

  • Proof that they have an appointed QPPV
  • Contact details of the QPPV who is ordinarily resident in the UK (or contact details of the EU/EEA QPPV who has assumed this responsibility during the transitional period)
  • The location of the PSMF (which must be in the UK)

The MAH must notify the MHRA of changes to the SPS following the registration of the UK PSMF and changes to the UK QPPV. The submission timelines are provided on the MHRA website and it is important to note that there are different requirements for MAs that were authorised via the EU centralised procedure and UK national MAs.  

Guidance relating to existing UK national licences

On exit day, no immediate action is required if the identity, location and contact details of the UK QPPV are the same as the EU/EEA QPPV, as entered in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).

The MHRA must be notified within two weeks if there is a change in the identity, location or contact details of the UK QPPV by submitting a single change Type IAIN C.I.8.a variation to cover all UK MAs (note, no more than 25 licenses should be included in one single variation).

Guidance relating to licences authorised via the EU Centralised Procedure

On exit day, all existing MAs authorised through the centrally authorised procedure will automatically be converted into UK MAs and issued with a UK MA number.

Starting on exit day, the MAH will have a period of one year to submit the initiating sequence data and related information in eCTD format.

Following submission of the initiating the eCTD sequence and receipt of approval from the MHRA, the MAH must notify the MHRA within two weeks if there is a change in the identity, location or contact details of the UK QPPV by submitting a single change Type IAIN C.I.8.a variation to cover all former EU centralised procedure UK MAs (note, no more than 25 licenses should be included in one single variation).

Guidance for applicants for UK MAs

The application for a UK MA must include an SPS (including the UK PSMF number) which must provide the following:

  • Proof that they have an appointed QPPV
  • Contact details of the QPPV who is ordinarily resident in the UK (or contact details of the EU/EEA QPPV who has assumed this responsibility during the transitional period)
  • The location of the PSMF (which must be in the UK)

 

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For more information on the guidance updates, please visit MHRA website. The MHRA has provided details on email addresses for any queries.

Reference:

https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf-if-the-uk-leaves-the-eu-w

QVigilance Team
QVigilance Team

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