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Oct 10

MHRA Guidance on No-Deal Brexit

Pharmacovigilance system requirements in the event of a no-deal Brexit

In the event of a no-deal Brexit on the 31st October, 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance to help UK based Marketing Authorisation Holders (MAH) best prepare themselves.

The role and responsibility of the UK QPPV are equivalent to that of the EU/EEA QPPV – in accordance with The Human Medicines Regulations (HMR) – with a temporary exemption allowance for EU/EAA QPPV’s (who reside in an EEA state) to assume responsibility for UK authorised products (for up to 21 months after exit) before absolutely requiring a UK QPPV to be established.

However, regarding guidance on the UK PSMF, this differs to the EU concept. It will become a legal requirement, for the UK PSMF, to be permanently situated; with immediate accessibility, at the stated UK location, and a formatting requirement equivalent to that of the EU PSMF – describing the global pharmacovigilance system and reflecting the global availability of safety information for UK authorised products – identifiable by a unique PSMF number.

Furthermore, when notifying UK QPPV and PSMF details to the MHRA, a Type IAIN – C.I.8.a variation, relating to the SPS, should be submitted – summarising the holder’s Pharmacovigilance system and UK PSMF number – within the outlined timeframes:

  • Identities, locations and contact details of UK QPPV’s identical to those of EU/EEA QPPV’s require no immediate action.
  • Identities, locations and contact details of UK QPPV’s that have changed the QPPV resident of EEA State should submit a single change within 2 weeks.
  • Identities, locations and contact details of UK QPPV’s that reside in the UK MUST be established within 21 months after exit

In a no deal scenario, all existing MA’s will automatically be converted into UK MA’s and issued a UK MA number – within a 1-year timeframe. Moreover, in regards to applications for UK MA’s, proof of the applicants appropriate qualified person for pharmacovigilance will need to be submitted; in addition to proof of UK residency and operation, contact details, signed statement of competency and reference to PSMF location.

PharSafer Comment

Conclusively, we would like to ensure that PharSafer does indeed have the internal capabilities to comply with these potential requirements. PharSafer already possesses a locally based UK QPPV and our QA team has already performed an impact assessment for new and existing processes; with a readiness for contingencies that accommodate any eventualities that may occur for our clients hereby endeavouring to maintain and progress the quality of our service in accordance with any outcome of a leave scenario on October 31st.

The one thing guaranteed in life is change – and at PharSafer, we will support you to be ready for it.

For a full review of the MHRA guidance document, please visit:

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