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Guidance on QPPV including Pharmacovigilance System Master Files– MHRA

UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on requesting a pharmacovigilance system master file (PSMF) number.


The updated guidance clarifies that companies do not need to update the information they provide online when they request a UK PSMF number, such as their telephone number, because the data is only used to generate and allocate the unique code.


The following legal obligations apply to holders of UK marketing authorisations (MA).

  • To operate a pharmacovigilance system for UK authorised products

  • To have an appropriately qualified person responsible for pharmacovigilance (QPPV) that resides and operates anywhere in the UK or in the EU/EEA and is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorised products

  • To maintain and make available upon request a pharmacovigilance system master file (PSMF) that describes the pharmacovigilance system for UK authorised products. The PSMF must be accessible electronically from the UK at the same site at which reports of suspected adverse reactions may be accessed

Guidance on the QPPV for UK authorised products

For all UK MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the marketing authorisation holder (MAH) must have permanently and continuously at its disposal a QPPV who resides and operates anywhere in the UK or in the EU/EEA, and is responsible for the establishment and maintenance of the pharmacovigilance system (“the UK QPPV”). Where the QPPV is not in the UK, there will be a need for a national contact person for pharmacovigilance.


Guidance on the PSMF for UK authorised products

For all UK national MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the MAH must maintain, and make available upon request of the MHRA, a PSMF that describes the pharmacovigilance system for UK authorised products (‘the UK PSMF’).


Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars.

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