On the 1st of September, the MHRA released their first update on what Pharmacovigilance in a post-Brexit UK will look like, having withdrawn most of their guidance earlier in the year. 

This came in the form of a guidance document titled ‘Updated guidance on pharmacovigilance procedures.  Shortly afterward, on the 4th of September, the MHRA release a further guidance document titled ‘Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021’.

Whilst these documents have provided some clarity on how to manage the key pharmacovigilance processes, they have also raised a few questions and concerns – in particular concerning product marketed in Northern Ireland.

Indeed, one of the first points addressed in the new guidance is that ‘products placed on the market in Northern Ireland will need to be in line with EU legislation and follow EU requirements.’, meaning UK MAHs may have to duplicate pharmacovigilance procedures for both the MHRA and the EMA, depending on how they market their product.

If a product is authorised in Great Britain (Guidance was also released concerning these ‘Great Britain MAs’ and is included in the links below, this is important for PV!), from the 1st January 2021 the MAH must submit ICSRs, PSURs, RMPs to the MHRA.

Furthermore, the MHRA confirmed that the EMA’s GVP modules are to remain in force with a guidance note on exceptions and modifications to be published later in the year.

We have extracted some of the important points of the two guidance documents and presented below.  If you would like to read the guidance in full, we have included links below.

  • The MHRA must be informed of both serious and non-serious ICSRs occurring in the UK, and serious ICSRs occurring outside the UK. This will be done via the MHRA-gateway or the ICSR submissions portal (Registration should be completed ASAP [see links below]).
  • If a product is marketed in Northern Ireland, ICSRs must be sent to both the EMA and the MHRA.
  • There will be no MHRA equivalent of the EVDAS signal detection requirements.
  • From the 1st January 2021, you must notify the MHRA of safety signal from any sources including the EMA.
  • The timeline for reporting an emerging safety issue to the MHRA is 3 days after it has met the GVP module IX definition of an emerging safety issue.
  • If a product is marketed in Northern Ireland, safety signal must be reported to both the EMA and the MHRA.
  • The MHRA will continue to accept EU versions of the RMP.
  • The MHRA may request UK specific information to be included in an annex.
  • The MHRA will continue to accept EU versions of the PSUR.
  • The MHRA may request UK specific information to be included in an annex.
  • The EURD list should be used until further notice.
  • If a product is not on the EURD list, the submissions timelines to the MHRA are at least six monthly during the first two years, once a year for the following two years, then every three years after that.
  • PSURs are to be submitted using the MHRA submissions portal.
  • GB only MAs – Submit only to the MHRA.
  • NI only MAs – Submit only to the EMA.
  • UK MAs – Submit to both the MHRA and the EMA.
  • The MHRA have scrapped the requirement for a UK based QPPV to be in place within 21 months of the 1st January 2021.
  • From the 1st January 2021, a QPPV based in the UK or in the EU must be in place to manage the UK MAs. This includes GB only MAs and NI only MAs.
  • A guidance document including exceptions and modifications to GVP module I will be published.
  • If the QPPV for UK MAs sits outside of the UK, the MAH must have in place a ‘National contact person for Pharmacovigilance’ within 12 months of the 1st January 2021.
  • This person must reside and operate in the UK and report to the QPPV.
  • For UK or NI specific MAs, the PSMF must be located in the EU where the main PV activities are performed or where the QPPV operates.
  • The PSMF must be electronically accessible at the point in the UK where ICSR reports are assessible.
  • A single PSMF can be used for all UK MAs, if they are all under the same PV system.
  • A guidance document including exceptions and modifications to GVP module I will be published.
  • The PSMF must describe the global PV system.
  • MAHs can establish more than one PV system and a PV system can be shared by several MAHs, as per GVP module II.
  • Each PV system must be assigned a unique PSMF number by the MHRA.
  • The PSMF number can be requested via the MHRA submissions portal from the 1st January 2021.
  • The MHRA will use the details included in the xEVMPD on 31st December 2020 to complete an MAHs baseline data.
  • A UK PSMF number should only be requested when changing the details of the QPPV from the baseline data.

There are now only 100 days to go until many of these new procedures need to be put in place.  We are expecting more guidance over the coming months, so now is the best time to begin preparing for the final exit of the UK from the EU.  Whether you are a UK based MAH or an EU MAH with product marketed in the UK, we would like to hear from you and what your plans are over the coming months.

If you have any questions regarding the information presented here, or for any other Pharmacovigilance matter, please contact David Lough (david.lough@jensongroup.com).

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