Summary of instructions for implementation of pharmacovigilance (PV) system in the UK according to the MHRA guidelines and instructions. For more information visit www.tepsivo.com

1. Post-Brexit Pharmacovigilance in UK
Summary

2. Summary
EU QPPV can be the UK QPPV but from 2022 onwards UK LCPPV is needed
UK PSMF is very similar to the EU PSMF. UK PSMF number can be obtained from MHRA Submissions
portal
UK address is required for the UK PSMF
ICSRs can be submitted through online portal or Gateway to MHRA
For Signal Management MHRA sends relevant cases to the UK license holders for storing in their
safety database

3. Current Situation
Brexit is still a work in progress
Updated legislation and guidance pending
First changes came into force on 01-Jan-2021
UK cases now need to be submitted to MHRA, and if serious, to EMA. Serious non-UK cases now
need to be submitted to MHRA
For some responsibilities, the transition period is until the end of 2021

4. Build on your EU PV System
From 01-Jan-2021 onwards, new pharmacovigilance guidelines from the MHRA have been followed in
the UK
With minor adjustments PV system compliant with the EU legislation and guidelines, will be
compliant in the UK

5. Northern Ireland
Grace period ongoing (01-Sep-2021)
From 01-Jan-2021 Northern Ireland (NI) has continued to be aligned with EU legislation and regulations
in respect to medicines and medical devices
There are several options available for pharmaceutical companies who want a license for a medicine for
use in NI:
• Marketing authorizations (MA) approved in the EU centralized procedure will automatically have effect in NI.
• NI may also be included in decentralized or mutual recognition procedures as a concerned member state.
• MHRA can also approve a medicine for use in NI, GB or the whole of the UK.

6. Available Guidelines
Guidance on pharmacovigilance procedures
Exceptions and modifications to the EU guidance on good pharmacovigilance practices (GVP) that apply
to UK MAHs and the MHRA
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance
system master files (PSMF)

7. Guidance on PV Procedures
For medicines which are authorized nationally in the UK, the license holder is required to submit PV
data to the MHRA, according to UK requirements, including:
• UK and non-UK Individual Case Safety Reports (ICSRs)
• Periodic Safety Update Reports (PSURs)
• Risk Management Plans (RMPs)
• Post-Authorisation Safety Studies (PASS) protocols and final study reports
MHRA assesses the documents based on how well they reflect UK clinical practice and support patient
safety in the UK

8. Exceptions and Modifications to EU GvP
The EU GVP modules remain in force in the UK, but MHRA has published a guidance note on the
exceptions and modifications to the EU GVP
The responsibilities of the MAH described in the guideline modules remain roughly the same but the
parts about EMA, PRAC, and the EU Member States have been removed
The goal of the guidance is to clarify the expectations on the application of the EU GVP for UK:
• The idea is to read a specific EU GVP Module and then check this guidance document what no longer applies
or what has been modified
In the sections below, you can see examples of these modifications

9. UK QPPV
From 01-Jan-2021 onwards, the QPPV for UK authorised products (UK QPPV) can reside and operate
anywhere in the UK or the EU/ EEA – same as before Brexit
If the UK QPPV is not based in UK, a UK national contact person for PV (UK LCPPV) must be appointed
and nominated by the 01-Jan-2022
QPPVs who reside in the UK cannot act as EU QPPV
EU QPPV can also be the UK QPPV

10. UK National Contact Person
The MHRA guidance describes the situation where the QPPV does not reside and operate in the UK,
which is probably the most common situation at the moment as most of the MAHs have moved their
EU QPPV roles away from the UK
In this situation, the MAH needs to have a UK National Contact Person or Local Contact Person (UK
LCPPV) who is nominated to the MHRA by 01-Jan-2022

11. UK LCPPV Requirements
• Nomination to the MHRA
• Resides and operates in the UK
• Reports to the QPPV
• Does not have to be directly employed by the license holder
• Has permanent access to the PSMF and to the ICSRs for UK authorised products.
• Has knowledge of pharmacovigilance requirements in the UK
• Ensures that queries raised by MHRA are answered fully and promptly
• Contact details are notified to MHRA and any changes to the contact details should be notified
within 14 calendar days

12. UK PSMF
UK PSMF is required for all UK national licenses
The UK PSMF can largely be the same as EU PSMF, but it needs to have the UK PSMF number, UK
location, and contain information about how the UK specific aspects of the pharmacovigilance aspects
are dealt with
The license holder is required to provide the UK PSMF to the MHRA on their request.

13. UK PSMF Requirements
Below are explained the minimum requirements for the UK PSMF document:
1) You need to have a computer with Internet connection in a UK address that can be used to access the PSMF
(and the UK ICSRs)
2) UK PSMF needs to be registered with the MHRA
a. First you need to obtain a PSMF number via the MHRA Submissions portal (instructions below)
3) To use the MHRA Submissions Portal, your organisation needs to be registered in the portal and you need to
have access to the organisation
4) The content and format of the UK PSMF are the same as for the EU document, with these exceptions:
a. Cover page has UK PSMF number
b. Section 1 organizational structure should be UK specific (including the UK QPPV)
c. It should describe how the PV system is applied to the UK authorized products.
d. The annexes should contain only information relevant to the UK authorized products.

14. Obtaining UK PSMF Number
Use the MHRA Submissions portal to obtain the UK PSMF number
If you do not have access to the MHRA Submissions, read below the instructions how to get access
To gain the UK PSMF number, follow these steps:
1) Ensure that you know the 5-digit code and the UK address of the company / companies that you
are creating the PSMF number for.
2) In the MHRA Submissions. Go to ‘Human Medicines’
3) Go to ‘Obtain UKPSMF Number’
4) Fill in the MHRA UK Pharmacovigilance Master File (UKPSMF) Number Request Form

15. MHRA Submissions
MHRA Submissions is a portal which can be used to directly submit documents to the authority, to read
instructions and to obtain the UK PSMF number as described above
The instructions for registering with the MHRA can be found here. First, you need the 5-digit company
number and then they go to the MHRA account request page
Established companies would already have the MHRA number:
• MAHs - the first 5 digits of your Product Licensing number
• Clinical trial applicants - the first 5 digits of the CTA number from a trial that your organisation has
previously submitted. This can be also be found on letter correspondences from the MHRA
Companies that do not have the MHRA number can obtain it by emailing

16. ICSR Submissions
ICSR Submissions portal is similar to EMA’s EudraVigilance and EVWEB - however, it is much more
modern and simpler to use
After gaining access to the portal are used to send or receive ICSRs
Users who wish to gain access to the new MHRA Gateway will need to first gain access to MHRA
Submissions

17. Reporting ICSRs
The license holders must send all UK ICSRs and serious non-UK ICSRs to the MHRA via either ICSR
Submissions portal or using a Gateway
ICSR Submissions can be entered at https://icsrsubmissions.mhra.gov.uk/login but first the license
holder must be registered
Once the license holder has registered for the ICSR Submissions following the instructions they can start
immediately the submissions to the MHRA after gaining access - gaining access to the ICSR Submissions
portal should take up to 5 days
UK is a third country to EU which means that serious cases from the UK must be reported to
EudraVigilance

18. ICSR Submission Acknowledgements
The MHRA makes relevant UK ICSRs available to the license holder for inclusion in their safety
databases
The license holder generates acknowledgement messages for all cases received from the MHRA
The acknowledgements can be generated by selecting the file received from the MHRA and selecting
the ‘create ack’ option
The purpose of the acknowledgements is to take the responsibility of these received cases and to
include them in the license holder’s safety database

19. Literature Monitoring
“The MHRA will not publish a literature monitoring list, instead MAHs will be responsible for conducting
relevant literature searches and sending these to the MHRA. These should include reports received from
the EMA Medical Literature Monitoring (MLM) service” - In practice, this means that MAH have to
continue performing both global and local literature screening
The monitoring of the medical literature by the EMA (MLM) continues to apply to UK MAHs for
products authorized in Northern Ireland. As required by Article 107(3) of Directive 2001/83/EC and to
avoid the submission of duplicate ICSRs, the MAH needs to submit only ICSRs from literature or for
products which are not covered by MLM.

20. Signal Management
MHRA is responsible for detecting and managing safety signals related to UK products in their database
The MAH is responsible to have a signal detection system that enables them to perform cumulative
signal detection across all available data sources - the MAH is not required to conduct signal detection
against MHRA’s ICSR database
In line with EU GVP Module IX – Signal Management requirements, standalone notifications of signals
should be sent to the MHRA (signalmanagement@mhra.gov.uk) using the standalone signal
notification form
When a MAH becomes aware of an emerging safety issue, they should notify it in writing to the MHRA
(signalmanagement@mhra.gov.uk)

21. About Tepsivo
First fully digital global provider of pharmacovigilance
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Founded by Martti Ahtola, Dominik Hodbod, and
Jan Chvojka in 2020.
Based in Helsinki, with global remote network in
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27. Want to have a closer look?
Reach out to us and we can schedule a demo of our
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Contacts:
General enquiries: info@tepsivo.com
RfI/RfP: bd@tepsivo.com
Solutions demo: demo@tepsivo.com
Or reach out directly to:
Dominik Hodbod
CEO
dominik.hodbod@tepsivo.com
+420 777 811 850