Current Published text

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

Notification of QPPV and PSMF details to

the MHRA by existing holders of UK
marketing authorisations
This guidance replaces the previous requirement to submit a Type IA(IN) variation and
an accompanying eCTD sequence to make these changes. This has been simplified
and only an update notification is required, there is no requirement to submit an eCTD
sequence. This guidance applies from 11 May 2023

The summary of Pharmacovigilance System (sPS) is a signed declaration by both the QPPV
and the MAH. It contains the MAH details (i.e. Company name and address), the QPPV
details (i.e. QPPV name and Contact address), the location in UK where the PSMF can be
accessed and the UK PSMF number. The eCTD place holder for the sPS is module 1.8.1.
Changes have now been made to the way MHRA should be notified of updates to the QPPV
and PSMF details by licence holders.
Module 1.8.1 of the eCTD product lifecycle will only need to be updated when the PSMF is
replaced or a new PSMF is registered. The registration or replacement of a PSMF will still
require a new UK PSMF number. All new Marketing Authorisation application will continue to
require the inclusion of a sPS under module 1.8.1. When the PSMF is replaced because of a
change of ownership, the new MAH must include a copy of the new sPS under module 1.8.1
of the COA dossier. A Type IA C.I.8.a variation will no longer be required when a new PSMF
is introduced or replaced because of a Change of Ownership.

The following changes to the sPS will no longer require the submission of a Type IA
variation to update the sPS but can be updated via a notification update:

 Changes to the MAH details (i.e. Company name and address) as specified in the
sPS
 The QPPV details (i.e. QPPV name and Contact address)
 The location in UK where the PSMF can be accessed.

To make these changes, a UK only sPS Update Notification, covering the affected product
licences (PL), under a unique pharmacovigilance system, needs to be submitted to the UK to
register these changes. An updated eCTD sequence is not required. There is currently no
fee for sPS Update Notifications. A Notification of Acceptance letter will be issued once
finalised on our systems. sPS Update notifications will be processed within 30 days of
receipt of the application.

How to make a sPS Update Notification

All applications to update the sPS are required to be submitted as an sPS Update
Notification via the MHRA Submissions Portal immediately soon after implementation:

 Agency Activity Reference ID G0109: Summary of Pharmacovigilance System

Update Notification - UK-QPPV-PSMF
 Subactivity Text: H002 – “Original Submission” must be selected.

You must submit your sPS Update Notifications outside of the eCTD product lifecycle, in
collections of no more than 25 PLs and you should submit no more than one collection in a
single package.

Documentation you need to supply:

You should supply the following documentation for a sPS Update Notification:
1. Cover letter (in PDF format) detailing the changes being made.

2. sPS-Update-Notification-form (in Excel format). Please download a copy from here

and complete sections A and B.

3. The sPS (in PDF format), which must include the following information:

a. Proof that the applicant has at their disposal a qualified person responsible for
pharmacovigilance and a statement signed by the applicant to the effect that
the applicant has the necessary means to fulfil the tasks and responsibilities
listed in Part 11 HMR 2012. A signed sPS by both the QPPV and the MAH
will suffice.
b. The country (which must be either the UK or a Member State) in which the
appropriately qualified person for pharmacovigilance resides and carries out
their tasks.
c. Contact details of the appropriately qualified person for pharmacovigilance
who resides and operates in the EU or the UK.
d. A reference to the location where the PSMF for the medicinal product can be
accessed, which must be in the UK.
e. UK PSMF number

Failing to supply all required documentation and information may lead to a rejection of the
notification, which will require you to make a resubmission addressing all discrepancies.
A notification of acceptance letter will be issued when we have made the changes on our
system.
Please note that any eCTD sequence submitted will be discarded as it is not required as part
of this process.
Contact

General queries relating to the QPPV, PSMF and establishment of pharmacovigilance

systems for UK authorised products should be sent to gpvpinspectors@mhra.gov.uk
Queries relating to the UK PSMF number should be sent to UKPSMFadmin@mhra.gov.uk
Queries relating to submission of Type IA variations should be sent
to variationqueries@mhra.gov.uk
For further information, please email our Customer Experience Centre
at info@mhra.gov.uk or call 020 3080 6000. You can also
email vigilanceservice@mhra.gov.uk with urgent questions. Alternatively, contact your Trade
Association by emailing:
 Association of the British Pharmaceutical Industry (ABPI): regulatory@abpi.org.uk
 British Generic Manufacturers Association (BGMA): info@britishgenerics.co.uk
 BioIndustry Association (BIA): regulatory@bioindustry.org
 Clinical & Contract Research Association (CCRA): mail@ccra.org.uk
 Ethical Medicines Industry Group (EMIG): info@emig.org.uk
 Health Food Manufacturers’ Association (HFMA): pennyviner@btconnect.com
 The National Pharmacy Association (NPA): independentsvoice@npa.co.uk
 Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk