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________________________________________ From: D Jackson
<[FOI #888095 email]> Sent: Wednesday, August 17,
2022 7:56:47 PM To: MHRA Customer Services Subject: Freedom of Information
request - PV Strategy Document, AESI spreadsheet, Pfizer case output files
Dear Medicines and Healthcare Products Regulatory Agency, Please provide
the following files: - All versions of the document referred to as the "PV
Strategy Document" or "Refined PV strategy document" in the December 2021
and June 2022 versions of "Monitoring and signal detection activities for
ADR reports concerning the COVID-19 vaccine" - The "AESI Line
Listing.xlsx" file in this sub-folder:
"https://eur01.safelinks.protection.outlo...
vigilance/COVID-19 Vaccine". - All files in the sub-folder:
"https://eur01.safelinks.protection.outlo...
vigilance/COVID-19 Vaccine/COVID-19 mRNA BioNTech Case Outputs" Yours
faithfully, D Jackson
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #888095 email] Is [MHRA request email] the wrong
address for Freedom of Information requests to Medicines and Healthcare
Products Regulatory Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
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https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections

Our Ref: FOI 22/912

Dear D Jackson,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 17 August 2022.

We confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...

Kind Regards,

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

show quoted sections

Dear D Jackson,

FOI 22/912

Thank you for your Freedom of Information (FOI) request dated 17^th August
2022, we apologise for the delay in response. You requested the following:

• All versions of the document referred to as the "PV Strategy Document"
or "Refined PV strategy document" in the December 2021 and June 2022
versions of "Monitoring and signal detection activities for ADR
reports concerning the COVID-19 vaccine"
• The "AESI Line Listing.xlsx" file (and then provided a link to a
sub-folder)
• All files in the sub-folder (COVID-19 mRNA BioNTech Case Outputs).

With regards to your request for all versions of the document referred to
as ‘PV strategy document’ or ‘Refined PV strategy document’ we are
refusing this aspect of your request under Section 14(1) of the FOI act.
We are unable to identify the value or purpose of this request, given that
the agreed position is publicly available via our website at the link
below:

[1]https://www.gov.uk/government/publicatio...

Your second two requests (for AESI line listings and for all files in a
particular sub folder): this information contains details of individual
Yellow Cards which have been submitted to us, and as such this information
could lead to patient identification. We are therefore exempting release
on account of Section 40 (Personal data) and Section 41 (Information
provided in confidence).

Members of the public and healthcare professionals voluntarily submit
reports of suspected side effects to us through the Yellow Card Scheme. As
outlined in our [2]Privacy Policy, we will not share the identity of
anyone submitting a Yellow Card report with any person outside the MHRA
without their explicit consent, unless we are required or permitted to do
so by law. The Policy also states that we may receive requests for Yellow
Card report data under the Freedom of Information Act. While we are
legally obliged to provide some of the requested information, we only
provide high-level summary information with all person-identifiable data
excluded.

We have been working proactively to encourage members of the public or
health professionals across the UK to immediately alert us to any concerns
they have without a formal diagnosis using the Yellow Card scheme. The
information and data provided to us by these third parties are shared in
confidence and, as above, are personal data. Sharing the information and
data received would not reflect the commitments we have made on our
confidentiality agreements. As this is personal data in relation to an
individuals’ health, this would be of detriment to them and may damage
their engagement with the scheme.

If you have a query about the information provided, please reply to this
email.

If you are dissatisfied with the handling of your request, you have the
right to ask for an internal review. Internal review requests should be
submitted within two months of the date you receive this response and
addressed to: [3][MHRA request email]

Please remember to quote the reference number above in any future
communications.

If you were to remain dissatisfied with the outcome of the internal
review, you would have the right to apply directly to the Information
Commissioner for a decision. Please bear in mind that the Information
Commissioner will not normally review our handling of your request unless
you have first contacted us to conduct an internal review. The Information
Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely,

MHRA Customer Experience Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000

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Internal Review of FOI 22/912

Dear D Jackson,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/912. We normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.  

Kind Regards  

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf,
London E14 4PU
Telephone 020 3080 6000

show quoted sections

Internal Review of FOI 22/912

Dear D Jackson,

Thank you for your email.

Please find attached the response and attached document to your Internal Review request.

Kind Regards

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

show quoted sections