COVID-19 Adverse Reaction procedures, policies and templates

The request was partially successful.

Dear MHRA,

Please provide the following in relation to COVID-19 vaccines:

- Procedures and policies relevant to the investigation of adverse reactions reported to the MHRA.

- Templates used for reporting adverse reaction data and investigations of adverse reactions to stakeholders.

Yours faithfully,

D Jackson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: D Jackson <[FOI #820353
email]> Sent: Thursday, January 6, 2022 7:38:58 PM To: MHRA Customer
Services Subject: Freedom of Information request - COVID-19 Adverse
Reaction procedures, policies and templates Dear MHRA, Please provide the
following in relation to COVID-19 vaccines: - Procedures and policies
relevant to the investigation of adverse reactions reported to the MHRA. -
Templates used for reporting adverse reaction data and investigations of
adverse reactions to stakeholders. Yours faithfully, D Jackson
------------------------------------------------------------------- Please
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 22/021

Dear D Jackson,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 7th January 2022.

I 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 Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000

show quoted sections

Dear MHRA Customer Services,

Please provide an update on my request.

Yours sincerely,

D Jackson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: D Jackson <[FOI #820353
email]> Sent: Friday, February 4, 2022 1:07:23 PM To: MHRA Customer
Services Subject: Re: FOI 22/021 - RE: Freedom of Information request -
COVID-19 Adverse Reaction procedures, policies and templates Dear MHRA
Customer Services, Please provide an update on my request. Yours
sincerely, D Jackson -----Original Message----- Our Ref: FOI 22/021 Dear D
Jackson, RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000 Thank you
for your enquiry which we received on 7th January 2022. I 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://eur01.safelinks.protection.outlo...
Kind Regards, MHRA Customer Service Centre Medicines and Healthcare
products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14
4PU Telephone 0203 080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #820353
email] Disclaimer: This message and any reply that you make will be
published on the internet. Our privacy and copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
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.

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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Sir/ Madam,

Please find attached the response to your FOI request.

Kind regards,

FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Dear Pharmacovigilanceservice,

Thank you for the response. With regards to my first question:

"Procedures and policies relevant to the investigation of adverse reactions reported to the MHRA."

This question is relevant to workplace procedures and policies. However, no documents of this type have been provided. The links I have been referred to provide higher level descriptions of a broader process.

Such workplace documentation might contain, for example: responsibilities, reporting requirements, sign-off's required, documentation to be completed, data handling policies, policies on contacting companies, patients, relatives etc.

In relation to my second question:

"Templates used for reporting adverse reaction data and investigations of adverse reactions to stakeholders."

This has been more broadly interpreted as "how the MHRA communicates with stakeholders". Does the MHRA use any document templates e.g. Excel, Word, Powerpoint, database reports etc. to provide reporting in a standard format to stakeholders? If so, please provide those templates.

Please conduct an internal review of my request as I do not think I have received all of the information I have requested.

Yours sincerely,

D Jackson

Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.
 
The Pharmacovigilance Service Team will aim to provide a response to your
query within seven working days – however where a contribution from a
specialist is required this may take longer; we endeavour to respond to
all requests within ten working days.
 
If you have not received a response within 10 working days, please feel
free to follow up via email.
 
If you are unsatisfied with the handling of your request, or for any
urgent matters, please contact the Service Team Manager Faiza Farooq on
0203 080 6511
 
All information provided is handled in line with our privacy policy, which
can be viewed on our website at
https://www.gov.uk/government/publicatio....
 
Kind Regards,
Pharmacovigilance Service Team
Vigilance and Risk Management of Medicines
MHRA
10 South Colonnade
Canary Wharf
London
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 22/021

Dear D Jackson,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/021. 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

Dear MHRA Customer Services,

Please provide an update to my request for an internal review.

Yours sincerely,

D Jackson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: D Jackson <[FOI #820353
email]> Sent: Sunday, April 3, 2022 1:01:32 PM To: MHRA Customer Services
Subject: Re: Internal Review of FOI 22/021 - RE: Internal review of
Freedom of Information request - COVID-19 Adverse Reaction procedures,
policies and templates Dear MHRA Customer Services, Please provide an
update to my request for an internal review. Yours sincerely, D Jackson
-----Original Message----- Internal Review of FOI 22/021 Dear D Jackson,
Thank you for your email. We confirm that an internal review will be
carried out on FOI 22/021. 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
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #820353
email] Disclaimer: This message and any reply that you make will be
published on the internet. Our privacy and copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
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

D Jackson left an annotation ()

IC-165697-H8S8

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

2 Attachments

Internal Review of FOI 22/021

Dear Mr Jackson

Thank you for your email.

Please find attached the response to your Internal request for FOI 22/021.

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 0203 080 6000

show quoted sections

Dear MHRA Customer Services,

Thank you for providing the document detailing the current approach.

Although having the current approach is informative, my request was made on 6th January 2022. It seems reasonable that I am provided the documented approach that existed at the time of my request. I assume these are controlled documents and a version of the MHRA approach from January will still be available?

I therefore do not think I have been provided with all of the information I have requested. If you can provide documentation from January, or confirm you are unable to do so, that would be very helpful.

Yours sincerely,

D Jackson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: D Jackson <[FOI #820353
email]> Sent: Thursday, August 11, 2022 3:33:25 PM To: MHRA Customer
Services Subject: RE: Internal Review of FOI 22/021 -IC-165697-H8S8 RE:
Internal review of Freedom of Information request Dear MHRA Customer
Services, Thank you for providing the document detailing the current
approach. Although having the current approach is informative, my request
was made on 6th January 2022. It seems reasonable that I am provided the
documented approach that existed at the time of my request. I assume these
are controlled documents and a version of the MHRA approach from January
will still be available? I therefore do not think I have been provided
with all of the information I have requested. If you can provide
documentation from January, or confirm you are unable to do so, that would
be very helpful. Yours sincerely, D Jackson

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Reference: CEC 112280

Dear Mr Jackson,

Thank you for your email.

We have redirected your query to the relevant team for further input.

Should you require any further advice or assistance on this matter please feel free to call us on 020 3080 6000 or reply to this email.

Our opening hours are Mon - Fri 9am to 5pm (excluding UK Public Holidays)

With 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
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data protection rights, please see our three centres' Privacy Notices: MHRA, CPRD and NIBSC.

Read our guidance on coronavirus (COVID-19)

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

CEC 112280

Dear Mr Jackson,

Thank you for your email.

It was thought helpful to provide the most up to date version, however, as requested, please find the version that was current at the time of the 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 0203 080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

MHRA Customer Services would like to recall the message, "CEC 112280 - RE: Internal Review of FOI 22/021 -IC-165697-H8S8 RE: Internal review of Freedom of Information request".

DISCLAIMER This email and any files transmitted with it are confidential. If you are not the intended recipient, any reading, printing, storage, disclosure, copying or any other action taken in respect of this email is prohibited and may be unlawful. If you are not the intended recipient, please notify the sender immediately by using the reply function and then permanently delete what you have received. Incoming and outgoing email messages are routinely monitored for compliance with the Department of Health's policy on the use of electronic communications. For more information on the Department of Health's email policy, click DHTermsAndConditions<https://www.gov.uk/help/terms-conditions>

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

CEC 112280

Dear Mr Jackson,

Thank you for your email.

As requested, please find the version that was current at the time of the request. Some names in the document have been redacted under Section 40 of the FOI act. Section 40 protects personal data, the disclosure of which would breach one or more of the data protection principles. The Agency is satisfied that disclosure here would breach the first data protection principle, in particular the requirement of fairness on the basis that disclosure would not be reasonably expected by the people mentioned in the information.

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 0203 080 6000

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WhatDoTheyKnow left an annotation ()

We have taken action to redact some accidentally released personal information that was included in the response received from MHRA on 11 August. Our ref [GDPR/BR/20220812-1]

WhatDoTheyKnow team

WhatDoTheyKnow left an annotation ()

On the 10th of October 2022 further action was taken to remove additional personal information from responses on this thread.

One of the consequences of the redactions which have taken place has been to remove the names of those identified as:

(AZ Lead)
(Moderna Lead)

and due to unavoidable collateral impact when a further name was removed the identification of one further meeting attendee as "Pfizer Lead" was also lost.

When the names of the individuals in these roles was present it was possible determine that they appeared to be Medicines and Healthcare Products Regulatory Agency staff rather than representatives of the companies.