Dear Medicines and Healthcare products Regulatory Agency,

Please release documentation that led to the format change on the COVID-19 vaccine DAPs from a pdf file with the ADRs in tables to one where the ADR tables are images, which are not (easily) machine searchable.

Please also release all information leading to the decision not to publish an iDAP for these products.

Yours faithfully,

Matt Cooper

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
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The UK has left the EU, and the transition period ends on 31 December
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References

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/620
       
Dear Matt Cooper,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 4 June 2021.
  
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

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Dear MHRA Customer Services,

I have noticed the pdf file DAP does contain text and is the same as older DAPs, so the first request can be disregarded. Apologies for any inconvenience this may have caused.

I would still like the information used to decide not to make iDAPs for these products.

Yours sincerely,

Matt Cooper

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. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...

Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

Dear Mr Cooper,

Thank you for your emails of 4th June. We can confirm that we intend to publish all suspected reactions reported in association with available COVID-19 vaccines in an interactive format as iDAPs, along with our ADR summary that is published each week. The use of iDAPs will enable users to view the data by categories of their choice such as age, sex and seriousness of reports. Users will also be able to download the data tables in CSV format. We would be happy to provide you with a link to this when it is published.

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

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Dear Medicines and Healthcare Products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare Products Regulatory Agency's handling of my FOI request 'COVID-19 Vaccine DAPs'.

I requested documentation which led to the decision not to make the COVID-19 vaccine ADRs available as iDAPs, which you are likely to hold.

The response contained no documentation which led to this decision to not publish or delay publication of the iDAPs.

There was however, a reply stating that iDAPs will be available in the future, which I understand would make the iDAP itself exempt from publication under FOI, however this is not what I requested.

Can you provide any advice as to when the iDAPs are due to go live and whether the team working on this project are on target to complete it by that date or whether they are ahead or behind schedule?

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/c...

Yours faithfully,

Matt Cooper

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. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 21/620

Dear Matt Cooper,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 21/620. 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 Service Centre

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

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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

2 Attachments

Dear Mr Cooper,

Please find attached the response to your FOI internal review 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

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Dear Medicines and Healthcare Products Regulatory Agency,

Relating to the internal review received for this FOI, can you confirm which part(s) of Section 35 have been invoked?

Yours faithfully,

Matt Cooper

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. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Reference: CSC 64082

Dear Matt Cooper,

Thank you for your email.

We have reviewed your enquiry and this has been passed on to our Vigilance Risk Management of Medicines experts.

Should you have any other questions or requests please feel free to call us on 0203 080 6000 or email at [MHRA request email]

Our opening hours are Mon – Fri 9am to 5pm (excluding UK Public Holidays)
Kind regards
 
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000

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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

Dear Mr Cooper,

 

The exemption cited is 35(1)(a) and in deciding that this was relevant we
took into account that releasing the information prematurely could impact
adversely on the policy around the wider government vaccine campaign as
the information may be misused once in the public domain by those who do
not agree with vaccination in general.

 

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

 

 

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