COVID-19 Vaccine DAPs

Currently waiting for a response from Medicines and Healthcare products Regulatory Agency, they should respond promptly and normally no later than (details).

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

Thank you for your email.  This auto-response is to inform you that your
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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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protection rights, please see our three centres’ Privacy Notices: MHRA,
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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

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

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

show quoted sections

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...