Bio

The request was partially successful.

Dear Medicines and Healthcare Products Regulatory Agency,

This is a request for information pursuant s.1 Freedom of Information Act 2000.

1. Please provide the information relevant to access biodistribution studies and related data for all COVID-19 vaccines currently granted MHRA Conditional Marketing Authorisation and/or any other form of approval used to treat and/or prevent SARS-CoV-2 and/or COVID-19.

We anticipate service by way of reply within 20 days or 1 calendar month.

Yours faithfully,

P Newton

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: P Newton
<[FOI #795052 email]> Sent: Thursday, September 23,
2021 11:56:00 PM To: MHRA Customer Services Subject: Freedom of
Information request - Bio Dear Medicines and Healthcare Products
Regulatory Agency, This is a request for information pursuant s.1 Freedom
of Information Act 2000. 1. Please provide the information relevant to
access biodistribution studies and related data for all COVID-19 vaccines
currently granted MHRA Conditional Marketing Authorisation and/or any
other form of approval used to treat and/or prevent SARS-CoV-2 and/or
COVID-19. We anticipate service by way of reply within 20 days or 1
calendar month. Yours faithfully, P Newton
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #795052 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://urldefense.proofpoint.com/v2/url...
Disclaimer: This message and any reply that you make will be published on
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https://urldefense.proofpoint.com/v2/url...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://urldefense.proofpoint.com/v2/url...
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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

 

 

Our Reference: CSC 68339

 

Dear P Newton,

 

Thank you for your email.

 

We have reviewed your enquiry and this has been passed on to our Licensing
experts.  

 

Should you have any other questions or requests please feel free to call
us on 0203 080 6000 or email at [1][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

[2]gov.uk/mhra

[3]Stay connected

 

For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: [4]MHRA,
[5]CPRD and [6]NIBSC

 

 

 

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear P Newton,

 

The Public Assessment Reports published by MHRA and EMA contain
information on the studies that have been conducted for the authorisation
of the vaccines.

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

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

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

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

[5]https://www.ema.europa.eu/en/medicines/h...

[6]https://www.ema.europa.eu/en/medicines/h...

[7]https://www.ema.europa.eu/en/medicines/h...

 

Original clinical data is available from the EMA database from the link
below

[8]https://clinicaldata.ema.europa.eu/web/cdp

 

Please note as this information is available in the public domain this has
not been treated as a Freedom of Information request.

 

Kind regards,

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 020 3080 6000

 

 

 

show quoted sections

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 'Bio’.

NOTICE OF COMPLAINT.

This is your notice of our complaint.

We asked to be provided specific information which we have not received.

1. Please provide the information relevant to access biodistribution studies and related data for all COVID-19 vaccines currently granted MHRA Conditional Marketing Authorisation and/or any other form of approval used to treat and/or prevent SARS-CoV-2 and/or COVID-19.

Some of the links provided return an error message.

1.1 Within the scope of this review, please focus on providing the information relevant to access the biodistribution studies.

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

Yours faithfully,

P Newton

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: P Newton
<[FOI #795052 email]> Sent: Sunday, October 3, 2021
11:46:09 PM To: MHRA Customer Services Subject: Internal review of Freedom
of Information request - Bio 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 'Bio’. NOTICE OF COMPLAINT. This is your notice of our complaint.
We asked to be provided specific information which we have not received.
1. Please provide the information relevant to access biodistribution
studies and related data for all COVID-19 vaccines currently granted MHRA
Conditional Marketing Authorisation and/or any other form of approval used
to treat and/or prevent SARS-CoV-2 and/or COVID-19. Some of the links
provided return an error message. 1.1 Within the scope of this review,
please focus on providing the information relevant to access the
biodistribution studies. A full history of my FOI request and all
correspondence is available on the Internet at this address:
https://eur01.safelinks.protection.outlo...
Yours faithfully, P Newton
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #795052 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

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: P Newton
<[FOI #795052 email]> Sent: Sunday, October 3, 2021
11:46:09 PM To: MHRA Customer Services Subject: Internal review of Freedom
of Information request - Bio 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 'Bio’. NOTICE OF COMPLAINT. This is your notice of our complaint.
We asked to be provided specific information which we have not received.
1. Please provide the information relevant to access biodistribution
studies and related data for all COVID-19 vaccines currently granted MHRA
Conditional Marketing Authorisation and/or any other form of approval used
to treat and/or prevent SARS-CoV-2 and/or COVID-19. Some of the links
provided return an error message. 1.1 Within the scope of this review,
please focus on providing the information relevant to access the
biodistribution studies. A full history of my FOI request and all
correspondence is available on the Internet at this address:
https://eur01.safelinks.protection.outlo...
Yours faithfully, P Newton
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #795052 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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear P Newton,

Thank you for your email.

Please could you inform me which of the links you were unable to access and I will seek to amend this?

As this request was not dealt with under a Freedom of Information request, we are not able to conduct an internal review, however I am happy to help you access the information you are seeking.

Kind regards,

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

show quoted sections

Dear MHRA Customer Services,

Thank you for your previous correspondence.

The only link which now does not appear to be working is link 1.

However, it is noted that none of the other links appear to allow access to the bio-distribution studies and neither has an explanation been provided for otherwise not allowing access.

Please attend to this particular point as our request only engaged this specific information, nothing more.

Yours sincerely,
P Newton

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: P Newton
<[FOI #795052 email]> Sent: Monday, October 11,
2021 8:26:19 PM To: MHRA Customer Services Subject: Re: CSC 68339 Internal
review of Freedom of Information request - Bio Dear MHRA Customer
Services, Thank you for your previous correspondence. The only link which
now does not appear to be working is link 1. However, it is noted that
none of the other links appear to allow access to the bio-distribution
studies and neither has an explanation been provided for otherwise not
allowing access. Please attend to this particular point as our request
only engaged this specific information, nothing more. Yours sincerely, P
Newton -----Original Message----- Dear P Newton, Thank you for your email.
Please could you inform me which of the links you were unable to access
and I will seek to amend this? As this request was not dealt with under a
Freedom of Information request, we are not able to conduct an internal
review, however I am happy to help you access the information you are
seeking. Kind regards, MHRA Customer Service Centre Medicines and
Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf,
London E14 4PU
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #795052 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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear P Newton,

Thank you for your email.

I apologise if they first link was not working for you. I have relinked this below.
https://www.gov.uk/government/publicatio...

The Public Assessment Reports which can be found within the links which have been sent to you previously contain details of the biodistribution studies.

Kind regards,

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

show quoted sections