Pfizer BNT162b2 conditions of authorisation
Dear Medicines and Healthcare Products Regulatory Agency,
Please could you confirm whether Pfizer Vaccine BNT162b2 complied with the CONDITIONS OF AUTHORISATION UNDER REGULATION 174 in full?
Yes or no.
Please provide evidence that each of the requirements outlined in this document https://www.gov.uk/government/publicatio... was compiled with.
Yours faithfully,
Alex Hicks
Our Ref: FOI 23/150
Dear Alex Hicks,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 16th February 2023.
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 Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000
Our ref: FOI: 23/150
Dear Alex Hicks,
Thank you for your request under the Freedom of Information Act, we apologise for the delay in response.
We have reviewed your request and consider that Section 12 of the Freedom of Information Act applies. Section 12 allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information (which we consider applies to your second question, given the list on the website page (linked to below) runs to over 40 items).
In order for us to proceed we kindly ask for you to specify which of the conditions listed on the below webpage you would like us to provide evidence for:
https://www.gov.uk/government/publicatio...
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: [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
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
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 'Pfizer BNT162b2 conditions of authorisation'.
My 1st question has a simple yes or no answer, there is no reason this would cost £600.
If Pfizer had met all of the conditions of authorisation, this data would be readily available & it would not cost £600 to collate and therefore my request could be completed in full.
If it has not met the conditions it would be in the public interest for this information to be disclosed if the vaccine has been given full marketing approval, without fulfilling the conditions of the temporary authorisation.
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/p...
Yours faithfully,
Alex Hicks
Internal Review of FOI 23/150
Dear Alex Hicks,
Thank you for your email.
We confirm that an internal review will be carried out on FOI 23/150. 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
Dear Alex Hicks
Thank you for your email.
Because the list of conditions is expansive, assessing the relevant form
of evidence to meet each condition will require careful consideration, we
are extending the deadline by 20 working days to Monday, 7 August 2023.
This is as per the [1]ICO guidance on the time limits for internal
reviews.
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
Dear Alex Hicks,
Please find attached our response to your request for an Internal Review.
MHRA Customer Experience Centre
Communications and engagement
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
From: MHRA Customer Services <[1][email address]>
Sent: Monday, July 10, 2023 3:03 PM
To: Alex Hicks <[2][FOI #950255 email]>
Subject: RE: Internal Review of FOI 23/150 - Internal review of Freedom of
Information request - Pfizer BNT162b2 conditions of authorisation
Dear Alex Hicks
Thank you for your email.
Because the list of conditions is expansive, assessing the relevant form
of evidence to meet each condition will require careful consideration, we
are extending the deadline by 20 working days to Monday, 7 August 2023.
This is as per the [3]ICO guidance on the time limits for internal
reviews.
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
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