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References

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Our Ref: FOI 18/232

Dear Mr Jason Evans,

Thank you for your enquiry which we received on 8 May 2018. Please note this request will be under FOI 18/232 along with attached email.

I confirm that your request is 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.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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Our reference: FOI 18/231 and 232

Dear Mr Evans,

Thank you for your emails of 8 May to the Agency and NIBSC in which you asked for information about files containing keywords relating to blood products and Factor VIII over the periods 1974-93 and 1976-86 respectively. Please note that NIBSC is one of the Agency’s centres and is not a separate public body for freedom of information purposes. As the Freedom of Information Act (FOIA) allows a public body to combine requests from a single requester, we have therefore considered both your requests together.

I can confirm that the MHRA does hold information relevant to your request.

However, we have also decided that the information is exempt from disclosure under Section 12 of the FOIA. Section 12 of the Act allows public authorities to refuse requests where the cost of complying 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.

To process your request, we would need to complete an Agency-wide review of all our files, and for all of your keywords. Additionally, due to the time period you have specified, any information we hold is most likely to be on paper and archived. This means it will have to be retrieved from our offsite archives and reviewed manually. We consider that this would take longer than 24 working hours to complete.

We advise that you narrow your request by, for example, significantly reducing the list of keywords and indicating if there is specific information about the products you wish to obtain.

Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that section 12 could still apply.

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] (quoting reference FOI 18/231 and 18/232).

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

If you have a query about the information provided, please reply to this email.

Yours sincerely,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]

Please note our London office will be moving in June. The new address will be:

10 South Colonnade, Canary Wharf, London E14 4PU

Please contact us nearer the time for precise dates as teams will move over a three week period.

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