FOI release

Freedom of Information request (FOI 22/1198 & FOI 22/1199 )

Published 17 January 2024

FOI 22/1198 and FOI 22/1199

28th December 2022

Dear

Thank you for your information requests dated 16 December 2022 where you asked for the following information:

“Please could you provide me with all MHRA inspection reports and correspondence, including details of action plans, with ITH Pharma Ltd between the period of 1st January 2014 and 31st December 2019.”

“Under Freedom of Information regulations could you please provide me with the investigation report and findings that was conducted on ITH Pharma and the supply of contaminated Total Parenteral Nutrition on 27th May 2014.

Please could you provide methodology, results, conclusions and recommendations.”

Whilst we initially treated these as two separate requests, your two requests were received on the same day and relate to the same subject. We are therefore treating as one request as we are entitled to do under the Freedom of Information Act. We have determined that the information you have requested is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further.

Section 12 of the Act 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.

In order for us to consider your request we recommend you consider reducing the date range, or reducing the amount of different documentation that you are requesting. We will be happy to consider any new request which you submit.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this 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 Service Centre