FOI release

Freedom of Information request (FOI 22/827)

Published 17 January 2024

15th August 2022

FOI 22/827

Dear

Thank you for your email.

I can confirm that the MHRA does hold some of the information that you have requested. However, we have also determined that the information 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 your request you state:

Is the MHRA discussing changes to policy and/or the implementation of existing or future policy? That includes internal discussions, advice provided to other people and bodies not part of the MHRA, requests made to the MHRA, and all other ways in which the MHRA could or would be involved in any future changes. And I include communications outside the UK such as, for one example, with the European Medicines Agency.

We have highlighted one part of this in bold text. Our interpretation of this is that we would need to locate and review any information we hold where someone outside the MHRA has made any reference to the importation of medicine. We would then, having located and extracted that information, need to review, and assess whether there is anything within that information that could fall within the scope of your request. Our assessment is that we are going to hold a significant amount of information which refers to terms such as ‘import’, ‘importation’ etc. That is before we consider other ways that individuals may phrase this type of importation (though not intended as an exhaustive list, some examples could include “bring in / bring back” “have sent to me from”).

As such, we consider that we have been able to demonstrate that dealing with your request would exceed the appropriate limits set out above.

Therefore, we ask that you refine your request by a timescale and a focus on specific information for example, internal discussion and/or exchanges with other bodies

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

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

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