FOI release

Freedom of Information request on the number of fatal adverse reaction reports submitted to the MHRA for "Side effect to a medicine, vaccine, herbal or homeopathic remedy" since your records begin for the Isle of Man (Post codes IM1 - IM9)(FOI 21/1259)

Published 31 May 2022

FOI 21/1259

15th December 2021

Dear,

Thank you for your FOI request dated 8th December 2021, where you asked:

Please can you provide to me the number of fatal adverse reaction reports submitted to the MHRA for “Side effect to a medicine, vaccine, herbal or homeopathic remedy” since your records begin for the Isle of Man (Post codes IM1 - IM9), NOT including and Covid-19 vaccination reports.

Please could you also provide a summary of all the reports made under “Side effect to a medicine, vaccine, herbal or homeopathic remedy” since your records began for the Isle of Man (IM1 to IM9 post codes).

We 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.

As your request has been refused under Section 12 of the FOI Act, we cannot answer any part of it however we will be happy to provide a response to any refined request you send in the future. For example, you could refine your request by choosing specific products/ substances that you are interested in.

I hope this information is useful, but 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 of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division