FOI release

Freedom of Information request on Project Orbis (FOI 21/704)

Published 29 December 2021

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21st July 2021 FOI 21/704

Dear Regarding your request that was received by MHRA on 23 June 2021, please see the MHRA’s response to each of your questions below:

  1. Any official documents (memorandum of understanding / contract / statement of obligations) that MHRA/UK Government were required to sign in order to join Project Orbis? MHRA were not required to sign any official documents in order to join Project Orbis.

  2. What criteria MHRA/UK Government were required to meet in order to join Project Orbis? MHRA were not required to meet any criteria in order to join Project Orbis.

  3. What financial/resource commitment MHRA/UK Government were required to make in order to join Project Orbis? There was no obligation for Orbis partners to participate in each product/variation going through Project Orbis. It is up to each regulatory authority if they wish to participate in each product licence or variation submitted through Project Orbis.

  4. Whether MHRA/UK Government have any future obligations when it comes to financial commitment and participation in Project Orbis? There are no future obligations regarding financial commitments or participation requited for Project Orbis. There is no obligation by individual regulatory authorities to participate in every product or variation going through Orbis.

The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-reuse-mhra-information

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: [email protected]

Yours sincerely,

MHRA Customer Service Centre

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