FOI release

Freedom of Information request - Informed consent process for drugs under EUA

Some or all of the information requested may not have been provided because we determined that the request was vexatious.

Case reference FOI2024/00643

Received 22 October 2024

Published 22 November 2024

Request

Regarding FOI 22/602 https://www.whatdotheyknow.com/request/risk_management_did_mhra_request#incoming-2018600 A. With reference to MHRA's response to questions 3 and 4 - "It is a requirement for any company seeking authorisation of their medicinal product by MHRA to provide all data from clinical studies conducted/what was the response to the request (or what were the responses) from the vaccine manufacturers?" - can you: (i) provide the data submitted (ii) confirm whether MHRA assessed this data and how they went about it (eg, "A 6-person team of independent experienced industry professionals employed/contracted by MHRA assessed the data over a period of one month"), and (iii) provide MHRA's final assessment of the data. B. Can you confirm which informed consent protocols apply during the administration of EUA medicinal products? Are a differing set of protocols adhered to in such circumstances that deviate from the norm (BMA/GMC/Green Book Chapter 2, etc)?

Response

see attached

Documents

• FOI2024-00643 redacted for publication.pdf (165.3 KB)

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