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Zadie420

04/16/24 11:31 AM

#685471 RE: StonkMaster #685467

My estimate for approval is sometimes by third week of May or early part of June if no RFI needed. If it happens earlier, then I am wrong in a good way.

Lykiri

04/16/24 12:16 PM

#685493 RE: StonkMaster #685467

I'm still waiting to hear back on my FOIR for the March CHM meeting minutes. Should be by end of this week. Don't anticipate it will reveal much but we'll see.


I agree.

Commission On Human Medicines
Question for Department of Health and Social Care
UIN 190785, tabled on 22 June 2023

Answered by Department of Health and Social Care on 29 June 2023

The role of CHM is to provide the Licensing Authority with independent advice on the safety, efficacy and quality of medicinal products. It is the role of the Licensing Authority, on behalf of Secretary of State, to take a final decision to grant a marketing authorisation for a medicinal product. Following this decision a Public Assessment Report (PAR), containing the non-confidential parts of the MHRA’s assessment, is published on the MHRA website.

CHM discuss high number of products and applications at each of their meetings. Information withheld under Section 43 of the Freedom of Information (FOI) Act is withheld because the information is either (1) a trade secret; (2) would likely prejudice the commercial interests of any legal person. There is no time limit after which this information can be released, moreover, any consideration of its release would be made by consideration of whether the public interest in releasing outweighs any commercial harm that could be caused by its release. More information on Section 43 of the FOI Act is available from the Information Commissioner’s Office.


https://questions-statements.parliament.uk/written-questions/detail/2023-06-22/190785/#