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Re: jesster64 post# 776311

Wednesday, 07/16/2025 4:50:37 PM

Wednesday, July 16, 2025 4:50:37 PM

Post# of 823002
MHRA response to several questions about info on their website and others.

"Thank you for you enquiry.
You can find the guidance for the approval process listed on this link:
https://www.gov.uk/guidance/national-assessment-procedure-for-medicines
Please note that:
We do not share updates of the applications externally.
We have a statute requirement to make determinations within 210 days which does not include periods where companies may request more time to answer questions.
We hope this information helps. Please do not hesitate to reach out to us if you have any further questions regarding this query.

Kind regards,
Angel
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, London E14 4PU
Telephone 020 3080 6000
gov.uk/mhra

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