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Re: Steady_T post# 671326

Monday, 02/12/2024 11:59:26 AM

Monday, February 12, 2024 11:59:26 AM

Post# of 700135
It's good to be sure. Usually "days" is total number of days and "Business Days" is the work days excluding weekends and holidays. Do you have a definition or link where there is a specific explanation of the meaning of "days" for that timeline? Or are you just speculating on weekends and holidays?

And just to be sure, I further put the question to ChatGPT. I do not have a relevant FAQ that specifies otherwise though I did look for one. If you have one, that would be great. But otherwise I would take "days" to mean actual days, not business days.

https://chat.openai.com/share/ef2b354e-8772-4804-9800-37833ec67f05

Answer:

The term "days" mentioned in the MHRA (Medicines Healthcare Products Regulatory Agency) timelines for assessment, such as the "150-day assessment timeline," refers to calendar days unless specifically stated otherwise. Generally, in regulatory contexts, "days" without any qualification tends to mean calendar days, which includes all days of the week, weekends, and public holidays.

When agencies or organizations specify "business days," they explicitly exclude weekends and public holidays from their calculations. Since the MHRA guidance does not specify "business days" but just "days," it is reasonable to interpret this as calendar days. This interpretation means that the 150-day timeline includes all consecutive days from the date of submission of a valid application.

However, for absolute clarity, especially in contexts where timing is critical for regulatory submissions and planning, it's advisable to directly confirm with the MHRA or consult the detailed guidance documents they provide. Regulatory bodies often have FAQs or guidance documents that clarify such terms, or they can be directly contacted for clarification to ensure compliance and proper planning.

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