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Re: rosemountbomber post# 351675

Sunday, 08/22/2021 8:47:09 AM

Sunday, August 22, 2021 8:47:09 AM

Post# of 426623
To answer your first question: The exclusivity formula is 8 years + 2 years + 1 additional for each new indication.

first time New Drugs get 8 years
Generics can't be considered for two years after the 8 years expire.
1 year extra for each new indication

Your second question: The UK has agreed to adopt all the EMA rules and processes for two years beginning Dec. January 1, 2021.

https://remapconsulting.com/the-uk-will-follow-ema-regulatory-decisions-for-2-years-after-brexit-and-is-looking-to-speed-up-regulatory-access-in-the-longer-term/
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