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Posted On: 10/27/2020 7:17:19 PM
Post# of 148902
After some research, I believe this is the webpage with Information regarding a drug approval in the U.K. There are a number of avenues to get a drug approved in the U.K and/or in the EU:
Decentralized procedure (DCP) if you want to market the medicine in the UK and other named EU countries (The UK can only be a CMS during the transition period). The procedure takes up to 210 days, excluding time taken to provide further information or data required.
National procedure if you want to market a medicine only in the U.K. The application process takes up to 210 days, excluding time taken to provide further information or data required.
Centralized procedure to market certain types of medicines throughout the EU only. Centralised licences are granted by the EMA. Find more information on the EMA website. No timeline given.
https://www.gov.uk/guidance/apply-for-a-licen...he-uk#fees
IMO, I’m assuming they’d apply the DCP route as that could get approval for the U.K. and the EU. Yes, it takes longer, but that’s a big market and worth the wait.
Decentralized procedure (DCP) if you want to market the medicine in the UK and other named EU countries (The UK can only be a CMS during the transition period). The procedure takes up to 210 days, excluding time taken to provide further information or data required.
National procedure if you want to market a medicine only in the U.K. The application process takes up to 210 days, excluding time taken to provide further information or data required.
Centralized procedure to market certain types of medicines throughout the EU only. Centralised licences are granted by the EMA. Find more information on the EMA website. No timeline given.
https://www.gov.uk/guidance/apply-for-a-licen...he-uk#fees
IMO, I’m assuming they’d apply the DCP route as that could get approval for the U.K. and the EU. Yes, it takes longer, but that’s a big market and worth the wait.
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