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Tuesday, February 20, 2024 8:35:52 PM
I know we are waiting for the nod from the UK (NICE) but do we also have a submission for EU approval? The reason I bring this up is I was reading news about other drug companies and saw that Phizer received EU approval on a drug. Does EU approval carry over to the UK?
They have not filed in the EU as far as we know.
An EU (EMA) approval would served as the basis for a UK MHRA approval. Previously this was based on the "Reliance Procedure"
The MHRA introduced the European Commission Decision Reliance Procedure (ECDRP) which relied upon the completed EU assessment to issue an MA valid in GB only, within 67 calendar days of validation of the application.
and this year the "International Recognition Procedure" which is extended to approve in the UK based on approvals issued in some other countries (notably the FDA)
Does not go the other way though. That is why basically nobody goes to the UK first. Last year they approved a total of 7 new medicines that were not based on a EU approval.
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