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Post# of 699195
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flipper44

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Re: Doc logic post# 568549

Friday, 02/17/2023 7:20:53 AM

Friday, February 17, 2023 7:20:53 AM

Post# of 699195
Regarding that paragraph, I have messaged the MHRA asking them to further define, via a response, what they mean when they state “the product is in the process of being approved.” I also questioned, regarding the new rolling review, what impact RR might have on this definition.

For your convenience, the passage under question is reprinted below.

Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved. https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
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