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Post# of 818099
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Lykiri

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Lykiri

Re: FeMike post# 428113

Monday, 12/20/2021 5:28:01 PM

Monday, December 20, 2021 5:28:01 PM

Post# of 818099

This is not a certification specifically to produce DCvax.



Femike,

Wrong.

It is a certification specifically to produce DCVax products.

2. Know your limits

The activities you are requesting to be included on the licence application or variation should reflect current reality and not future aspirations! The Inspector will expect to see that you have the necessary procedures, control systems, equipment and expertise to support the range of products and activities you are proposing to include on the licence.

Activities that you do not have capability to perform will need to be removed from the application before it can be approved. Such changes create extra work and result in delays in processing applications.
https://mhrainspectorate.blog.gov.uk/2017/01/05/helping-us-to-help-you/

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