CRED Managing Variations Effectively
Common deficiencies leading to rejections (2)
Regulatory • Change(s) do not apply to the entire bulk Change to the name of the FPM; however the site has different functions in some of the licences in the bulk; bulking is not applicable
CMDh Q&A
All changes in a grouped application according to article 7 of the Regulation (EC) 1234/2008 must apply to all the products that are listed in the application form. It is not allowed that single changes of this grouped application do only concern parts of the list of products.
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