December 2022
Real Regulatory Tips and Insights

published 4 Jan 2023

Please find below a roundup of our weekly Regulatory Tips and Insights from our Regulatory experts on our Real Regulatory LinkedIn page. The tips we published in December 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.


MA Holder & Delegated Activities

Remember that the holder of an MA, as the person or entity responsible for placing a product on the market, bears the legal responsibility for that product and this cannot be delegated. Where activities such as manufacture are conducted by third parties, an MAH must ensure that they have - and can demonstrate - adequate oversight of these activities.


Questions & Commitments from Prior Submissions

For amendments to CTAs and variations to MAs, it’s always worth checking prior submissions for questions or commitments relevant to the current submission. For example, an updated investigator's brochure should always incorporate any comments made by authorities on the previous version, or the comments may be raised as questions or findings on the updated version.


EMA QRD Guidance Documents

If you are preparing documents using the EMA QRD templates, remember that there are reference documents available concerning formatting conventions, use of abbreviations, past QRD recommendations etc. These can be found on the EMA website at:


EMA Christmas Closure

EMA Christmas Closure The EMA will close for Christmas from 23rd Dec 2022 – 3rd Jan 2023




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