January 2023
Real Regulatory Tips and Insights

published 3 Feb 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 January 2023 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.


Importing investigational medicinal products (IMPs) into Great Britain from an approved country – end of transition period

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.


IRIS-Scientific Advice

From October 2020 it has been mandatory to use the IRIS platform when applying to the EMA for scientific advice. Applicants should be aware that, where they wish to apply for follow-up scientific advice and the original advice was given to a different organisation, that organisation needs to transfer the original procedure to the applicant. This is accomplished within IRIS using the process type ‘Transfer of Scientific Advice’; procedures occurring prior to October 2020 should be available for selection within IRIS.


Transferring a Research Product Identifier (RPI) in IRIS

For certain types of scientific procedures in the EMA’s IRIS portal, you first need to create an RPI for your research product. Remember that, if the product is subsequently transferred to a new sponsor/owner, you will also need to transfer the RPI to this organisation if they need to create new procedures based on the RPI – for example initial scientific advice or a new orphan designation. Full details are available in the IRIS guide to registration, available at:



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