Spring Intro 2023

03/03/2023

Summary of recommended references

● EMA Website (www.ema.europa.eu/) ● Heads of Agencies Website (http://www.hma.eu/)

● CMDh website (https://www.hma.eu/human-medicines/cmdh.html) ● Notice to Applicants Vol 2A Procedures for marketing authorisation https://health.ec.europa.eu/medicinal-products/eudralex/eudralex volume-2_en ● List of data requested by MSs that’s not in the legislation https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/pro cedural_guidance/Application_for_MA/CMDh_043_2007_Rev_18_2021_ 04_clean_-_Data_requested_for_New_Applications.pdf

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Future help and questions

If you need any help and advice ……. or have any questions

st@s-cubed.co.uk

The Organisation for Professionals in Regulatory Affairs

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