Module 1 2021

30/06/2021

Statistics –CMDh 2020

CMDh statistics (hma.eu)

The Organisation for Professionals in Regulatory Affairs

47

Recommended references

 www.ema.europa.eu ● Marketing Authorisation: Pre-authorisation Guidance Q&A ● Research & Development: scientific guidelines  ec.europa.eu/health/documents/eudralex/ ● The rules governing medicinal product in the EU; – Volume 2, Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use  www.hma.eu/ ● Heads of Medicines Agency  http://www.hma.eu/cmdh.html ● CMDh website

The Organisation for Professionals in Regulatory Affairs

48

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