Spring Intro 2023

Jenny Lamport

Module 3.2.S – Options

All relevant data in 3.2.S

Drug Master File ● Means of protecting confidential know how of third party manufacturer ● ‘Open’ part in 3.2.S ● ‘Open’ and ‘closed’ parts + QOS submitted to authorities by third party ● Letter of access ● Agreement to notify changes to MA holder

https://www.ema.europa.eu/en/active-substance-master file-procedure

The Organisation for Professionals in Regulatory Affairs

31

Module 3.2.S – Options

Certificate of Suitability ● Ph Eur drug substances ● 3.2.S + QOS submitted to EDQM – Evidence to show that the Ph Eur monograph can adequately control quality – Typically 12 month procedure – Certificate or Certificate Plus granted ● CEP referenced in Module 3 in lieu of data

EDQM = European Directorate for the Quality of Medicines & Healthcare

https://www.edqm.eu/en/certification

The Organisation for Professionals in Regulatory Affairs

32

16