EMA QA Document for the Implementation of the Variations Guidelines

Recommendation

6/7 September 2022

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

The European Medicines Agency (EMA) has published a document with practical questions and answers to support the implementation of the variations guidelines in the centralised procedure. The Q&A Document provides practical considerations concerning the implementation of the various categories of variations, on the operation of the respective procedures and on the documentation to be submitted pursuant to those procedures (the 'variations guidelines')

The questions are organised into the following themes:

• general consideration
• new classification category C.1.11
• new classification category C.1.13
• impact on post-authorisation measure (PAM) submissions
• revised classification category C.I.8
• new classification category A.8

Source: EMA/427505/2013 Rev.1