23-25 April 2024
Barcelona, Spain
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:
Source: EMA/427505/2013 Rev.1