CRED Managing Variations Effectively

Practical Aspects of Submission: Application Form Electronic application form is mandatory for applications via all procedures (Centralised, MRP/DCP and National)

Important Notes • Use a valid version of the form (there are frequent updates!) • Check how the electronic application form can be managed in publishing software • TIP: Once ‘signed’, the form is locked. Take a copy prior to Signature in case changes are needed later! • Guidance available: • Questions and answers relating to practical and technical aspects of the Electronic Application Forms (Human and Veterinary), June 2016 - EMA/167541/2016 • Practical User Guide for Electronic Application Forms (eAF) for human and veterinary medicinal products in the EU. Version 1.6, December 2017 • EMA/CMDh Explanatory Notes On Variation Application Form (Human medicinal products only) CMDh/EMA/133/2010/Rev.7 - Dec 2014 • European Medicines Agency practical guidance on the application form for centralised type IA and IB variations EMA/233564/2014 Rev.2 – June 2017