eSubmission updates: v1.20 electronic application forms released, but issues found with variation form

21 June, 2016

The EMA has released v1.20 of the electronic application forms as of 14 June 2016, but it has since been discovered that the variations form has issues relating to its use for MRP / DCP. Full details and the updated forms can be found on the eSubmissions website (Link).

Business Units: 

Regulatory Outsourcing Options

Cyton’s dedicated regulatory procedures team can support you with:
 - Dossier preparation, submission & regulatory procedures
 - Regulatory intelligence and strategic planning
 - Life cycle management
 - Key person cover
 - Pharmacovigilance
 - Brexit support services