Updated guidance on variations has been published by the EMA, clarifying what can be considered an editorial change and how can it be submitted as part of a variation:
The updated Q & A on Type II variations also includes new guidance on what can be submitted under a single Type II variation with respect to introduction of a new manufacturing site.
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