Clarification from the EMA regarding variations for editorial changes and additional of new manufacturing sites

23 June, 2016

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:

  • Updated Q & A on Type IA variations (Link)
  • Updated Q & A on Type IB variations (Link)
  • Updated Q & A on Type II variations (Link)

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.

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