Home › Forums › General Discussion › Zone 4 data applicable toward Zone 1 approval?

Viewing 1 post (of 1 total)
  • Author
    Posts
  • John O’Neill
    Moderator
    August 23, 2023 at 4:42 pm
    Post count: 73
    #24973

    Posted for an industry colleague.

    We are operating in a Zone IV A country and want to file and get approval for our product in the EU (Zone 1).
    We currently have extensive stability data at Zone IVA (product approved in countries in the same Zone). Can we use this data to support approval in Zone 1 (since Zone 1 is less restrictive and contained within Zone IVA)?

  • Author
    Posts
Viewing 1 post (of 1 total)
  • You must be logged in to reply to this topic.