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

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  • John O’Neill
    Post count: 75

    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)?

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