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Therapeutic indication

Therapeutic indication

Deleting or adding a therapeutic indication for a medicinal product when the indication is patent-protected?

The marketing authorisation holder is responsible for determining whether, during the MRP/DCP process, a therapeutic indication was approved that is protected by a patent valid in Finland. The therapeutic indication and references to it can be deleted from national texts either during the national phase of the marketing authorisation application or a national type IB variation (subtype C.I.z). A therapeutic indication and references thereto that were deleted due to a patent can be added into national texts by means of a national type IB variation (subtype C.I.z).

21 Apr 2017
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