For these reasons the Court of Justice (Fourth Chamber) has ruled in favor of justice:
Articles 34 and 36 TFEU are to be interpreted in such a way that they preclude the competent authority of a member state from approving changes to the information and documents relating to a medicinal product that is authorized in another member state and a parallel import authorization for the former Member State rejects the only reason that the reference authorization in that Member State has expired and that the proposed changes are based both on the information on the parallel-imported medicinal product authorized in the other Member State and on the information on a medicinal product with the same therapeutic indication which is authorized in the two Member States concerned and which is essentially manufactured with the same active substance but in a different pharmaceutical form,if the parallel import authorization in question is still valid and there are no sufficient indications of a risk to the effective protection of human life and health.
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