46It should be borne in mind in that regard that Article 5(1) of Directive 2001/83 is a specific derogating provision, which must be interpreted strictly, applicable in exceptional cases where it is appropriate to meet special medical needs, in circumstances in which a doctor, following an actual examination of his patients and on the basis of purely therapeutic considerations, prescribes a medicinal product which does not have a valid marketing authorisation in the European Union and for which there is no authorised equivalent on the national market or which is unavailable on that market (see, to that effect, Case C-185/10 Commission v Poland [2012] ECR, paragraphs 35, 36 and 48). The Court pointed out in particular, in paragraph 37 of that judgment, that Article 5(1) cannot be relied on where medicinal products having the same active substances, the same dosage and the same form as those which the doctor providing treatment considers that he must prescribe to treat his patients are already authorised and available on the national market.
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