56Moreover, by virtue of Article 5(1) of Directive 2001/83, a Member State may, to fulfil special needs, exclude from the provisions of that directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under his direct personal responsibility. In that regard, the court has held that it is apparent from the conditions as a whole set out in that provision, read in the light of the fundamental objectives of that directive, and in particular the objective of seeking to safeguard public health, that the exception provided for in that provision can only concern situations in which the doctor considers that the state of health of his individual patients requires that a medicinal product be administered for which there is no authorised equivalent on the national market or which is unavailable on that market (see, to that effect, judgment in Commission v Poland, C‑185/10, EU:C:2012:181, paragraphs 29 and 36).
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