Named patient use

Supply of a medicinal product which is excluded by a Member State from the provisions of Directive 2001/83/EC, in accordance with legislation in force and to fulfil special needs, 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 [based on DIR 2001/83/EC Art 5(1)].