Subsection 3: Hospital prescription medicines

Classification as a hospital prescription-only medicinal product may only take place if the restrictions placed on the prescription of the medicinal product are justified by the need to carry out the diagnosis and monitoring of the diseases for the treatment of which the medicinal product is normally used in establishments with suitable facilities, or by its pharmacological characteristics, its degree of innovation, or another public health reason.

Classification in the category of medicinal products subject to hospital prescription means that the medicinal product may only be prescribed : 1° To a doctor, dental surgeon or midwife who meets the conditions laid down in Book I of Part IV of this Code, as well as in I of Article 60 of Law no. 99-641 of 27 July 1999 creating universal health cover, and who is practising in a…

The marketing authorisation, the early access authorisation under 1° of II of article L. 5121-12 or the compassionate access authorisation under II of article L. 5121-12-1 or the compassionate prescription framework under III of article L. 5121-12-1 or the import authorisation for the medicinal product may reserve its prescription to the doctors mentioned in article R. 5121-85 who hold a qualification recognised under the conditions set out in article R….