Classification in the category of medicinal products subject to initial hospital prescription has the following effects: 1° The initial prescription of the medicinal product is reserved : a) 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…
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. 5121-88 who hold a qualification recognised under the conditions set out in article R….
A medicinal product may only be classified as a prescription-only medicine if the restrictions on prescribing are justified by the constraints involved in implementing the treatment, having regard to the specific nature of the pathology and the pharmacological characteristics of the medicinal product, its degree of innovation, or another public health reason.
Classification in the category of medicinal products for which prescription is reserved for certain specialist doctors has the following effects: 1° The prescription or initial prescription of the medicinal product is reserved for doctors who have been awarded a specialist qualification under the conditions set out in decree no. 2004-252 of 19 March 2004 relating to the conditions under which doctors of medicine may obtain a specialist qualification; 2° In…
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, depending on its characteristics, set a time limit after which the initial prescription lapses and may no longer be renewed by persons other than…
Classification as a medicinal product requiring special monitoring during treatment can only be made if the restrictions on prescribing the medicinal product are justified by the seriousness of the undesirable effects that its use may cause.
The classification of a medicinal product in the category of medicinal products requiring special monitoring during treatment has the effect of making its prescription subject to periodic examinations which the patient must undergo.
The marketing authorisation, the early access authorisation pursuant to 1° of II of article L. 5121-12 or the compassionate access authorisation pursuant to II of article L. 5121-12-1 or the compassionate prescription framework pursuant to III of article L. 5121-12-1 or the import authorisation for the medicinal product classified in the category of medicinal products requiring special monitoring during treatment indicates the nature and frequency of the examinations which the…
Doctors, dental surgeons or midwives who do not practice in an establishment, service or centre mentioned in article R. 5121-88 or who do not meet the conditions set out in article R. 5121-91 may be authorised to administer themselves certain medicinal products classified in one of the categories mentioned in 1°, 2°, 3° or 4° of article R. 5121-77. This authorisation is only valid in cases where they intervene in…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall register the homeopathic medicinal products referred to in Article L. 5121-13 and the traditional herbal medicinal products referred to in Article L. 5121-14-1 on the basis of an application accompanied by a dossier submitted and examined under the conditions defined in this section.
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75001, Paris France
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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