French Public Health Code
In forceI.- Clinical trials of medicinal products are governed by the provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014.
The competent authority for carrying out the assessment of Part I of the assessment report provided for in Article 6 of this Regulation is the National Agency for the Safety of Medicines and Health Products.
The assessment of Part II provided for in Article 7 of this Regulation is the responsibility of the Committees for the Protection of Individuals mentioned in Articles L. 1123-1 and L. 1123-16.
The Agence nationale de sécurité du médicament et des produits de santé notifies the sponsor of the single decision relating to the clinical trial mentioned in paragraph 1 of article 8 of these regulations.
II - In the event of refusal to authorise a trial as provided for in paragraph 4 of article 8 of the aforementioned regulation, the sponsor may submit a request for re-examination to the following authorities:
1° The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), when this request concerns elements falling under part I provided for in article 6 of the above-mentioned regulation;
2° The Minister for Health when this request relates to elements covered by part II as provided for in article 7 of the above-mentioned regulation.
The request for re-examination is submitted and investigated within the time limits and in accordance with the procedures laid down by decree in the Conseil d'Etat.
III - The first administration of a medicinal product to humans may only be carried out in sites which have been authorised in accordance with the second paragraph ofarticle L. 1121-13.
Clinical trials of advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 and clinical trials of advanced therapy medicinal products as defined in 17° of Article L. 5121-1 may only be carried out in health establishments, at the Établissement français du sang, in army hospitals or other elements of the army health service mentioned in Article L. 6147-7 or at the Institution nationale des invalides.
IV - The provisions of this chapter and the provisions of articles L. 1121-10, L. 1121-11, L. 1121-13, L. 1121-14, L. 1121-16, L. 1121-16-1, L. 1123-10, L. 1128-1 to L. 1128-12, L. 5121-1-1, L. 5125-1 and L. 5126-1 apply to the clinical trials mentioned in I. These tests are prohibited on a person who is not affiliated to a social security scheme or a beneficiary of such a scheme.
They are also subject to the provisions of 1° of article 76 of law no. 78-17 of 6 January 1978, as amended, relating to information technology and civil liberties.
