Chapter I: General provisions.

The procedures for applying this chapter are determined by decree in the Conseil d'Etat, and in particular :

1° The scientific criteria justifying, where appropriate, exemption from bioavailability studies for generic proprietary medicinal products as defined in 5° of Article L. 5121-1, the procedure for inclusion in the register of generic groups referred to in Article L. 5121-10, as well as the procedures for inclusion in an existing generic group of a proprietary medicinal product meeting the condition for being a reference proprietary medicinal product and for the creation of generic groups in the absence of a reference proprietary medicinal product ;

2° The conditions under which marketing authorisations may be considered as part of a global marketing authorisation;

3° The rules relating to the labelling, packaging, package leaflet and name of the medicinal products and products mentioned in this chapter;

4° The procedures for submitting applications for the marketing authorisation provided for in article L. 5121-8, the content of the dossier submitted in support of these applications, the conditions under which the applicant may be exempted from producing certain elements of the dossier and the conditions for decisions granting, modifying, renewing, suspending or withdrawing these authorisations as well as, after the authorisation has been granted, the procedures for updating it;

5° The justifications, including those relating to the labelling of medicinal products or products, which must be provided in support of applications for marketing authorisation and which must include verification of the existence of the properties defined in article L. 5121-9 by experts with the technical and professional qualifications laid down by the same decree;

6° The procedures for submitting applications to obtain the registration of homeopathic medicinal products provided for in article L. 5121-13, the content of the dossier submitted in support of these applications, as well as the conditions under which decisions granting, amending, renewing, suspending or withdrawing these registrations are taken;

7° The conditions for marketing authorisation when the applicant can demonstrate that he is unable to provide complete information on the efficacy and safety of the medicinal product in accordance with the provisions of article L. 5121-9 ;

8° The procedures for submitting applications for the authorisations provided for in articles L. 5121-12 and L. 5121-12-1, the content of the dossier submitted in support of these applications, the conditions and procedures for granting, modifying, renewing, suspending or withdrawing these authorisations as well as the procedures for establishing, modifying, suspending and withdrawing the compassionate prescription frameworks provided for in article L. 5121-12-1;

9° The rules applicable to the testing of medicinal products with a view to their marketing authorisation as well as to trials organised after this authorisation has been granted;

10° The restrictions which may be imposed in the interests of public health on the prescription and supply of certain medicinal products;

11° The rules applicable in the event of a change in the holder of the marketing authorisation or the holder of the registration for a homeopathic medicinal product or the holder of the registration for a traditional herbal medicinal product;

12° The procedures for submitting applications to obtain the registration of traditional herbal medicinal products provided for in Article L. 5121-14-1, the content of the dossier submitted in support of these applications, as well as the conditions under which registration takes place and the decisions refusing, amending, renewing, suspending or withdrawing this registration;

13° The rules applicable to pharmacovigilance carried out on the medicinal products and products mentioned in article L. 5121-1, in particular the reporting obligations incumbent on members of the health professions and companies exploiting a medicinal product or a product subject to this Title, as well as the procedures for reporting adverse reactions carried out directly by patients or communicated by approved patients' associations;

14° Specific rules applicable to pharmacovigilance of blood-derived medicinal products and other medicinal products of human origin;

15° The prescribing procedures and the conditions for identifying medicinal products for which the conditional dispensing prescription mentioned in article L. 5121-12-1-1 may be used;

16° The specific rules applicable to pharmacological, toxicological and clinical trials of homeopathic medicinal products which are the subject of a marketing authorisation, taking into account the specific nature of homeopathic medicinal products and a use which is generally linked to tradition;

17° The conditions under which the Agence nationale de sécurité du médicament et des produits de santé issues, modifies, suspends or withdraws the authorisations referred to in 12° and 13° of Article L. 5121-1 relating to gene therapy preparations and xenogenic cell therapy preparations;

18° The conditions under which the Agence française de sécurité sanitaire des produits de santé issues, modifies, suspends or withdraws the authorisations for advanced therapy medicinal products referred to in 17° of Article L. 5121-1;

19° The procedure for inclusion in the reference list of similar biological groups mentioned in b of 15° of Article L. 5121-1 and in Article L. 5121-10-2, as well as the content of this list, specifying in particular the name of the biological medicinal products concerned, their dosage, their posology and their therapeutic indication.