Chapter I: General provisions.

The following definitions apply

1° Magistral preparation means any medicinal product prepared in accordance with a medical prescription intended for a specific patient when there is no suitable or available proprietary medicinal product, including because it is not actually marketed, which has a marketing authorisation, one of the authorisations or a compassionate prescribing framework mentioned in articles L. 5121-9-1, L. 5121-12 and L. 5121-12-1 , a parallel import authorisation or an import authorisation issued to a pharmaceutical establishment as part of a stock shortage of a medicinal product, either extemporaneously in pharmacies or under the conditions provided for in Article L. 5125-1 or Article L. 5126-6 ;

2° Hospital preparation, any medicinal product, with the exception of gene or cell therapy products, prepared according to the pharmacopoeia indications and in compliance with the good practices mentioned in article L. 5121-5, when there is no suitable or available proprietary medicinal product, including due to the absence of effective marketing, with a marketing authorisation, one of the authorisations or a compassionate prescription framework mentioned in articles L. 5121-9-1, L. 5121-12 and L. 5121-12-1 , a parallel import authorisation or an import authorisation issued to a pharmaceutical establishment in the context of a stock shortage of a medicinal product, by an in-house pharmacy of a health care establishment, or by the pharmaceutical establishment of this health care establishment authorised in application ofarticle L. 5124-9 or under the conditions provided for in article L. 5126-6. Hospital preparations are dispensed on medical prescription to one or more patients by a pharmacy for internal use in the said establishment. They must be declared to the Agence nationale de sécurité du médicament et des produits de santé, under conditions defined by order of the Minister for Health;

A decree in the Conseil d'Etat defines the special hospital preparations which, due to the technical difficulties of their manufacture or the limited availability of the necessary active substances, are made in pharmacies for internal use or in pharmaceutical establishments of health establishments or of the Agence nationale de santé publique authorised, under conditions that it determines, by the Minister responsible for health or under their responsibility under the conditions provided for in 4° of Article L. 5126-6. These preparations are the subject of an authorisation specifying how they are to be made, issued on an exceptional and temporary basis by :

a) The Director General of the Agence nationale de sécurité du médicament et des produits de santé, in the event of a stock shortage of a medicinal product of major therapeutic interest ;

b) The Minister for Health, to deal with a serious health threat or crisis;

3° Compendial preparation means any medicinal product prepared in a pharmacy, listed in the pharmacopoeia or in the national formulary and intended to be dispensed directly to patients supplied by that pharmacy;

4° (Repealed) ;

5° a) Without prejudice to Articles L. 611-2 et seq. of the French Intellectual Property Code, a generic medicinal product of a reference medicinal product is one which has the same qualitative and quantitative composition in terms of active ingredients and the same pharmaceutical form and whose bioequivalence with the reference medicinal product is demonstrated by appropriate bioavailability studies. A proprietary medicinal product may only be classified as a reference proprietary medicinal product if its marketing authorisation has been granted on the basis of a dossier containing, under conditions laid down by regulation, all the data necessary and sufficient in themselves for its assessment. For the purposes of this paragraph, the different immediate-release oral pharmaceutical forms are considered to be the same pharmaceutical form. Similarly, the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active principle are considered to have the same qualitative composition in terms of active principle, unless they have significantly different properties with regard to safety or efficacy. In this case, additional information providing evidence of the safety and efficacy of the different salts, esters or derivatives of an authorised active substance must be provided by the applicant for marketing authorisation;

b) Generic group, the grouping together of a reference medicinal product and the medicinal products which are generic to it. However, a medicinal product which fulfils the conditions for being a reference medicinal product, which has the same qualitative composition in terms of active substance, the same quantitative composition in terms of active substance or, failing that, an identical active therapeutic moiety within the limits laid down in Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and the same pharmaceutical form as a reference medicinal product in an existing generic group, and whose bioequivalence with this medicinal product is demonstrated by appropriate bioavailability studies, may also be included in this generic group, provided that these two medicinal products are considered to be covered by the same global marketing authorisation, defined by regulation, and that they do not have significantly different properties with regard to safety or efficacy. In the absence of a reference medicinal product, a generic group may be made up of medicinal products with the same qualitative and quantitative composition in active ingredients, the same pharmaceutical form and whose characteristics in terms of safety and efficacy are equivalent. For the purposes of this b, proprietary medicinal products in a modified-release oral pharmaceutical form different from that of the reference proprietary medicinal product are entered in the register of generic groups, provided that these proprietary medicinal products and the reference proprietary medicinal product belong to the same category of modified-release pharmaceutical form and do not have significantly different properties with regard to safety or efficacy;

c) Hybrid of a reference medicinal product, a medicinal product which does not meet the definition of a generic medicinal product because it differs from the reference medicinal product in terms of therapeutic indications, strength, pharmaceutical form or route of administration, or where bioequivalence with respect to this reference medicinal product has not been demonstrated by bioavailability studies. The marketing authorisation of a hybrid medicinal product is based at least in part on the results of appropriate preclinical and clinical trials determined on the basis of these differences;

d) Hybrid group, the grouping together of a reference medicinal product and medicinal products which are hybrids thereof;

For the purposes of this b, herbal medicinal products as defined in 16° of this Article, excluding those mentioned in Article L. 5121-14-1, which have the same qualitative and quantitative composition in terms of active herbal substance, the same pharmaceutical form and which have equivalent therapeutic activity, may be entered in the register of proprietary medicinal products. Herbal medicinal products are considered to have the same qualitative composition if their active herbal substance :

- complies with the description in the Community monographs drawn up by the European Medicines Agency, as defined by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use; and

- is unlikely to result in significant differences in terms of therapeutic efficacy or adverse reactions.

For the application of this b, proprietary medicinal products whose active substance(s) is (are) exclusively one or more mineral substances, which have the same qualitative and quantitative composition in terms of substance, the same pharmaceutical form and which have a therapeutic activity equivalent to that of the reference proprietary medicinal product may be entered in the register of proprietary medicinal products. Proprietary medicinal products whose active substance(s) is/are exclusively one or more mineral substances are considered to have an identical qualitative composition if their mineral active substance complies with the specifications of the pharmacopoeia monographs, where they exist, and is not likely to result in significant differences in terms of therapeutic efficacy or adverse reactions;

6° Immunological medicinal product: any medicinal product consisting of :

a) Allergen, defined as any product intended to identify or provoke a specific and acquired modification of the immunological response to an allergenic agent;

b) Vaccine, toxin or serum, defined as any agent used to induce active or passive immunity or to diagnose the state of immunity;

7° Radiopharmaceutical: any medicinal product which, when ready for use, contains one or more radioactive isotopes, known as radionuclides, incorporated for medical purposes;

8° Generator, any system containing a parent radionuclide determined due to the absence of an available pharmaceutical speciality with a marketing authorisation, one of the authorisations or a compassionate prescription framework mentioned in Articles L. 5121-9-1, L. 5121-12 and L. 5121-12-1 , a parallel import authorisation or an import authorisation issued to a pharmaceutical establishment in the context of a stock-out of a medicinal product, used for the production of a daughter radionuclide obtained by elution or any other method and used in a radiopharmaceutical ;

9° Kit means any preparation which is to be reconstituted or combined with radionuclides in the final radiopharmaceutical;

10° Precursor means any other radionuclide produced for the radioactive labelling of another substance prior to administration;

11° Homeopathic medicinal product, any medicinal product obtained from substances known as homeopathic stocks, in accordance with a homeopathic manufacturing process described by the European pharmacopoeia, the French pharmacopoeia or, failing this, by the pharmacopoeias used officially in another Member State of the European Union. A homeopathic medicinal product may also contain several principles ;

12° Gene therapy preparation, any medicinal product other than proprietary medicinal products and industrially manufactured medicinal products mentioned in Article L. 5121-8, used to transfer genetic material and not consisting of cells of human or animal origin. These preparations are prepared in advance and dispensed on medical prescription to one or more patients. They are authorised by the Agence nationale de sécurité du médicament et des produits de santé for a given therapeutic indication. This authorisation may be subject to special conditions or restrictions on use. It may be modified, suspended or withdrawn;

13° Xenogenic cell therapy preparation, any medicinal product other than the proprietary medicinal products and industrially manufactured medicinal products mentioned in Article L. 5121-8, consisting of cells of animal origin and their derivatives used for therapeutic purposes, including cells used to transfer genetic material, whatever their level of transformation. These preparations are prepared in advance and dispensed on medical prescription to one or more patients. They are authorised by the Agence nationale de sécurité du médicament et des produits de santé for a given therapeutic indication. This authorisation may be subject to special conditions or restrictions on use. It may be modified, suspended or withdrawn. The Agence de la biomédecine is informed of decisions relating to these preparations taken in application of this paragraph;

14° Biological medicinal product: any medicinal product whose active substance is produced from or extracted from a biological source and whose characterisation and quality determination require a combination of physical, chemical and biological tests as well as knowledge of its manufacturing process and its control;

15° a) Without prejudice to Articles L. 611-2 et seq. of the French Intellectual Property Code, similar biological medicinal product means any biological medicinal product with the same qualitative and quantitative composition in terms of active substance and the same pharmaceutical form as a reference biological medicinal product, but which does not meet the conditions laid down in a) of 5° of this Article in order to be considered as a generic speciality due to differences linked in particular to the variability of the raw material or the manufacturing processes and requiring additional preclinical and clinical data to be produced under conditions determined by regulation;

A biological medicinal product may only be classified as a reference biological medicinal product if its authorisation has been granted on the basis of a dossier containing, under conditions laid down by regulation, all the data necessary and sufficient in themselves for its evaluation;

b) Similar biological group, the grouping of a reference biological medicinal product and its similar biological medicinal products, as defined in a of this 15°. They are grouped together on the reference list of similar biological groups drawn up by the Agence nationale de sécurité du médicament et des produits de santé;

16° Herbal medicinal product: any medicinal product whose active substances are exclusively one or more herbal substances or preparations or a combination of several herbal substances or preparations;

17° Advanced therapy medicinal product prepared on an ad hoc basis, any medicinal product as defined in 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, manufactured in France in accordance with specific quality standards and used in a hospital in France, under the responsibility of a doctor, to carry out a specific medical prescription for a product specially designed for a specific patient. These medicinal products are subject to authorisation by the Agence nationale de sécurité du médicament et des produits de santé. This authorisation may be subject to special conditions or restrictions on use. By way of derogation, these medicinal products may also be manufactured, imported or exported as part of the research defined in article L. 1121-1 of this code. The authorisation may be modified, suspended or withdrawn. The Agence de la biomédecine is informed of decisions taken in application of this 17°;

18° Blood-derived medicinal product: any medicinal product prepared industrially from blood or its components. They are subject to this Title, subject to the specific provisions applicable to them. They include in particular

a) Medicinal products derived from the fractionation of plasma;

b) Plasma for transfusion purposes, the production of which involves an industrial process, the marketing authorisation of which complies with Article L. 5121-11 of this Code and the collection and biological qualification of which comply with the requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC.