Chapter I: General provisions.

For a similar biological medicinal product defined in a of 15° of Article L. 5121-1, the marketing authorisation may be granted before the expiry of the intellectual property rights attached to the reference biological medicinal product. The applicant for authorisation must inform the holder of these rights at the same time as he submits his application. Where the Agence nationale de sécurité du médicament et des produits de santé has…

The holder of an intellectual property right protecting the appearance and texture of the oral pharmaceutical forms of a reference medicinal product within the meaning of Article L. 5121-1 may not prohibit the oral pharmaceutical forms of a generic medicinal product that may be substituted for this medicinal product pursuant to Article L. 5125-23 from having an identical or similar appearance and texture.

The marketing authorisation provided for in Article L. 5121-8 may only be granted for a blood-derived medicinal product when it is prepared from blood or blood components collected under the conditions defined in Articles L. 1221-3 to L. 1221-7. Under conditions determined by regulation, a medicinal product mentioned in the first paragraph may be marked with an “ethical label” pictogram indicating that it is prepared from blood or blood components…

I. – Early access as defined in this article governs the use, on an exceptional basis, of certain medicinal products, in specific therapeutic indications, intended to treat serious, rare or incapacitating diseases, when the following conditions are met: 1° There is no appropriate treatment ; 2° Implementation of the treatment cannot be deferred; 3° The efficacy and safety of these medicines are strongly presumed on the basis of the results…

I. – Articles L. 5121-8 and L. 5121-9-1 do not preclude the exceptional use of certain medicinal products for specific therapeutic indications under compassionate access when the following conditions are met: 1° The medicinal product is not the subject of research involving the human person for commercial purposes; 2° No appropriate treatment exists; 3° The efficacy and safety of the medicinal product are presumed on the basis of available clinical…

Prescribers may make the dispensing of certain medicines conditional on the performance and results of medical tests, in particular biological or diagnostic tests, by means of a prescription known as a conditional dispensing prescription.

In the absence of the authorisation or compassionate prescribing framework mentioned in article L. 5121-12-1 for the indication in question, a medicinal product may only be prescribed in a manner that does not comply with its marketing authorisation if there is no appropriate medicinal product alternative with a marketing authorisation or early access authorisation and provided that the prescriber considers it essential, in the light of proven medical knowledge, to…

I.-To meet specific defence needs, the Minister for Defence may authorise the armed forces health service to use a proprietary medicinal product outside the conditions of prescription and supply laid down in its marketing authorisation, after obtaining the opinion of the Director General of the National Agency for the Safety of Medicines and Health Products. II.-To meet specific defence needs, the Minister for the Interior may authorise these structures to…

Homeopathic medicinal products which satisfy all the conditions listed below are not subject to the marketing authorisation provided for in Article L. 5121-8: 1° Oral or external administration ; 2° No specific therapeutic indication on the labelling or in any information relating to the medicinal product; 3° Degree of dilution guaranteeing the safety of the medicinal product; in particular, the medicinal product may contain neither more than one part per…

The registration provided for in Article L. 5121-13 may cover a series of homeopathic medicinal products obtained from the same homeopathic stock or stocks. The application for registration must be accompanied by documents demonstrating the quality and homogeneity of the batches manufactured for these homeopathic medicinal products.