French Business Law - French Legislation

Article L5121-10 of the French Public Health Code

November 7, 2023

For a generic or hybrid medicinal product defined in 5° of Article L. 5121-1, the marketing authorisation may be granted before the expiry of the intellectual property rights attached to the reference medicinal product concerned. The applicant for this authorisation must inform the holder of these rights at the same time as the application is submitted. Where the Agence nationale de sécurité du médicament et des produits de santé has…

Article L5121-10-1 of the French Public Health Code

November 7, 2023

A generic medicinal product may not be marketed until ten years have elapsed following the initial marketing authorisation of the reference medicinal product. However, this period is extended to eleven years if, during the first eight years following the authorisation of the reference medicinal product, the holder of the latter obtains authorisation for one or more new therapeutic indications considered, during the scientific evaluation carried out with a view to…

Article L5121-10-2 of the French Public Health Code

November 7, 2023

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…

Article L5121-10-3 of the French Public Health Code

November 7, 2023

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.

Article L5121-11 of the French Public Health Code

November 7, 2023

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…

Article L5121-12 of the French Public Health Code

November 7, 2023

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…

Article L5121-12-1 of the French Public Health Code

November 7, 2023

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…

Article L5121-12-1-1 of the French Public Health Code

November 7, 2023

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.

Article L5121-12-1-2 of the French Public Health Code

November 7, 2023

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…

Article L5121-12-2 of the French Public Health Code

November 7, 2023

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…

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Legislative part

Article L5121-10 of the French Public Health Code

Article L5121-10-1 of the French Public Health Code

Article L5121-10-2 of the French Public Health Code

Article L5121-10-3 of the French Public Health Code

Article L5121-11 of the French Public Health Code

Article L5121-12 of the French Public Health Code

Article L5121-12-1 of the French Public Health Code

Article L5121-12-1-1 of the French Public Health Code

Article L5121-12-1-2 of the French Public Health Code

Article L5121-12-2 of the French Public Health Code

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