Book I: Pharmaceutical products

The company or organisation exploiting a medicinal product or health product shall immediately notify the National Agency for the Safety of Medicines and Health Products of any prohibition or restriction imposed by the competent authority of any country in which the medicinal product for human use is marketed and of any other new information likely to influence the evaluation of the benefits and risks of the medicinal product for human…

In order to be able to continuously assess the benefit/risk balance of the medicinal product as defined in the first paragraph of Article L. 5121-9, the Agence nationale de sécurité du médicament et des produits de santé may at any time ask the marketing authorisation holder to submit data demonstrating that this balance remains favourable.

The holder of a marketing authorisation for a medicinal product shall immediately inform the Agence nationale de sécurité du médicament et des produits de santé, specifying the reasons, of any action taken, in France or in another Member State of the European Union, to suspend or stop the marketing of this medicinal product, to request the withdrawal of this authorisation or not to apply for its renewal, specifying in particular…

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…

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…

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…