Chapter I: General provisions.

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 granted a marketing authorisation for a generic or hybrid medicinal product, it will inform the holder of the marketing authorisation for the reference medicinal product.

The Director General of the Agency will register the generic medicinal product in the register of generic groups within sixty days, after informing the marketing authorisation holder of the reference medicinal product that marketing authorisation has been granted. However, this generic medicinal product may not be marketed until the intellectual property rights have expired, unless the holder of these rights agrees.

Prior to marketing, the holder of the marketing authorisation for the generic medicinal product will inform the Director General of the Agency of the indications, pharmaceutical forms and strengths of the reference medicinal product for which the intellectual property rights have not expired.

For the sole purpose of ensuring publicity, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall make available to the public the list of intellectual property rights attached to a reference medicinal product if the holder of the marketing authorisation for this medicinal product has communicated it to him for this purpose. The laboratory is solely responsible for the accuracy of the information provided.

For hybrid medicinal products, a register of hybrid groups is created, comprising the groups into which a reference medicinal product and medicinal products which are hybrids of it are grouped. The conditions for drawing up this register are laid down by decree in the Conseil d'Etat, in particular the procedures for including proprietary medicinal products in the corresponding hybrid groups or for removing proprietary medicinal products from these groups by the Director General of the Agence nationale de sécurité des médicaments et des produits de santé. An order of the ministers responsible for health and social security sets the list of classes of medicinal products that may be included in groups entered in this register.