Title II: Medicinal products for human use

With a view to their inclusion in the register of generic groups referred to in Article L. 5121-10, generic medicinal products are identified by a decision of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) mentioning the corresponding reference medicinal product. This decision may, where appropriate, specify that the substitution of the reference medicinal product…

Unless there is a risk to patients’ health, proprietary medicinal products which fulfil the conditions for being a reference proprietary medicinal product in an existing generic group may, by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, be entered in the register of generic groups in the same group, until a marketing authorisation is issued for a generic proprietary medicinal…

Except where there is a risk to patients’ health, the proprietary medicinal products mentioned in b of 5° of Article L. 5121-1 which are presented in a modified-release oral pharmaceutical form different from that of the reference proprietary medicinal product are identified by a decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé mentioning the corresponding reference proprietary medicinal product. This…

Generic herbal medicinal products are covered by the provisions of articles R. 5121-6 and R. 5121-7.

Generic proprietary medicinal products whose active substance(s) is/are exclusively one or more mineral substances are covered by the provisions of articles R. 5121-5, R. 5121-5-1 and R. 5121-5-2.

Generic groups without a reference medicinal product, as provided for in Article L. 5121-1, are created in the register of generic groups by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé. For the purposes of applying these provisions, the Ministers responsible for health and social security, at the request of an applicant, may refer to the Director General of the…