Section 3: Generic specialities

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…

A generic medicinal product or a medicinal product belonging to a generic group without a reference medicinal product, whose marketing authorisation is withdrawn, is removed from the register of generic groups. When the marketing authorisation of a generic medicinal product or of a medicinal product belonging to a generic group without a reference medicinal product is suspended, a reference to it is included in the register of generic groups for…

The directory of generic groups lists the medicinal products included in each generic group, specifying their strength and pharmaceutical form. The generic groups are grouped by active substance designated by its common name preceded by the words “common name” and by route of administration. The information which, in application of article R. 5125-55, must be included in a prescription under a non-proprietary name is specified in the directory for the…

Decisions to include a medicinal product in the register of generic groups, to amend these decisions and to remove a medicinal product from this register, governed by this section, are published on the website of the Agence nationale de sécurité du médicament et des produits de santé.