Section 3b: Hybrid specialities

With a view to their inclusion in the register of hybrid groups mentioned in the last paragraph of Article L. 5121-10, hybrid medicinal products 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 medicinal product. This decision is notified to the holder of the marketing authorisation issued for this hybrid medicinal product. Within…

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 hybrid 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 hybrid groups in the same group, until a marketing authorisation is granted for a hybrid proprietary medicinal…

The register of hybrid groups shows the proprietary medicinal products included in each hybrid group. The hybrid groups are grouped by active substance designated by its common name preceded by the words “common name”. The register of hybrid groups indicates, for each medicinal product, its name, strength, pharmaceutical form and the name of the marketing authorisation holder and, if different from the marketing authorisation holder, the name of the company…

Decisions to include a medicinal product in the register of hybrid 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.

A reference medicinal product may belong to both a generic group and a hybrid group as defined respectively in b and d of 5° of Article L. 5121-1.

The request for an opinion from the Agence nationale de sécurité du médicament et des produits de santé by the ministers responsible for health and social security, on the order mentioned in the last paragraph of II of Article L. 5125-23, specifies the time limit within which this opinion is to be given.