French Business Law - French Legislation

Article R5121-7 of the French Public Health Code

November 2, 2023

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medicinal product belonging to a generic group without a reference medicinal product, whose marketing authorisation is withdrawn, is removed from the register of generic groups.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…

Article R5121-8 of the French Public Health Code

November 2, 2023

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…

Article R5121-9 of the French Public Health Code

November 2, 2023

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.

Article R5121-9-1 of the French Public Health Code

November 2, 2023

The reference list of similar biological groups provided for in article L. 5121-10-2 is presented for each reference biological medicinal product for which the name, strength, pharmaceutical form and common name of the active substance it contains are indicated. This list includes the medicinal products included in each similar biological group within the meaning of b of 15° of article L. 5121-1 and specifies, for each of these medicinal products,…

Article R5121-9-2 of the French Public Health Code

November 2, 2023

When a marketing authorisation is granted for a biological medicinal product which may be identified as a similar biological medicinal product, the Director General of the Agence nationale de sécurité des médicaments et des produits de santé : 1° Identifies it as a similar biological medicinal product, mentioning the corresponding reference medicinal product, by means of a decision, which may include recommendations and warnings, and which he notifies to the…

Article R5121-9-3 of the French Public Health Code

November 2, 2023

The Director General of the Agence nationale de sécurité des médicaments et des produits de santé: 1° Suspends or withdraws the decision referred to in 1° of Article R. 5121-9-2 identifying a similar biological medicinal product in the event of non-renewal, suspension, withdrawal or lapse of the marketing authorisation for this medicinal product; 2° Removes the similar biological medicinal product from the reference list of similar biological groups in the…

Article R5121-9-4 of the French Public Health Code

November 2, 2023

Decisions to include a medicinal product on the reference list of similar biological groups, to amend these decisions and to remove it from this list are published on the website of the Agence nationale de sécurité du médicament et des produits de santé.

Article R5121-9-5 of the French Public Health Code

November 2, 2023

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…

Article R5121-9-6 of the French Public Health Code

November 2, 2023

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…

Article R5121-9-7 of the French Public Health Code

November 2, 2023

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…

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Title II: Medicinal products for human use

Article R5121-7 of the French Public Health Code

Article R5121-8 of the French Public Health Code

Article R5121-9 of the French Public Health Code

Article R5121-9-1 of the French Public Health Code

Article R5121-9-2 of the French Public Health Code

Article R5121-9-3 of the French Public Health Code

Article R5121-9-4 of the French Public Health Code

Article R5121-9-5 of the French Public Health Code

Article R5121-9-6 of the French Public Health Code

Article R5121-9-7 of the French Public Health Code

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Title II: Medicinal products for human use

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