French Business Law - French Legislation

Article R5112-1 of the French Public Health Code

November 2, 2023

The pharmacopoeia referred to in article L. 5112-1 is a compendium comprising : 1° The nomenclature of drugs, simple and compound medicinal products and officinal articles; 2° A list of common names of medicinal products; 3° Maximum and usual dosage tables for medicinal products for adults and children; 4° Information which may be useful to the pharmacist for pharmaceutical practice. The pharmacopoeia indicates the characteristics of medicinal products, the means…

Article R5112-2 of the French Public Health Code

November 2, 2023

The provisions of the French pharmacopoeia and the European pharmacopoeia are made mandatory by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, published on the Agency’s website.

Article R5112-4 of the French Public Health Code

November 2, 2023

The French pharmacopoeia is supplemented by a national formulary. The provisions of this national formulary may be made compulsory under the conditions set out in article R. 5112-2.

Article R5112-5 of the French Public Health Code

November 2, 2023

The French pharmacopoeia and the national formulary mentioned in Article R. 5112-4 are published on the website of the Agence nationale de sécurité du médicament et des produits de santé.

Article R5121-1 of the French Public Health Code

November 2, 2023

For the purposes of this Book, the following definitions shall apply 1° Bioavailability means the rate and intensity of absorption into the body, from a pharmaceutical form, of the active substance or its therapeutic moiety intended to become available at the sites of action; 2° Bioequivalence, the equivalence of bioavailabilities; 3° Primary packaging: the container or other form of packaging with which the medicinal product comes into direct contact; 4°…

Article R5121-2 of the French Public Health Code

November 2, 2023

The name of a medicinal product may be either an invented name or a common or scientific name accompanied by a trade mark or the name of the holder of the marketing authorisation or of the company responsible for exploiting the medicinal product. The invented name may not be confused with the common name.

Article R5121-3 of the French Public Health Code

November 2, 2023

Without prejudice to the application of legislation relating to trademarks or service marks, the invented name is chosen in such a way as to avoid any confusion with other medicinal products and not to mislead as to the quality or properties of the speciality.

Article R5121-4 of the French Public Health Code

November 2, 2023

For any medicinal product authorised on the French market, each of its presentations and, where applicable, each common dispensing unit, is allocated a national identification number. This number is allocated by the Director General of the Agence nationale de sécurité du médicament et des produits de santé in accordance with the allocation procedures and technical specifications that comply with the provisions of Commission Delegated Regulation (EU) 2016/161 of 2 October…

Article R5121-5 of the French Public Health Code

November 2, 2023

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…

Article R5121-5-1 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 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…

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Part five: Health products

Article R5112-1 of the French Public Health Code

Article R5112-2 of the French Public Health Code

Article R5112-4 of the French Public Health Code

Article R5112-5 of the French Public Health Code

Article R5121-1 of the French Public Health Code

Article R5121-2 of the French Public Health Code

Article R5121-3 of the French Public Health Code

Article R5121-4 of the French Public Health Code

Article R5121-5 of the French Public Health Code

Article R5121-5-1 of the French Public Health Code

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Part five: Health products

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