French Business Law - French Legislation

Article L5124-8-2 of the French Public Health Code

November 7, 2023

In the absence of an available or suitable pharmaceutical speciality, the medical supply establishments of the armed forces health service may, in order to meet specific defence requirements, import, export and distribute, after obtaining the opinion of the Agence nationale de sécurité du médicament et des produits de santé, a medicinal product authorised in another Member State of the European Union or a State party to the Agreement on the…

Article L5124-8-3 of the French Public Health Code

November 7, 2023

To meet specific defence requirements, the medical supply establishments of the armed forces health service may repackage and repackage health products in accordance with the rules laid down by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products). These rules shall take account of the specific characteristics of the armed forces health service. Repackaged medicinal products…

Article L5124-8-4 of the French Public Health Code

November 7, 2023

Subject to fulfilling their priority mission of providing medical support to the armed forces as mentioned in article L. 6147-7, the medical supply establishments of the armed forces health service may carry out the activities mentioned in I of article L. 5124-8 and in article L. 5124-8-3 on behalf of other ministerial departments or public or private organisations responsible for a public service mission contributing to national security.

Article L5124-9 of the French Public Health Code

November 7, 2023

Notwithstanding the provisions of the first paragraph of article L. 5124-2, public health establishments manufacturing medicinal products industrially on 31 December 1991 may apply for the authorisation provided for in article L. 5124-3.

Article L5124-9-1 of the French Public Health Code

November 7, 2023

The activities referred to in Article L. 5124-1 may be carried out by pharmaceutical establishments set up within non-profit organisations or public establishments other than health establishments: 1° When these activities concern radiopharmaceutical medicinal products ; 2° When these activities concern advanced therapy medicinal products as defined in 17° of Article L. 5121-1 and advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the…

Article L5124-10 of the French Public Health Code

November 7, 2023

Notwithstanding the provisions of Article L. 4211-1 and those of the first paragraph of Article L. 5124-2, Institut Pasteur remains authorised to ensure, in accordance with its statutes, the preparation and distribution of attenuated or non-attenuated viruses, therapeutic sera, modified or non-modified toxins, and in general the various products of non-chemically defined microbial origin which may be used, in any form, for diagnosis, prophylaxis or therapy, as well as allergens.

Article L5124-11 of the French Public Health Code

November 6, 2023

A pharmaceutical establishment exporting a medicinal product must ask the Agence nationale de sécurité du médicament et des produits de santé to certify that it holds the authorisation referred to in article L. 5124-3 or, for establishments or organisations manufacturing products referred to in article L. 1243-1 and in 12° and 13° of article L. 5121-1, the authorisation referred to in articles L. 1243-2, L. 4211-8 and L. 4211-9. A…

Article L5124-13 of the French Public Health Code

November 6, 2023

The import into the customs territory of medicinal products for human use and the import and export of gene therapy preparations or xenogenic cell therapy preparations mentioned in 12° and 13° of Article L. 5121-1 are subject to prior authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé. The marketing authorisation provided for in Article L. 5121-8 and Article L. 5121-9-1, the registrations provided…

Article L5124-13-1 of the French Public Health Code

November 6, 2023

In the case of research involving the human person relating to the gene therapy and xenogenic cell therapy preparations mentioned in 12° and 13° of Article L. 5121-1, the authorisation to conduct the research also constitutes authorisation for this research of the storage and preparation sites mentioned in Articles L. 4211-8 and L. 4211-9, and it constitutes the import and export authorisation mentioned in Article L. 5124-13.

Article L5124-13-2 of the French Public Health Code

November 6, 2023

A proprietary medicinal product subject to parallel distribution is a proprietary medicinal product : 1° Has a marketing authorisation issued by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ; 2° And imported from…

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Legislative part

Article L5124-8-2 of the French Public Health Code

Article L5124-8-3 of the French Public Health Code

Article L5124-8-4 of the French Public Health Code

Article L5124-9 of the French Public Health Code

Article L5124-9-1 of the French Public Health Code

Article L5124-10 of the French Public Health Code

Article L5124-11 of the French Public Health Code

Article L5124-13 of the French Public Health Code

Article L5124-13-1 of the French Public Health Code

Article L5124-13-2 of the French Public Health Code

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