French Business Law - French Legislation

Article R1245-7 of the French Public Health Code

November 5, 2023

In particular, the authorisations specify the type of activity authorised and the category of products imported or exported and, for imported finished products, the therapeutic indications. In the case of imports, they shall also include the information listed in Annex II to Directive (EU) 2015/566. Authorisations issued in this way may be modified, suspended or withdrawn in whole or in part by the Director General of the Agence nationale de…

Article R1245-8 of the French Public Health Code

November 5, 2023

Any modification of the information contained in the initial import and export authorisation application dossier, concerning the nature or origin of the products, as well as the substantial modifications mentioned in 4° of Article R. 1243-7, are subject to authorisation issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The application for modification is submitted and examined under the same conditions…

Article R1245-9 of the French Public Health Code

November 5, 2023

I. – Applicant establishments or organisations appoint a responsible person who ensures compliance with the regulations relating to the quality and safety of tissues or their derivatives or cell therapy preparations, as well as one or more interim responsible persons who, for the period of replacement, are entrusted with the same powers and duties as those conferred on the responsible person and effectively exercise them for the duration of the…

Article R1245-10 of the French Public Health Code

November 5, 2023

I. – Natural or legal persons holding the authorisation referred to in Article R. 1245-7 inform the Agence nationale de sécurité du médicament et des produits de santé of their decision to cease all or part of their import activities. II. – Where they carry out the activity of importing, they must notify the Agence nationale de sécurité du médicament et des produits de santé without delay of any total…

Article R1245-11 of the French Public Health Code

November 5, 2023

The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorised legal entities or individuals, giving their names and addresses and the category of products that each of them is authorised to import or export. This list is accessible to the public.

Article R1245-12 of the French Public Health Code

November 5, 2023

The application for authorisation provided for in III of Article L. 1245-5 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by any means enabling its receipt to be dated, by an establishment or body already authorised under Article L. 1243-2, accompanied by a letter from the applicant justifying the need to import or export as a matter of…

Article R1245-13 of the French Public Health Code

November 5, 2023

The application for authorisation provided for in the second paragraph of II of Article L. 1245-5 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by any means enabling its receipt to be dated, by an establishment or body already authorised under Article L. 1243-2. This request is accompanied by a letter from the applicant justifying the need to…

Article R1245-14 of the French Public Health Code

November 5, 2023

Establishments or organisations authorised to carry out imports in application of the second paragraph of II and III of article L. 1245-5 shall mention in the annual activity report provided for in article R. 1243-22 the types and quantities of tissues and cells imported as well as their origin and destination.

Article R1245-15 of the French Public Health Code

November 5, 2023

I. – The application for authorisation provided for in the second paragraph of I of Article L. 1245-5 for products from Member States of the European Union or parties to the Agreement on the European Economic Area that do not have the authorisation provided for in Article 6(2) of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human…

Article R1245-16 of the French Public Health Code

November 5, 2023

I. – The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within three months of the date on which the application is deemed to be complete. II. – He may request any additional information he considers necessary, by any means capable of providing a definite date for this request. In this case, the time limit stipulated…

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French Public Health Code

Article R1245-7 of the French Public Health Code

Article R1245-8 of the French Public Health Code

Article R1245-9 of the French Public Health Code

Article R1245-10 of the French Public Health Code

Article R1245-11 of the French Public Health Code

Article R1245-12 of the French Public Health Code

Article R1245-13 of the French Public Health Code

Article R1245-14 of the French Public Health Code

Article R1245-15 of the French Public Health Code

Article R1245-16 of the French Public Health Code

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French Public Health Code

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