The provisions of this chapter apply to the legal and natural persons mentioned in II of article L. 1245-5 and in article L. 1245-5-1 who, for the purposes mentioned in these articles, bring tissues, their derivatives or cells from the human body, whatever their level of processing and cell therapy preparations, with the exception of gametes, into or out of national territory.
The legal or natural persons referred to in Article R. 1245-1 who bring into national territory elements or products of the human body referred to in that same article shall ensure : 1° That these have been removed or collected with the prior consent of the donor ; 2° That no payment of any kind has been made to the donor.
Any entry into or exit from national territory of the products mentioned in Article R. 1245-1, excluding transit, is subject to the affixing on the package of the information defined by order of the Minister for Health and the Minister for Research pursuant to Annex IV 1.7 of Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council concerning certain technical requirements…
The legal entities or natural persons mentioned in article R. 1245-1 who procure, supply, import or export for therapeutic purposes, including research involving the human person within the meaning of article L. 1121-1, elements or products of the human body mentioned in article R. 1245-1, shall not disclose any information that would enable the donor and recipient to be identified. They shall ensure compliance with the provisions of article R….
I. – The application for an import authorisation for therapeutic purposes, provided for in the first paragraph of II of Article L. 1245-5, is sent by the legal entities or natural persons mentioned in the same paragraph to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by any means that enables the application to be dated with certainty. The application for an…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will send a copy of the dossier to the Director General of the Agence de la biomédecine, who will give his opinion within one month. If no response is received within this period, this will be deemed to be a favourable opinion. The Director General of the Agence nationale de sécurité du médicament et…
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…
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…
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…
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…
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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