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Article R1245-28 of the French Public Health Code

The provisions of articles R. 1245-4 and R. 1245-9 are applicable to establishments or organisations authorised under article R. 1245-24. For the application of article R. 1245-9, the responsible person is the pharmacist in charge for pharmaceutical establishments, the responsible person mentioned in article R. 4211-37 for establishments authorised under article L. 4211-9-1 and the responsible person mentioned in article R. 4211-55 for establishments authorised under article L. 4211-9-2.

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Article R1245-29 of the French Public Health Code

Pharmaceutical establishments and establishments authorised under articles L. 4211-9-1 and L. 4211-9-2 may procure tissues, their derivatives and cells from the human body, whatever their level of processing, in a Member State of the European Union or a party to the Agreement on the European Economic Area. These same establishments may supply tissues, their derivatives and cells from the human body, whatever their level of processing, to a Member State…

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Article R1245-30 of the French Public Health Code

The biological samples referred to in the third paragraph of II of Article L. 1245-5-1 may be obtained in a Member State of the European Union or supplied to a Member State of the European Union or imported or exported: 1° Any medical biology laboratory, any medical biology laboratory or department of a public health establishment or a blood transfusion establishment, as well as any medical specialist or hospital department…

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Article R1245-31 of the French Public Health Code

For the purposes of this section, the following definitions shall apply: 1° Unique European code: unique identifier applied to tissues and cells circulating in the European Union. This code is composed of two parts: a) The donation identification sequence defined in 2° ; b) The product identification sequence defined in 3°; 2° Donation identification sequence: this is the first part of the unique European code. It is made up of…

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Article R1245-32 of the French Public Health Code

The single European code is allocated to all tissues, their derivatives and cells or cell therapy preparations used for therapeutic purposes, regardless of their country of origin, prior to their distribution in France or their transfer for the purposes of grafting or administration to another Member State of the European Union or party to the Agreement on the European Economic Area, with the exception of emergency importation of these tissues…

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Article R1245-33 of the French Public Health Code

An order of the Minister for Health made on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Director General of the Agence de la biomédecine, defines: 1° The structure of the unique European code set out in Annex VIII to Commission Directive 2015/565/EU of 8 April 2015 amending Directive 2006/86/EC as regards certain…

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Article R1245-34 of the French Public Health Code

The Agence nationale de sécurité du médicament et des produits de santé is responsible for : 1° Assigning the code defined in a of 2° of Article R. 1245-31 to the establishments it authorises pursuant to Article L. 1243-2, the first and second paragraphs of II of Article L. 1245-5, the first paragraph of II of Article L. 1245-5-1, and Articles L. 4211-9-1, L. 4211-9-2, L. 5124-3 and L. 5124-9-1…

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Article R1245-35 of the French Public Health Code

I. – Unless the single European code has already been allocated to tissues or cells from a Member State of the European Union, the single European code is allocated at the latest before the tissues or cells are distributed in France or transferred, for the purposes of grafting or administration, to another Member State of the European Union or party to the Agreement on the European Economic Area, by the…

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Article R1245-36 of the French Public Health Code

Unless the donation identification sequence has already been allocated to tissues or cells from a Member State of the European Union, the donation identification sequence is allocated by the establishments or organisations authorised under Article L. 1243-2, the first and second paragraphs of II of Article L. 1245-5, the first paragraph of II of article L. 1245-5-1, and articles L. 4211-9-1, L. 4211-9-2, L. 5124-3 and L. 5124-9-1 which receive…

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