Article R4211-45 of the French Public Health Code
November 3, 2023
Changes other than those mentioned in articles R. 4211-43 and R. 4211-44 are declared in the annual activity report provided for in article R. 4211-47.
Changes other than those mentioned in articles R. 4211-43 and R. 4211-44 are declared in the annual activity report provided for in article R. 4211-47.
In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisation are ordered by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These decisions may concern all or part of the authorised activity and may only be taken after the party concerned…
The authorised establishment or body sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Agence de la biomédecine, as well as, where appropriate, the Director General of the regional health agency, an annual activity report containing, in particular, any information necessary for the evaluation of all the activities for which it is authorised. The form and…
Establishments or authorised organisations shall draw up and keep up-to-date a full list of the agreements they have entered into with third parties whose involvement has an influence on the quality and safety of advanced therapy medicinal products prepared on an ad hoc basis. They shall make these agreements available to the Agence nationale de sécurité du médicament et des produits de santé and to the inspectors mentioned in article…
Advanced therapy medicinal products prepared on an ad hoc basis are distributed, under the responsibility of the person in charge referred to in article R. 4211-37 or, where applicable, the person in charge of site activities referred to in the same article, to an identified practitioner, on the basis of a named medical prescription. They may only be distributed if they are recognised as complying with the health safety rules…
Establishments and authorised organisations shall implement a procedure for the withdrawal of advanced therapy medicinal products prepared on an ad hoc basis in accordance with the rules of good practice provided for in Article L. 5121-5 and including a description of the responsibilities and measures to be taken. The responsible person undertakes and coordinates the necessary actions. It shall immediately notify the Director General of the Agence nationale de sécurité…
An authorised establishment or organisation may transfer to another authorised establishment or organisation advanced therapy medicinal products prepared on an ad hoc basis with a view to their storage and distribution or components of these medicinal products with a view to their preparation by this second establishment or organisation. Only advanced therapy medicinal products prepared on an ad hoc basis in compliance with the health safety rules adopted in application…
I.-In accordance with the provisions of II of Article L. 4211-9-1, an establishment or organisation authorised under this section may have the preparation and distribution of an individually prepared advanced therapy medicinal product as mentioned in Article R. 1124-6 and in the second paragraph of Article R. 5121-209, by the health establishment or army hospital which removes the autologous tissues or cells, i.e. from the person himself, used in its…
For the application of the provisions of sub-sections 1 to 4a, army hospitals are considered to be health establishments and the Minister for Defence exercises, with regard to them and the army blood transfusion centre, the powers of the Director General of the regional health agency. For the application of articles R. 4211-34 and R. 4211-43 to army hospitals, the request for authorisation is sent by the Minister of Defence.
The provisions of this section apply to health establishments which hold the authorisation referred to in Article L. 1243-2 and which meet the conditions for obtaining the authorisation provided for in Article L. 4211-9-2 to carry out, in the context of the research referred to in the first paragraph of Article L. 1121-1, the activities of manufacturing, importing, exporting and distributing advanced therapy medicinal products as defined in Article 2…
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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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