Subsection 4: Rules applicable to authorised establishments and organisations

I.-Establishments or organisations that prepare or import investigational advanced therapy medicinal products prepared on an ad hoc basis ensure that all preparation operations are carried out in accordance with the information provided by the sponsor in the application for authorisation referred to in article L. 1123-8 and accepted by the Agence nationale de sécurité du médicament et des produits de santé. II.-The importing establishment or organisation ensures that the investigational…

I. – Substantial changes to the activities authorised in application of this section which relate to: – the preparation of a new pharmaceutical form of an advanced therapy medicinal product prepared on a one-off basis; – the preparation of a new pharmaceutical form of an advanced therapy medicinal product prepared on a one-off basis; – the preparation of a new pharmaceutical form of an advanced therapy medicinal product prepared on…

I. – Any changes relating to: 1° The name or administrative address of the registered office of the establishment or authorised body; 2° The appointment of a new director of the establishment or authorised body; 3° The implementation of new technical equipment, including new medico-technical software used for the traceability of products linked to activities; 4° Third parties and agreements entered into with these third parties as provided for in…

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…