Section 8: Authorisation of establishments or organisations carrying out activities relating to advanced therapy medicinal products prepared on an ad hoc basis

Applicant establishments or organisations appoint a responsible person who ensures compliance with the regulations relating to the quality and safety of advanced therapy medicinal products prepared on an ad hoc basis, and one or more interim responsible persons who are entrusted with the same powers and duties as those conferred on the responsible person for the period of the replacement and actually exercise them for the duration of the replacement….

The person in charge referred to in Article R. 4211-37, the interim persons in charge, the person in charge of site activities and the interim person in charge of site activities must hold the qualifications required to practise medicine or pharmacy or hold a doctorate in the life and health sciences. The persons mentioned in the first paragraph must have qualifications and practical experience of at least two years in…

The establishment or authorised body must send the Director General of the Agence nationale de sécurité du médicament et des produits de santé a copy of any instrument appointing the responsible person referred to in Article R. 4211-37 and the interim responsible person or persons. When the responsible person or the acting responsible person is temporarily or permanently replaced, the authorised establishment or body immediately informs the Director General of…

To avoid any risk of cross-contamination, where storage, preparation and transfer activities for scientific purposes are carried out on the same premises as those dedicated to the preparation, storage, distribution and transfer of advanced therapy medicinal products prepared on an ad hoc basis, the establishment or organisation applying for authorisation must put in place procedures to ensure compliance with health and safety rules and separate circuits according to the purpose…

Applicant establishments or organisations are required to have: 1° Premises fitted out, arranged and maintained in accordance with the rules of good practice provided for in the first or third paragraph of Article L. 5121-5 and, where applicable, in accordance with the containment requirements adopted in application of Article L. 532-1 of the Environmental Code; 2° Staff whose skills and qualifications comply with these rules of good practice; 3° Equipment…