Subsection 3: Conditions for authorisation

I.-Establishments applying for the authorisation required to carry out the activities mentioned in article R. 4211-53 appoint a responsible person and one or more interim responsible persons to replace him/her, with the same powers and responsibilities as those conferred on the responsible person. The responsible person is responsible for: 1° Ensuring that advanced therapy medicinal products used in the context of research mentioned in the first paragraph of article L….

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

In the event of cessation of activity of an establishment mentioned in Article R. 4211-53 authorised to manufacture advanced therapy medicinal products intended for use in research mentioned in Article L. 1121-1, the sponsor of this research may either terminate it or continue it. If he decides to continue it, he shall put in place agreements or procedures to transfer the advanced therapy medicinal products to another establishment or other…