Subsection 1: General authorisation conditions

I. – The provisions of this section apply to the categories of establishments or organisations defined in the second paragraph of this article which meet the conditions for obtaining the authorisation provided for in I of Article L. 4211-9-1 to prepare, store, distribute and transfer individually prepared advanced therapy medicinal products as defined in 17° of Article L. 5121-1, including in the context of biomedical research as referred to in…

Establishments or organisations which store and distribute individually prepared advanced therapy medicinal products which have been transferred to them by an establishment or organisation authorised to prepare, store, distribute or transfer these products may not carry out these storage and distribution activities without being authorised to do so under the conditions laid down by the provisions of this section, with the exception of those of articles R. 4211-47 and R….