Section 13: Pharmacovigilance

The pharmacovigilance carried out on individually prepared advanced therapy medicinal products includes monitoring to ensure traceability between the various stages, from the removal of tissues, cells or blood, where applicable, to the administration of the individually prepared advanced therapy medicinal product to a patient. This traceability also applies to the research referred to in Article L. 1121-1. This traceability supplements the requirements relating to the traceability of tissues and cells…

I.-Any establishment or body referred to in Article L. 4211-9-1 or any pharmaceutical establishment referred to in Articles L. 5124-1 or L. 5124-9-1 shall set up and keep up to date a system ensuring the traceability of advanced therapy medicinal products prepared on an ad hoc basis. II – Establishments which prepare punctually prepared advanced therapy medicinal products shall keep data enabling the identification of samples of tissues, cells, blood…

Before administering the punctually prepared advanced therapy medicinal product, the health professional in the health establishment must ensure that the information required for the traceability of the medicinal product appears on the labelling of its immediate packaging. After administering it, the health professional draws up an administration record which includes the following information: 1° The name of the advanced therapy medicinal product prepared on an ad hoc basis; 2° The…

The data referred to in II and III of Article R. 5121-201-5 and a copy of the administration record referred to in Article R. 5121-201-6 shall be kept by the establishments referred to in Article R. 5121-201-5 for at least thirty years after the expiry date of the advanced therapy medicinal product prepared on an ad hoc basis.

In the event of interruption or cessation of activity of an establishment or organisation mentioned in article L. 4211-9-1, the data relating to the traceability of advanced therapy medicinal products prepared on an ad hoc basis are transferred to the establishment or organisation authorised under the same article, with which it has set up agreements or procedures in application of I of article R. 4211-42. In the event of interruption…