French Public Health Code
In forceApplicant 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 is responsible for:
1° Ensuring that advanced therapy medicinal products prepared on an ad hoc basis are prepared, stored, distributed or transferred in accordance with the legislative and regulatory provisions in force;
2° Ensuring that the quality assurance system is set up, evaluated and updated in compliance with the rules of good practice provided for in the third paragraph of Article L. 5121-5 ;
3° Organising and monitoring the application of the pharmacovigilance system.
With the exception of establishments or organisations authorised under article R. 4211-33, when an establishment or organisation is authorised to carry out the activities provided for in this section at different sites, a site activity manager and an acting site activity manager are appointed by the person responsible for each site where the activities are carried out.
For each site, the person in charge of activities carries out the tasks mentioned in the previous paragraphs under the authority of the person in charge.
