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Showing 4491–4500 of 9212 articles for “Art. 8 févr. 2024”
The training of the workers mentioned in II of article R. 4451-58 is paid for by the employer and renewed at least every three years.
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…
I. - The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within ninety days from the date of receipt of the applic…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will send a copy of the complete application to the Director General of the Agence de la biomédecine for…
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 perso…
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 paragra…
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…
…port conditions for investigational advanced therapy medicinal products prepared on an ad hoc basis;8° Where the application comes from a health establishment, a copy of the letter and the notice of r…
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 qualifi…
I. - With the exception of the establishments and organisations mentioned in II and III, any establishment or organisation benefiting from the authorisation provided for in this section shall put in p…
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