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Showing 7811–7820 of 32219 articles for “Art. Décret 87-713 du 26-8-1987”
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…
…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 person re…
…les of good practice to guarantee the quality, health safety and traceability of medicines and to reduce as far as possible any risk to patients and staff.
…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 wit…
…arry out the activities referred to in Article R. 4211-32 relating to advanced therapy medicinal products prepared on an ad hoc basis is sent to the Director General of the Agence nationale de sécurit…
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…
…enefiting from the authorisation provided for in this section shall put in place agreements or procedures with another establishment or other establishments or organisations authorised under this sect…
…e dedicated to the preparation, storage, distribution and transfer of advanced therapy medicinal products prepared on an ad hoc basis, the establishment or organisation applying for authorisation must…
…Article L. 411-1 Order no. 2020-116 of 12 February 2020 Articles L. 411-2 and L. 411-3Loi n° 92-597 du 1er juillet 1992 Articles L. 411-4 and L. 411-5 Order no. 2020-116 of 12 February 2020 Article L.…
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