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Article R4211-40 of the French Public Health Code

To avoid any risk of cross-contamination, where storage, preparation and transfer activities for scientific purposes are carried out on the same premises as those 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 put in place procedures to ensure compliance with health and safety rules and separate circuits according to the purpose of these activities.

Original in French 🇫🇷
Article R4211-40
Pour éviter tout risque de contamination croisée, lorsque des activités de conservation, de préparation et de cession à des fins scientifiques sont réalisées dans les mêmes locaux que ceux dédiés à la préparation, la conservation, la distribution et la cession de médicaments de thérapie innovante préparés ponctuellement, l’établissement ou l’organisme sollicitant l’autorisation prévoit la mise en place de procédures garantissant le respect des règles d’hygiène et de sécurité ainsi que des circuits séparés selon la finalité de ces activités.

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