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Showing 4911–4920 of 35417 articles for “Art. R. 145-8”
…ccompanied by a file containing all the documents mentioned in the decision provided for in Article R. 4211-34.The Director General may request any additional information or carry out an investigation…
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…
…produits de santé a copy of any instrument appointing the responsible person referred to in Article R. 4211-37 and the interim responsible person or persons. When the responsible person or the acting…
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…
…acovigilance 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…
…uthorisation of an establishment or organisation to carry 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 th…
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…
…ruption or cessation of activity, establishments authorised for the activities mentioned in Article R. 4211-33 transfer unused advanced therapy medicinal products prepared on an ad hoc basis to the es…
I. - The provisions of this section apply to the categories of establishments or organisations defined in the second paragraph of this article which meet the conditions for obtaining the authorisation…
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…
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