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Showing 6121–6130 of 52210 articles for “Art. 2332-1°”
I. - The application for authorisation to carry out the stool collection activity provided for in Article L. 513-11-1 shall be sent to the Director General of the Agence nationale de sécurité du médic…
Faeces are collected on the premises of the establishment or body referred to in Article L. 513-11-1. By way of derogation from the first paragraph, the collection of faeces may, in the context of res…
Prior to donation, the stool donor receives information from the establishment or organisation carrying out the collection on the conditions for : 1° Biological donor selection ; 2° Clinical selection…
In order to obtain a marketing authorisation for a medicinal product which is not covered by the marketing authorisation procedure issued by the European Commission pursuant to Regulation (EC) No 726/…
The certificate of compliance with good practice relating to raw materials for pharmaceutical use is issued in accordance with Articles R. 5138-3 to R. 5138-6. When the inspection reveals serious brea…
The Agence nationale de sécurité du médicament et des produits de santé carries out an inspection of each blood establishment at least once every two years. The purpose of these inspections is to ensu…
I.-When a reasoned request is made to this end, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall send, by any means, the report mentioned in Articl…
I.-The statutory auditor will only receive, through the intermediary of a doctor acting under his responsibility as an expert, the personal data mentioned in article R. 6113-1 which are necessary to v…
When a health care institution uses an external service provider mentioned in 4° of the I of article R. 6113-5 to implement the activities mentioned in this chapter, this service provider may not reta…
The "Systemic drug treatments for cancer" modality comprises the following entries: 1° Entry A providing systemic drug treatments for cancer in adults, excluding intensive chemotherapy mentioned in en…
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