Article R513-11-4
…pplication 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 médicament et d…
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Showing 6101–6110 of 52210 articles for “Art. al. 1”
…pplication 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 médicament et d…
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…
…ormation from the establishment or organisation carrying out the collection on the conditions for : 1° Biological donor selection ; 2° Clinical selection of donors; 3° Collection of the faeces; 4° Sto…
…ommission pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, in more than one Member State of the European Union, the applicant must follow one of…
…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 breaches of the good practices mentioned in…
…tablishment's blood transfusion activities comply with the good practices referred to in article L. 1222-12 and with the operating and equipment standards applicable to them. As part of these inspecti…
…médicament et des produits de santé shall send, by any means, the report mentioned in Article R. 5313-3 to the European authorities responsible for the safety of the health products mentioned in Arti…
…f a doctor acting under his responsibility as an expert, the personal data mentioned in article R. 6113-1 which are necessary to verify, by sampling on the basis of relevant samples of files, the reli…
…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 retain th…
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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