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Showing 5641–5650 of 59948 articles for “Art. R. 612-1”
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…
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/…
…ood 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…
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…
…té du 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…
…ry of 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…
…hen 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 retai…
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…
…logical surgery; 2° External radiotherapy, brachytherapy; 3° Systemic medicinal treatments for cancer.
…uthorisation holder for systemic cancer drug treatments in application of 1° and 2° of I of article R. 6123-94; 2° Carry out the follow-up of such treatments without prejudice to the application of 5°…
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