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Showing 8351–8360 of 52609 articles for “Art. 13 §1”
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/…
…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…
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…
…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…
…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 relia…
…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 the…
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…
Authorisation for a cancer treatment activity is granted for one or more of the following procedures: 1° Oncological surgery; 2° External radiotherapy, brachytherapy; 3° Systemic medicinal treatments…
I.- Authorisation holders for medicine, surgery, interventional radiology, medical care and rehabilitation or home hospitalisation may be associated with an authorisation holder for cancer treatment u…
The "Oncological surgery" modality comprises the following entries: I.-Category A providing oncology surgery in adults for one or more of the following seven tumour locations, mentioned in the authori…
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