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Showing 2021–2030 of 45413 articles for “Art. 12 al. 2”
The authorisation holder keeps the list provided for in 1° of Article R. 5139-3 up to date and sends it to the Agence nationale de sécurité du médicament et des produits de santé by 15 February each y…
The registers or records mentioned in articles R. 5141-118 to R. 5141-120 are kept for five years and must be produced whenever required by the competent authorities. The recording systems comply with…
The authorisation provided for in Article L. 5141-10 is issued by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.
…vice in France must bear the CE mark certifying that it meets the conditions set out in article R. 5211-17. However, CE marking is not required for custom-made devices and for devices which are to be…
…healthcare professionals not practising in one of the establishments mentioned in 4° of Article R. 5222-3 or in a blood transfusion establishment who are aware of incidents or risks of incidents invol…
…nomic Area, with the implementation of the conformity assessment procedures defined in articles R. 5221-24 to R. 5221-28.
The service provider and equipment distributor apply the advice on use and safety given by the equipment manufacturer. They provide the person who is ill or has an incapacity or disability and their f…
…ent and evaluation of the patient, drawing up the patient's therapeutic plan and facilitating referral. Within this framework, the holder may set up telehealth activities and mobile teams.
I.-The holder of the authorisation organises both full inpatient and part-time care. If the holder can only offer one form of care, it offers the other form by means of an agreement with another estab…
Interventional cardiology imaging includes all diagnostic or therapeutic cardiology procedures performed percutaneously, transparietally or intra-luminally on one or more inaccessible targets under sa…
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