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Showing 3491–3500 of 58065 articles for “Art. s 15 and 17”
The interventional radiology activity referred to in 21° of article R. 6122-25 includes all medical procedures for diagnostic or therapeutic purposes performed with medical imaging guidance and contro…
I. - The holder of the authorisation for category A has access to a continuous monitoring unit on site or by agreement, under conditions that allow the patient to be cared for within a timeframe that…
Distributions of profits made by companies that have entered into an agreement with the Minister of the Economy and Finance in accordance with the provisions of l'ordonnance n° 59-248 du 4 février 195…
The automated road traffic offence recording centre constitutes a joint service within which the officers and agents of the judicial police of the national police and gendarmerie carry out their usual…
The application for authorisation is deemed to be complete if, within one month of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not info…
For the purposes of this section, advanced therapy medicinal products prepared on an ad hoc basis mean the advanced therapy medicinal products mentioned in 17° of Article L. 5121-1.For the purposes of…
The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.
The authorisation may be subject to special conditions requiring the beneficiary of the authorisation to implement a plan for monitoring the efficacy and safety of the medicinal product, including the…
I. - The application for authorisation of an individually prepared advanced therapy medicinal product is accompanied by a dossier, the content of which is laid down by decision of the Director General…
In the event of failure to comply with the legislative and regulatory requirements, the conditions for granting or monitoring the authorisation referred to in Articles R. 5121-212 and R. 5121-213, or…
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