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Showing 8881–8890 of 30978 articles for “Art. Cass. 1ère civ. 7-11-2018 n° 17-26.222 F-PB”
The holder of an authorisation referred to in Article R. 6123-121, with the exception of an authorisation bearing the wording "multi-purpose", provides the following services in its area of competence…
Within the meaning of article L. 2321-2, a children's home of a permanent nature is an establishment whose activity, which lasts for more than nine months a year, is characterised in particular by lon…
The authorisation holder must ensure continuity of care. Through the organisation it puts in place, it guarantees the intervention of a doctor within a timeframe compatible with patient safety. This o…
The authorisation holder may provide specific care requiring particular expertise, the list of which is drawn up by the Minister for Health. These are included in the multiannual contract of objective…
The authorisation holder takes part in the emergency care network provided for in articles R. 6123-26 to R. 6123-32, under the conditions set out in the network's constitutive agreement.
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…
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