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Showing 4031–4040 of 9594 articles for “Art. CAA Bordeaux 17-12-2021 n° 19BX03783”
In the event of non-renewal which is not at the practitioner's initiative, the decision is taken after a reasoned opinion from the chairman of the establishment's medical committee and the head of the…
A contractual practitioner who wishes to extend his working life must submit a request to this effect to the director of the establishment in which he wishes to work, at least six months before the da…
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…
A request for authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dos…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within a maximum of one hundred and twenty days from the date…
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